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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-2025-659
Date of Submission: 2025-05-29
This report was submitted by a Other Healthcare Professional from Sanders LLC Medical Center concerning patient ANON-PX-7462. The subject is a 28-year-old other with a significant medical history including asthma, atrial fibrillation, 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): Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 108mg, initiated on 2025-04-21 for Neuropathic pain and discontinued on 2025-05-25.
On approximately 2025-05-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache, Diarrhea. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. 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 '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: Back small foot drug. Information project future place. Use little event those hair.</data>
|
report_id: ADR-2025-659
report_date: '2025-05-29'
patient_details:
patient_id: ANON-PX-7462
gender: Other
relevant_history:
- asthma
- atrial fibrillation
- type 2 diabetes
- chronic kidney disease
age_at_reaction: 28
suspected_drugs:
- drug_name: Gabapentin
dosage: 108mg
route_of_administration: Intravenous
start_date: '2025-04-21'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-05-25'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-05-25'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-05-25'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-05-25'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Sanders LLC Medical Center
reporter_type: Other Healthcare Professional
notes: Back small foot drug. Information project future place. Use little event those
hair.
|
<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-2025-880
Date of Submission: 2025-08-06
This report was submitted by a Other Healthcare Professional from Harper, Kane and Caldwell Medical Center concerning patient ANON-PX-7904. The subject is an adult female with a significant medical history including 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): Warfarin (Anticoagulant) administered via the Oral route at a dosage of 113mg, initiated on 2025-06-05 for Thromboembolism prevention and discontinued on 2025-07-16; Ibuprofen (NSAID) administered via the Topical route at a dosage of 213mg, initiated on 2025-06-05 for Pain and inflammation and discontinued on 2025-07-16.
On approximately 2025-07-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Pruritus, Angioedema. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. 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 'Recovering'. The Pruritus was classified as Mild 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. 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 8 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.
</data>
|
report_id: ADR-2025-880
report_date: '2025-08-06'
patient_details:
patient_id: ANON-PX-7904
gender: Female
relevant_history:
- coronary artery disease
- chronic kidney disease
suspected_drugs:
- drug_name: Warfarin
dosage: 113mg
route_of_administration: Oral
start_date: '2025-06-05'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-07-16'
- drug_name: Ibuprofen
dosage: 213mg
route_of_administration: Topical
start_date: '2025-06-05'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-07-16'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-07-03'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-07-03'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-07-03'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-07-03'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Harper, Kane and Caldwell 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-2025-968
Date of Submission: 2025-04-26
This report was submitted by a Physician from Kent-Coleman Medical Center concerning patient ANON-PX-6856. The subject is an adult female with a significant medical history including anxiety, asthma, 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): Atorvastatin administered via the Topical route at a dosage of 296mg, initiated on 2025-02-27 for Hypercholesterolemia and discontinued on 2025-04-16.
On approximately 2025-03-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea, Angioedema, Anaphylaxis, Hepatotoxicity. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed network and advised north. 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 'Not Recovered'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity 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 9 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: Follow now drug seek leave leg such myself.</data>
|
report_id: ADR-2025-968
report_date: '2025-04-26'
patient_details:
patient_id: ANON-PX-6856
gender: Female
relevant_history:
- anxiety
- asthma
- coronary artery disease
- type 2 diabetes
suspected_drugs:
- drug_name: Atorvastatin
dosage: 296mg
route_of_administration: Topical
start_date: '2025-02-27'
indication_for_use: Hypercholesterolemia
end_date: '2025-04-16'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-03-12'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed network and advised north.
- symptom_name: Nausea
onset_date: '2025-03-12'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-03-12'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2025-03-12'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-03-12'
severity: Mild
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Kent-Coleman Medical Center
reporter_type: Physician
notes: Follow now drug seek leave leg such myself.
|
<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-2025-765
Date of Submission: 2025-07-12
This report was submitted by a Nurse from Melendez, Martin and Payne Medical Center concerning patient ANON-PX-3527. The subject is a 89-year-old female with a significant medical history including asthma, 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 (ACE inhibitor) administered via the Intravenous route at a dosage of 28mg, initiated on 2025-06-12 for Hypertension and discontinued on 2025-07-09.
On approximately 2025-07-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Maculopapular Rash, Somnolence. The Anaphylaxis was classified as Mild 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 'Not Recovered'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. 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 '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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Building such quickly deal. Cultural science scientist pressure.</data>
|
report_id: ADR-2025-765
report_date: '2025-07-12'
patient_details:
patient_id: ANON-PX-3527
gender: Female
relevant_history:
- asthma
- chronic kidney disease
- seasonal allergies
age_at_reaction: 89
suspected_drugs:
- drug_name: Lisinopril
dosage: 28mg
route_of_administration: Intravenous
start_date: '2025-06-12'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-07-09'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-07-09'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-07-09'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-07-09'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-07-09'
severity: Severe
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Melendez, Martin and Payne Medical Center
reporter_type: Nurse
notes: Building such quickly deal. Cultural science scientist pressure.
|
<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-2025-629
Date of Submission: 2025-05-09
This report was submitted by a Physician from Smith and Sons Medical Center concerning patient ANON-PX-7540. The subject is an adult male with a significant medical history including chronic kidney disease, type 2 diabetes, 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 administered via the Intravenous route at a dosage of 57mg, initiated on 2025-04-08 for Thromboembolism prevention and discontinued on 2025-05-03; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 426mg, initiated on 2025-04-08 for Bacterial infection and discontinued on 2025-05-03.
On approximately 2025-05-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Somnolence, Stevens-Johnson syndrome. The Pruritus 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 Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild 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 3 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: Cell every professional. Personal cause charge cultural. Result tonight far arm.</data>
|
report_id: ADR-2025-629
report_date: '2025-05-09'
patient_details:
patient_id: ANON-PX-7540
gender: Male
relevant_history:
- chronic kidney disease
- type 2 diabetes
- osteoarthritis
suspected_drugs:
- drug_name: Warfarin
dosage: 57mg
route_of_administration: Intravenous
start_date: '2025-04-08'
indication_for_use: Thromboembolism prevention
end_date: '2025-05-03'
- drug_name: Amoxicillin
dosage: 426mg
route_of_administration: Intramuscular
start_date: '2025-04-08'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-05-03'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-05-01'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-05-01'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-01'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Smith and Sons Medical Center
reporter_type: Physician
notes: Cell every professional. Personal cause charge cultural. Result tonight far
arm.
|
<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-2024-559
Date of Submission: 2024-10-23
This report was submitted by a Pharmacist from Middleton-Shelton Medical Center concerning patient ANON-PX-2427. The subject is an adult male with a significant medical history including migraines, anxiety, 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): Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 78mg, initiated on 2024-10-05 for Bacterial infection and discontinued on 2024-10-21.
On approximately 2024-10-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Maculopapular Rash, Diarrhea. 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 Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 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'. The Diarrhea was classified as Moderate 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 5 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: Itself position agreement hotel. Degree prove never before. Practice realize five watch whether.</data>
|
report_id: ADR-2024-559
report_date: '2024-10-23'
patient_details:
patient_id: ANON-PX-2427
gender: Male
relevant_history:
- migraines
- anxiety
- asthma
suspected_drugs:
- drug_name: Amoxicillin
dosage: 78mg
route_of_administration: Intravenous
start_date: '2024-10-05'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-10-21'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-09'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-10-09'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2024-10-09'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-10-09'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 5
reporting_facility: Middleton-Shelton Medical Center
reporter_type: Pharmacist
notes: Itself position agreement hotel. Degree prove never before. Practice realize
five watch whether.
|
<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-2025-480
Date of Submission: 2025-03-13
This report was submitted by a Patient from Nixon-Reyes Medical Center concerning patient ANON-PX-4185. The subject is a 36-year-old female with a significant medical history including seasonal allergies, hypertension, 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): Metformin (Biguanide) administered via the Intravenous route at a dosage of 470mg, initiated on 2025-01-05 for Type 2 diabetes and discontinued on 2025-02-25.
On approximately 2025-02-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Vomiting, 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 Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed performance and advised science. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. 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.
</data>
|
report_id: ADR-2025-480
report_date: '2025-03-13'
patient_details:
patient_id: ANON-PX-4185
gender: Female
relevant_history:
- seasonal allergies
- hypertension
- atrial fibrillation
- asthma
age_at_reaction: 36
suspected_drugs:
- drug_name: Metformin
dosage: 470mg
route_of_administration: Intravenous
start_date: '2025-01-05'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-02-25'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-02-24'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-24'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed performance and advised science.
- symptom_name: Dizziness
onset_date: '2025-02-24'
severity: Moderate
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Nixon-Reyes 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-2025-508
Date of Submission: 2025-01-21
This report was submitted by a Patient from Fisher, Smith and Francis Medical Center concerning patient ANON-PX-4291. The subject is a 80-year-old male with a significant medical history including seasonal allergies, 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 Subcutaneous route at a dosage of 197mg, initiated on 2024-11-03 for Neuropathic pain and discontinued on 2024-12-09; Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 489mg, initiated on 2024-11-03 for Gastroesophageal reflux disease and discontinued on 2024-12-09.
On approximately 2024-12-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Pruritus. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. 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 own and advised the. 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: Hair discuss suffer lose opportunity very drug.</data>
|
report_id: ADR-2025-508
report_date: '2025-01-21'
patient_details:
patient_id: ANON-PX-4291
gender: Male
relevant_history:
- seasonal allergies
- migraines
age_at_reaction: 80
suspected_drugs:
- drug_name: Gabapentin
dosage: 197mg
route_of_administration: Subcutaneous
start_date: '2024-11-03'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-12-09'
- drug_name: Omeprazole
dosage: 489mg
route_of_administration: Intravenous
start_date: '2024-11-03'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-12-09'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-12-02'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-12-02'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed own and advised the.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Fisher, Smith and Francis Medical Center
reporter_type: Patient
notes: Hair discuss suffer lose opportunity very drug.
|
<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-2024-656
Date of Submission: 2024-09-08
This report was submitted by a Physician from Monroe PLC Medical Center concerning patient ANON-PX-1037. The subject is a 46-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): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 36mg, initiated on 2024-06-11 for Pain and inflammation with the course ongoing.
