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<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-939
Date of Submission: 2025-01-25
This report was submitted by a Patient from Walker-Palmer Medical Center concerning patient ANON-PX-2455. The subject is a 31-year-old other with a significant medical history including seasonal allergies, migraines, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 472mg, initiated on 2024-12-06 for Neuropathic pain and discontinued on 2025-01-07.
On approximately 2024-12-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Somnolence. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Nice tree build seat. Citizen husband bed source here maybe. View walk sport.</data>
|
report_id: ADR-2025-939
report_date: '2025-01-25'
patient_details:
patient_id: ANON-PX-2455
gender: Other
relevant_history:
- seasonal allergies
- migraines
- anxiety
age_at_reaction: 31
suspected_drugs:
- drug_name: Gabapentin
dosage: 472mg
route_of_administration: Oral
start_date: '2024-12-06'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-07'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-12-10'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-12-10'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Walker-Palmer Medical Center
reporter_type: Patient
notes: Nice tree build seat. Citizen husband bed source here maybe. View walk sport.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-906
Date of Submission: 2024-10-08
This report was submitted by a Other Healthcare Professional from Kelly, Zamora and Thornton Medical Center concerning patient ANON-PX-2563. The subject is a 65-year-old female with a significant medical history including migraines, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 168mg, initiated on 2024-09-27 for Thromboembolism prevention with the course ongoing.
On approximately 2024-10-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Somnolence, Stevens-Johnson syndrome, Maculopapular Rash, Diarrhea. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed huge and advised perhaps. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed tonight and advised I. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Our who ask success term.</data>
|
report_id: ADR-2024-906
report_date: '2024-10-08'
patient_details:
patient_id: ANON-PX-2563
gender: Female
relevant_history:
- migraines
- anxiety
age_at_reaction: 65
suspected_drugs:
- drug_name: Warfarin
dosage: 168mg
route_of_administration: Topical
start_date: '2024-09-27'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-10-06'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-10-06'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed huge and advised perhaps.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-06'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed tonight and advised I.
- symptom_name: Maculopapular Rash
onset_date: '2024-10-06'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-10-06'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Kelly, Zamora and Thornton Medical Center
reporter_type: Other Healthcare Professional
notes: Our who ask success term.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-592
Date of Submission: 2025-02-26
This report was submitted by a Other Healthcare Professional from Johnson PLC Medical Center concerning patient ANON-PX-5076. The subject is a 33-year-old female with a significant medical history including hypertension, asthma, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Intravenous route at a dosage of 500mg, initiated on 2024-11-28 for Major depressive disorder with the course ongoing; Atorvastatin (Statin) administered via the Topical route at a dosage of 392mg, initiated on 2024-11-28 for Hypercholesterolemia with the course ongoing.
On approximately 2024-12-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Angioedema. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Shoulder consumer hand agreement that analysis poor skin. Argue world outside light nor court doctor. Level somebody house let foreign.</data>
|
report_id: ADR-2025-592
report_date: '2025-02-26'
patient_details:
patient_id: ANON-PX-5076
gender: Female
relevant_history:
- hypertension
- asthma
- coronary artery disease
age_at_reaction: 33
suspected_drugs:
- drug_name: Sertraline
dosage: 500mg
route_of_administration: Intravenous
start_date: '2024-11-28'
indication_for_use: Major depressive disorder
- drug_name: Atorvastatin
dosage: 392mg
route_of_administration: Topical
start_date: '2024-11-28'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-12-09'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-09'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-12-09'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 7
reporting_facility: Johnson PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Shoulder consumer hand agreement that analysis poor skin. Argue world outside
light nor court doctor. Level somebody house let foreign.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-471
Date of Submission: 2024-10-13
This report was submitted by a Other Healthcare Professional from Clark-Rose Medical Center concerning patient ANON-PX-2062. The subject is a 23-year-old other with a significant medical history including migraines, seasonal allergies, coronary artery disease, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin administered via the Oral route at a dosage of 373mg, initiated on 2024-07-29 for Thromboembolism prevention and discontinued on 2024-09-15.
On approximately 2024-08-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Hepatotoxicity, Dizziness. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed off and advised best. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed foreign and advised onto. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed case and advised dark. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-471
report_date: '2024-10-13'
patient_details:
patient_id: ANON-PX-2062
gender: Other
relevant_history:
- migraines
- seasonal allergies
- coronary artery disease
- type 2 diabetes
age_at_reaction: 23
suspected_drugs:
- drug_name: Warfarin
dosage: 373mg
route_of_administration: Oral
start_date: '2024-07-29'
indication_for_use: Thromboembolism prevention
end_date: '2024-09-15'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-08-28'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed off and advised best.
- symptom_name: Headache
onset_date: '2024-08-28'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-08-28'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed foreign and advised onto.
- symptom_name: Dizziness
onset_date: '2024-08-28'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed case and advised dark.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Clark-Rose Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-673
Date of Submission: 2025-04-08
This report was submitted by a Pharmacist from Scott-Wagner Medical Center concerning patient ANON-PX-7276. The subject is a 78-year-old male with a significant medical history including coronary artery disease, chronic kidney disease, asthma, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 8mg, initiated on 2025-02-11 for Hypertension with the course ongoing.
On approximately 2025-04-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Vomiting, Stevens-Johnson syndrome. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed identify and advised car. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed car and advised help. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-673
report_date: '2025-04-08'
patient_details:
patient_id: ANON-PX-7276
gender: Male
relevant_history:
- coronary artery disease
- chronic kidney disease
- asthma
- type 2 diabetes
age_at_reaction: 78
suspected_drugs:
- drug_name: Lisinopril
dosage: 8mg
route_of_administration: Intramuscular
start_date: '2025-02-11'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-04-02'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed identify and advised car.
- symptom_name: Vomiting
onset_date: '2025-04-02'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-02'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed car and advised help.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 8
reporting_facility: Scott-Wagner Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-216
Date of Submission: 2024-12-05
This report was submitted by a Patient from Wright, Ortiz and Parker Medical Center concerning patient ANON-PX-3527. The subject is an adult female with a significant medical history including migraines, hypertension, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril administered via the Intramuscular route at a dosage of 181mg, initiated on 2024-09-06 for Hypertension with the course ongoing; Ibuprofen (NSAID) administered via the Oral route at a dosage of 463mg, initiated on 2024-09-06 for Pain and inflammation with the course ongoing.
On approximately 2024-10-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea, Vomiting, Hepatotoxicity, Angioedema. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed end and advised concern. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-216
report_date: '2024-12-05'
patient_details:
patient_id: ANON-PX-3527
gender: Female
relevant_history:
- migraines
- hypertension
- anxiety
suspected_drugs:
- drug_name: Lisinopril
dosage: 181mg
route_of_administration: Intramuscular
start_date: '2024-09-06'
indication_for_use: Hypertension
- drug_name: Ibuprofen
dosage: 463mg
route_of_administration: Oral
start_date: '2024-09-06'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-26'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-10-26'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-10-26'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed end and advised concern.
- symptom_name: Hepatotoxicity
onset_date: '2024-10-26'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-10-26'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Wright, Ortiz and Parker Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-167
Date of Submission: 2024-09-05
This report was submitted by a Other Healthcare Professional from Davis, Acosta and Jenkins Medical Center concerning patient ANON-PX-9235. The subject is an adult other with a significant medical history including coronary artery disease, anxiety, atrial fibrillation, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril administered via the Intramuscular route at a dosage of 116mg, initiated on 2024-06-19 for Hypertension and discontinued on 2024-08-31; Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 498mg, initiated on 2024-06-19 for Hypercholesterolemia and discontinued on 2024-08-31.
On approximately 2024-08-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Somnolence, Headache, Pruritus. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed small and advised leader. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed should and advised anyone. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: School increase my hope least ground. Take season article wish take around water.</data>
|
report_id: ADR-2024-167
report_date: '2024-09-05'
patient_details:
patient_id: ANON-PX-9235
gender: Other
relevant_history:
- coronary artery disease
- anxiety
- atrial fibrillation
- asthma
suspected_drugs:
- drug_name: Lisinopril
dosage: 116mg
route_of_administration: Intramuscular
start_date: '2024-06-19'
indication_for_use: Hypertension
end_date: '2024-08-31'
- drug_name: Atorvastatin
dosage: 498mg
route_of_administration: Subcutaneous
start_date: '2024-06-19'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-08-31'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-08-27'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed small and advised leader.
- symptom_name: Somnolence
onset_date: '2024-08-27'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed should and advised anyone.
- symptom_name: Headache
onset_date: '2024-08-27'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-08-27'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Davis, Acosta and Jenkins Medical Center
reporter_type: Other Healthcare Professional
notes: School increase my hope least ground. Take season article wish take around
water.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-434
Date of Submission: 2024-11-29
This report was submitted by a Physician from Meyer, Burnett and Preston Medical Center concerning patient ANON-PX-6340. The subject is a 31-year-old other with a significant medical history including atrial fibrillation, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 347mg, initiated on 2024-11-05 for Hypothyroidism and discontinued on 2024-11-22; Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 40mg, initiated on 2024-11-05 for Gastroesophageal reflux disease and discontinued on 2024-11-22.
On approximately 2024-11-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Maculopapular Rash, Headache. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed or and advised city. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed central and advised meeting. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: College agency scientist hit story hold than. Class training lawyer prevent coach commercial admit relationship.</data>
|
report_id: ADR-2024-434
report_date: '2024-11-29'
patient_details:
patient_id: ANON-PX-6340
gender: Other
relevant_history:
- atrial fibrillation
- seasonal allergies
age_at_reaction: 31
suspected_drugs:
- drug_name: Levothyroxine
dosage: 347mg
route_of_administration: Intramuscular
start_date: '2024-11-05'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-22'
- drug_name: Omeprazole
dosage: 40mg
route_of_administration: Intramuscular
start_date: '2024-11-05'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-11-22'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-11-17'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed or and advised city.
- symptom_name: Maculopapular Rash
onset_date: '2024-11-17'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Headache
onset_date: '2024-11-17'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed central and advised meeting.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Meyer, Burnett and Preston Medical Center
reporter_type: Physician
notes: College agency scientist hit story hold than. Class training lawyer prevent
coach commercial admit relationship.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-975
Date of Submission: 2025-03-23
This report was submitted by a Pharmacist from Cooke, Ramos and Roberson Medical Center concerning patient ANON-PX-6544. The subject is an adult female with a significant medical history including coronary artery disease, chronic kidney disease, asthma, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin administered via the Oral route at a dosage of 93mg, initiated on 2025-01-05 for Hypercholesterolemia and discontinued on 2025-03-10; Levothyroxine (Thyroid hormone) administered via the Intravenous route at a dosage of 92mg, initiated on 2025-01-05 for Hypothyroidism and discontinued on 2025-03-10.
On approximately 2025-02-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Anaphylaxis, Maculopapular Rash, Vomiting. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Attack certain style leader question program see. Style very Democrat left everybody create remember.</data>
|
report_id: ADR-2025-975
report_date: '2025-03-23'
patient_details:
patient_id: ANON-PX-6544
gender: Female
relevant_history:
- coronary artery disease
- chronic kidney disease
- asthma
- atrial fibrillation
suspected_drugs:
- drug_name: Atorvastatin
dosage: 93mg
route_of_administration: Oral
start_date: '2025-01-05'
indication_for_use: Hypercholesterolemia
end_date: '2025-03-10'
- drug_name: Levothyroxine
dosage: 92mg
route_of_administration: Intravenous
start_date: '2025-01-05'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-03-10'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-02-27'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-02-27'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-27'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Cooke, Ramos and Roberson Medical Center
reporter_type: Pharmacist
notes: Attack certain style leader question program see. Style very Democrat left
everybody create remember.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-837
Date of Submission: 2025-03-15
This report was submitted by a Patient from Gonzalez-Mckay Medical Center concerning patient ANON-PX-2719. The subject is a 49-year-old other with a significant medical history including hypertension, anxiety, osteoarthritis, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 407mg, initiated on 2025-02-11 for Type 2 diabetes and discontinued on 2025-03-04.
On approximately 2025-03-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed play and advised go. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Improve high study appear range inside least. Keep beat stand four significant everyone. Single talk prevent rise.</data>
|
report_id: ADR-2025-837
report_date: '2025-03-15'
patient_details:
patient_id: ANON-PX-2719
gender: Other
relevant_history:
- hypertension
- anxiety
- osteoarthritis
- atrial fibrillation
age_at_reaction: 49
suspected_drugs:
- drug_name: Metformin
dosage: 407mg
route_of_administration: Subcutaneous
start_date: '2025-02-11'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-03-04'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-04'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed play and advised go.
- symptom_name: Somnolence
onset_date: '2025-03-04'
severity: Mild
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Gonzalez-Mckay Medical Center
reporter_type: Patient
notes: Improve high study appear range inside least. Keep beat stand four significant
everyone. Single talk prevent rise.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-918
Date of Submission: 2024-10-22
This report was submitted by a Patient from Martin-Navarro Medical Center concerning patient ANON-PX-5159. The subject is an adult female with a significant medical history including asthma, atrial fibrillation, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 147mg, initiated on 2024-08-10 for Major depressive disorder and discontinued on 2024-10-20; Metformin (Biguanide) administered via the Oral route at a dosage of 462mg, initiated on 2024-08-10 for Type 2 diabetes and discontinued on 2024-10-20.
On approximately 2024-10-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Diarrhea, Hepatotoxicity, Vomiting. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed somebody and advised real. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed place and advised author. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed prove and advised site. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-918
report_date: '2024-10-22'
patient_details:
patient_id: ANON-PX-5159
gender: Female
relevant_history:
- asthma
- atrial fibrillation
- coronary artery disease
suspected_drugs:
- drug_name: Sertraline
dosage: 147mg
route_of_administration: Subcutaneous
start_date: '2024-08-10'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-10-20'
- drug_name: Metformin
dosage: 462mg
route_of_administration: Oral
start_date: '2024-08-10'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-10-20'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-10-13'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed somebody and advised real.
- symptom_name: Diarrhea
onset_date: '2024-10-13'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed place and advised author.
- symptom_name: Hepatotoxicity
onset_date: '2024-10-13'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed prove and advised site.
- symptom_name: Vomiting
onset_date: '2024-10-13'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Martin-Navarro Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-294
Date of Submission: 2025-03-05
This report was submitted by a Patient from Bennett-Cohen Medical Center concerning patient ANON-PX-5790. The subject is a 73-year-old other with a significant medical history including type 2 diabetes, asthma, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intravenous route at a dosage of 431mg, initiated on 2024-12-15 for Gastroesophageal reflux disease and discontinued on 2025-03-03.
On approximately 2025-02-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Dizziness, Headache, Vomiting, Diarrhea. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed per and advised cell. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed long and advised when. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-294
report_date: '2025-03-05'
patient_details:
patient_id: ANON-PX-5790
gender: Other
relevant_history:
- type 2 diabetes
- asthma
- atrial fibrillation
age_at_reaction: 73
suspected_drugs:
- drug_name: Omeprazole
dosage: 431mg
route_of_administration: Intravenous
start_date: '2024-12-15'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-03-03'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-02-15'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-02-15'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed per and advised cell.
- symptom_name: Headache
onset_date: '2025-02-15'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-15'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-15'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed long and advised when.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Bennett-Cohen Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-267
Date of Submission: 2024-11-28
This report was submitted by a Pharmacist from Strickland, Richards and Kelly Medical Center concerning patient ANON-PX-5049. The subject is a 64-year-old female with a significant medical history including migraines, anxiety, seasonal allergies, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 9mg, initiated on 2024-11-17 for Bacterial infection and discontinued on 2024-11-26; Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 232mg, initiated on 2024-11-17 for Hypertension and discontinued on 2024-11-26.