On approximately 2024-07-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache, Pruritus. 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 Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed every and advised product. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Seat course few change.</data>
|
report_id: ADR-2024-656
report_date: '2024-09-08'
patient_details:
patient_id: ANON-PX-1037
gender: Male
relevant_history:
- osteoarthritis
- atrial fibrillation
- type 2 diabetes
- migraines
age_at_reaction: 46
suspected_drugs:
- drug_name: Ibuprofen
dosage: 36mg
route_of_administration: Intravenous
start_date: '2024-06-11'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-07-18'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2024-07-18'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed every and advised product.
- symptom_name: Pruritus
onset_date: '2024-07-18'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Monroe PLC Medical Center
reporter_type: Physician
notes: Seat course few change.
|
<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-2025-246
Date of Submission: 2025-05-20
This report was submitted by a Patient from Roberts Ltd Medical Center concerning patient ANON-PX-1576. The subject is an adult other with a significant medical history including type 2 diabetes, seasonal allergies, 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 Intramuscular route at a dosage of 277mg, initiated on 2025-04-05 for Pain and inflammation and discontinued on 2025-05-13.
On approximately 2025-04-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome, Somnolence. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed pull and advised various. 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 '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-2025-246
report_date: '2025-05-20'
patient_details:
patient_id: ANON-PX-1576
gender: Other
relevant_history:
- type 2 diabetes
- seasonal allergies
- atrial fibrillation
- osteoarthritis
suspected_drugs:
- drug_name: Ibuprofen
dosage: 277mg
route_of_administration: Intramuscular
start_date: '2025-04-05'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-05-13'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-04-27'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-27'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed pull and advised various.
- symptom_name: Somnolence
onset_date: '2025-04-27'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Roberts 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-2025-119
Date of Submission: 2025-07-22
This report was submitted by a Nurse from Lawrence Inc Medical Center concerning patient ANON-PX-7053. The subject is a 61-year-old other with a significant medical history including anxiety, 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): Metformin (Biguanide) administered via the Oral route at a dosage of 10mg, initiated on 2025-06-18 for Type 2 diabetes with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 260mg, initiated on 2025-06-18 for Major depressive disorder with the course ongoing.
On approximately 2025-06-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Somnolence, Vomiting, Angioedema, Maculopapular Rash. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed and and advised deal. 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 'Fatal'. The Vomiting was classified as Life-threatening 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 impact and advised professional. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed crime and advised from. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Feel the expect mother foreign radio bit. Themselves story goal firm dream today field.</data>
|
report_id: ADR-2025-119
report_date: '2025-07-22'
patient_details:
patient_id: ANON-PX-7053
gender: Other
relevant_history:
- anxiety
- coronary artery disease
- seasonal allergies
age_at_reaction: 61
suspected_drugs:
- drug_name: Metformin
dosage: 10mg
route_of_administration: Oral
start_date: '2025-06-18'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
- drug_name: Sertraline
dosage: 260mg
route_of_administration: Topical
start_date: '2025-06-18'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-06-19'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed and and advised deal.
- symptom_name: Somnolence
onset_date: '2025-06-19'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-06-19'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-06-19'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed impact and advised professional.
- symptom_name: Maculopapular Rash
onset_date: '2025-06-19'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed crime and advised from.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Lawrence Inc Medical Center
reporter_type: Nurse
notes: Feel the expect mother foreign radio bit. Themselves story goal firm dream
today field.
|
<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-2024-411
Date of Submission: 2024-09-10
This report was submitted by a Patient from Meadows, Lopez and Gomez Medical Center concerning patient ANON-PX-2789. The subject is a 56-year-old other with a significant medical history including atrial fibrillation, 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): Levothyroxine administered via the Topical route at a dosage of 470mg, initiated on 2024-06-12 for Hypothyroidism and discontinued on 2024-08-13; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 153mg, initiated on 2024-06-12 for Hypertension and discontinued on 2024-08-13.
On approximately 2024-08-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Somnolence, Vomiting. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 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 9 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.
Reporter's Narrative Summary: You best trouble course specific owner. Film picture hope sound court him name trial. Risk can stock open put.</data>
|
report_id: ADR-2024-411
report_date: '2024-09-10'
patient_details:
patient_id: ANON-PX-2789
gender: Other
relevant_history:
- atrial fibrillation
- chronic kidney disease
age_at_reaction: 56
suspected_drugs:
- drug_name: Levothyroxine
dosage: 470mg
route_of_administration: Topical
start_date: '2024-06-12'
indication_for_use: Hypothyroidism
end_date: '2024-08-13'
- drug_name: Lisinopril
dosage: 153mg
route_of_administration: Intravenous
start_date: '2024-06-12'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-08-13'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-08-05'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-08-05'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-08-05'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 9
reporting_facility: Meadows, Lopez and Gomez Medical Center
reporter_type: Patient
notes: You best trouble course specific owner. Film picture hope sound court him name
trial. Risk can stock open put.
|
<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-2025-764
Date of Submission: 2025-05-28
This report was submitted by a Pharmacist from Hicks Inc Medical Center concerning patient ANON-PX-9201. The subject is a 62-year-old female with a significant medical history including 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): Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 285mg, initiated on 2025-03-16 for Bacterial infection with the course ongoing.
On approximately 2025-05-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Pruritus. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed film and advised respond. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed summer and advised as. The current patient status regarding this symptom is 'Unknown'. 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 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-2025-764
report_date: '2025-05-28'
patient_details:
patient_id: ANON-PX-9201
gender: Female
relevant_history:
- type 2 diabetes
- migraines
age_at_reaction: 62
suspected_drugs:
- drug_name: Amoxicillin
dosage: 285mg
route_of_administration: Intramuscular
start_date: '2025-03-16'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-05-19'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed film and advised respond.
- symptom_name: Headache
onset_date: '2025-05-19'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed summer and advised as.
- symptom_name: Pruritus
onset_date: '2025-05-19'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Hicks 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-2025-159
Date of Submission: 2025-04-16
This report was submitted by a Pharmacist from Davis Ltd Medical Center concerning patient ANON-PX-3400. The subject is a 55-year-old female with a significant medical history including migraines, coronary artery disease, osteoarthritis, 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 (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 377mg, initiated on 2025-02-16 for Bacterial infection and discontinued on 2025-04-02; Sertraline (SSRI) administered via the Oral route at a dosage of 68mg, initiated on 2025-02-16 for Major depressive disorder and discontinued on 2025-04-02.
On approximately 2025-03-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Pruritus, Dizziness, Anaphylaxis. 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 Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed she and advised talk. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed wait and advised matter. 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 'Recovered'. The Anaphylaxis 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 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: Decision dog fish body. Pull development price spring at child. Least democratic significant while. Boy every them fast.</data>
|
report_id: ADR-2025-159
report_date: '2025-04-16'
patient_details:
patient_id: ANON-PX-3400
gender: Female
relevant_history:
- migraines
- coronary artery disease
- osteoarthritis
- seasonal allergies
age_at_reaction: 55
suspected_drugs:
- drug_name: Amoxicillin
dosage: 377mg
route_of_administration: Subcutaneous
start_date: '2025-02-16'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-04-02'
- drug_name: Sertraline
dosage: 68mg
route_of_administration: Oral
start_date: '2025-02-16'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-04-02'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-18'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-03-18'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed she and advised talk.
- symptom_name: Pruritus
onset_date: '2025-03-18'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed wait and advised matter.
- symptom_name: Dizziness
onset_date: '2025-03-18'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-03-18'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 10
reporting_facility: Davis Ltd Medical Center
reporter_type: Pharmacist
notes: Decision dog fish body. Pull development price spring at child. Least democratic
significant while. Boy every them fast.
|
<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-2024-214
Date of Submission: 2024-08-22
This report was submitted by a Nurse from Smith PLC Medical Center concerning patient ANON-PX-6807. The subject is a 49-year-old male with a significant medical history including type 2 diabetes, coronary artery 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): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 104mg, initiated on 2024-08-06 for Hypertension and discontinued on 2024-08-20; Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 341mg, initiated on 2024-08-06 for Bacterial infection and discontinued on 2024-08-20.
On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Angioedema, Maculopapular Rash, Vomiting. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed right and advised for. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed sure and advised huge. The current patient status regarding this symptom is 'Fatal'. The Vomiting 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.
</data>
|
report_id: ADR-2024-214
report_date: '2024-08-22'
patient_details:
patient_id: ANON-PX-6807
gender: Male
relevant_history:
- type 2 diabetes
- coronary artery disease
- hypertension
age_at_reaction: 49
suspected_drugs:
- drug_name: Lisinopril
dosage: 104mg
route_of_administration: Topical
start_date: '2024-08-06'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-08-20'
- drug_name: Amoxicillin
dosage: 341mg
route_of_administration: Topical
start_date: '2024-08-06'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-08-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-08-12'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-08-12'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed right and advised for.
- symptom_name: Maculopapular Rash
onset_date: '2024-08-12'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed sure and advised huge.
- symptom_name: Vomiting
onset_date: '2024-08-12'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Smith 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-2025-715
Date of Submission: 2025-03-23
This report was submitted by a Physician from Higgins, Cruz and Cummings Medical Center concerning patient ANON-PX-5697. The subject is an adult other 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): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 13mg, initiated on 2025-01-04 for Hypertension with the course ongoing.
On approximately 2025-01-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Somnolence, Hepatotoxicity, Headache. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed argue and advised base. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening 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 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'.
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.
</data>
|
report_id: ADR-2025-715
report_date: '2025-03-23'
patient_details:
patient_id: ANON-PX-5697
gender: Other
relevant_history:
- migraines
- anxiety
suspected_drugs:
- drug_name: Lisinopril
dosage: 13mg
route_of_administration: Topical
start_date: '2025-01-04'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-01-27'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed argue and advised base.
- symptom_name: Angioedema
onset_date: '2025-01-27'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-01-27'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-01-27'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2025-01-27'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Higgins, Cruz and Cummings 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-2024-854
Date of Submission: 2024-10-25
This report was submitted by a Pharmacist from Banks-Ewing Medical Center concerning patient ANON-PX-8883. The subject is a 65-year-old female with a significant medical history including asthma, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 145mg, initiated on 2024-08-06 for Major depressive disorder and discontinued on 2024-10-13.
On approximately 2024-09-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Somnolence. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed race and advised measure. 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 'Recovering'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed real and advised soon. 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Piece society culture industry. Tend media charge data consider against pass. Do six available protect quality reason point.</data>
|
report_id: ADR-2024-854
report_date: '2024-10-25'
patient_details:
patient_id: ANON-PX-8883
gender: Female
relevant_history:
- asthma
- migraines
- hypertension
age_at_reaction: 65
suspected_drugs:
- drug_name: Sertraline
dosage: 145mg
route_of_administration: Topical
start_date: '2024-08-06'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-10-13'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-09-28'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed race and advised measure.
- symptom_name: Nausea
onset_date: '2024-09-28'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-09-28'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed real and advised soon.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Banks-Ewing Medical Center
reporter_type: Pharmacist
notes: Piece society culture industry. Tend media charge data consider against pass.
Do six available protect quality reason point.
|
<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-2025-826
Date of Submission: 2025-02-23
This report was submitted by a Other Healthcare Professional from Hernandez-Carpenter Medical Center concerning patient ANON-PX-3460. The subject is a 24-year-old female 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): Sertraline (SSRI) administered via the Oral route at a dosage of 421mg, initiated on 2024-12-26 for Major depressive disorder and discontinued on 2025-02-18.
On approximately 2025-02-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Vomiting. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting 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. 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: Surface theory remain star call. What day last bank.</data>
|
report_id: ADR-2025-826
report_date: '2025-02-23'
patient_details:
patient_id: ANON-PX-3460
gender: Female
relevant_history:
- chronic kidney disease
- atrial fibrillation
- osteoarthritis
age_at_reaction: 24
suspected_drugs:
- drug_name: Sertraline
dosage: 421mg
route_of_administration: Oral
start_date: '2024-12-26'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-02-18'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-02-02'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-02'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Hernandez-Carpenter Medical Center
reporter_type: Other Healthcare Professional
notes: Surface theory remain star call. What day last bank.
|
<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-2025-775
Date of Submission: 2025-07-02
This report was submitted by a Pharmacist from Farmer-Wood Medical Center concerning patient ANON-PX-6568. The subject is an adult female with a significant medical history including seasonal allergies, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 119mg, initiated on 2025-05-03 for Major depressive disorder and discontinued on 2025-05-31.
On approximately 2025-05-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Pruritus, Angioedema, Headache. The Anaphylaxis was classified as Mild 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 Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed agreement and advised Congress. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed relate and advised old. 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 '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: Pay service reach. State hit peace four.</data>
|
report_id: ADR-2025-775
report_date: '2025-07-02'
patient_details:
patient_id: ANON-PX-6568
gender: Female
relevant_history:
- seasonal allergies
- chronic kidney disease
- coronary artery disease
suspected_drugs:
- drug_name: Sertraline
dosage: 119mg
route_of_administration: Topical
start_date: '2025-05-03'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-05-31'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-05-04'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-05-04'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-05-04'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed agreement and advised Congress.
- symptom_name: Angioedema
onset_date: '2025-05-04'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed relate and advised old.
- symptom_name: Headache
onset_date: '2025-05-04'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 5
reporting_facility: Farmer-Wood Medical Center
reporter_type: Pharmacist
notes: Pay service reach. State hit peace four.
|
<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-2024-443
Date of Submission: 2024-12-09
This report was submitted by a Physician from Murphy, Flores and Swanson Medical Center concerning patient ANON-PX-1966. The subject is a 64-year-old male with a significant medical history including asthma, 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): Levothyroxine administered via the Subcutaneous route at a dosage of 179mg, initiated on 2024-11-26 for Hypothyroidism and discontinued on 2024-12-08; Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 461mg, initiated on 2024-11-26 for Neuropathic pain and discontinued on 2024-12-08.
On approximately 2024-12-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Maculopapular Rash. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed east and advised top. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate 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 8 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: Prepare prevent city still best century whom perform.</data>
|
report_id: ADR-2024-443
report_date: '2024-12-09'
patient_details:
patient_id: ANON-PX-1966
gender: Male
relevant_history:
- asthma
- osteoarthritis
age_at_reaction: 64
suspected_drugs:
- drug_name: Levothyroxine
dosage: 179mg
route_of_administration: Subcutaneous
start_date: '2024-11-26'
indication_for_use: Hypothyroidism
end_date: '2024-12-08'
- drug_name: Gabapentin
dosage: 461mg
route_of_administration: Intramuscular
start_date: '2024-11-26'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-12-08'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-12-06'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed east and advised top.
- symptom_name: Maculopapular Rash
onset_date: '2024-12-06'
severity: Moderate
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Murphy, Flores and Swanson Medical Center
reporter_type: Physician
notes: Prepare prevent city still best century whom perform.
|
<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-2025-910
Date of Submission: 2025-05-30
This report was submitted by a Pharmacist from Yang-Rice Medical Center concerning patient ANON-PX-5321. The subject is a 78-year-old other with a significant medical history including seasonal allergies, 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): Amoxicillin administered via the Intramuscular route at a dosage of 480mg, initiated on 2025-03-30 for Bacterial infection and discontinued on 2025-05-18.
On approximately 2025-04-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Stevens-Johnson syndrome, Anaphylaxis, Dizziness, Hepatotoxicity. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. 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 'Recovered'. The Anaphylaxis 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 current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity 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 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-2025-910
report_date: '2025-05-30'
patient_details:
patient_id: ANON-PX-5321
gender: Other
relevant_history:
- seasonal allergies
- asthma
- atrial fibrillation
age_at_reaction: 78
suspected_drugs:
- drug_name: Amoxicillin
dosage: 480mg
route_of_administration: Intramuscular
start_date: '2025-03-30'
indication_for_use: Bacterial infection
end_date: '2025-05-18'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-04-29'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-29'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-04-29'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-04-29'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-04-29'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 10
reporting_facility: Yang-Rice 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-2024-914
Date of Submission: 2024-12-04
This report was submitted by a Patient from Garza-Peterson Medical Center concerning patient ANON-PX-7285. The subject is a 24-year-old female with a significant medical history including hypertension, migraines, 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 Oral route at a dosage of 407mg, initiated on 2024-11-11 for Gastroesophageal reflux disease and discontinued on 2024-11-29; Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 455mg, initiated on 2024-11-11 for Thromboembolism prevention and discontinued on 2024-11-29.
On approximately 2024-11-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Diarrhea, Somnolence, Stevens-Johnson syndrome. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed project and advised never. 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 college and advised source. 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'. The Stevens-Johnson syndrome was classified as Moderate 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 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: Establish mouth soon special entire. Worker specific wear.</data>
|
report_id: ADR-2024-914
report_date: '2024-12-04'
patient_details:
patient_id: ANON-PX-7285
gender: Female
relevant_history:
- hypertension
- migraines
- coronary artery disease
age_at_reaction: 24
suspected_drugs:
- drug_name: Omeprazole
dosage: 407mg
route_of_administration: Oral
start_date: '2024-11-11'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-11-29'
- drug_name: Warfarin
dosage: 455mg
route_of_administration: Intramuscular
start_date: '2024-11-11'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-11-29'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-11-29'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed project and advised never.
- symptom_name: Diarrhea
onset_date: '2024-11-29'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed college and advised source.
- symptom_name: Somnolence
onset_date: '2024-11-29'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-29'
severity: Moderate
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Garza-Peterson Medical Center
reporter_type: Patient
notes: Establish mouth soon special entire. Worker specific wear.
|
<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-2025-500
Date of Submission: 2025-07-04
This report was submitted by a Patient from Moreno, Chung and Brown Medical Center concerning patient ANON-PX-9480. The subject is a 34-year-old male 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): Gabapentin administered via the Oral route at a dosage of 465mg, initiated on 2025-04-05 for Neuropathic pain and discontinued on 2025-06-11.
On approximately 2025-06-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Maculopapular Rash, Hepatotoxicity. The Somnolence 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 Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed newspaper and advised poor. 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 Hepatotoxicity was classified as Life-threatening 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: Everything quickly cost position approach. Tv fact probably bank seek score add song. Respond fact card situation.</data>
|
report_id: ADR-2025-500
report_date: '2025-07-04'
patient_details:
patient_id: ANON-PX-9480
gender: Male
relevant_history:
- chronic kidney disease
- asthma
- migraines
age_at_reaction: 34
suspected_drugs:
- drug_name: Gabapentin
dosage: 465mg
route_of_administration: Oral
start_date: '2025-04-05'
indication_for_use: Neuropathic pain
end_date: '2025-06-11'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-06-03'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-06-03'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed newspaper and advised poor.
- symptom_name: Maculopapular Rash
onset_date: '2025-06-03'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-06-03'
severity: Life-threatening
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Moreno, Chung and Brown Medical Center
reporter_type: Patient
notes: Everything quickly cost position approach. Tv fact probably bank seek score
add song. Respond fact card situation.
|
<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-2025-693
Date of Submission: 2025-04-04
This report was submitted by a Patient from Collins PLC Medical Center concerning patient ANON-PX-4973. The subject is a 41-year-old female with a significant medical history including hypertension, 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 (Anticonvulsant) administered via the Subcutaneous route at a dosage of 404mg, initiated on 2025-01-29 for Neuropathic pain and discontinued on 2025-03-24.
On approximately 2025-03-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Hepatotoxicity, Angioedema, Headache, Stevens-Johnson syndrome. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed agree and advised paper. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed woman and advised little. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild 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 'Recovered'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed throughout and advised always. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-693
report_date: '2025-04-04'
patient_details:
patient_id: ANON-PX-4973
gender: Female
relevant_history:
- hypertension
- atrial fibrillation
- osteoarthritis
age_at_reaction: 41
suspected_drugs:
- drug_name: Gabapentin
dosage: 404mg
route_of_administration: Subcutaneous
start_date: '2025-01-29'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-03-24'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-03-17'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed agree and advised paper.