On approximately 2024-11-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Headache, Maculopapular Rash. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed player and advised traditional. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed eight and advised score. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: That film growth million sister. Short mention something. Rest education somebody cell majority law situation doctor. Finally reveal news seven so.</data>
|
report_id: ADR-2024-267
report_date: '2024-11-28'
patient_details:
patient_id: ANON-PX-5049
gender: Female
relevant_history:
- migraines
- anxiety
- seasonal allergies
- hypertension
age_at_reaction: 64
suspected_drugs:
- drug_name: Amoxicillin
dosage: 9mg
route_of_administration: Subcutaneous
start_date: '2024-11-17'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-11-26'
- drug_name: Lisinopril
dosage: 232mg
route_of_administration: Topical
start_date: '2024-11-17'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-11-26'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-11-21'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-11-21'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed player and advised traditional.
- symptom_name: Headache
onset_date: '2024-11-21'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-21'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed eight and advised score.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Strickland, Richards and Kelly Medical Center
reporter_type: Pharmacist
notes: That film growth million sister. Short mention something. Rest education somebody
cell majority law situation doctor. Finally reveal news seven so.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-674
Date of Submission: 2025-05-07
This report was submitted by a Nurse from Rivera, West and Williams Medical Center concerning patient ANON-PX-7213. The subject is an adult female with a significant medical history including seasonal allergies, anxiety, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 54mg, initiated on 2025-03-16 for Gastroesophageal reflux disease and discontinued on 2025-05-04.
On approximately 2025-04-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Diarrhea. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed action and advised after. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Finally take this add instead scene range. Each fast nature activity. Consider third despite audience house edge bill.</data>
|
report_id: ADR-2025-674
report_date: '2025-05-07'
patient_details:
patient_id: ANON-PX-7213
gender: Female
relevant_history:
- seasonal allergies
- anxiety
- osteoarthritis
suspected_drugs:
- drug_name: Omeprazole
dosage: 54mg
route_of_administration: Topical
start_date: '2025-03-16'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-05-04'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-04-06'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed action and advised after.
- symptom_name: Diarrhea
onset_date: '2025-04-06'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Rivera, West and Williams Medical Center
reporter_type: Nurse
notes: Finally take this add instead scene range. Each fast nature activity. Consider
third despite audience house edge bill.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-376
Date of Submission: 2025-01-10
This report was submitted by a Physician from Davis-Tate Medical Center concerning patient ANON-PX-5173. The subject is a 32-year-old male with a significant medical history including type 2 diabetes, asthma, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 442mg, initiated on 2024-12-08 for Neuropathic pain and discontinued on 2025-01-07.
On approximately 2024-12-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache, Vomiting, Diarrhea. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Go family leader final. Charge enjoy every teach well news region. Low toward throughout actually. Government reason chair rate lay size.</data>
|
report_id: ADR-2025-376
report_date: '2025-01-10'
patient_details:
patient_id: ANON-PX-5173
gender: Male
relevant_history:
- type 2 diabetes
- asthma
- migraines
age_at_reaction: 32
suspected_drugs:
- drug_name: Gabapentin
dosage: 442mg
route_of_administration: Oral
start_date: '2024-12-08'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-07'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-12-16'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2024-12-16'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-12-16'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-12-16'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Davis-Tate Medical Center
reporter_type: Physician
notes: Go family leader final. Charge enjoy every teach well news region. Low toward
throughout actually. Government reason chair rate lay size.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-424
Date of Submission: 2024-09-23
This report was submitted by a Other Healthcare Professional from Golden, Soto and Hernandez Medical Center concerning patient ANON-PX-6069. The subject is an adult female with a significant medical history including type 2 diabetes, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Intravenous route at a dosage of 91mg, initiated on 2024-07-01 for Major depressive disorder and discontinued on 2024-09-16.
On approximately 2024-07-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Diarrhea, Anaphylaxis, Stevens-Johnson syndrome. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed citizen and advised probably. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-424
report_date: '2024-09-23'
patient_details:
patient_id: ANON-PX-6069
gender: Female
relevant_history:
- type 2 diabetes
- anxiety
suspected_drugs:
- drug_name: Sertraline
dosage: 91mg
route_of_administration: Intravenous
start_date: '2024-07-01'
indication_for_use: Major depressive disorder
end_date: '2024-09-16'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-07-24'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-07-24'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-07-24'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-07-24'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed citizen and advised probably.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Golden, Soto and Hernandez Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-460
Date of Submission: 2024-11-15
This report was submitted by a Nurse from Mccann and Sons Medical Center concerning patient ANON-PX-1444. The subject is a 89-year-old male with a significant medical history including coronary artery disease, atrial fibrillation, migraines, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 484mg, initiated on 2024-09-27 for Major depressive disorder and discontinued on 2024-10-28; Metformin administered via the Intravenous route at a dosage of 387mg, initiated on 2024-09-27 for Type 2 diabetes and discontinued on 2024-10-28.
On approximately 2024-10-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Maculopapular Rash, Anaphylaxis, Nausea, Stevens-Johnson syndrome. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed reality and advised identify. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed single and advised skin. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-460
report_date: '2024-11-15'
patient_details:
patient_id: ANON-PX-1444
gender: Male
relevant_history:
- coronary artery disease
- atrial fibrillation
- migraines
- seasonal allergies
age_at_reaction: 89
suspected_drugs:
- drug_name: Sertraline
dosage: 484mg
route_of_administration: Subcutaneous
start_date: '2024-09-27'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-10-28'
- drug_name: Metformin
dosage: 387mg
route_of_administration: Intravenous
start_date: '2024-09-27'
indication_for_use: Type 2 diabetes
end_date: '2024-10-28'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-10-20'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed reality and advised identify.
- symptom_name: Maculopapular Rash
onset_date: '2024-10-20'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-10-20'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-10-20'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-20'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed single and advised skin.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 7
reporting_facility: Mccann and Sons Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-147
Date of Submission: 2025-08-08
This report was submitted by a Pharmacist from Sanders, Wilkins and Meyer Medical Center concerning patient ANON-PX-5303. The subject is an adult female with a significant medical history including seasonal allergies, atrial fibrillation, type 2 diabetes, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 212mg, initiated on 2025-05-23 for Pain and inflammation and discontinued on 2025-08-03; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 314mg, initiated on 2025-05-23 for Hypothyroidism and discontinued on 2025-08-03.
On approximately 2025-07-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Dizziness, Pruritus, Somnolence. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Space positive office trouble mouth what administration day. Everybody trial see area Mrs just theory defense. Whether hard structure sell within.</data>
|
report_id: ADR-2025-147
report_date: '2025-08-08'
patient_details:
patient_id: ANON-PX-5303
gender: Female
relevant_history:
- seasonal allergies
- atrial fibrillation
- type 2 diabetes
- anxiety
suspected_drugs:
- drug_name: Ibuprofen
dosage: 212mg
route_of_administration: Subcutaneous
start_date: '2025-05-23'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-08-03'
- drug_name: Levothyroxine
dosage: 314mg
route_of_administration: Intramuscular
start_date: '2025-05-23'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-08-03'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-07-25'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-25'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-07-25'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-07-25'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-07-25'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Sanders, Wilkins and Meyer Medical Center
reporter_type: Pharmacist
notes: Space positive office trouble mouth what administration day. Everybody trial
see area Mrs just theory defense. Whether hard structure sell within.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-882
Date of Submission: 2025-01-20
This report was submitted by a Physician from Patel, Garner and Arnold Medical Center concerning patient ANON-PX-2702. The subject is a 36-year-old other with a significant medical history including chronic kidney disease, seasonal allergies, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 223mg, initiated on 2024-12-21 for Pain and inflammation and discontinued on 2025-01-09.
On approximately 2024-12-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Keep whatever story professor strategy sort. Still go common off house form.</data>
|
report_id: ADR-2025-882
report_date: '2025-01-20'
patient_details:
patient_id: ANON-PX-2702
gender: Other
relevant_history:
- chronic kidney disease
- seasonal allergies
- type 2 diabetes
age_at_reaction: 36
suspected_drugs:
- drug_name: Ibuprofen
dosage: 223mg
route_of_administration: Subcutaneous
start_date: '2024-12-21'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-01-09'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-27'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-12-27'
severity: Moderate
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Patel, Garner and Arnold Medical Center
reporter_type: Physician
notes: Keep whatever story professor strategy sort. Still go common off house form.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-493
Date of Submission: 2025-01-26
This report was submitted by a Other Healthcare Professional from Ross, Spencer and Ramirez Medical Center concerning patient ANON-PX-2218. The subject is an adult female with a significant medical history including osteoarthritis, atrial fibrillation, coronary artery disease, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 448mg, initiated on 2025-01-06 for Gastroesophageal reflux disease with the course ongoing; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 96mg, initiated on 2025-01-06 for Hypertension with the course ongoing.
On approximately 2025-01-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed course and advised as. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Hospital rather four yard father sort.</data>
|
report_id: ADR-2025-493
report_date: '2025-01-26'
patient_details:
patient_id: ANON-PX-2218
gender: Female
relevant_history:
- osteoarthritis
- atrial fibrillation
- coronary artery disease
- asthma
suspected_drugs:
- drug_name: Omeprazole
dosage: 448mg
route_of_administration: Intravenous
start_date: '2025-01-06'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Lisinopril
dosage: 96mg
route_of_administration: Intravenous
start_date: '2025-01-06'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-01-14'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-01-14'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed course and advised as.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Ross, Spencer and Ramirez Medical Center
reporter_type: Other Healthcare Professional
notes: Hospital rather four yard father sort.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-653
Date of Submission: 2025-04-01
This report was submitted by a Physician from Clark Ltd Medical Center concerning patient ANON-PX-8126. The subject is a 82-year-old female with a significant medical history including chronic kidney disease, asthma, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intravenous route at a dosage of 107mg, initiated on 2025-03-14 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-03-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Maculopapular Rash, Stevens-Johnson syndrome, Angioedema. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Herself coach huge research. Them kind investment ground.</data>
|
report_id: ADR-2025-653
report_date: '2025-04-01'
patient_details:
patient_id: ANON-PX-8126
gender: Female
relevant_history:
- chronic kidney disease
- asthma
- migraines
age_at_reaction: 82
suspected_drugs:
- drug_name: Omeprazole
dosage: 107mg
route_of_administration: Intravenous
start_date: '2025-03-14'
indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-03-28'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-03-28'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-28'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-03-28'
severity: Life-threatening
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Clark Ltd Medical Center
reporter_type: Physician
notes: Herself coach huge research. Them kind investment ground.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-132
Date of Submission: 2025-06-26
This report was submitted by a Physician from Fisher, Hardy and Shelton Medical Center concerning patient ANON-PX-6284. The subject is an adult other with a significant medical history including seasonal allergies, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 469mg, initiated on 2025-06-16 for Hypertension and discontinued on 2025-06-25; Levothyroxine (Thyroid hormone) administered via the Oral route at a dosage of 298mg, initiated on 2025-06-16 for Hypothyroidism and discontinued on 2025-06-25.
On approximately 2025-06-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea, Diarrhea. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed impact and advised but. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Democrat society candidate difficult quality. Someone event since peace may agree.</data>
|
report_id: ADR-2025-132
report_date: '2025-06-26'
patient_details:
patient_id: ANON-PX-6284
gender: Other
relevant_history:
- seasonal allergies
- coronary artery disease
suspected_drugs:
- drug_name: Lisinopril
dosage: 469mg
route_of_administration: Subcutaneous
start_date: '2025-06-16'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-06-25'
- drug_name: Levothyroxine
dosage: 298mg
route_of_administration: Oral
start_date: '2025-06-16'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-06-25'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-06-23'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed impact and advised but.
- symptom_name: Nausea
onset_date: '2025-06-23'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-06-23'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 7
reporting_facility: Fisher, Hardy and Shelton Medical Center
reporter_type: Physician
notes: Democrat society candidate difficult quality. Someone event since peace may
agree.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-600
Date of Submission: 2024-09-21
This report was submitted by a Nurse from Vance-Williams Medical Center concerning patient ANON-PX-5533. The subject is an adult male with a significant medical history including seasonal allergies, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Topical route at a dosage of 48mg, initiated on 2024-07-08 for Hypercholesterolemia and discontinued on 2024-09-05.
On approximately 2024-08-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Maculopapular Rash, Somnolence, Headache. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed a and advised dog. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed within and advised present. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Stand though answer beautiful sign wear behind. Together office though small. Heart dinner wrong government race gun.</data>
|
report_id: ADR-2024-600
report_date: '2024-09-21'
patient_details:
patient_id: ANON-PX-5533
gender: Male
relevant_history:
- seasonal allergies
- coronary artery disease
suspected_drugs:
- drug_name: Atorvastatin
dosage: 48mg
route_of_administration: Topical
start_date: '2024-07-08'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-09-05'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-08-18'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2024-08-18'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-08-18'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed a and advised dog.
- symptom_name: Headache
onset_date: '2024-08-18'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed within and advised present.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Vance-Williams Medical Center
reporter_type: Nurse
notes: Stand though answer beautiful sign wear behind. Together office though small.
Heart dinner wrong government race gun.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-680
Date of Submission: 2025-01-09
This report was submitted by a Other Healthcare Professional from Moore, Kim and Harmon Medical Center concerning patient ANON-PX-3358. The subject is a 85-year-old other with a significant medical history including hypertension, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Topical route at a dosage of 307mg, initiated on 2024-12-10 for Major depressive disorder and discontinued on 2025-01-05.
On approximately 2024-12-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Dizziness. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed none and advised PM. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Military star western after. Soon enter effort life color door suggest. Present read whole card military. Resource however skill.</data>
|
report_id: ADR-2025-680
report_date: '2025-01-09'
patient_details:
patient_id: ANON-PX-3358
gender: Other
relevant_history:
- hypertension
- migraines
age_at_reaction: 85
suspected_drugs:
- drug_name: Sertraline
dosage: 307mg
route_of_administration: Topical
start_date: '2024-12-10'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-01-05'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-12-20'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed none and advised PM.
- symptom_name: Dizziness
onset_date: '2024-12-20'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Moore, Kim and Harmon Medical Center
reporter_type: Other Healthcare Professional
notes: Military star western after. Soon enter effort life color door suggest. Present
read whole card military. Resource however skill.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-669
Date of Submission: 2024-09-08
This report was submitted by a Nurse from Thomas, Campbell and Williams Medical Center concerning patient ANON-PX-1274. The subject is a 35-year-old female with a significant medical history including chronic kidney disease, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Intramuscular route at a dosage of 30mg, initiated on 2024-07-07 for Major depressive disorder with the course ongoing.
On approximately 2024-08-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Maculopapular Rash, Diarrhea, Angioedema. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed yet and advised resource. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed less and advised could. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Give Mr five listen. Although here paper even.</data>
|
report_id: ADR-2024-669
report_date: '2024-09-08'
patient_details:
patient_id: ANON-PX-1274
gender: Female
relevant_history:
- chronic kidney disease
- atrial fibrillation
age_at_reaction: 35
suspected_drugs:
- drug_name: Sertraline
dosage: 30mg
route_of_administration: Intramuscular
start_date: '2024-07-07'
indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-08-13'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed yet and advised resource.
- symptom_name: Vomiting
onset_date: '2024-08-13'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-13'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-08-13'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed less and advised could.
- symptom_name: Angioedema
onset_date: '2024-08-13'
severity: Severe
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Thomas, Campbell and Williams Medical Center
reporter_type: Nurse
notes: Give Mr five listen. Although here paper even.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-407
Date of Submission: 2024-12-05
This report was submitted by a Pharmacist from Vasquez and Sons Medical Center concerning patient ANON-PX-8833. The subject is an adult other with a significant medical history including coronary artery disease, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intravenous route at a dosage of 441mg, initiated on 2024-10-20 for Gastroesophageal reflux disease and discontinued on 2024-11-29.
On approximately 2024-11-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache, Stevens-Johnson syndrome. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed heavy and advised box. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed weight and advised after. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Exactly serve space upon center machine. Network citizen pretty discuss how across ready picture. Play near why consider common natural staff.</data>
|
report_id: ADR-2024-407
report_date: '2024-12-05'
patient_details:
patient_id: ANON-PX-8833
gender: Other
relevant_history:
- coronary artery disease
- migraines
suspected_drugs:
- drug_name: Omeprazole
dosage: 441mg
route_of_administration: Intravenous
start_date: '2024-10-20'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-11-29'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-11-16'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed heavy and advised box.
- symptom_name: Headache
onset_date: '2024-11-16'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-16'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed weight and advised after.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Vasquez and Sons Medical Center
reporter_type: Pharmacist
notes: Exactly serve space upon center machine. Network citizen pretty discuss how
across ready picture. Play near why consider common natural staff.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-547
Date of Submission: 2024-08-28
This report was submitted by a Pharmacist from Hill-English Medical Center concerning patient ANON-PX-8200. The subject is a 43-year-old male with a significant medical history including asthma, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 187mg, initiated on 2024-07-30 for Gastroesophageal reflux disease with the course ongoing; Metformin (Biguanide) administered via the Oral route at a dosage of 39mg, initiated on 2024-07-30 for Type 2 diabetes with the course ongoing.
On approximately 2024-08-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache, Stevens-Johnson syndrome, Dizziness, Somnolence. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed likely and advised culture. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Address owner main less. Collection she the protect. Maybe know behavior pass. Option ready democratic strong senior process.</data>
|
report_id: ADR-2024-547
report_date: '2024-08-28'
patient_details:
patient_id: ANON-PX-8200
gender: Male
relevant_history:
- asthma
- atrial fibrillation
age_at_reaction: 43
suspected_drugs:
- drug_name: Omeprazole
dosage: 187mg
route_of_administration: Intramuscular
start_date: '2024-07-30'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Metformin
dosage: 39mg
route_of_administration: Oral
start_date: '2024-07-30'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-08-17'
severity: Life-threatening
outcome: Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2024-08-17'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-17'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-08-17'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed likely and advised culture.
- symptom_name: Somnolence
onset_date: '2024-08-17'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Hill-English Medical Center
reporter_type: Pharmacist
notes: Address owner main less. Collection she the protect. Maybe know behavior pass.
Option ready democratic strong senior process.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-262
Date of Submission: 2025-02-09
This report was submitted by a Patient from Johnson-Vazquez Medical Center concerning patient ANON-PX-3091. The subject is a 58-year-old other with a significant medical history including anxiety, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Intravenous route at a dosage of 38mg, initiated on 2025-01-19 for Hypercholesterolemia with the course ongoing.
On approximately 2025-01-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Headache. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Talk level husband trial. Choose student traditional call million. Major series long reflect.</data>
|
report_id: ADR-2025-262
report_date: '2025-02-09'
patient_details:
patient_id: ANON-PX-3091
gender: Other
relevant_history:
- anxiety
- migraines
age_at_reaction: 58
suspected_drugs:
- drug_name: Atorvastatin
dosage: 38mg
route_of_administration: Intravenous
start_date: '2025-01-19'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-01-31'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2025-01-31'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Johnson-Vazquez Medical Center
reporter_type: Patient
notes: Talk level husband trial. Choose student traditional call million. Major series
long reflect.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-885
Date of Submission: 2025-07-14
This report was submitted by a Patient from Brown-Grant Medical Center concerning patient ANON-PX-2170. The subject is a 78-year-old male with a significant medical history including chronic kidney disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin administered via the Oral route at a dosage of 74mg, initiated on 2025-06-12 for Bacterial infection and discontinued on 2025-06-26.
On approximately 2025-06-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Dizziness. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed loss and advised step. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Structure represent room produce phone. Movie then figure pick guy she. Billion arrive teacher center sign step citizen.</data>
|
report_id: ADR-2025-885
report_date: '2025-07-14'
patient_details:
patient_id: ANON-PX-2170
gender: Male
relevant_history:
- chronic kidney disease
- anxiety
age_at_reaction: 78
suspected_drugs:
- drug_name: Amoxicillin
dosage: 74mg
route_of_administration: Oral
start_date: '2025-06-12'
indication_for_use: Bacterial infection
end_date: '2025-06-26'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-06-16'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed loss and advised step.
- symptom_name: Dizziness
onset_date: '2025-06-16'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Brown-Grant Medical Center
reporter_type: Patient
notes: Structure represent room produce phone. Movie then figure pick guy she. Billion
arrive teacher center sign step citizen.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-332
Date of Submission: 2025-06-12
This report was submitted by a Pharmacist from Jones-Summers Medical Center concerning patient ANON-PX-8381. The subject is a 65-year-old other with a significant medical history including coronary artery disease, atrial fibrillation, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intramuscular route at a dosage of 489mg, initiated on 2025-05-14 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-05-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Dizziness, Maculopapular Rash, Hepatotoxicity. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed federal and advised speech. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Door peace local approach space know. Fast glass within democratic describe exactly. Fire what need great.</data>
|
report_id: ADR-2025-332
report_date: '2025-06-12'
patient_details:
patient_id: ANON-PX-8381
gender: Other
relevant_history:
- coronary artery disease
- atrial fibrillation
- osteoarthritis
age_at_reaction: 65
suspected_drugs:
- drug_name: Omeprazole
dosage: 489mg
route_of_administration: Intramuscular
start_date: '2025-05-14'
indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-05-24'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-05-24'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed federal and advised speech.
- symptom_name: Dizziness
onset_date: '2025-05-24'
severity: Mild
outcome: Recovered
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-05-24'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-05-24'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Jones-Summers Medical Center
reporter_type: Pharmacist
notes: Door peace local approach space know. Fast glass within democratic describe
exactly. Fire what need great.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-654
Date of Submission: 2024-09-05
This report was submitted by a Nurse from Le and Sons Medical Center concerning patient ANON-PX-2453. The subject is a 69-year-old other with a significant medical history including hypertension, type 2 diabetes, anxiety, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 151mg, initiated on 2024-06-09 for Neuropathic pain and discontinued on 2024-08-12.
On approximately 2024-07-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Stevens-Johnson syndrome, Headache, Hepatotoxicity. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed sing and advised boy. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed box and advised inside. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed bar and advised again. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Public manage prevent important claim. Dream people road Mr machine PM continue. Available too start worry.</data>
|
report_id: ADR-2024-654
report_date: '2024-09-05'
patient_details:
patient_id: ANON-PX-2453
gender: Other
relevant_history:
- hypertension
- type 2 diabetes
- anxiety
- migraines
age_at_reaction: 69
suspected_drugs:
- drug_name: Gabapentin
dosage: 151mg
route_of_administration: Topical
start_date: '2024-06-09'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-08-12'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-07-11'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Nausea
onset_date: '2024-07-11'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-07-11'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed sing and advised boy.
- symptom_name: Headache
onset_date: '2024-07-11'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed box and advised inside.
- symptom_name: Hepatotoxicity
onset_date: '2024-07-11'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed bar and advised again.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Le and Sons Medical Center
reporter_type: Nurse
notes: Public manage prevent important claim. Dream people road Mr machine PM continue.
Available too start worry.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-503
Date of Submission: 2025-03-25
This report was submitted by a Patient from Harris, Alvarado and Parsons Medical Center concerning patient ANON-PX-9869. The subject is a 38-year-old female with a significant medical history including coronary artery disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intravenous route at a dosage of 377mg, initiated on 2025-01-14 for Gastroesophageal reflux disease and discontinued on 2025-03-12; Sertraline (SSRI) administered via the Intravenous route at a dosage of 234mg, initiated on 2025-01-14 for Major depressive disorder and discontinued on 2025-03-12.
On approximately 2025-03-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Many and including project trial. Nearly arm member student every social. Assume back significant book visit if if already.</data>
|
report_id: ADR-2025-503
report_date: '2025-03-25'
patient_details:
patient_id: ANON-PX-9869
gender: Female
relevant_history:
- coronary artery disease
- seasonal allergies
age_at_reaction: 38
suspected_drugs:
- drug_name: Omeprazole
dosage: 377mg
route_of_administration: Intravenous
start_date: '2025-01-14'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-03-12'
- drug_name: Sertraline
dosage: 234mg
route_of_administration: Intravenous
start_date: '2025-01-14'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-03-12'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-03-05'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2025-03-05'
severity: Mild
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Harris, Alvarado and Parsons Medical Center
reporter_type: Patient
notes: Many and including project trial. Nearly arm member student every social. Assume
back significant book visit if if already.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-739
Date of Submission: 2024-08-28
This report was submitted by a Pharmacist from Brandt PLC Medical Center concerning patient ANON-PX-1649. The subject is a 84-year-old male with a significant medical history including asthma, migraines, chronic kidney disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intravenous route at a dosage of 332mg, initiated on 2024-06-19 for Type 2 diabetes and discontinued on 2024-08-18; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 359mg, initiated on 2024-06-19 for Bacterial infection and discontinued on 2024-08-18.
On approximately 2024-07-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Anaphylaxis, Maculopapular Rash. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-739
report_date: '2024-08-28'
patient_details:
patient_id: ANON-PX-1649
gender: Male
relevant_history:
- asthma
- migraines
- chronic kidney disease
- anxiety
age_at_reaction: 84
suspected_drugs:
- drug_name: Metformin
dosage: 332mg
route_of_administration: Intravenous
start_date: '2024-06-19'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-08-18'
- drug_name: Amoxicillin
dosage: 359mg
route_of_administration: Subcutaneous
start_date: '2024-06-19'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-08-18'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-07-29'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-07-29'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-07-29'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 10
reporting_facility: Brandt PLC Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-230
Date of Submission: 2024-10-12
This report was submitted by a Other Healthcare Professional from Hampton Inc Medical Center concerning patient ANON-PX-2219. The subject is a 77-year-old other with a significant medical history including anxiety, chronic kidney disease, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin administered via the Subcutaneous route at a dosage of 434mg, initiated on 2024-07-14 for Type 2 diabetes with the course ongoing.
On approximately 2024-07-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Nausea, Angioedema, Somnolence, Dizziness. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed knowledge and advised anything. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed country and advised too. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Travel ago team agent pressure beyond.</data>
|
report_id: ADR-2024-230
report_date: '2024-10-12'
patient_details:
patient_id: ANON-PX-2219
gender: Other
relevant_history:
- anxiety
- chronic kidney disease
- asthma
age_at_reaction: 77
suspected_drugs:
- drug_name: Metformin
dosage: 434mg
route_of_administration: Subcutaneous
start_date: '2024-07-14'
indication_for_use: Type 2 diabetes
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-07-21'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed knowledge and advised anything.
- symptom_name: Nausea
onset_date: '2024-07-21'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-07-21'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-07-21'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-07-21'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed country and advised too.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Hampton Inc Medical Center
reporter_type: Other Healthcare Professional
notes: Travel ago team agent pressure beyond.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-477
Date of Submission: 2025-05-02
This report was submitted by a Other Healthcare Professional from Jensen Inc Medical Center concerning patient ANON-PX-7599. The subject is a 39-year-old female with a significant medical history including migraines, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin administered via the Subcutaneous route at a dosage of 261mg, initiated on 2025-02-20 for Bacterial infection and discontinued on 2025-04-06; Atorvastatin administered via the Intramuscular route at a dosage of 462mg, initiated on 2025-02-20 for Hypercholesterolemia and discontinued on 2025-04-06.
On approximately 2025-03-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised throw. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-477
report_date: '2025-05-02'
patient_details:
patient_id: ANON-PX-7599
gender: Female
relevant_history:
- migraines
- anxiety
age_at_reaction: 39
suspected_drugs:
- drug_name: Amoxicillin
dosage: 261mg
route_of_administration: Subcutaneous
start_date: '2025-02-20'
indication_for_use: Bacterial infection
end_date: '2025-04-06'
- drug_name: Atorvastatin
dosage: 462mg
route_of_administration: Intramuscular
start_date: '2025-02-20'
indication_for_use: Hypercholesterolemia
end_date: '2025-04-06'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-03-05'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed modern and advised throw.
- symptom_name: Somnolence
onset_date: '2025-03-05'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 3
reporting_facility: Jensen Inc Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-416
Date of Submission: 2025-07-19
This report was submitted by a Pharmacist from Patel, Rose and Hall Medical Center concerning patient ANON-PX-4993. The subject is a 88-year-old male with a significant medical history including hypertension, atrial fibrillation, chronic kidney disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin administered via the Topical route at a dosage of 457mg, initiated on 2025-06-16 for Thromboembolism prevention with the course ongoing.
On approximately 2025-06-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Dizziness, Diarrhea, Hepatotoxicity, Stevens-Johnson syndrome. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed significant and advised set. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed where and advised concern. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed money and advised list. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Thing song big high. Resource democratic happy prove. Success matter draw might.</data>
|
report_id: ADR-2025-416
report_date: '2025-07-19'
patient_details:
patient_id: ANON-PX-4993
gender: Male
relevant_history:
- hypertension
- atrial fibrillation
- chronic kidney disease
- seasonal allergies
age_at_reaction: 88
suspected_drugs:
- drug_name: Warfarin
dosage: 457mg
route_of_administration: Topical
start_date: '2025-06-16'
indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-06-29'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-06-29'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed significant and advised set.
- symptom_name: Diarrhea
onset_date: '2025-06-29'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed where and advised concern.
- symptom_name: Hepatotoxicity
onset_date: '2025-06-29'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed money and advised list.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-29'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Patel, Rose and Hall Medical Center
reporter_type: Pharmacist
notes: Thing song big high. Resource democratic happy prove. Success matter draw might.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-396
Date of Submission: 2025-04-05
This report was submitted by a Pharmacist from Wilson, Jones and Schaefer Medical Center concerning patient ANON-PX-2020. The subject is a 28-year-old other with a significant medical history including chronic kidney disease, atrial fibrillation, osteoarthritis, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 311mg, initiated on 2025-02-22 for Hypothyroidism and discontinued on 2025-03-31; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 423mg, initiated on 2025-02-22 for Pain and inflammation and discontinued on 2025-03-31.
On approximately 2025-03-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Hepatotoxicity, Maculopapular Rash, Diarrhea, Anaphylaxis. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Affect remember ago question hair plan. Ever kitchen cut local determine fund.</data>
|
report_id: ADR-2025-396
report_date: '2025-04-05'
patient_details:
patient_id: ANON-PX-2020
gender: Other
relevant_history:
- chronic kidney disease
- atrial fibrillation
- osteoarthritis
- hypertension
age_at_reaction: 28
suspected_drugs:
- drug_name: Levothyroxine
dosage: 311mg
route_of_administration: Subcutaneous
start_date: '2025-02-22'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-03-31'
- drug_name: Ibuprofen
dosage: 423mg
route_of_administration: Intramuscular
start_date: '2025-02-22'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-03-31'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-03-12'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-03-12'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-03-12'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-03-12'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-03-12'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 4
reporting_facility: Wilson, Jones and Schaefer Medical Center
reporter_type: Pharmacist
notes: Affect remember ago question hair plan. Ever kitchen cut local determine fund.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-949
Date of Submission: 2025-01-15
This report was submitted by a Nurse from Grimes-Simpson Medical Center concerning patient ANON-PX-4802. The subject is an adult male with a significant medical history including migraines, osteoarthritis, type 2 diabetes, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin administered via the Subcutaneous route at a dosage of 81mg, initiated on 2024-10-25 for Thromboembolism prevention and discontinued on 2025-01-05; Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 491mg, initiated on 2024-10-25 for Neuropathic pain and discontinued on 2025-01-05.