- symptom_name: Hepatotoxicity
onset_date: '2025-03-17'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed woman and advised little.
- symptom_name: Angioedema
onset_date: '2025-03-17'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-03-17'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-17'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed throughout and advised always.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 7
reporting_facility: Collins PLC 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-2025-516
Date of Submission: 2025-03-20
This report was submitted by a Patient from Gonzales PLC Medical Center concerning patient ANON-PX-7542. The subject is a 64-year-old female with a significant medical history including type 2 diabetes, osteoarthritis, 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 Intramuscular route at a dosage of 459mg, initiated on 2025-02-06 for Hypertension and discontinued on 2025-02-28.
On approximately 2025-02-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea, Somnolence, Maculopapular Rash, Vomiting. The Hepatotoxicity 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 'Not Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed know and advised age. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Severe 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. This necessitated clinical intervention. The documented action was: Prescribed just and advised nature. The current patient status regarding this symptom is 'Unknown'.
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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Trouble share available word keep machine. State develop deep third prevent camera against about.</data>
|
report_id: ADR-2025-516
report_date: '2025-03-20'
patient_details:
patient_id: ANON-PX-7542
gender: Female
relevant_history:
- type 2 diabetes
- osteoarthritis
- seasonal allergies
age_at_reaction: 64
suspected_drugs:
- drug_name: Lisinopril
dosage: 459mg
route_of_administration: Intramuscular
start_date: '2025-02-06'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-28'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-02-20'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-20'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-02-20'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed know and advised age.
- symptom_name: Maculopapular Rash
onset_date: '2025-02-20'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-20'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed just and advised nature.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 9
reporting_facility: Gonzales PLC Medical Center
reporter_type: Patient
notes: Trouble share available word keep machine. State develop deep third prevent
camera against about.
|
<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-2024-328
Date of Submission: 2024-08-18
This report was submitted by a Pharmacist from Graham-Henderson Medical Center concerning patient ANON-PX-8317. The subject is a 49-year-old female 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): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 182mg, initiated on 2024-07-05 for Thromboembolism prevention and discontinued on 2024-08-13; Levothyroxine administered via the Intravenous route at a dosage of 169mg, initiated on 2024-07-05 for Hypothyroidism and discontinued on 2024-08-13.
On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Nausea, Diarrhea. 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 Nausea was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Diarrhea 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 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: Discussion less thousand fast early so. Capital cut American quickly member home during.</data>
|
report_id: ADR-2024-328
report_date: '2024-08-18'
patient_details:
patient_id: ANON-PX-8317
gender: Female
relevant_history:
- hypertension
- coronary artery disease
- chronic kidney disease
age_at_reaction: 49
suspected_drugs:
- drug_name: Warfarin
dosage: 182mg
route_of_administration: Intramuscular
start_date: '2024-07-05'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-08-13'
- drug_name: Levothyroxine
dosage: 169mg
route_of_administration: Intravenous
start_date: '2024-07-05'
indication_for_use: Hypothyroidism
end_date: '2024-08-13'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-08-12'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-08-12'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-08-12'
severity: Mild
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Graham-Henderson Medical Center
reporter_type: Pharmacist
notes: Discussion less thousand fast early so. Capital cut American quickly member
home during.
|
<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-2025-977
Date of Submission: 2025-01-28
This report was submitted by a Patient from Gould-Dunn Medical Center concerning patient ANON-PX-4281. The subject is a 69-year-old female with a significant medical history including type 2 diabetes, osteoarthritis, 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): Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 92mg, initiated on 2025-01-02 for Pain and inflammation and discontinued on 2025-01-12; Sertraline (SSRI) administered via the Intravenous route at a dosage of 298mg, initiated on 2025-01-02 for Major depressive disorder and discontinued on 2025-01-12.
On approximately 2025-01-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Anaphylaxis, Somnolence. The Pruritus 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. This necessitated clinical intervention. The documented action was: Prescribed human and advised door. The current patient status regarding this symptom is 'Not Recovered'. 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. 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: Probably dinner court yeah particularly. Garden myself benefit such situation current hold.</data>
|
report_id: ADR-2025-977
report_date: '2025-01-28'
patient_details:
patient_id: ANON-PX-4281
gender: Female
relevant_history:
- type 2 diabetes
- osteoarthritis
- chronic kidney disease
- hypertension
age_at_reaction: 69
suspected_drugs:
- drug_name: Ibuprofen
dosage: 92mg
route_of_administration: Intramuscular
start_date: '2025-01-02'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-01-12'
- drug_name: Sertraline
dosage: 298mg
route_of_administration: Intravenous
start_date: '2025-01-02'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-01-12'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-01-06'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-01-06'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed human and advised door.
- symptom_name: Somnolence
onset_date: '2025-01-06'
severity: Severe
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Gould-Dunn Medical Center
reporter_type: Patient
notes: Probably dinner court yeah particularly. Garden myself benefit such situation
current hold.
|
<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-2024-637
Date of Submission: 2024-10-21
This report was submitted by a Nurse from Smith, Pennington and Griffin Medical Center concerning patient ANON-PX-5757. The subject is a 73-year-old female with a significant medical history including seasonal allergies, 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): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 131mg, initiated on 2024-07-26 for Gastroesophageal reflux disease and discontinued on 2024-10-18.
On approximately 2024-09-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Headache. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed key and advised responsibility. 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 'Not Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed would and advised weight. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-637
report_date: '2024-10-21'
patient_details:
patient_id: ANON-PX-5757
gender: Female
relevant_history:
- seasonal allergies
- asthma
- chronic kidney disease
age_at_reaction: 73
suspected_drugs:
- drug_name: Omeprazole
dosage: 131mg
route_of_administration: Oral
start_date: '2024-07-26'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-10-18'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-09-07'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed key and advised responsibility.
- symptom_name: Nausea
onset_date: '2024-09-07'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-09-07'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed would and advised weight.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Smith, Pennington and Griffin 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-2025-798
Date of Submission: 2025-06-02
This report was submitted by a Physician from Alvarez, White and Wood Medical Center concerning patient ANON-PX-3726. The subject is a 70-year-old other with a significant medical history including asthma, osteoarthritis, 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 312mg, initiated on 2025-05-10 for Thromboembolism prevention with the course ongoing.
On approximately 2025-05-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Angioedema, Pruritus. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed democratic and advised experience. 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 'Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. 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 '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: World expect house partner. List inside car kind discover guy expert reality.</data>
|
report_id: ADR-2025-798
report_date: '2025-06-02'
patient_details:
patient_id: ANON-PX-3726
gender: Other
relevant_history:
- asthma
- osteoarthritis
- anxiety
age_at_reaction: 70
suspected_drugs:
- drug_name: Warfarin
dosage: 312mg
route_of_administration: Subcutaneous
start_date: '2025-05-10'
indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-05-25'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed democratic and advised experience.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-25'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-05-25'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-05-25'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 8
reporting_facility: Alvarez, White and Wood Medical Center
reporter_type: Physician
notes: World expect house partner. List inside car kind discover guy expert reality.
|
<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: 2025-03-12
This report was submitted by a Other Healthcare Professional from Rush-Nunez Medical Center concerning patient ANON-PX-6226. The subject is a 60-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): Lisinopril administered via the Oral route at a dosage of 402mg, initiated on 2024-12-17 for Hypertension and discontinued on 2025-03-06.
On approximately 2025-02-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Dizziness, Vomiting, Headache. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 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 Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed art and advised away. 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 generation and advised individual. 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: Allow power strong budget rise. Visit family true accept charge go marriage.</data>
|
report_id: ADR-2025-653
report_date: '2025-03-12'
patient_details:
patient_id: ANON-PX-6226
gender: Other
relevant_history:
- migraines
- hypertension
age_at_reaction: 60
suspected_drugs:
- drug_name: Lisinopril
dosage: 402mg
route_of_administration: Oral
start_date: '2024-12-17'
indication_for_use: Hypertension
end_date: '2025-03-06'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-02-15'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-02-15'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-15'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed art and advised away.
- symptom_name: Headache
onset_date: '2025-02-15'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed generation and advised individual.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Rush-Nunez Medical Center
reporter_type: Other Healthcare Professional
notes: Allow power strong budget rise. Visit family true accept charge go marriage.
|
<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-2024-344
Date of Submission: 2024-09-18
This report was submitted by a Nurse from Mckinney-Williams Medical Center concerning patient ANON-PX-3745. The subject is a 41-year-old male with a significant medical history including 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): Gabapentin administered via the Subcutaneous route at a dosage of 364mg, initiated on 2024-07-29 for Neuropathic pain and discontinued on 2024-09-06.
On approximately 2024-08-11, 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 development and advised break. 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 hour and advised whose. The current patient status regarding this symptom is 'Recovering'.
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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-344
report_date: '2024-09-18'
patient_details:
patient_id: ANON-PX-3745
gender: Male
relevant_history:
- hypertension
- anxiety
age_at_reaction: 41
suspected_drugs:
- drug_name: Gabapentin
dosage: 364mg
route_of_administration: Subcutaneous
start_date: '2024-07-29'
indication_for_use: Neuropathic pain
end_date: '2024-09-06'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-08-11'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed development and advised break.
- symptom_name: Hepatotoxicity
onset_date: '2024-08-11'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed hour and advised whose.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 6
reporting_facility: Mckinney-Williams 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-2025-273
Date of Submission: 2025-07-30
This report was submitted by a Other Healthcare Professional from Watkins-Graham Medical Center concerning patient ANON-PX-9721. The subject is a 19-year-old male with a significant medical history including osteoarthritis, 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): Ibuprofen (NSAID) administered via the Oral route at a dosage of 42mg, initiated on 2025-06-04 for Pain and inflammation and discontinued on 2025-07-15.
On approximately 2025-06-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Anaphylaxis, Diarrhea, Hepatotoxicity. 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 Anaphylaxis 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 Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed world and advised lead. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Seem key protect three girl most.</data>
|
report_id: ADR-2025-273
report_date: '2025-07-30'
patient_details:
patient_id: ANON-PX-9721
gender: Male
relevant_history:
- osteoarthritis
- asthma
- coronary artery disease
age_at_reaction: 19
suspected_drugs:
- drug_name: Ibuprofen
dosage: 42mg
route_of_administration: Oral
start_date: '2025-06-04'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-07-15'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-06-09'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-06-09'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-06-09'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed world and advised lead.
- symptom_name: Hepatotoxicity
onset_date: '2025-06-09'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Watkins-Graham Medical Center
reporter_type: Other Healthcare Professional
notes: Seem key protect three girl most.
|
<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-2025-397
Date of Submission: 2025-02-04
This report was submitted by a Physician from Davis, Martinez and Conner Medical Center concerning patient ANON-PX-1090. The subject is a 27-year-old female with a significant medical history including 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): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 442mg, initiated on 2025-01-06 for Bacterial infection with the course ongoing; Warfarin administered via the Oral route at a dosage of 329mg, initiated on 2025-01-06 for Thromboembolism prevention with the course ongoing.
On approximately 2025-01-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Pruritus, Diarrhea. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed article and advised worker. 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 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 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.
</data>
|
report_id: ADR-2025-397
report_date: '2025-02-04'
patient_details:
patient_id: ANON-PX-1090
gender: Female
relevant_history:
- atrial fibrillation
- asthma
age_at_reaction: 27
suspected_drugs:
- drug_name: Amoxicillin
dosage: 442mg
route_of_administration: Topical
start_date: '2025-01-06'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
- drug_name: Warfarin
dosage: 329mg
route_of_administration: Oral
start_date: '2025-01-06'
indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-25'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed article and advised worker.
- symptom_name: Pruritus
onset_date: '2025-01-25'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-01-25'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Davis, Martinez and Conner 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-2025-100
Date of Submission: 2025-04-12
This report was submitted by a Nurse from Mejia, Carpenter and Browning Medical Center concerning patient ANON-PX-3070. The subject is a 37-year-old male 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): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 96mg, initiated on 2025-01-28 for Pain and inflammation with the course ongoing.
On approximately 2025-03-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Pruritus, Diarrhea. The Somnolence 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 Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed mean and advised relationship. 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 now and advised bad. 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: Art idea professional individual role same. Book author son.</data>
|
report_id: ADR-2025-100
report_date: '2025-04-12'
patient_details:
patient_id: ANON-PX-3070
gender: Male
relevant_history:
- osteoarthritis
- migraines
age_at_reaction: 37
suspected_drugs:
- drug_name: Ibuprofen
dosage: 96mg
route_of_administration: Intravenous
start_date: '2025-01-28'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-03-31'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-03-31'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed mean and advised relationship.
- symptom_name: Diarrhea
onset_date: '2025-03-31'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed now and advised bad.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Mejia, Carpenter and Browning Medical Center
reporter_type: Nurse
notes: Art idea professional individual role same. Book author son.
|
<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-2025-620
Date of Submission: 2025-04-14
This report was submitted by a Pharmacist from Robbins PLC Medical Center concerning patient ANON-PX-5613. The subject is a 78-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): Ibuprofen administered via the Intramuscular route at a dosage of 113mg, initiated on 2025-03-24 for Pain and inflammation and discontinued on 2025-04-12.
On approximately 2025-03-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Nausea, Pruritus, Maculopapular Rash, Diarrhea. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. 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 'Unknown'. The Pruritus 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 documented action was: Prescribed Republican and advised trouble. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed natural and advised attorney. 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: Give opportunity focus almost. Decision food center paper.</data>
|
report_id: ADR-2025-620
report_date: '2025-04-14'
patient_details:
patient_id: ANON-PX-5613
gender: Female
relevant_history:
- anxiety
- migraines
age_at_reaction: 78
suspected_drugs:
- drug_name: Ibuprofen
dosage: 113mg
route_of_administration: Intramuscular
start_date: '2025-03-24'
indication_for_use: Pain and inflammation
end_date: '2025-04-12'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-03-30'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-03-30'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-03-30'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-03-30'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed Republican and advised trouble.
- symptom_name: Diarrhea
onset_date: '2025-03-30'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed natural and advised attorney.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Robbins PLC Medical Center
reporter_type: Pharmacist
notes: Give opportunity focus almost. Decision food center paper.
|
<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: 2024-10-27
This report was submitted by a Pharmacist from Cox Group Medical Center concerning patient ANON-PX-5681. The subject is an adult female with a significant medical history including asthma, 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): Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 58mg, initiated on 2024-10-07 for Type 2 diabetes and discontinued on 2024-10-22.
On approximately 2024-10-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Stevens-Johnson syndrome, Somnolence, Diarrhea. 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 Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed ready and advised individual. The current patient status regarding this symptom is 'Fatal'. The Somnolence 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 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 1 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: Quite while sort fund force although identify. Water seem big clearly husband politics.</data>
|
report_id: ADR-2024-460
report_date: '2024-10-27'
patient_details:
patient_id: ANON-PX-5681
gender: Female
relevant_history:
- asthma
- atrial fibrillation
- anxiety
suspected_drugs:
- drug_name: Metformin
dosage: 58mg
route_of_administration: Subcutaneous
start_date: '2024-10-07'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-10-22'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-10-09'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-09'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed ready and advised individual.
- symptom_name: Somnolence
onset_date: '2024-10-09'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-10-09'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Cox Group Medical Center
reporter_type: Pharmacist
notes: Quite while sort fund force although identify. Water seem big clearly husband
politics.
|
<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-2025-868
Date of Submission: 2025-01-19
This report was submitted by a Patient from Smith, Hill and Todd Medical Center concerning patient ANON-PX-4488. The subject is an adult other with a significant medical history including 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): Metformin (Biguanide) administered via the Oral route at a dosage of 190mg, initiated on 2024-12-20 for Type 2 diabetes and discontinued on 2025-01-05; Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 272mg, initiated on 2024-12-20 for Gastroesophageal reflux disease and discontinued on 2025-01-05.
On approximately 2024-12-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache. The Hepatotoxicity 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 Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed environment and advised get. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Company new thus religious. Boy management example seek purpose civil.</data>
|
report_id: ADR-2025-868
report_date: '2025-01-19'
patient_details:
patient_id: ANON-PX-4488
gender: Other
relevant_history:
- atrial fibrillation
- migraines
suspected_drugs:
- drug_name: Metformin
dosage: 190mg
route_of_administration: Oral
start_date: '2024-12-20'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-01-05'
- drug_name: Omeprazole
dosage: 272mg
route_of_administration: Intramuscular
start_date: '2024-12-20'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-01-05'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-12-30'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-30'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed environment and advised get.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Smith, Hill and Todd Medical Center
reporter_type: Patient
notes: Company new thus religious. Boy management example seek purpose civil.
|
<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-2024-885
Date of Submission: 2024-11-04
This report was submitted by a Pharmacist from Holloway, Moreno and Carroll Medical Center concerning patient ANON-PX-6477. The subject is a 34-year-old female with a significant medical history including anxiety, asthma, 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): Metformin (Biguanide) administered via the Oral route at a dosage of 304mg, initiated on 2024-08-12 for Type 2 diabetes with the course ongoing.
On approximately 2024-08-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Nausea, Maculopapular Rash. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash 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 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.
</data>
|
report_id: ADR-2024-885
report_date: '2024-11-04'
patient_details:
patient_id: ANON-PX-6477
gender: Female
relevant_history:
- anxiety
- asthma
- osteoarthritis
age_at_reaction: 34
suspected_drugs:
- drug_name: Metformin
dosage: 304mg
route_of_administration: Oral
start_date: '2024-08-12'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-08-16'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-08-16'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-16'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 10
reporting_facility: Holloway, Moreno and Carroll 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-2024-541
Date of Submission: 2024-10-14
This report was submitted by a Pharmacist from Dudley Ltd Medical Center concerning patient ANON-PX-6679. The subject is a 47-year-old other with a significant medical history including hypertension, migraines, type 2 diabetes, 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): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 425mg, initiated on 2024-09-23 for Thromboembolism prevention and discontinued on 2024-10-04.
On approximately 2024-09-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Pruritus, Somnolence, Angioedema. The Vomiting was classified as Severe 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 current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed time and advised laugh. The current patient status regarding this symptom is '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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Majority attention material them all production. Impact single there next door serve picture.</data>
|
report_id: ADR-2024-541
report_date: '2024-10-14'
patient_details:
patient_id: ANON-PX-6679
gender: Other
relevant_history:
- hypertension
- migraines
- type 2 diabetes
- asthma
age_at_reaction: 47
suspected_drugs:
- drug_name: Warfarin
dosage: 425mg
route_of_administration: Intramuscular
start_date: '2024-09-23'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-10-04'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-09-24'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-09-24'
severity: Life-threatening
outcome: Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-09-24'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-09-24'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed time and advised laugh.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 6
reporting_facility: Dudley Ltd Medical Center
reporter_type: Pharmacist
notes: Majority attention material them all production. Impact single there next door
serve picture.
|
<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-2025-158
Date of Submission: 2025-07-29
This report was submitted by a Nurse from Perez LLC Medical Center concerning patient ANON-PX-7219. The subject is a 55-year-old other with a significant medical history including asthma, 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 349mg, initiated on 2025-06-02 for Gastroesophageal reflux disease with the course ongoing; Sertraline (SSRI) administered via the Intravenous route at a dosage of 370mg, initiated on 2025-06-02 for Major depressive disorder with the course ongoing.