On approximately 2024-11-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Diarrhea, Nausea. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-949
report_date: '2025-01-15'
patient_details:
patient_id: ANON-PX-4802
gender: Male
relevant_history:
- migraines
- osteoarthritis
- type 2 diabetes
- anxiety
suspected_drugs:
- drug_name: Warfarin
dosage: 81mg
route_of_administration: Subcutaneous
start_date: '2024-10-25'
indication_for_use: Thromboembolism prevention
end_date: '2025-01-05'
- drug_name: Gabapentin
dosage: 491mg
route_of_administration: Topical
start_date: '2024-10-25'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-05'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-11-09'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-11-09'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-09'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-11-09'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Grimes-Simpson Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-936
Date of Submission: 2024-10-31
This report was submitted by a Pharmacist from Day-Hill Medical Center concerning patient ANON-PX-3967. The subject is an adult other with a significant medical history including hypertension, osteoarthritis, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine administered via the Intramuscular route at a dosage of 246mg, initiated on 2024-08-26 for Hypothyroidism with the course ongoing.
On approximately 2024-10-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Dizziness, Stevens-Johnson syndrome. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed store and advised work. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed star and advised arrive. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed go and advised seem. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed traditional and advised sister. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Star through tend. Prevent suffer character color parent. More chair join material fine mind purpose.</data>
|
report_id: ADR-2024-936
report_date: '2024-10-31'
patient_details:
patient_id: ANON-PX-3967
gender: Other
relevant_history:
- hypertension
- osteoarthritis
- atrial fibrillation
suspected_drugs:
- drug_name: Levothyroxine
dosage: 246mg
route_of_administration: Intramuscular
start_date: '2024-08-26'
indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-10-24'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed store and advised work.
- symptom_name: Anaphylaxis
onset_date: '2024-10-24'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed star and advised arrive.
- symptom_name: Dizziness
onset_date: '2024-10-24'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed go and advised seem.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-24'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed traditional and advised sister.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Day-Hill Medical Center
reporter_type: Pharmacist
notes: Star through tend. Prevent suffer character color parent. More chair join material
fine mind purpose.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-390
Date of Submission: 2025-08-01
This report was submitted by a Pharmacist from Holmes, Rodriguez and Doyle Medical Center concerning patient ANON-PX-8248. The subject is a 35-year-old male with a significant medical history including hypertension, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine administered via the Topical route at a dosage of 411mg, initiated on 2025-07-18 for Hypothyroidism with the course ongoing.
On approximately 2025-07-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Nausea, Pruritus, Dizziness. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed west and advised road. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed response and advised behavior. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-390
report_date: '2025-08-01'
patient_details:
patient_id: ANON-PX-8248
gender: Male
relevant_history:
- hypertension
- seasonal allergies
age_at_reaction: 35
suspected_drugs:
- drug_name: Levothyroxine
dosage: 411mg
route_of_administration: Topical
start_date: '2025-07-18'
indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-07-23'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-07-23'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed west and advised road.
- symptom_name: Nausea
onset_date: '2025-07-23'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-07-23'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-07-23'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed response and advised behavior.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Holmes, Rodriguez and Doyle Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-203
Date of Submission: 2024-08-16
This report was submitted by a Other Healthcare Professional from Ortiz, Price and Reyes Medical Center concerning patient ANON-PX-1486. The subject is an adult other with a significant medical history including hypertension, chronic kidney disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril administered via the Oral route at a dosage of 146mg, initiated on 2024-06-29 for Hypertension with the course ongoing; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 334mg, initiated on 2024-06-29 for Pain and inflammation with the course ongoing.
On approximately 2024-06-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Headache, Anaphylaxis, Somnolence, Stevens-Johnson syndrome. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed price and advised compare. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-203
report_date: '2024-08-16'
patient_details:
patient_id: ANON-PX-1486
gender: Other
relevant_history:
- hypertension
- chronic kidney disease
- seasonal allergies
suspected_drugs:
- drug_name: Lisinopril
dosage: 146mg
route_of_administration: Oral
start_date: '2024-06-29'
indication_for_use: Hypertension
- drug_name: Ibuprofen
dosage: 334mg
route_of_administration: Intramuscular
start_date: '2024-06-29'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-06-30'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2024-06-30'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed price and advised compare.
- symptom_name: Anaphylaxis
onset_date: '2024-06-30'
severity: Mild
outcome: Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-06-30'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-06-30'
severity: Severe
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Ortiz, Price and Reyes Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-176
Date of Submission: 2025-02-02
This report was submitted by a Nurse from Kline Ltd Medical Center concerning patient ANON-PX-1639. The subject is a 72-year-old female with a significant medical history including seasonal allergies, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 318mg, initiated on 2024-11-16 for Bacterial infection and discontinued on 2024-12-21.
On approximately 2024-12-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Pruritus, Stevens-Johnson syndrome. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed hot and advised media. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Seek she parent. Set power do data too Mr.</data>
|
report_id: ADR-2025-176
report_date: '2025-02-02'
patient_details:
patient_id: ANON-PX-1639
gender: Female
relevant_history:
- seasonal allergies
- type 2 diabetes
age_at_reaction: 72
suspected_drugs:
- drug_name: Amoxicillin
dosage: 318mg
route_of_administration: Subcutaneous
start_date: '2024-11-16'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-12-21'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-12-02'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed hot and advised media.
- symptom_name: Pruritus
onset_date: '2024-12-02'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-02'
severity: Severe
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Kline Ltd Medical Center
reporter_type: Nurse
notes: Seek she parent. Set power do data too Mr.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-287
Date of Submission: 2024-10-23
This report was submitted by a Other Healthcare Professional from Randolph, Fitzgerald and Rios Medical Center concerning patient ANON-PX-3958. The subject is an adult female with a significant medical history including type 2 diabetes, asthma, atrial fibrillation, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin administered via the Subcutaneous route at a dosage of 101mg, initiated on 2024-10-05 for Hypercholesterolemia and discontinued on 2024-10-12; Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 478mg, initiated on 2024-10-05 for Pain and inflammation and discontinued on 2024-10-12.
On approximately 2024-10-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Pruritus, Diarrhea, Anaphylaxis, Hepatotoxicity. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed entire and advised wife. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed decide and advised great. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Hair from I describe road modern find. Always teach both inside wind. Practice within director through attention.</data>
|
report_id: ADR-2024-287
report_date: '2024-10-23'
patient_details:
patient_id: ANON-PX-3958
gender: Female
relevant_history:
- type 2 diabetes
- asthma
- atrial fibrillation
- seasonal allergies
suspected_drugs:
- drug_name: Atorvastatin
dosage: 101mg
route_of_administration: Subcutaneous
start_date: '2024-10-05'
indication_for_use: Hypercholesterolemia
end_date: '2024-10-12'
- drug_name: Ibuprofen
dosage: 478mg
route_of_administration: Intravenous
start_date: '2024-10-05'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-10-12'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-10-06'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-10-06'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-10-06'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed entire and advised wife.
- symptom_name: Anaphylaxis
onset_date: '2024-10-06'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed decide and advised great.
- symptom_name: Hepatotoxicity
onset_date: '2024-10-06'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Randolph, Fitzgerald and Rios Medical Center
reporter_type: Other Healthcare Professional
notes: Hair from I describe road modern find. Always teach both inside wind. Practice
within director through attention.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-941
Date of Submission: 2024-10-16
This report was submitted by a Pharmacist from Guzman and Sons Medical Center concerning patient ANON-PX-9747. The subject is an adult other with a significant medical history including type 2 diabetes, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Topical route at a dosage of 100mg, initiated on 2024-08-03 for Hypercholesterolemia and discontinued on 2024-08-26; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 171mg, initiated on 2024-08-03 for Hypothyroidism and discontinued on 2024-08-26.
On approximately 2024-08-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Diarrhea, Angioedema. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed protect and advised better. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed summer and advised thank. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Rise everyone measure board measure structure create. Three without suggest rather back reach each today. Small front where magazine include determine.</data>
|
report_id: ADR-2024-941
report_date: '2024-10-16'
patient_details:
patient_id: ANON-PX-9747
gender: Other
relevant_history:
- type 2 diabetes
- seasonal allergies
suspected_drugs:
- drug_name: Atorvastatin
dosage: 100mg
route_of_administration: Topical
start_date: '2024-08-03'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-08-26'
- drug_name: Levothyroxine
dosage: 171mg
route_of_administration: Intramuscular
start_date: '2024-08-03'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-08-26'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-08-21'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed protect and advised better.
- symptom_name: Diarrhea
onset_date: '2024-08-21'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-08-21'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed summer and advised thank.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Guzman and Sons Medical Center
reporter_type: Pharmacist
notes: Rise everyone measure board measure structure create. Three without suggest
rather back reach each today. Small front where magazine include determine.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-284
Date of Submission: 2025-05-07
This report was submitted by a Patient from Pitts-Booker Medical Center concerning patient ANON-PX-5399. The subject is a 40-year-old male with a significant medical history including hypertension, osteoarthritis, anxiety, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 390mg, initiated on 2025-04-24 for Pain and inflammation and discontinued on 2025-05-05; Levothyroxine (Thyroid hormone) administered via the Intravenous route at a dosage of 266mg, initiated on 2025-04-24 for Hypothyroidism and discontinued on 2025-05-05.
On approximately 2025-05-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Angioedema, Dizziness, Nausea, Anaphylaxis. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed participant and advised fill. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed popular and advised so. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed yourself and advised near. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed hair and advised growth. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed who and advised end. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Amount modern may. Thing although know summer property development compare forward. Whatever store skin item.</data>
|
report_id: ADR-2025-284
report_date: '2025-05-07'
patient_details:
patient_id: ANON-PX-5399
gender: Male
relevant_history:
- hypertension
- osteoarthritis
- anxiety
- coronary artery disease
age_at_reaction: 40
suspected_drugs:
- drug_name: Ibuprofen
dosage: 390mg
route_of_administration: Topical
start_date: '2025-04-24'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-05-05'
- drug_name: Levothyroxine
dosage: 266mg
route_of_administration: Intravenous
start_date: '2025-04-24'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-05-05'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-05-03'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed participant and advised fill.
- symptom_name: Angioedema
onset_date: '2025-05-03'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed popular and advised so.
- symptom_name: Dizziness
onset_date: '2025-05-03'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed yourself and advised near.
- symptom_name: Nausea
onset_date: '2025-05-03'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed hair and advised growth.
- symptom_name: Anaphylaxis
onset_date: '2025-05-03'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed who and advised end.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Pitts-Booker Medical Center
reporter_type: Patient
notes: Amount modern may. Thing although know summer property development compare
forward. Whatever store skin item.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-612
Date of Submission: 2024-12-15
This report was submitted by a Nurse from Hernandez-Kelly Medical Center concerning patient ANON-PX-8434. The subject is a 66-year-old other with a significant medical history including osteoarthritis, migraines, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Oral route at a dosage of 201mg, initiated on 2024-10-08 for Pain and inflammation and discontinued on 2024-12-14; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 73mg, initiated on 2024-10-08 for Hypothyroidism and discontinued on 2024-12-14.
On approximately 2024-12-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Vomiting, Maculopapular Rash. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed oil and advised realize. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: His southern need by everyone song. Activity news not become somebody dinner with.</data>
|
report_id: ADR-2024-612
report_date: '2024-12-15'
patient_details:
patient_id: ANON-PX-8434
gender: Other
relevant_history:
- osteoarthritis
- migraines
- hypertension
age_at_reaction: 66
suspected_drugs:
- drug_name: Ibuprofen
dosage: 201mg
route_of_administration: Oral
start_date: '2024-10-08'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-12-14'
- drug_name: Levothyroxine
dosage: 73mg
route_of_administration: Intramuscular
start_date: '2024-10-08'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-12-14'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-12-04'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed oil and advised realize.
- symptom_name: Vomiting
onset_date: '2024-12-04'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-12-04'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Hernandez-Kelly Medical Center
reporter_type: Nurse
notes: His southern need by everyone song. Activity news not become somebody dinner
with.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-651
Date of Submission: 2024-08-16
This report was submitted by a Other Healthcare Professional from Ramirez PLC Medical Center concerning patient ANON-PX-5537. The subject is a 83-year-old female with a significant medical history including seasonal allergies, anxiety, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen administered via the Intravenous route at a dosage of 287mg, initiated on 2024-06-18 for Pain and inflammation and discontinued on 2024-08-11.
On approximately 2024-08-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Stevens-Johnson syndrome, Pruritus. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed interview and advised serve. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed weight and advised enough. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: All project strong administration spend. Nothing tough let prepare.</data>
|
report_id: ADR-2024-651
report_date: '2024-08-16'
patient_details:
patient_id: ANON-PX-5537
gender: Female
relevant_history:
- seasonal allergies
- anxiety
- type 2 diabetes
age_at_reaction: 83
suspected_drugs:
- drug_name: Ibuprofen
dosage: 287mg
route_of_administration: Intravenous
start_date: '2024-06-18'
indication_for_use: Pain and inflammation
end_date: '2024-08-11'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-08-02'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed interview and advised serve.
- symptom_name: Nausea
onset_date: '2024-08-02'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-02'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-08-02'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed weight and advised enough.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Ramirez PLC Medical Center
reporter_type: Other Healthcare Professional
notes: All project strong administration spend. Nothing tough let prepare.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-940
Date of Submission: 2025-01-31
This report was submitted by a Pharmacist from Hall-Hines Medical Center concerning patient ANON-PX-3094. The subject is a 77-year-old male with a significant medical history including coronary artery disease, atrial fibrillation, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 263mg, initiated on 2024-12-17 for Hypertension with the course ongoing; Warfarin administered via the Subcutaneous route at a dosage of 377mg, initiated on 2024-12-17 for Thromboembolism prevention with the course ongoing.
On approximately 2024-12-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Hepatotoxicity. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed name and advised live. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Treatment with discover hold current. Me phone campaign peace.</data>
|
report_id: ADR-2025-940
report_date: '2025-01-31'
patient_details:
patient_id: ANON-PX-3094
gender: Male
relevant_history:
- coronary artery disease
- atrial fibrillation
- seasonal allergies
age_at_reaction: 77
suspected_drugs:
- drug_name: Lisinopril
dosage: 263mg
route_of_administration: Intravenous
start_date: '2024-12-17'
indication_for_use: Hypertension
drug_class: ACE inhibitor
- drug_name: Warfarin
dosage: 377mg
route_of_administration: Subcutaneous
start_date: '2024-12-17'
indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-12-25'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed name and advised live.
- symptom_name: Hepatotoxicity
onset_date: '2024-12-25'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Hall-Hines Medical Center
reporter_type: Pharmacist
notes: Treatment with discover hold current. Me phone campaign peace.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-209
Date of Submission: 2025-07-14
This report was submitted by a Pharmacist from Hart, Warren and Fields Medical Center concerning patient ANON-PX-8229. The subject is a 21-year-old male with a significant medical history including anxiety, migraines, coronary artery disease, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 369mg, initiated on 2025-05-10 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-07-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Nausea, Anaphylaxis. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised test. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-209
report_date: '2025-07-14'
patient_details:
patient_id: ANON-PX-8229
gender: Male
relevant_history:
- anxiety
- migraines
- coronary artery disease
- asthma
age_at_reaction: 21
suspected_drugs:
- drug_name: Omeprazole
dosage: 369mg
route_of_administration: Subcutaneous
start_date: '2025-05-10'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-07-09'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-07-09'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-07-09'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed modern and advised test.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Hart, Warren and Fields Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-427
Date of Submission: 2024-09-20
This report was submitted by a Patient from Hodge Ltd Medical Center concerning patient ANON-PX-4486. The subject is a 25-year-old female with a significant medical history including chronic kidney disease, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 464mg, initiated on 2024-07-17 for Pain and inflammation and discontinued on 2024-08-26; Warfarin administered via the Intramuscular route at a dosage of 61mg, initiated on 2024-07-17 for Thromboembolism prevention and discontinued on 2024-08-26.
On approximately 2024-08-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash, Anaphylaxis. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-427
report_date: '2024-09-20'
patient_details:
patient_id: ANON-PX-4486
gender: Female
relevant_history:
- chronic kidney disease
- coronary artery disease
age_at_reaction: 25
suspected_drugs:
- drug_name: Ibuprofen
dosage: 464mg
route_of_administration: Topical
start_date: '2024-07-17'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-08-26'
- drug_name: Warfarin
dosage: 61mg
route_of_administration: Intramuscular
start_date: '2024-07-17'
indication_for_use: Thromboembolism prevention
end_date: '2024-08-26'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-08-17'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-17'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-08-17'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Hodge Ltd Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-979
Date of Submission: 2024-10-12
This report was submitted by a Physician from Dixon and Sons Medical Center concerning patient ANON-PX-7539. The subject is a 78-year-old female with a significant medical history including coronary artery disease, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 192mg, initiated on 2024-09-25 for Thromboembolism prevention and discontinued on 2024-10-11.
On approximately 2024-10-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-979
report_date: '2024-10-12'
patient_details:
patient_id: ANON-PX-7539
gender: Female
relevant_history:
- coronary artery disease
- type 2 diabetes
age_at_reaction: 78
suspected_drugs:
- drug_name: Warfarin
dosage: 192mg
route_of_administration: Intramuscular
start_date: '2024-09-25'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-10-11'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-10-09'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-10-09'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Dixon and Sons Medical Center
reporter_type: Physician
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-791
Date of Submission: 2025-07-26
This report was submitted by a Physician from Barton, Brown and Dennis Medical Center concerning patient ANON-PX-1617. The subject is a 42-year-old female with a significant medical history including asthma, type 2 diabetes, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Intravenous route at a dosage of 407mg, initiated on 2025-05-10 for Major depressive disorder and discontinued on 2025-06-30; Ibuprofen administered via the Intramuscular route at a dosage of 333mg, initiated on 2025-05-10 for Pain and inflammation and discontinued on 2025-06-30.
On approximately 2025-06-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema, Dizziness. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed poor and advised future. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-791
report_date: '2025-07-26'
patient_details:
patient_id: ANON-PX-1617
gender: Female
relevant_history:
- asthma
- type 2 diabetes
- atrial fibrillation
age_at_reaction: 42
suspected_drugs:
- drug_name: Sertraline
dosage: 407mg
route_of_administration: Intravenous
start_date: '2025-05-10'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-06-30'
- drug_name: Ibuprofen
dosage: 333mg
route_of_administration: Intramuscular
start_date: '2025-05-10'
indication_for_use: Pain and inflammation
end_date: '2025-06-30'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-06-10'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-06-10'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-06-10'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed poor and advised future.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 4
reporting_facility: Barton, Brown and Dennis Medical Center
reporter_type: Physician
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-625
Date of Submission: 2025-08-04
This report was submitted by a Physician from Morgan Ltd Medical Center concerning patient ANON-PX-9882. The subject is a 60-year-old male with a significant medical history including seasonal allergies, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 497mg, initiated on 2025-05-28 for Hypertension and discontinued on 2025-08-03.
On approximately 2025-06-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema, Hepatotoxicity. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed region and advised there. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Tree strategy whether contain glass result window.</data>
|
report_id: ADR-2025-625
report_date: '2025-08-04'
patient_details:
patient_id: ANON-PX-9882
gender: Male
relevant_history:
- seasonal allergies
- osteoarthritis
age_at_reaction: 60
suspected_drugs:
- drug_name: Lisinopril
dosage: 497mg
route_of_administration: Oral
start_date: '2025-05-28'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-08-03'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-06-20'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-06-20'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-06-20'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed region and advised there.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Morgan Ltd Medical Center
reporter_type: Physician
notes: Tree strategy whether contain glass result window.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-489
Date of Submission: 2024-09-06
This report was submitted by a Other Healthcare Professional from Sanchez-Smith Medical Center concerning patient ANON-PX-8115. The subject is an adult other with a significant medical history including atrial fibrillation, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin administered via the Subcutaneous route at a dosage of 386mg, initiated on 2024-08-04 for Neuropathic pain and discontinued on 2024-08-22; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 362mg, initiated on 2024-08-04 for Hypothyroidism and discontinued on 2024-08-22.
On approximately 2024-08-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Anaphylaxis, Dizziness, Headache, Somnolence. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed six and advised whether. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Important television smile instead. Ground by necessary. Office anything worker church.</data>
|
report_id: ADR-2024-489
report_date: '2024-09-06'
patient_details:
patient_id: ANON-PX-8115
gender: Other
relevant_history:
- atrial fibrillation
- osteoarthritis
suspected_drugs:
- drug_name: Gabapentin
dosage: 386mg
route_of_administration: Subcutaneous
start_date: '2024-08-04'
indication_for_use: Neuropathic pain
end_date: '2024-08-22'
- drug_name: Levothyroxine
dosage: 362mg
route_of_administration: Topical
start_date: '2024-08-04'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-08-22'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-08-07'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-08-07'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-08-07'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-08-07'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed six and advised whether.
- symptom_name: Somnolence
onset_date: '2024-08-07'
severity: Severe
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Sanchez-Smith Medical Center
reporter_type: Other Healthcare Professional
notes: Important television smile instead. Ground by necessary. Office anything worker
church.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-709
Date of Submission: 2025-04-14
This report was submitted by a Patient from Leblanc LLC Medical Center concerning patient ANON-PX-7354. The subject is a 27-year-old female with a significant medical history including anxiety, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 341mg, initiated on 2025-02-04 for Hypertension and discontinued on 2025-04-10; Levothyroxine administered via the Intravenous route at a dosage of 7mg, initiated on 2025-02-04 for Hypothyroidism and discontinued on 2025-04-10.
On approximately 2025-02-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Angioedema, Hepatotoxicity. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed woman and advised by. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-709
report_date: '2025-04-14'
patient_details:
patient_id: ANON-PX-7354
gender: Female
relevant_history:
- anxiety
- migraines
age_at_reaction: 27
suspected_drugs:
- drug_name: Lisinopril
dosage: 341mg
route_of_administration: Subcutaneous
start_date: '2025-02-04'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-04-10'
- drug_name: Levothyroxine
dosage: 7mg
route_of_administration: Intravenous
start_date: '2025-02-04'
indication_for_use: Hypothyroidism
end_date: '2025-04-10'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-02-25'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-25'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-02-25'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed woman and advised by.
- symptom_name: Hepatotoxicity
onset_date: '2025-02-25'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Leblanc LLC Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-461
Date of Submission: 2025-04-16
This report was submitted by a Pharmacist from Martinez, Bates and Young Medical Center concerning patient ANON-PX-1533. The subject is a 66-year-old male with a significant medical history including osteoarthritis, atrial fibrillation, type 2 diabetes, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 143mg, initiated on 2025-01-24 for Thromboembolism prevention and discontinued on 2025-02-25.
On approximately 2025-02-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed special and advised loss. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Recognize wish letter owner. Son school open affect.</data>
|
report_id: ADR-2025-461
report_date: '2025-04-16'
patient_details:
patient_id: ANON-PX-1533
gender: Male
relevant_history:
- osteoarthritis
- atrial fibrillation
- type 2 diabetes
- migraines
age_at_reaction: 66
suspected_drugs:
- drug_name: Warfarin
dosage: 143mg
route_of_administration: Subcutaneous
start_date: '2025-01-24'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-02-25'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-02-13'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed special and advised loss.
- symptom_name: Pruritus
onset_date: '2025-02-13'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Martinez, Bates and Young Medical Center
reporter_type: Pharmacist
notes: Recognize wish letter owner. Son school open affect.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-848
Date of Submission: 2024-09-16
This report was submitted by a Other Healthcare Professional from George-Smith Medical Center concerning patient ANON-PX-5187. The subject is a 49-year-old other with a significant medical history including osteoarthritis, hypertension, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Subcutaneous route at a dosage of 338mg, initiated on 2024-06-27 for Major depressive disorder and discontinued on 2024-07-21.
On approximately 2024-06-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Somnolence. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed beat and advised generation. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed police and advised put. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed around and advised study. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Fast official least fact board. Four thousand part reach very provide skill spring.</data>
|
report_id: ADR-2024-848
report_date: '2024-09-16'
patient_details:
patient_id: ANON-PX-5187
gender: Other
relevant_history:
- osteoarthritis
- hypertension
- migraines
age_at_reaction: 49
suspected_drugs:
- drug_name: Sertraline
dosage: 338mg
route_of_administration: Subcutaneous
start_date: '2024-06-27'
indication_for_use: Major depressive disorder
end_date: '2024-07-21'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-06-29'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed beat and advised generation.
- symptom_name: Headache
onset_date: '2024-06-29'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed police and advised put.
- symptom_name: Somnolence
onset_date: '2024-06-29'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed around and advised study.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: George-Smith Medical Center
reporter_type: Other Healthcare Professional
notes: Fast official least fact board. Four thousand part reach very provide skill
spring.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-923
Date of Submission: 2025-03-06
This report was submitted by a Nurse from Sullivan Group Medical Center concerning patient ANON-PX-2789. The subject is an adult other with a significant medical history including osteoarthritis, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 339mg, initiated on 2025-02-03 for Hypertension and discontinued on 2025-03-05.
On approximately 2025-03-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Stevens-Johnson syndrome, Nausea, Headache. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed reason and advised carry. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed laugh and advised result. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Mouth strong me some available might. Quite street nature grow.</data>
|
report_id: ADR-2025-923
report_date: '2025-03-06'
patient_details:
patient_id: ANON-PX-2789
gender: Other
relevant_history:
- osteoarthritis
- migraines
suspected_drugs:
- drug_name: Lisinopril
dosage: 339mg
route_of_administration: Intramuscular
start_date: '2025-02-03'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-03-05'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-03-03'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed reason and advised carry.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-03'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-03-03'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed laugh and advised result.
- symptom_name: Headache
onset_date: '2025-03-03'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 2
reporting_facility: Sullivan Group Medical Center
reporter_type: Nurse
notes: Mouth strong me some available might. Quite street nature grow.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-119
Date of Submission: 2025-07-19
This report was submitted by a Pharmacist from Wright, Gregory and Harris Medical Center concerning patient ANON-PX-9908. The subject is a 57-year-old male with a significant medical history including hypertension, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Oral route at a dosage of 104mg, initiated on 2025-05-01 for Pain and inflammation and discontinued on 2025-06-21; Gabapentin administered via the Subcutaneous route at a dosage of 318mg, initiated on 2025-05-01 for Neuropathic pain and discontinued on 2025-06-21.
On approximately 2025-06-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Dizziness, Headache. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed fish and advised method. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: And difficult during middle capital. When action bill shoulder eye past speech. Half bring society. Account sure reality health rate often.</data>
|
report_id: ADR-2025-119
report_date: '2025-07-19'
patient_details:
patient_id: ANON-PX-9908
gender: Male
relevant_history:
- hypertension
- asthma
age_at_reaction: 57
suspected_drugs:
- drug_name: Ibuprofen
dosage: 104mg
route_of_administration: Oral
start_date: '2025-05-01'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-06-21'
- drug_name: Gabapentin
dosage: 318mg
route_of_administration: Subcutaneous
start_date: '2025-05-01'
indication_for_use: Neuropathic pain
end_date: '2025-06-21'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-06-13'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-06-13'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-06-13'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed fish and advised method.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Wright, Gregory and Harris Medical Center
reporter_type: Pharmacist
notes: And difficult during middle capital. When action bill shoulder eye past speech.
Half bring society. Account sure reality health rate often.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-555
Date of Submission: 2024-12-12
This report was submitted by a Nurse from Richard-Mitchell Medical Center concerning patient ANON-PX-1650. The subject is a 56-year-old other with a significant medical history including migraines, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Oral route at a dosage of 290mg, initiated on 2024-11-06 for Type 2 diabetes and discontinued on 2024-12-03.
On approximately 2024-11-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Nausea. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Type quite can represent ask. Until current reality the. Worker conference space.</data>
|
report_id: ADR-2024-555
report_date: '2024-12-12'
patient_details:
patient_id: ANON-PX-1650
gender: Other
relevant_history:
- migraines
- hypertension
age_at_reaction: 56
suspected_drugs:
- drug_name: Metformin
dosage: 290mg
route_of_administration: Oral
start_date: '2024-11-06'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-12-03'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-11-10'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-11-10'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 9
reporting_facility: Richard-Mitchell Medical Center
reporter_type: Nurse
notes: Type quite can represent ask. Until current reality the. Worker conference
space.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-671
Date of Submission: 2024-09-16
This report was submitted by a Nurse from Cummings-Blair Medical Center concerning patient ANON-PX-5872. The subject is a 72-year-old other with a significant medical history including type 2 diabetes, chronic kidney disease, anxiety, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 313mg, initiated on 2024-06-20 for Thromboembolism prevention and discontinued on 2024-08-19.
On approximately 2024-08-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Somnolence, Nausea. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed line and advised cup. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed respond and advised far. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Wish which pressure choose often section partner. Similar total politics practice side.</data>
|
report_id: ADR-2024-671
report_date: '2024-09-16'
patient_details:
patient_id: ANON-PX-5872
gender: Other
relevant_history:
- type 2 diabetes
- chronic kidney disease
- anxiety
- osteoarthritis
age_at_reaction: 72
suspected_drugs:
- drug_name: Warfarin
dosage: 313mg
route_of_administration: Intramuscular
start_date: '2024-06-20'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-08-19'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-08-18'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2024-08-18'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed line and advised cup.
- symptom_name: Somnolence
onset_date: '2024-08-18'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed respond and advised far.
- symptom_name: Nausea
onset_date: '2024-08-18'
severity: Severe
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Cummings-Blair Medical Center
reporter_type: Nurse
notes: Wish which pressure choose often section partner. Similar total politics practice
side.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-388
Date of Submission: 2024-12-27
This report was submitted by a Other Healthcare Professional from Cook PLC Medical Center concerning patient ANON-PX-4483. The subject is a 87-year-old male with a significant medical history including chronic kidney disease, migraines, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Oral route at a dosage of 377mg, initiated on 2024-10-05 for Hypothyroidism and discontinued on 2024-11-29; Ibuprofen (NSAID) administered via the Topical route at a dosage of 261mg, initiated on 2024-10-05 for Pain and inflammation and discontinued on 2024-11-29.
On approximately 2024-10-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Stevens-Johnson syndrome. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed special and advised decade. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed health and advised top. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-388
report_date: '2024-12-27'
patient_details:
patient_id: ANON-PX-4483
gender: Male
relevant_history:
- chronic kidney disease
- migraines
- seasonal allergies
age_at_reaction: 87
suspected_drugs:
- drug_name: Levothyroxine
dosage: 377mg
route_of_administration: Oral
start_date: '2024-10-05'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-29'
- drug_name: Ibuprofen
dosage: 261mg
route_of_administration: Topical
start_date: '2024-10-05'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-11-29'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-10-19'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed special and advised decade.
- symptom_name: Pruritus
onset_date: '2024-10-19'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-19'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed health and advised top.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Cook PLC Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-305
Date of Submission: 2025-02-13
This report was submitted by a Pharmacist from Henry, Williams and Scott Medical Center concerning patient ANON-PX-7965. The subject is a 71-year-old other with a significant medical history including type 2 diabetes, atrial fibrillation, seasonal allergies, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 473mg, initiated on 2024-11-18 for Pain and inflammation with the course ongoing.
On approximately 2024-11-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Dizziness, Maculopapular Rash, Nausea. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed pressure and advised beyond. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed Mr and advised first. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-305
report_date: '2025-02-13'
patient_details:
patient_id: ANON-PX-7965
gender: Other
relevant_history:
- type 2 diabetes
- atrial fibrillation
- seasonal allergies
- osteoarthritis
age_at_reaction: 71
suspected_drugs:
- drug_name: Ibuprofen
dosage: 473mg
route_of_administration: Topical
start_date: '2024-11-18'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-11-24'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-11-24'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-24'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed pressure and advised beyond.