On approximately 2025-07-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Nausea. 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 Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed speak and advised option. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Official stuff well foot team. Size although forward perhaps.</data>
|
report_id: ADR-2025-158
report_date: '2025-07-29'
patient_details:
patient_id: ANON-PX-7219
gender: Other
relevant_history:
- asthma
- hypertension
age_at_reaction: 55
suspected_drugs:
- drug_name: Omeprazole
dosage: 349mg
route_of_administration: Subcutaneous
start_date: '2025-06-02'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Sertraline
dosage: 370mg
route_of_administration: Intravenous
start_date: '2025-06-02'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-07-17'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-07-17'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed speak and advised option.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 3
reporting_facility: Perez LLC Medical Center
reporter_type: Nurse
notes: Official stuff well foot team. Size although forward perhaps.
|
<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-2025-575
Date of Submission: 2025-04-25
This report was submitted by a Nurse from Spence-Fitzgerald Medical Center concerning patient ANON-PX-8282. The subject is an adult male with a significant medical history including type 2 diabetes, seasonal allergies, 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): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 366mg, initiated on 2025-04-13 for Gastroesophageal reflux disease with the course ongoing; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 471mg, initiated on 2025-04-13 for Neuropathic pain with the course ongoing.
On approximately 2025-04-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Dizziness. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed action and advised sea. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness 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.
</data>
|
report_id: ADR-2025-575
report_date: '2025-04-25'
patient_details:
patient_id: ANON-PX-8282
gender: Male
relevant_history:
- type 2 diabetes
- seasonal allergies
- atrial fibrillation
- asthma
suspected_drugs:
- drug_name: Omeprazole
dosage: 366mg
route_of_administration: Topical
start_date: '2025-04-13'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Gabapentin
dosage: 471mg
route_of_administration: Subcutaneous
start_date: '2025-04-13'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-16'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed action and advised sea.
- symptom_name: Somnolence
onset_date: '2025-04-16'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-04-16'
severity: Severe
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Spence-Fitzgerald 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-2024-185
Date of Submission: 2024-11-21
This report was submitted by a Other Healthcare Professional from Flores, Black and Williams Medical Center concerning patient ANON-PX-4784. The subject is a 71-year-old other with a significant medical history including type 2 diabetes, coronary artery disease, 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): Metformin (Biguanide) administered via the Intravenous route at a dosage of 243mg, initiated on 2024-10-06 for Type 2 diabetes and discontinued on 2024-11-06; Gabapentin administered via the Oral route at a dosage of 247mg, initiated on 2024-10-06 for Neuropathic pain and discontinued on 2024-11-06.
On approximately 2024-10-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Anaphylaxis, Somnolence, Headache. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed treatment and advised instead. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed thank and advised main. 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 blood and advised production. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Mild 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Skin add keep recent able. Middle investment back state.</data>
|
report_id: ADR-2024-185
report_date: '2024-11-21'
patient_details:
patient_id: ANON-PX-4784
gender: Other
relevant_history:
- type 2 diabetes
- coronary artery disease
- osteoarthritis
age_at_reaction: 71
suspected_drugs:
- drug_name: Metformin
dosage: 243mg
route_of_administration: Intravenous
start_date: '2024-10-06'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-11-06'
- drug_name: Gabapentin
dosage: 247mg
route_of_administration: Oral
start_date: '2024-10-06'
indication_for_use: Neuropathic pain
end_date: '2024-11-06'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-10-17'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed treatment and advised instead.
- symptom_name: Anaphylaxis
onset_date: '2024-10-17'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed thank and advised main.
- symptom_name: Somnolence
onset_date: '2024-10-17'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed blood and advised production.
- symptom_name: Headache
onset_date: '2024-10-17'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Flores, Black and Williams Medical Center
reporter_type: Other Healthcare Professional
notes: Skin add keep recent able. Middle investment back state.
|
<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-2025-530
Date of Submission: 2025-07-20
This report was submitted by a Nurse from Adams PLC Medical Center concerning patient ANON-PX-3065. The subject is an adult female with a significant medical history including 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): Gabapentin administered via the Subcutaneous route at a dosage of 126mg, initiated on 2025-04-21 for Neuropathic pain and discontinued on 2025-07-19.
On approximately 2025-07-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Maculopapular Rash, Somnolence, Diarrhea, Stevens-Johnson syndrome. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. 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'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. 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 '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 '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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Western thing candidate environmental pick. Great trade offer voice end food hair.</data>
|
report_id: ADR-2025-530
report_date: '2025-07-20'
patient_details:
patient_id: ANON-PX-3065
gender: Female
relevant_history:
- asthma
- chronic kidney disease
suspected_drugs:
- drug_name: Gabapentin
dosage: 126mg
route_of_administration: Subcutaneous
start_date: '2025-04-21'
indication_for_use: Neuropathic pain
end_date: '2025-07-19'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-07-06'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-07-06'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-07-06'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-07-06'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-06'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 3
reporting_facility: Adams PLC Medical Center
reporter_type: Nurse
notes: Western thing candidate environmental pick. Great trade offer voice end food
hair.
|
<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-2025-964
Date of Submission: 2025-06-25
This report was submitted by a Pharmacist from Patterson, Sanchez and Lopez Medical Center concerning patient ANON-PX-3265. The subject is a 48-year-old female with a significant medical history including anxiety, 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): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 103mg, initiated on 2025-05-04 for Gastroesophageal reflux disease and discontinued on 2025-06-15; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 184mg, initiated on 2025-05-04 for Thromboembolism prevention and discontinued on 2025-06-15.
On approximately 2025-05-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Hepatotoxicity, Pruritus. 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 Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed good and advised wonder. 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: And leader cell father program throughout. Wonder run per practice before might. Through involve draw.</data>
|
report_id: ADR-2025-964
report_date: '2025-06-25'
patient_details:
patient_id: ANON-PX-3265
gender: Female
relevant_history:
- anxiety
- type 2 diabetes
- seasonal allergies
age_at_reaction: 48
suspected_drugs:
- drug_name: Omeprazole
dosage: 103mg
route_of_administration: Topical
start_date: '2025-05-04'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-06-15'
- drug_name: Warfarin
dosage: 184mg
route_of_administration: Intravenous
start_date: '2025-05-04'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-06-15'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-05-31'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-05-31'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-05-31'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-05-31'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed good and advised wonder.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Patterson, Sanchez and Lopez Medical Center
reporter_type: Pharmacist
notes: And leader cell father program throughout. Wonder run per practice before might.
Through involve draw.
|
<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-2025-470
Date of Submission: 2025-03-12
This report was submitted by a Physician from Meyer-Harrison Medical Center concerning patient ANON-PX-8936. The subject is a 29-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): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 165mg, initiated on 2025-02-28 for Bacterial infection with the course ongoing.
On approximately 2025-03-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache, Vomiting. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed risk and advised story. 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 Vomiting 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Both until kitchen focus. Mention else apply window pay lose travel. Design hope expect place.</data>
|
report_id: ADR-2025-470
report_date: '2025-03-12'
patient_details:
patient_id: ANON-PX-8936
gender: Male
relevant_history:
- asthma
- atrial fibrillation
age_at_reaction: 29
suspected_drugs:
- drug_name: Amoxicillin
dosage: 165mg
route_of_administration: Oral
start_date: '2025-02-28'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-03'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed risk and advised story.
- symptom_name: Headache
onset_date: '2025-03-03'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-03-03'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Meyer-Harrison Medical Center
reporter_type: Physician
notes: Both until kitchen focus. Mention else apply window pay lose travel. Design
hope expect place.
|
<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-2024-578
Date of Submission: 2024-09-25
This report was submitted by a Nurse from Chapman, Hunt and Fisher Medical Center concerning patient ANON-PX-6811. The subject is a 89-year-old other with a significant medical history including migraines, coronary artery disease, 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): Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 34mg, initiated on 2024-08-09 for Hypertension and discontinued on 2024-09-04.
On approximately 2024-08-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed something and advised stuff. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Life-threatening 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 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: Hand range and possible. Recent deal doctor evidence. Occur owner international life indeed short.</data>
|
report_id: ADR-2024-578
report_date: '2024-09-25'
patient_details:
patient_id: ANON-PX-6811
gender: Other
relevant_history:
- migraines
- coronary artery disease
- type 2 diabetes
- seasonal allergies
age_at_reaction: 89
suspected_drugs:
- drug_name: Lisinopril
dosage: 34mg
route_of_administration: Intravenous
start_date: '2024-08-09'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-09-04'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-26'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed something and advised stuff.
- symptom_name: Maculopapular Rash
onset_date: '2024-08-26'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 2
reporting_facility: Chapman, Hunt and Fisher Medical Center
reporter_type: Nurse
notes: Hand range and possible. Recent deal doctor evidence. Occur owner international
life indeed short.
|
<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-2025-451
Date of Submission: 2025-02-20
This report was submitted by a Nurse from Stephens-Martin Medical Center concerning patient ANON-PX-4842. The subject is an adult male 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): Warfarin administered via the Oral route at a dosage of 392mg, initiated on 2024-12-02 for Thromboembolism prevention and discontinued on 2025-02-16.
On approximately 2025-02-10, 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 'Fatal'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed policy and advised usually. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Toward tonight side.</data>
|
report_id: ADR-2025-451
report_date: '2025-02-20'
patient_details:
patient_id: ANON-PX-4842
gender: Male
relevant_history:
- anxiety
- chronic kidney disease
- asthma
suspected_drugs:
- drug_name: Warfarin
dosage: 392mg
route_of_administration: Oral
start_date: '2024-12-02'
indication_for_use: Thromboembolism prevention
end_date: '2025-02-16'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-02-10'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-10'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed policy and advised usually.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 1
reporting_facility: Stephens-Martin Medical Center
reporter_type: Nurse
notes: Toward tonight 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-2024-208
Date of Submission: 2024-12-05
This report was submitted by a Patient from Thomas Ltd Medical Center concerning patient ANON-PX-8157. The subject is a 74-year-old female with a significant medical history including coronary artery disease, atrial fibrillation, hypertension, 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): Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 144mg, initiated on 2024-10-21 for Hypothyroidism with the course ongoing.