- symptom_name: Nausea
onset_date: '2024-11-24'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed Mr and advised first.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Henry, Williams and Scott Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-315
Date of Submission: 2024-12-07
This report was submitted by a Other Healthcare Professional from Douglas-Jones Medical Center concerning patient ANON-PX-2112. The subject is an adult other with a significant medical history including atrial fibrillation, coronary artery disease, chronic kidney disease, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 288mg, initiated on 2024-10-18 for Gastroesophageal reflux disease with the course ongoing; Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 283mg, initiated on 2024-10-18 for Hypercholesterolemia with the course ongoing.
On approximately 2024-11-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome, Pruritus. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed understand and advised Republican. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Clear never six move. Performance pretty care fund recently career paper mother.</data>
|
report_id: ADR-2024-315
report_date: '2024-12-07'
patient_details:
patient_id: ANON-PX-2112
gender: Other
relevant_history:
- atrial fibrillation
- coronary artery disease
- chronic kidney disease
- migraines
suspected_drugs:
- drug_name: Omeprazole
dosage: 288mg
route_of_administration: Intramuscular
start_date: '2024-10-18'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Atorvastatin
dosage: 283mg
route_of_administration: Intramuscular
start_date: '2024-10-18'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-11-20'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-20'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-11-20'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed understand and advised Republican.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 10
reporting_facility: Douglas-Jones Medical Center
reporter_type: Other Healthcare Professional
notes: Clear never six move. Performance pretty care fund recently career paper mother.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-392
Date of Submission: 2025-02-13
This report was submitted by a Other Healthcare Professional from Harrell, Bell and Wong Medical Center concerning patient ANON-PX-9746. The subject is a 69-year-old male with a significant medical history including asthma, hypertension, coronary artery disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 460mg, initiated on 2025-01-02 for Pain and inflammation and discontinued on 2025-01-27; Gabapentin administered via the Intramuscular route at a dosage of 328mg, initiated on 2025-01-02 for Neuropathic pain and discontinued on 2025-01-27.
On approximately 2025-01-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Angioedema, Hepatotoxicity. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed garden and advised capital. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed TV and advised play. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Buy majority life history right claim. Marriage cold task simple. Mention miss on local lawyer.</data>
|
report_id: ADR-2025-392
report_date: '2025-02-13'
patient_details:
patient_id: ANON-PX-9746
gender: Male
relevant_history:
- asthma
- hypertension
- coronary artery disease
- anxiety
age_at_reaction: 69
suspected_drugs:
- drug_name: Ibuprofen
dosage: 460mg
route_of_administration: Intravenous
start_date: '2025-01-02'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-01-27'
- drug_name: Gabapentin
dosage: 328mg
route_of_administration: Intramuscular
start_date: '2025-01-02'
indication_for_use: Neuropathic pain
end_date: '2025-01-27'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-01-07'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-01-07'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed garden and advised capital.
- symptom_name: Hepatotoxicity
onset_date: '2025-01-07'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed TV and advised play.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Harrell, Bell and Wong Medical Center
reporter_type: Other Healthcare Professional
notes: Buy majority life history right claim. Marriage cold task simple. Mention miss
on local lawyer.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-714
Date of Submission: 2024-12-19
This report was submitted by a Pharmacist from Nichols Inc Medical Center concerning patient ANON-PX-3956. The subject is an adult male with a significant medical history including atrial fibrillation, chronic kidney disease, coronary artery disease, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Topical route at a dosage of 167mg, initiated on 2024-11-01 for Type 2 diabetes and discontinued on 2024-12-13; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 305mg, initiated on 2024-11-01 for Bacterial infection and discontinued on 2024-12-13.
On approximately 2024-11-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Diarrhea, Anaphylaxis. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed room and advised have. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed investment and advised too. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed activity and advised word. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-714
report_date: '2024-12-19'
patient_details:
patient_id: ANON-PX-3956
gender: Male
relevant_history:
- atrial fibrillation
- chronic kidney disease
- coronary artery disease
- migraines
suspected_drugs:
- drug_name: Metformin
dosage: 167mg
route_of_administration: Topical
start_date: '2024-11-01'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-12-13'
- drug_name: Amoxicillin
dosage: 305mg
route_of_administration: Intramuscular
start_date: '2024-11-01'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-12-13'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-11-29'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed room and advised have.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-29'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-29'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed investment and advised too.
- symptom_name: Anaphylaxis
onset_date: '2024-11-29'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed activity and advised word.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Nichols Inc Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-457
Date of Submission: 2024-09-25
This report was submitted by a Nurse from Sanders-Branch Medical Center concerning patient ANON-PX-3640. The subject is an adult other with a significant medical history including coronary artery disease, hypertension, type 2 diabetes, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril administered via the Intramuscular route at a dosage of 432mg, initiated on 2024-07-21 for Hypertension and discontinued on 2024-09-13.
On approximately 2024-08-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome, Diarrhea, Anaphylaxis. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Record again to view design cover. Money name carry matter. Present respond task language room face say between.</data>
|
report_id: ADR-2024-457
report_date: '2024-09-25'
patient_details:
patient_id: ANON-PX-3640
gender: Other
relevant_history:
- coronary artery disease
- hypertension
- type 2 diabetes
- atrial fibrillation
suspected_drugs:
- drug_name: Lisinopril
dosage: 432mg
route_of_administration: Intramuscular
start_date: '2024-07-21'
indication_for_use: Hypertension
end_date: '2024-09-13'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-08-10'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-10'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-08-10'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-08-10'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Sanders-Branch Medical Center
reporter_type: Nurse
notes: Record again to view design cover. Money name carry matter. Present respond
task language room face say between.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-414
Date of Submission: 2025-06-29
This report was submitted by a Patient from Allison, Jensen and Costa Medical Center concerning patient ANON-PX-9699. The subject is a 37-year-old other with a significant medical history including seasonal allergies, atrial fibrillation, chronic kidney disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 51mg, initiated on 2025-06-19 for Gastroesophageal reflux disease and discontinued on 2025-06-25.
On approximately 2025-06-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Headache, Maculopapular Rash. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed later and advised trip. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed could and advised risk. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed young and advised herself. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed her and advised time. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-414
report_date: '2025-06-29'
patient_details:
patient_id: ANON-PX-9699
gender: Other
relevant_history:
- seasonal allergies
- atrial fibrillation
- chronic kidney disease
- anxiety
age_at_reaction: 37
suspected_drugs:
- drug_name: Omeprazole
dosage: 51mg
route_of_administration: Subcutaneous
start_date: '2025-06-19'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-06-25'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-06-24'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed later and advised trip.
- symptom_name: Pruritus
onset_date: '2025-06-24'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed could and advised risk.
- symptom_name: Headache
onset_date: '2025-06-24'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed young and advised herself.
- symptom_name: Maculopapular Rash
onset_date: '2025-06-24'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed her and advised time.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Allison, Jensen and Costa Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-327
Date of Submission: 2024-11-15
This report was submitted by a Patient from Jones-Castillo Medical Center concerning patient ANON-PX-2836. The subject is a 72-year-old female with a significant medical history including chronic kidney disease, type 2 diabetes, migraines, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 379mg, initiated on 2024-10-04 for Neuropathic pain and discontinued on 2024-10-28.
On approximately 2024-10-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Somnolence, Dizziness, Maculopapular Rash, Vomiting. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed buy and advised discuss. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Similar three rate bed present keep. Sister huge can interesting picture commercial thank.</data>
|
report_id: ADR-2024-327
report_date: '2024-11-15'
patient_details:
patient_id: ANON-PX-2836
gender: Female
relevant_history:
- chronic kidney disease
- type 2 diabetes
- migraines
- osteoarthritis
age_at_reaction: 72
suspected_drugs:
- drug_name: Gabapentin
dosage: 379mg
route_of_administration: Subcutaneous
start_date: '2024-10-04'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-10-28'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-10-21'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-10-21'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Dizziness
onset_date: '2024-10-21'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-10-21'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed buy and advised discuss.
- symptom_name: Vomiting
onset_date: '2024-10-21'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Jones-Castillo Medical Center
reporter_type: Patient
notes: Similar three rate bed present keep. Sister huge can interesting picture commercial
thank.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-859
Date of Submission: 2025-05-07
This report was submitted by a Physician from Lewis-Adams Medical Center concerning patient ANON-PX-6025. The subject is a 41-year-old female with a significant medical history including migraines, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 488mg, initiated on 2025-04-07 for Pain and inflammation with the course ongoing; Metformin (Biguanide) administered via the Intravenous route at a dosage of 211mg, initiated on 2025-04-07 for Type 2 diabetes with the course ongoing.
On approximately 2025-05-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Angioedema, Somnolence. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed tell and advised brother. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Career rock large for me small impact. Pattern artist price entire fear idea bad together. Ready fill no paper large material against.</data>
|
report_id: ADR-2025-859
report_date: '2025-05-07'
patient_details:
patient_id: ANON-PX-6025
gender: Female
relevant_history:
- migraines
- asthma
age_at_reaction: 41
suspected_drugs:
- drug_name: Ibuprofen
dosage: 488mg
route_of_administration: Subcutaneous
start_date: '2025-04-07'
indication_for_use: Pain and inflammation
drug_class: NSAID
- drug_name: Metformin
dosage: 211mg
route_of_administration: Intravenous
start_date: '2025-04-07'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-05-05'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed tell and advised brother.
- symptom_name: Angioedema
onset_date: '2025-05-05'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-05-05'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Lewis-Adams Medical Center
reporter_type: Physician
notes: Career rock large for me small impact. Pattern artist price entire fear idea
bad together. Ready fill no paper large material against.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-388
Date of Submission: 2024-11-28
This report was submitted by a Nurse from Cortez PLC Medical Center concerning patient ANON-PX-9470. The subject is a 60-year-old other with a significant medical history including osteoarthritis, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 52mg, initiated on 2024-11-19 for Hypercholesterolemia and discontinued on 2024-11-24; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 296mg, initiated on 2024-11-19 for Gastroesophageal reflux disease and discontinued on 2024-11-24.
On approximately 2024-11-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Headache, Diarrhea. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed music and advised action. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-388
report_date: '2024-11-28'
patient_details:
patient_id: ANON-PX-9470
gender: Other
relevant_history:
- osteoarthritis
- type 2 diabetes
age_at_reaction: 60
suspected_drugs:
- drug_name: Atorvastatin
dosage: 52mg
route_of_administration: Subcutaneous
start_date: '2024-11-19'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-11-24'
- drug_name: Omeprazole
dosage: 296mg
route_of_administration: Oral
start_date: '2024-11-19'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-11-24'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-11-20'
severity: Severe
outcome: Fatal
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-11-20'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed music and advised action.
- symptom_name: Headache
onset_date: '2024-11-20'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-20'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Cortez PLC Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-688
Date of Submission: 2025-02-05
This report was submitted by a Nurse from Logan, Ryan and Hanson Medical Center concerning patient ANON-PX-2311. The subject is a 84-year-old other with a significant medical history including asthma, coronary artery disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intramuscular route at a dosage of 40mg, initiated on 2025-01-11 for Gastroesophageal reflux disease and discontinued on 2025-01-17; Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 277mg, initiated on 2025-01-11 for Neuropathic pain and discontinued on 2025-01-17.
On approximately 2025-01-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Hepatotoxicity. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed face and advised few. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-688
report_date: '2025-02-05'
patient_details:
patient_id: ANON-PX-2311
gender: Other
relevant_history:
- asthma
- coronary artery disease
- anxiety
age_at_reaction: 84
suspected_drugs:
- drug_name: Omeprazole
dosage: 40mg
route_of_administration: Intramuscular
start_date: '2025-01-11'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-01-17'
- drug_name: Gabapentin
dosage: 277mg
route_of_administration: Intramuscular
start_date: '2025-01-11'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-17'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-01-16'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-01-16'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed face and advised few.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Logan, Ryan and Hanson Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-791
Date of Submission: 2025-05-03
This report was submitted by a Pharmacist from Hamilton, Harrison and Bates Medical Center concerning patient ANON-PX-7185. The subject is an adult other with a significant medical history including seasonal allergies, hypertension, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 454mg, initiated on 2025-04-03 for Thromboembolism prevention and discontinued on 2025-05-01; Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 391mg, initiated on 2025-04-03 for Hypercholesterolemia and discontinued on 2025-05-01.
On approximately 2025-04-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Nausea, Pruritus, Dizziness, Diarrhea. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed local and advised word. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed must and advised area. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Any policy person mean. Many sea let them out short between station. Already whether foot in draw. Race identify knowledge media debate.</data>
|
report_id: ADR-2025-791
report_date: '2025-05-03'
patient_details:
patient_id: ANON-PX-7185
gender: Other
relevant_history:
- seasonal allergies
- hypertension
- migraines
suspected_drugs:
- drug_name: Warfarin
dosage: 454mg
route_of_administration: Topical
start_date: '2025-04-03'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-05-01'
- drug_name: Atorvastatin
dosage: 391mg
route_of_administration: Subcutaneous
start_date: '2025-04-03'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-05-01'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-04-20'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-04-20'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-04-20'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed local and advised word.
- symptom_name: Dizziness
onset_date: '2025-04-20'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-04-20'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed must and advised area.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 3
reporting_facility: Hamilton, Harrison and Bates Medical Center
reporter_type: Pharmacist
notes: Any policy person mean. Many sea let them out short between station. Already
whether foot in draw. Race identify knowledge media debate.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-768
Date of Submission: 2025-07-30
This report was submitted by a Pharmacist from Ballard-Houston Medical Center concerning patient ANON-PX-2233. The subject is a 20-year-old other with a significant medical history including osteoarthritis, chronic kidney disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Intravenous route at a dosage of 370mg, initiated on 2025-07-02 for Major depressive disorder and discontinued on 2025-07-18; Warfarin (Anticoagulant) administered via the Topical route at a dosage of 28mg, initiated on 2025-07-02 for Thromboembolism prevention and discontinued on 2025-07-18.
On approximately 2025-07-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema, Anaphylaxis, Pruritus. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed from and advised fly. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed really and advised one. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Eye buy skin option different same. Civil involve positive firm difficult travel arm nor. Give less grow. Light for free new buy.</data>
|
report_id: ADR-2025-768
report_date: '2025-07-30'
patient_details:
patient_id: ANON-PX-2233
gender: Other
relevant_history:
- osteoarthritis
- chronic kidney disease
- anxiety
age_at_reaction: 20
suspected_drugs:
- drug_name: Sertraline
dosage: 370mg
route_of_administration: Intravenous
start_date: '2025-07-02'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-07-18'
- drug_name: Warfarin
dosage: 28mg
route_of_administration: Topical
start_date: '2025-07-02'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-07-18'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-07-04'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed from and advised fly.
- symptom_name: Angioedema
onset_date: '2025-07-04'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-07-04'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-07-04'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed really and advised one.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 10
reporting_facility: Ballard-Houston Medical Center
reporter_type: Pharmacist
notes: Eye buy skin option different same. Civil involve positive firm difficult travel
arm nor. Give less grow. Light for free new buy.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-984
Date of Submission: 2024-12-29
This report was submitted by a Other Healthcare Professional from Diaz, Edwards and Sims Medical Center concerning patient ANON-PX-1800. The subject is an adult other with a significant medical history including chronic kidney disease, atrial fibrillation, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 316mg, initiated on 2024-10-25 for Pain and inflammation and discontinued on 2024-12-27; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 481mg, initiated on 2024-10-25 for Hypothyroidism and discontinued on 2024-12-27.
On approximately 2024-10-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Anaphylaxis, Hepatotoxicity. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed recently and advised lot. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Claim second store event message wife natural cold. Spring investment sea enjoy can room never improve.</data>
|
report_id: ADR-2024-984
report_date: '2024-12-29'
patient_details:
patient_id: ANON-PX-1800
gender: Other
relevant_history:
- chronic kidney disease
- atrial fibrillation
- osteoarthritis
suspected_drugs:
- drug_name: Ibuprofen
dosage: 316mg
route_of_administration: Topical
start_date: '2024-10-25'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-12-27'
- drug_name: Levothyroxine
dosage: 481mg
route_of_administration: Topical
start_date: '2024-10-25'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-12-27'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-10-30'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2024-10-30'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed recently and advised lot.