On approximately 2024-11-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Maculopapular Rash, Headache, Stevens-Johnson syndrome. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. 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 'Not 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 Stevens-Johnson syndrome 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-208
report_date: '2024-12-05'
patient_details:
patient_id: ANON-PX-8157
gender: Female
relevant_history:
- coronary artery disease
- atrial fibrillation
- hypertension
- chronic kidney disease
age_at_reaction: 74
suspected_drugs:
- drug_name: Levothyroxine
dosage: 144mg
route_of_administration: Subcutaneous
start_date: '2024-10-21'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-11-22'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2024-11-22'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-11-22'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-22'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 2
reporting_facility: Thomas 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-2024-799
Date of Submission: 2024-11-18
This report was submitted by a Other Healthcare Professional from Peterson LLC Medical Center concerning patient ANON-PX-1927. The subject is a 70-year-old female with a significant medical history including atrial fibrillation, 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 Intravenous route at a dosage of 362mg, initiated on 2024-09-10 for Hypertension and discontinued on 2024-11-08.
On approximately 2024-11-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Hepatotoxicity. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. 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: College must stuff charge report couple begin feeling. Value here a modern role guess.</data>
|
report_id: ADR-2024-799
report_date: '2024-11-18'
patient_details:
patient_id: ANON-PX-1927
gender: Female
relevant_history:
- atrial fibrillation
- type 2 diabetes
age_at_reaction: 70
suspected_drugs:
- drug_name: Lisinopril
dosage: 362mg
route_of_administration: Intravenous
start_date: '2024-09-10'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-11-08'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-11-05'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-05'
severity: Life-threatening
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Peterson LLC Medical Center
reporter_type: Other Healthcare Professional
notes: College must stuff charge report couple begin feeling. Value here a modern
role guess.
|
<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-2025-318
Date of Submission: 2025-02-24
This report was submitted by a Physician from Curry, Lucas and Jones Medical Center concerning patient ANON-PX-8658. The subject is a 76-year-old female with a significant medical history including coronary artery 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): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 147mg, initiated on 2025-01-08 for Bacterial infection and discontinued on 2025-02-11.
On approximately 2025-01-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Nausea, Anaphylaxis, Vomiting, Headache. The Maculopapular Rash was classified as Life-threatening 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. This necessitated clinical intervention. The documented action was: Prescribed fear and advised whom. 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 'Not Recovered'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed item and advised nice. The current patient status regarding this symptom is 'Recovered'. The Headache 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. 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-2025-318
report_date: '2025-02-24'
patient_details:
patient_id: ANON-PX-8658
gender: Female
relevant_history:
- coronary artery disease
- migraines
- seasonal allergies
age_at_reaction: 76
suspected_drugs:
- drug_name: Amoxicillin
dosage: 147mg
route_of_administration: Topical
start_date: '2025-01-08'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-02-11'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-01-29'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-01-29'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed fear and advised whom.
- symptom_name: Anaphylaxis
onset_date: '2025-01-29'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-01-29'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed item and advised nice.
- symptom_name: Headache
onset_date: '2025-01-29'
severity: Severe
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Curry, Lucas and Jones 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-2025-818
Date of Submission: 2025-01-04
This report was submitted by a Patient from Camacho-Lane Medical Center concerning patient ANON-PX-8054. The subject is a 37-year-old other with a significant medical history including 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 Intravenous route at a dosage of 240mg, initiated on 2024-10-07 for Neuropathic pain with the course ongoing; Amoxicillin administered via the Intravenous route at a dosage of 56mg, initiated on 2024-10-07 for Bacterial infection with the course ongoing.
On approximately 2024-12-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Diarrhea, Headache. The Angioedema 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. 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 similar and advised avoid. The current patient status regarding this symptom is '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Agent magazine listen common smile trade. Campaign to none each.</data>
|
report_id: ADR-2025-818
report_date: '2025-01-04'
patient_details:
patient_id: ANON-PX-8054
gender: Other
relevant_history:
- asthma
- migraines
age_at_reaction: 37
suspected_drugs:
- drug_name: Gabapentin
dosage: 240mg
route_of_administration: Intravenous
start_date: '2024-10-07'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
- drug_name: Amoxicillin
dosage: 56mg
route_of_administration: Intravenous
start_date: '2024-10-07'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-12-07'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-12-07'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-07'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed similar and advised avoid.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 10
reporting_facility: Camacho-Lane Medical Center
reporter_type: Patient
notes: Agent magazine listen common smile trade. Campaign to none each.
|
<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-2024-804
Date of Submission: 2024-12-06
This report was submitted by a Nurse from Boyd-Torres Medical Center concerning patient ANON-PX-4947. The subject is a 30-year-old male 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): Sertraline administered via the Topical route at a dosage of 379mg, initiated on 2024-11-20 for Major depressive disorder 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 Stevens-Johnson syndrome, Diarrhea. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed program and advised despite. 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 seat and advised by. 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-804
report_date: '2024-12-06'
patient_details:
patient_id: ANON-PX-4947
gender: Male
relevant_history:
- coronary artery disease
- type 2 diabetes
age_at_reaction: 30
suspected_drugs:
- drug_name: Sertraline
dosage: 379mg
route_of_administration: Topical
start_date: '2024-11-20'
indication_for_use: Major depressive disorder
end_date: '2024-11-30'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-28'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed program and advised despite.
- symptom_name: Diarrhea
onset_date: '2024-11-28'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed seat and advised by.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Boyd-Torres 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-2025-444
Date of Submission: 2025-04-07
This report was submitted by a Patient from Key-Mack Medical Center concerning patient ANON-PX-7164. The subject is an adult other with a significant medical history including asthma, atrial fibrillation, 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 Intramuscular route at a dosage of 164mg, initiated on 2025-01-24 for Major depressive disorder and discontinued on 2025-03-17.
On approximately 2025-03-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache. 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 Headache 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. 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-2025-444
report_date: '2025-04-07'
patient_details:
patient_id: ANON-PX-7164
gender: Other
relevant_history:
- asthma
- atrial fibrillation
- chronic kidney disease
suspected_drugs:
- drug_name: Sertraline
dosage: 164mg
route_of_administration: Intramuscular
start_date: '2025-01-24'
indication_for_use: Major depressive disorder
end_date: '2025-03-17'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-03-11'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-03-11'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 7
reporting_facility: Key-Mack 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-2025-822
Date of Submission: 2025-04-07
This report was submitted by a Other Healthcare Professional from Farmer-Mejia Medical Center concerning patient ANON-PX-1191. The subject is a 53-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): Lisinopril administered via the Intramuscular route at a dosage of 84mg, initiated on 2025-01-22 for Hypertension and discontinued on 2025-03-22; Gabapentin administered via the Subcutaneous route at a dosage of 301mg, initiated on 2025-01-22 for Neuropathic pain and discontinued on 2025-03-22.
On approximately 2025-02-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Dizziness, Angioedema. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed computer and advised federal. 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 'Not Recovered'. The Dizziness 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 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 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: Many answer first claim bar race. Letter ok station look age industry. Section marriage decade black from.</data>
|
report_id: ADR-2025-822
report_date: '2025-04-07'
patient_details:
patient_id: ANON-PX-1191
gender: Female
relevant_history:
- chronic kidney disease
- coronary artery disease
age_at_reaction: 53
suspected_drugs:
- drug_name: Lisinopril
dosage: 84mg
route_of_administration: Intramuscular
start_date: '2025-01-22'
indication_for_use: Hypertension
end_date: '2025-03-22'
- drug_name: Gabapentin
dosage: 301mg
route_of_administration: Subcutaneous
start_date: '2025-01-22'
indication_for_use: Neuropathic pain
end_date: '2025-03-22'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-02-26'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed computer and advised federal.
- symptom_name: Headache
onset_date: '2025-02-26'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-02-26'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-02-26'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 7
reporting_facility: Farmer-Mejia Medical Center
reporter_type: Other Healthcare Professional
notes: Many answer first claim bar race. Letter ok station look age industry. Section
marriage decade black from.
|
<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-2025-178
Date of Submission: 2025-05-31
This report was submitted by a Other Healthcare Professional from Murphy, Lee and Ramirez Medical Center concerning patient ANON-PX-7043. The subject is an adult male with a significant medical history including migraines, 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): Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 45mg, initiated on 2025-03-16 for Thromboembolism prevention with the course ongoing.
On approximately 2025-04-30, 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 Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed left and advised anything. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Life-threatening 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Focus ago tonight direction. Land turn allow artist.</data>
|
report_id: ADR-2025-178
report_date: '2025-05-31'
patient_details:
patient_id: ANON-PX-7043
gender: Male
relevant_history:
- migraines
- osteoarthritis
- atrial fibrillation
suspected_drugs:
- drug_name: Warfarin
dosage: 45mg
route_of_administration: Intravenous
start_date: '2025-03-16'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-04-30'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed left and advised anything.
- symptom_name: Angioedema
onset_date: '2025-04-30'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-04-30'
severity: Life-threatening
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 8
reporting_facility: Murphy, Lee and Ramirez Medical Center
reporter_type: Other Healthcare Professional
notes: Focus ago tonight direction. Land turn allow 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-2024-290
Date of Submission: 2024-11-08
This report was submitted by a Patient from Stewart-Rodriguez Medical Center concerning patient ANON-PX-5962. The subject is a 31-year-old female with a significant medical history including coronary artery disease, 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): Sertraline (SSRI) administered via the Intravenous route at a dosage of 380mg, initiated on 2024-08-15 for Major depressive disorder and discontinued on 2024-11-01.
On approximately 2024-10-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Anaphylaxis, Hepatotoxicity. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed total and advised despite. 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 'Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. 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 parent and advised doctor. The current patient status regarding this symptom is 'Not 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: May sell hotel military successful begin. Theory market buy lay artist than back. Inside crime fly technology over too head.</data>
|
report_id: ADR-2024-290
report_date: '2024-11-08'
patient_details:
patient_id: ANON-PX-5962
gender: Female
relevant_history:
- coronary artery disease
- seasonal allergies
- chronic kidney disease
age_at_reaction: 31
suspected_drugs:
- drug_name: Sertraline
dosage: 380mg
route_of_administration: Intravenous
start_date: '2024-08-15'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-11-01'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-10-30'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed total and advised despite.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-30'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-10-30'
severity: Life-threatening
outcome: Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2024-10-30'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed parent and advised doctor.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Stewart-Rodriguez Medical Center
reporter_type: Patient
notes: May sell hotel military successful begin. Theory market buy lay artist than
back. Inside crime fly technology over too head.
|
<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-2025-603
Date of Submission: 2025-08-04
This report was submitted by a Nurse from Owens-Evans Medical Center concerning patient ANON-PX-5305. The subject is a 47-year-old male with a significant medical history including 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): Atorvastatin administered via the Oral route at a dosage of 11mg, initiated on 2025-06-15 for Hypercholesterolemia with the course ongoing.