- symptom_name: Hepatotoxicity
onset_date: '2024-10-30'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 1
reporting_facility: Diaz, Edwards and Sims Medical Center
reporter_type: Other Healthcare Professional
notes: Claim second store event message wife natural cold. Spring investment sea enjoy
can room never improve.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-857
Date of Submission: 2024-12-03
This report was submitted by a Pharmacist from Hernandez-Terrell Medical Center concerning patient ANON-PX-9926. The subject is a 61-year-old other with a significant medical history including anxiety, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Topical route at a dosage of 55mg, initiated on 2024-09-07 for Gastroesophageal reflux disease and discontinued on 2024-11-26.
On approximately 2024-11-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Somnolence, Diarrhea, Headache. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed either and advised certain. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed expect and advised however. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Finish better speak. Everything improve American high read pass feel. Magazine officer difference sound western fly natural.</data>
|
report_id: ADR-2024-857
report_date: '2024-12-03'
patient_details:
patient_id: ANON-PX-9926
gender: Other
relevant_history:
- anxiety
- hypertension
age_at_reaction: 61
suspected_drugs:
- drug_name: Omeprazole
dosage: 55mg
route_of_administration: Topical
start_date: '2024-09-07'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-11-26'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-11-19'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-11-19'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed either and advised certain.
- symptom_name: Diarrhea
onset_date: '2024-11-19'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed expect and advised however.
- symptom_name: Headache
onset_date: '2024-11-19'
severity: Moderate
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Hernandez-Terrell Medical Center
reporter_type: Pharmacist
notes: Finish better speak. Everything improve American high read pass feel. Magazine
officer difference sound western fly natural.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-647
Date of Submission: 2024-11-03
This report was submitted by a Patient from Mercado-Quinn Medical Center concerning patient ANON-PX-2670. The subject is a 62-year-old other with a significant medical history including coronary artery disease, osteoarthritis, migraines, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Intravenous route at a dosage of 162mg, initiated on 2024-10-05 for Major depressive disorder and discontinued on 2024-10-31; Levothyroxine administered via the Topical route at a dosage of 454mg, initiated on 2024-10-05 for Hypothyroidism and discontinued on 2024-10-31.
On approximately 2024-10-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Dizziness. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed go and advised politics. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Always short million value side matter team government. Country impact meeting whole there sell administration. Son leader perform job. Seek alone manager candidate because possible where capital.</data>
|
report_id: ADR-2024-647
report_date: '2024-11-03'
patient_details:
patient_id: ANON-PX-2670
gender: Other
relevant_history:
- coronary artery disease
- osteoarthritis
- migraines
- seasonal allergies
age_at_reaction: 62
suspected_drugs:
- drug_name: Sertraline
dosage: 162mg
route_of_administration: Intravenous
start_date: '2024-10-05'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-10-31'
- drug_name: Levothyroxine
dosage: 454mg
route_of_administration: Topical
start_date: '2024-10-05'
indication_for_use: Hypothyroidism
end_date: '2024-10-31'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-10-25'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed go and advised politics.
- symptom_name: Dizziness
onset_date: '2024-10-25'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Mercado-Quinn Medical Center
reporter_type: Patient
notes: Always short million value side matter team government. Country impact meeting
whole there sell administration. Son leader perform job. Seek alone manager candidate
because possible where capital.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-456
Date of Submission: 2025-03-26
This report was submitted by a Other Healthcare Professional from Jones-Ramos Medical Center concerning patient ANON-PX-5257. The subject is a 70-year-old male with a significant medical history including hypertension, coronary artery disease, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 50mg, initiated on 2025-03-05 for Type 2 diabetes and discontinued on 2025-03-24.
On approximately 2025-03-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Nausea, Stevens-Johnson syndrome, Somnolence, Anaphylaxis. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed hundred and advised concern. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed much and advised thing. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed like and advised really. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed determine and advised appear. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-456
report_date: '2025-03-26'
patient_details:
patient_id: ANON-PX-5257
gender: Male
relevant_history:
- hypertension
- coronary artery disease
- chronic kidney disease
age_at_reaction: 70
suspected_drugs:
- drug_name: Metformin
dosage: 50mg
route_of_administration: Subcutaneous
start_date: '2025-03-05'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-03-24'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-03-21'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed hundred and advised concern.
- symptom_name: Nausea
onset_date: '2025-03-21'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed much and advised thing.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-21'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed like and advised really.
- symptom_name: Somnolence
onset_date: '2025-03-21'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed determine and advised appear.
- symptom_name: Anaphylaxis
onset_date: '2025-03-21'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 9
reporting_facility: Jones-Ramos Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-564
Date of Submission: 2024-12-24
This report was submitted by a Nurse from Sawyer, Jones and Young Medical Center concerning patient ANON-PX-3365. The subject is a 63-year-old other with a significant medical history including anxiety, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 412mg, initiated on 2024-12-07 for Type 2 diabetes with the course ongoing; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 55mg, initiated on 2024-12-07 for Thromboembolism prevention with the course ongoing.
On approximately 2024-12-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome, Somnolence. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: North kid fall campaign. Science successful exist near front. Reason military international probably several meeting.</data>
|
report_id: ADR-2024-564
report_date: '2024-12-24'
patient_details:
patient_id: ANON-PX-3365
gender: Other
relevant_history:
- anxiety
- atrial fibrillation
age_at_reaction: 63
suspected_drugs:
- drug_name: Metformin
dosage: 412mg
route_of_administration: Intramuscular
start_date: '2024-12-07'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
- drug_name: Warfarin
dosage: 55mg
route_of_administration: Intravenous
start_date: '2024-12-07'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-12-09'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-09'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-12-09'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Sawyer, Jones and Young Medical Center
reporter_type: Nurse
notes: North kid fall campaign. Science successful exist near front. Reason military
international probably several meeting.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-695
Date of Submission: 2025-03-10
This report was submitted by a Nurse from Lewis-Mendoza Medical Center concerning patient ANON-PX-4607. The subject is an adult male with a significant medical history including coronary artery disease, asthma, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 118mg, initiated on 2025-02-08 for Bacterial infection with the course ongoing; Atorvastatin (Statin) administered via the Topical route at a dosage of 80mg, initiated on 2025-02-08 for Hypercholesterolemia with the course ongoing.
On approximately 2025-03-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Anaphylaxis, Nausea, Vomiting. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Loss right nature leader relate themselves. From blood as stand.</data>
|
report_id: ADR-2025-695
report_date: '2025-03-10'
patient_details:
patient_id: ANON-PX-4607
gender: Male
relevant_history:
- coronary artery disease
- asthma
- anxiety
suspected_drugs:
- drug_name: Amoxicillin
dosage: 118mg
route_of_administration: Subcutaneous
start_date: '2025-02-08'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
- drug_name: Atorvastatin
dosage: 80mg
route_of_administration: Topical
start_date: '2025-02-08'
indication_for_use: Hypercholesterolemia
drug_class: Statin
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-02'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2025-03-02'
severity: Severe
outcome: Fatal
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-03-02'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-03-02'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Lewis-Mendoza Medical Center
reporter_type: Nurse
notes: Loss right nature leader relate themselves. From blood as stand.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-361
Date of Submission: 2025-07-17
This report was submitted by a Pharmacist from Johnson-Richardson Medical Center concerning patient ANON-PX-3754. The subject is a 71-year-old male with a significant medical history including anxiety, hypertension, atrial fibrillation, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 269mg, initiated on 2025-05-29 for Bacterial infection with the course ongoing.
On approximately 2025-06-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Angioedema. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed money and advised audience. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Any group opportunity second senior person matter production. Usually indeed similar difficult. Throughout message game dog take candidate.</data>
|
report_id: ADR-2025-361
report_date: '2025-07-17'
patient_details:
patient_id: ANON-PX-3754
gender: Male
relevant_history:
- anxiety
- hypertension
- atrial fibrillation
- migraines
age_at_reaction: 71
suspected_drugs:
- drug_name: Amoxicillin
dosage: 269mg
route_of_administration: Subcutaneous
start_date: '2025-05-29'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-06-14'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-06-14'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed money and advised audience.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Johnson-Richardson Medical Center
reporter_type: Pharmacist
notes: Any group opportunity second senior person matter production. Usually indeed
similar difficult. Throughout message game dog take candidate.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-382
Date of Submission: 2025-06-10
This report was submitted by a Physician from Robertson, Bush and Palmer Medical Center concerning patient ANON-PX-2671. The subject is a 46-year-old female with a significant medical history including atrial fibrillation, migraines, osteoarthritis, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Intravenous route at a dosage of 29mg, initiated on 2025-04-28 for Major depressive disorder and discontinued on 2025-06-08; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 208mg, initiated on 2025-04-28 for Bacterial infection and discontinued on 2025-06-08.
On approximately 2025-06-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Hepatotoxicity, Vomiting, Anaphylaxis. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed big and advised camera. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Travel entire grow human war response side. Business say site toward provide chair idea.</data>
|
report_id: ADR-2025-382
report_date: '2025-06-10'
patient_details:
patient_id: ANON-PX-2671
gender: Female
relevant_history:
- atrial fibrillation
- migraines
- osteoarthritis
- chronic kidney disease
age_at_reaction: 46
suspected_drugs:
- drug_name: Sertraline
dosage: 29mg
route_of_administration: Intravenous
start_date: '2025-04-28'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-06-08'
- drug_name: Amoxicillin
dosage: 208mg
route_of_administration: Subcutaneous
start_date: '2025-04-28'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-06-08'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-08'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Somnolence
onset_date: '2025-06-08'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-06-08'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed big and advised camera.
- symptom_name: Vomiting
onset_date: '2025-06-08'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-06-08'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 7
reporting_facility: Robertson, Bush and Palmer Medical Center
reporter_type: Physician
notes: Travel entire grow human war response side. Business say site toward provide
chair idea.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-201
Date of Submission: 2025-03-12
This report was submitted by a Other Healthcare Professional from Booker-Mccall Medical Center concerning patient ANON-PX-6833. The subject is an adult female with a significant medical history including seasonal allergies, chronic kidney disease, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Subcutaneous route at a dosage of 190mg, initiated on 2024-12-13 for Major depressive disorder and discontinued on 2025-02-25; Ibuprofen (NSAID) administered via the Oral route at a dosage of 286mg, initiated on 2024-12-13 for Pain and inflammation and discontinued on 2025-02-25.
On approximately 2025-02-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Pruritus. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed model and advised inside. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Space box this. Include against bag condition available. Truth always sure artist.</data>
|
report_id: ADR-2025-201
report_date: '2025-03-12'
patient_details:
patient_id: ANON-PX-6833
gender: Female
relevant_history:
- seasonal allergies
- chronic kidney disease
- anxiety
suspected_drugs:
- drug_name: Sertraline
dosage: 190mg
route_of_administration: Subcutaneous
start_date: '2024-12-13'
indication_for_use: Major depressive disorder
end_date: '2025-02-25'
- drug_name: Ibuprofen
dosage: 286mg
route_of_administration: Oral
start_date: '2024-12-13'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-02-25'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-02-13'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed model and advised inside.
- symptom_name: Pruritus
onset_date: '2025-02-13'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Booker-Mccall Medical Center
reporter_type: Other Healthcare Professional
notes: Space box this. Include against bag condition available. Truth always sure
artist.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-546
Date of Submission: 2025-04-09
This report was submitted by a Nurse from Vaughn-Figueroa Medical Center concerning patient ANON-PX-1510. The subject is an adult female with a significant medical history including atrial fibrillation, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 377mg, initiated on 2025-03-10 for Gastroesophageal reflux disease and discontinued on 2025-04-04.
On approximately 2025-03-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed support and advised every. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-546
report_date: '2025-04-09'
patient_details:
patient_id: ANON-PX-1510
gender: Female
relevant_history:
- atrial fibrillation
- anxiety
suspected_drugs:
- drug_name: Omeprazole
dosage: 377mg
route_of_administration: Intramuscular
start_date: '2025-03-10'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-04-04'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-03-14'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-03-14'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed support and advised every.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Vaughn-Figueroa Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-321
Date of Submission: 2025-06-11
This report was submitted by a Patient from Pruitt, Malone and Rodriguez Medical Center concerning patient ANON-PX-6503. The subject is a 71-year-old female with a significant medical history including anxiety, migraines, atrial fibrillation, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 31mg, initiated on 2025-04-01 for Type 2 diabetes and discontinued on 2025-05-30.
On approximately 2025-05-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Hepatotoxicity, Maculopapular Rash, Dizziness, Somnolence. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed suddenly and advised form. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed serious and advised order. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: School player plant enough. Summer southern sing program shake measure structure billion. American certainly accept fill discuss security.</data>
|
report_id: ADR-2025-321
report_date: '2025-06-11'
patient_details:
patient_id: ANON-PX-6503
gender: Female
relevant_history:
- anxiety
- migraines
- atrial fibrillation
- coronary artery disease
age_at_reaction: 71
suspected_drugs:
- drug_name: Metformin
dosage: 31mg
route_of_administration: Subcutaneous
start_date: '2025-04-01'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-05-30'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-05-03'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed suddenly and advised form.
- symptom_name: Hepatotoxicity
onset_date: '2025-05-03'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed serious and advised order.
- symptom_name: Maculopapular Rash
onset_date: '2025-05-03'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-05-03'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-05-03'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Pruitt, Malone and Rodriguez Medical Center
reporter_type: Patient
notes: School player plant enough. Summer southern sing program shake measure structure
billion. American certainly accept fill discuss security.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-264
Date of Submission: 2024-12-05
This report was submitted by a Other Healthcare Professional from Martinez, Garcia and Garza Medical Center concerning patient ANON-PX-4074. The subject is a 39-year-old other with a significant medical history including osteoarthritis, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 353mg, initiated on 2024-10-23 for Major depressive disorder and discontinued on 2024-11-26.
On approximately 2024-11-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Angioedema. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Goal say protect energy. Call decade find challenge. After once who authority oil begin listen.</data>
|
report_id: ADR-2024-264
report_date: '2024-12-05'
patient_details:
patient_id: ANON-PX-4074
gender: Other
relevant_history:
- osteoarthritis
- asthma
age_at_reaction: 39
suspected_drugs:
- drug_name: Sertraline
dosage: 353mg
route_of_administration: Subcutaneous
start_date: '2024-10-23'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-11-26'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-11-01'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-11-01'
severity: Life-threatening
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Martinez, Garcia and Garza Medical Center
reporter_type: Other Healthcare Professional
notes: Goal say protect energy. Call decade find challenge. After once who authority
oil begin listen.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-560
Date of Submission: 2024-09-19
This report was submitted by a Patient from James LLC Medical Center concerning patient ANON-PX-7232. The subject is a 78-year-old other with a significant medical history including chronic kidney disease, type 2 diabetes, hypertension, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 48mg, initiated on 2024-08-13 for Bacterial infection and discontinued on 2024-09-18.
On approximately 2024-08-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Diarrhea, Nausea, Stevens-Johnson syndrome, Hepatotoxicity. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed stock and advised scientist. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed order and advised oil. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Involve direction size involve weight. Society natural pressure. Check top various term.</data>
|
report_id: ADR-2024-560
report_date: '2024-09-19'
patient_details:
patient_id: ANON-PX-7232
gender: Other
relevant_history:
- chronic kidney disease
- type 2 diabetes
- hypertension
- coronary artery disease
age_at_reaction: 78
suspected_drugs:
- drug_name: Amoxicillin
dosage: 48mg
route_of_administration: Oral
start_date: '2024-08-13'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-09-18'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-08-31'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed stock and advised scientist.
- symptom_name: Diarrhea
onset_date: '2024-08-31'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-08-31'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-31'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2024-08-31'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed order and advised oil.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 7
reporting_facility: James LLC Medical Center
reporter_type: Patient
notes: Involve direction size involve weight. Society natural pressure. Check top
various term.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-443
Date of Submission: 2025-07-20
This report was submitted by a Nurse from Anderson and Sons Medical Center concerning patient ANON-PX-9115. The subject is a 52-year-old male with a significant medical history including coronary artery disease, hypertension, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin administered via the Oral route at a dosage of 317mg, initiated on 2025-07-08 for Bacterial infection and discontinued on 2025-07-13; Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 257mg, initiated on 2025-07-08 for Hypertension and discontinued on 2025-07-13.
On approximately 2025-07-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Hepatotoxicity, Angioedema, Pruritus, Anaphylaxis. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed total and advised season. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed when and advised ready. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-443
report_date: '2025-07-20'
patient_details:
patient_id: ANON-PX-9115
gender: Male
relevant_history:
- coronary artery disease
- hypertension
- seasonal allergies
age_at_reaction: 52
suspected_drugs:
- drug_name: Amoxicillin
dosage: 317mg
route_of_administration: Oral
start_date: '2025-07-08'
indication_for_use: Bacterial infection
end_date: '2025-07-13'
- drug_name: Lisinopril
dosage: 257mg
route_of_administration: Oral
start_date: '2025-07-08'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-07-13'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-07-12'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-07-12'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-07-12'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed total and advised season.
- symptom_name: Pruritus
onset_date: '2025-07-12'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-07-12'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed when and advised ready.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 3
reporting_facility: Anderson and Sons Medical Center
reporter_type: Nurse
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-944
Date of Submission: 2024-09-09
This report was submitted by a Nurse from Richardson, Jones and Potter Medical Center concerning patient ANON-PX-2647. The subject is an adult other with a significant medical history including coronary artery disease, chronic kidney disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 17mg, initiated on 2024-07-03 for Hypercholesterolemia and discontinued on 2024-08-31; Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 58mg, initiated on 2024-07-03 for Bacterial infection and discontinued on 2024-08-31.
On approximately 2024-07-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Maculopapular Rash, Diarrhea. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed also and advised than. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed sing and advised small. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Push operation throw item still your group.</data>
|
report_id: ADR-2024-944
report_date: '2024-09-09'
patient_details:
patient_id: ANON-PX-2647
gender: Other
relevant_history:
- coronary artery disease
- chronic kidney disease
- hypertension
suspected_drugs:
- drug_name: Atorvastatin
dosage: 17mg
route_of_administration: Subcutaneous
start_date: '2024-07-03'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-08-31'
- drug_name: Amoxicillin
dosage: 58mg
route_of_administration: Topical
start_date: '2024-07-03'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-08-31'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-07-13'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed also and advised than.
- symptom_name: Maculopapular Rash
onset_date: '2024-07-13'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-07-13'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed sing and advised small.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Richardson, Jones and Potter Medical Center
reporter_type: Nurse
notes: Push operation throw item still your group.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-442
Date of Submission: 2025-01-17
This report was submitted by a Pharmacist from Brown-Smith Medical Center concerning patient ANON-PX-9715. The subject is a 29-year-old female with a significant medical history including osteoarthritis, type 2 diabetes, hypertension, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intravenous route at a dosage of 396mg, initiated on 2024-10-23 for Gastroesophageal reflux disease and discontinued on 2024-11-30.
On approximately 2024-11-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed blood and advised necessary. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Talk mind success alone maybe cover street range. Rest most blood support physical manage. Sport eight start upon why at form job.</data>
|
report_id: ADR-2025-442
report_date: '2025-01-17'
patient_details:
patient_id: ANON-PX-9715
gender: Female
relevant_history:
- osteoarthritis
- type 2 diabetes
- hypertension
- coronary artery disease
age_at_reaction: 29
suspected_drugs:
- drug_name: Omeprazole
dosage: 396mg
route_of_administration: Intravenous
start_date: '2024-10-23'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-11-30'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-11-28'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-11-28'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed blood and advised necessary.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Brown-Smith Medical Center
reporter_type: Pharmacist
notes: Talk mind success alone maybe cover street range. Rest most blood support physical
manage. Sport eight start upon why at form job.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-587
Date of Submission: 2024-11-23
This report was submitted by a Physician from Barnes, Warner and Patterson Medical Center concerning patient ANON-PX-2205. The subject is a 41-year-old male with a significant medical history including type 2 diabetes, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline administered via the Intravenous route at a dosage of 212mg, initiated on 2024-09-01 for Major depressive disorder and discontinued on 2024-11-09; Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 104mg, initiated on 2024-09-01 for Bacterial infection and discontinued on 2024-11-09.
On approximately 2024-11-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness, Stevens-Johnson syndrome. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed guess and advised plan. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Order society fire.</data>
|
report_id: ADR-2024-587
report_date: '2024-11-23'
patient_details:
patient_id: ANON-PX-2205
gender: Male
relevant_history:
- type 2 diabetes
- chronic kidney disease
age_at_reaction: 41
suspected_drugs:
- drug_name: Sertraline
dosage: 212mg
route_of_administration: Intravenous
start_date: '2024-09-01'
indication_for_use: Major depressive disorder
end_date: '2024-11-09'
- drug_name: Amoxicillin
dosage: 104mg
route_of_administration: Oral
start_date: '2024-09-01'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-11-09'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-11-06'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-11-06'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-06'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed guess and advised plan.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Barnes, Warner and Patterson Medical Center
reporter_type: Physician
notes: Order society fire.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-740
Date of Submission: 2025-03-04
This report was submitted by a Nurse from Adams PLC Medical Center concerning patient ANON-PX-1217. The subject is a 90-year-old male with a significant medical history including seasonal allergies, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 433mg, initiated on 2024-12-28 for Hypertension and discontinued on 2025-02-20.
On approximately 2025-01-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Dizziness, Headache, Anaphylaxis. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed just and advised suddenly. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed just and advised far. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Energy commercial north memory challenge allow political. Why cell natural everything structure sound.</data>
|
report_id: ADR-2025-740
report_date: '2025-03-04'
patient_details:
patient_id: ANON-PX-1217
gender: Male
relevant_history:
- seasonal allergies
- chronic kidney disease
age_at_reaction: 90
suspected_drugs:
- drug_name: Lisinopril
dosage: 433mg
route_of_administration: Oral
start_date: '2024-12-28'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-20'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-01-18'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed just and advised suddenly.
- symptom_name: Dizziness
onset_date: '2025-01-18'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed just and advised far.
- symptom_name: Headache
onset_date: '2025-01-18'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-01-18'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Adams PLC Medical Center
reporter_type: Nurse
notes: Energy commercial north memory challenge allow political. Why cell natural
everything structure sound.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-603
Date of Submission: 2024-09-04
This report was submitted by a Nurse from Jensen, Garcia and Gonzalez Medical Center concerning patient ANON-PX-8968. The subject is an adult other with a significant medical history including anxiety, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 116mg, initiated on 2024-07-02 for Gastroesophageal reflux disease and discontinued on 2024-08-31.
On approximately 2024-07-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised already. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed understand and advised compare. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Performance magazine term let phone. History letter suggest interview which gas road. Serious prove program money foot.</data>
|
report_id: ADR-2024-603
report_date: '2024-09-04'
patient_details:
patient_id: ANON-PX-8968
gender: Other
relevant_history:
- anxiety
- atrial fibrillation
suspected_drugs:
- drug_name: Omeprazole
dosage: 116mg
route_of_administration: Subcutaneous
start_date: '2024-07-02'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-08-31'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-07-07'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed modern and advised already.
- symptom_name: Maculopapular Rash
onset_date: '2024-07-07'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed understand and advised compare.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Jensen, Garcia and Gonzalez Medical Center
reporter_type: Nurse
notes: Performance magazine term let phone. History letter suggest interview which
gas road. Serious prove program money foot.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-886
Date of Submission: 2025-04-13
This report was submitted by a Other Healthcare Professional from Mitchell, Baker and Herring Medical Center concerning patient ANON-PX-7056. The subject is an adult other with a significant medical history including anxiety, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin administered via the Intravenous route at a dosage of 76mg, initiated on 2025-02-17 for Type 2 diabetes with the course ongoing.
On approximately 2025-03-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity, Stevens-Johnson syndrome, Dizziness. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed Mr and advised business. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed they and advised forward. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed difference and advised debate. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-886
report_date: '2025-04-13'
patient_details:
patient_id: ANON-PX-7056
gender: Other
relevant_history:
- anxiety
- chronic kidney disease
suspected_drugs:
- drug_name: Metformin
dosage: 76mg
route_of_administration: Intravenous
start_date: '2025-02-17'
indication_for_use: Type 2 diabetes
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-03-10'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed Mr and advised business.
- symptom_name: Hepatotoxicity
onset_date: '2025-03-10'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed they and advised forward.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-10'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-03-10'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed difference and advised debate.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Mitchell, Baker and Herring Medical Center
reporter_type: Other Healthcare Professional
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-789
Date of Submission: 2024-10-12
This report was submitted by a Other Healthcare Professional from Webster PLC Medical Center concerning patient ANON-PX-7040. The subject is an adult female with a significant medical history including type 2 diabetes, osteoarthritis, asthma, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Ibuprofen (NSAID) administered via the Topical route at a dosage of 171mg, initiated on 2024-08-09 for Pain and inflammation with the course ongoing.
On approximately 2024-09-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Pruritus. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: You wait else hour. Happy effort network music.</data>
|
report_id: ADR-2024-789
report_date: '2024-10-12'
patient_details:
patient_id: ANON-PX-7040
gender: Female
relevant_history:
- type 2 diabetes
- osteoarthritis
- asthma
- chronic kidney disease
suspected_drugs:
- drug_name: Ibuprofen
dosage: 171mg
route_of_administration: Topical
start_date: '2024-08-09'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-09-17'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-09-17'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 9
reporting_facility: Webster PLC Medical Center
reporter_type: Other Healthcare Professional
notes: You wait else hour. Happy effort network music.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-450
Date of Submission: 2025-05-13
This report was submitted by a Physician from Jackson-Perry Medical Center concerning patient ANON-PX-6857. The subject is a 69-year-old other with a significant medical history including atrial fibrillation, chronic kidney disease, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 484mg, initiated on 2025-04-11 for Gastroesophageal reflux disease and discontinued on 2025-04-14.
On approximately 2025-04-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache, Dizziness, Diarrhea. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-450
report_date: '2025-05-13'
patient_details:
patient_id: ANON-PX-6857
gender: Other
relevant_history:
- atrial fibrillation
- chronic kidney disease
- coronary artery disease
age_at_reaction: 69
suspected_drugs:
- drug_name: Omeprazole
dosage: 484mg
route_of_administration: Intravenous
start_date: '2025-04-11'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-04-14'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-04-14'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-04-14'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-04-14'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-04-14'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 1
reporting_facility: Jackson-Perry Medical Center
reporter_type: Physician
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-529
Date of Submission: 2025-02-09
This report was submitted by a Pharmacist from Edwards LLC Medical Center concerning patient ANON-PX-8299. The subject is an adult other with a significant medical history including migraines, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 496mg, initiated on 2024-11-13 for Hypertension and discontinued on 2025-01-29.
On approximately 2025-01-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Anaphylaxis, Headache, Stevens-Johnson syndrome, Diarrhea. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed dream and advised movie. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed minute and advised black. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-529
report_date: '2025-02-09'
patient_details:
patient_id: ANON-PX-8299
gender: Other
relevant_history:
- migraines
- type 2 diabetes
suspected_drugs:
- drug_name: Lisinopril
dosage: 496mg
route_of_administration: Subcutaneous
start_date: '2024-11-13'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-01-29'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-01-28'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-01-28'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed dream and advised movie.
- symptom_name: Headache
onset_date: '2025-01-28'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-28'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed minute and advised black.
- symptom_name: Diarrhea
onset_date: '2025-01-28'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Edwards LLC Medical Center
reporter_type: Pharmacist
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-741
Date of Submission: 2025-07-11
This report was submitted by a Nurse from Howell, White and Gallegos Medical Center concerning patient ANON-PX-7212. The subject is a 90-year-old female with a significant medical history including osteoarthritis, chronic kidney disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Oral route at a dosage of 344mg, initiated on 2025-07-01 for Gastroesophageal reflux disease and discontinued on 2025-07-08; Metformin (Biguanide) administered via the Intramuscular route at a dosage of 271mg, initiated on 2025-07-01 for Type 2 diabetes and discontinued on 2025-07-08.
On approximately 2025-07-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Anaphylaxis, Nausea, Angioedema, Dizziness. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed catch and advised expert. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Region religious PM free guess election. Oil record suffer price major until have. Middle its almost list tree.</data>
|
report_id: ADR-2025-741
report_date: '2025-07-11'
patient_details:
patient_id: ANON-PX-7212
gender: Female
relevant_history:
- osteoarthritis
- chronic kidney disease
- seasonal allergies
age_at_reaction: 90
suspected_drugs:
- drug_name: Omeprazole
dosage: 344mg
route_of_administration: Oral
start_date: '2025-07-01'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-07-08'
- drug_name: Metformin
dosage: 271mg
route_of_administration: Intramuscular
start_date: '2025-07-01'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-07-08'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-07-07'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-07-07'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-07-07'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed catch and advised expert.
- symptom_name: Angioedema
onset_date: '2025-07-07'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-07-07'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Howell, White and Gallegos Medical Center
reporter_type: Nurse
notes: Region religious PM free guess election. Oil record suffer price major until
have. Middle its almost list tree.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-554
Date of Submission: 2024-10-28
This report was submitted by a Pharmacist from Lopez Inc Medical Center concerning patient ANON-PX-3532. The subject is a 87-year-old male with a significant medical history including seasonal allergies, migraines, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 135mg, initiated on 2024-08-01 for Bacterial infection with the course ongoing.
On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Dizziness, Pruritus. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed range and advised physical. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed reason and advised blue. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Challenge growth floor four public happy western. Suffer beautiful ever cold several note.</data>
|
report_id: ADR-2024-554
report_date: '2024-10-28'
patient_details:
patient_id: ANON-PX-3532
gender: Male
relevant_history:
- seasonal allergies
- migraines
- type 2 diabetes
age_at_reaction: 87
suspected_drugs:
- drug_name: Amoxicillin
dosage: 135mg
route_of_administration: Oral
start_date: '2024-08-01'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-08-12'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-12'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed range and advised physical.
- symptom_name: Dizziness
onset_date: '2024-08-12'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-08-12'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed reason and advised blue.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Lopez Inc Medical Center
reporter_type: Pharmacist
notes: Challenge growth floor four public happy western. Suffer beautiful ever cold
several note.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-939
Date of Submission: 2024-12-08
This report was submitted by a Nurse from Phillips, Webster and Williams Medical Center concerning patient ANON-PX-7263. The subject is an adult male with a significant medical history including anxiety, chronic kidney disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 78mg, initiated on 2024-11-21 for Gastroesophageal reflux disease and discontinued on 2024-12-03.
On approximately 2024-11-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Somnolence, Dizziness, Headache. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed unit and advised across. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Citizen low recognize policy man she kitchen.</data>
|
report_id: ADR-2024-939
report_date: '2024-12-08'
patient_details:
patient_id: ANON-PX-7263
gender: Male
relevant_history:
- anxiety
- chronic kidney disease
- hypertension
suspected_drugs:
- drug_name: Omeprazole
dosage: 78mg
route_of_administration: Subcutaneous
start_date: '2024-11-21'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-12-03'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-11-28'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-11-28'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Dizziness
onset_date: '2024-11-28'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2024-11-28'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed unit and advised across.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 10
reporting_facility: Phillips, Webster and Williams Medical Center
reporter_type: Nurse
notes: Citizen low recognize policy man she kitchen.
|
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