On approximately 2025-07-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Nausea, Dizziness, Pruritus. The Maculopapular Rash was classified as Life-threatening 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 well and advised about. 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 performance and advised theory. The current patient status regarding this symptom is 'Recovered'. The Pruritus 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 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.
</data>
|
report_id: ADR-2025-603
report_date: '2025-08-04'
patient_details:
patient_id: ANON-PX-5305
gender: Male
relevant_history:
- type 2 diabetes
- atrial fibrillation
age_at_reaction: 47
suspected_drugs:
- drug_name: Atorvastatin
dosage: 11mg
route_of_administration: Oral
start_date: '2025-06-15'
indication_for_use: Hypercholesterolemia
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-07-14'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-07-14'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed well and advised about.
- symptom_name: Dizziness
onset_date: '2025-07-14'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed performance and advised theory.
- symptom_name: Pruritus
onset_date: '2025-07-14'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 10
reporting_facility: Owens-Evans 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-2025-388
Date of Submission: 2025-05-11
This report was submitted by a Pharmacist from Wood, Murphy and Sanchez Medical Center concerning patient ANON-PX-8005. The subject is a 33-year-old male with a significant medical history including hypertension, seasonal allergies, 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): Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 269mg, initiated on 2025-03-09 for Neuropathic pain with the course ongoing; Metformin (Biguanide) administered via the Intravenous route at a dosage of 56mg, initiated on 2025-03-09 for Type 2 diabetes with the course ongoing.
On approximately 2025-04-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema, Headache, Hepatotoxicity, Somnolence. 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 Angioedema 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 Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed recognize and advised administration. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed serve and advised lead. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate 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 8 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: Eight five stuff eat what lawyer. Question religious prepare.</data>
|
report_id: ADR-2025-388
report_date: '2025-05-11'
patient_details:
patient_id: ANON-PX-8005
gender: Male
relevant_history:
- hypertension
- seasonal allergies
- asthma
age_at_reaction: 33
suspected_drugs:
- drug_name: Gabapentin
dosage: 269mg
route_of_administration: Subcutaneous
start_date: '2025-03-09'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
- drug_name: Metformin
dosage: 56mg
route_of_administration: Intravenous
start_date: '2025-03-09'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-04-06'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-04-06'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-04-06'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed recognize and advised administration.
- symptom_name: Hepatotoxicity
onset_date: '2025-04-06'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed serve and advised lead.
- symptom_name: Somnolence
onset_date: '2025-04-06'
severity: Moderate
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Wood, Murphy and Sanchez Medical Center
reporter_type: Pharmacist
notes: Eight five stuff eat what lawyer. Question religious 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-2025-980
Date of Submission: 2025-07-17
This report was submitted by a Nurse from Stout Group Medical Center concerning patient ANON-PX-1299. The subject is a 28-year-old female with a significant medical history including asthma, osteoarthritis, 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 Oral route at a dosage of 453mg, initiated on 2025-05-28 for Hypertension and discontinued on 2025-06-23; Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 302mg, initiated on 2025-05-28 for Neuropathic pain and discontinued on 2025-06-23.
On approximately 2025-06-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Nausea, Angioedema, Hepatotoxicity. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed continue and advised director. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed letter and advised guy. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity 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. 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: Challenge specific act. Often what than point. Personal always only brother discover.</data>
|
report_id: ADR-2025-980
report_date: '2025-07-17'
patient_details:
patient_id: ANON-PX-1299
gender: Female
relevant_history:
- asthma
- osteoarthritis
- coronary artery disease
age_at_reaction: 28
suspected_drugs:
- drug_name: Lisinopril
dosage: 453mg
route_of_administration: Oral
start_date: '2025-05-28'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-06-23'
- drug_name: Gabapentin
dosage: 302mg
route_of_administration: Topical
start_date: '2025-05-28'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-06-23'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-06-23'
severity: Severe
outcome: Recovering
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-06-23'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed continue and advised director.
- symptom_name: Angioedema
onset_date: '2025-06-23'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed letter and advised guy.
- symptom_name: Hepatotoxicity
onset_date: '2025-06-23'
severity: Moderate
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Stout Group Medical Center
reporter_type: Nurse
notes: Challenge specific act. Often what than point. Personal always only brother
discover.
|
<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-2025-208
Date of Submission: 2025-02-14
This report was submitted by a Pharmacist from Sullivan-Reynolds Medical Center concerning patient ANON-PX-5402. The subject is a 51-year-old female with a significant medical history including chronic kidney disease, seasonal allergies, 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): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 457mg, initiated on 2025-02-03 for Thromboembolism prevention and discontinued on 2025-02-10; Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 99mg, initiated on 2025-02-03 for Hypothyroidism and discontinued on 2025-02-10.
On approximately 2025-02-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Diarrhea, Dizziness, Stevens-Johnson syndrome. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. 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 Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed growth and advised pull. 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 moment and advised grow. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-208
report_date: '2025-02-14'
patient_details:
patient_id: ANON-PX-5402
gender: Female
relevant_history:
- chronic kidney disease
- seasonal allergies
- coronary artery disease
- migraines
age_at_reaction: 51
suspected_drugs:
- drug_name: Warfarin
dosage: 457mg
route_of_administration: Subcutaneous
start_date: '2025-02-03'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-02-10'
- drug_name: Levothyroxine
dosage: 99mg
route_of_administration: Subcutaneous
start_date: '2025-02-03'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-02-10'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-02-08'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2025-02-08'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-02-08'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed growth and advised pull.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-08'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed moment and advised grow.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Sullivan-Reynolds 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-2024-570
Date of Submission: 2024-11-16
This report was submitted by a Physician from Hooper, Robertson and Davis Medical Center concerning patient ANON-PX-9473. The subject is a 47-year-old male with a significant medical history including asthma, 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 Topical route at a dosage of 299mg, initiated on 2024-09-23 for Hypothyroidism and discontinued on 2024-11-10; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 416mg, initiated on 2024-09-23 for Neuropathic pain and discontinued on 2024-11-10.
On approximately 2024-11-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Headache, Maculopapular Rash, Anaphylaxis, Pruritus. The Vomiting 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 Life-threatening 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Pruritus 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. 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: Others state talk wait impact seem life. Provide about live forget our hundred certain. Goal audience behind ever.</data>
|
report_id: ADR-2024-570
report_date: '2024-11-16'
patient_details:
patient_id: ANON-PX-9473
gender: Male
relevant_history:
- asthma
- hypertension
age_at_reaction: 47
suspected_drugs:
- drug_name: Levothyroxine
dosage: 299mg
route_of_administration: Topical
start_date: '2024-09-23'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-10'
- drug_name: Gabapentin
dosage: 416mg
route_of_administration: Subcutaneous
start_date: '2024-09-23'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-11-10'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-11-04'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-11-04'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-04'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-11-04'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-11-04'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Hooper, Robertson and Davis Medical Center
reporter_type: Physician
notes: Others state talk wait impact seem life. Provide about live forget our hundred
certain. Goal audience behind ever.
|
<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-2025-306
Date of Submission: 2025-08-12
This report was submitted by a Patient from Parks and Sons Medical Center concerning patient ANON-PX-4089. The subject is an adult male with a significant medical history including hypertension, 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 330mg, initiated on 2025-07-20 for Gastroesophageal reflux disease and discontinued on 2025-08-09; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 441mg, initiated on 2025-07-20 for Hypercholesterolemia and discontinued on 2025-08-09.
On approximately 2025-07-31, 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. 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 documented action was: Prescribed local and advised no. 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: Chance draw yeah open. Score give give new while. Win director place.</data>
|
report_id: ADR-2025-306
report_date: '2025-08-12'
patient_details:
patient_id: ANON-PX-4089
gender: Male
relevant_history:
- hypertension
- osteoarthritis
- migraines
suspected_drugs:
- drug_name: Omeprazole
dosage: 330mg
route_of_administration: Subcutaneous
start_date: '2025-07-20'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-08-09'
- drug_name: Atorvastatin
dosage: 441mg
route_of_administration: Intravenous
start_date: '2025-07-20'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-08-09'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-07-31'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-07-31'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed local and advised no.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Parks and Sons Medical Center
reporter_type: Patient
notes: Chance draw yeah open. Score give give new while. Win director place.
|
<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-2025-947
Date of Submission: 2025-02-11
This report was submitted by a Patient from Townsend and Sons Medical Center concerning patient ANON-PX-5469. The subject is an adult other 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 Intravenous route at a dosage of 476mg, initiated on 2024-12-30 for Thromboembolism prevention and discontinued on 2025-02-07.
On approximately 2025-02-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Dizziness, Vomiting, Hepatotoxicity. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. 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 recent and advised like. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: News natural hour.</data>
|
report_id: ADR-2025-947
report_date: '2025-02-11'
patient_details:
patient_id: ANON-PX-5469
gender: Other
relevant_history:
- coronary artery disease
- type 2 diabetes
suspected_drugs:
- drug_name: Warfarin
dosage: 476mg
route_of_administration: Intravenous
start_date: '2024-12-30'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-02-07'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-02-06'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-02-06'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-02-06'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed recent and advised like.
- symptom_name: Hepatotoxicity
onset_date: '2025-02-06'
severity: Severe
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Townsend and Sons Medical Center
reporter_type: Patient
notes: News natural hour.
|
<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-2024-259
Date of Submission: 2024-09-08
This report was submitted by a Nurse from Madden, Welch and Hubbard Medical Center concerning patient ANON-PX-8336. The subject is a 37-year-old female 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 95mg, initiated on 2024-07-02 for Pain and inflammation with the course ongoing; Metformin (Biguanide) administered via the Oral route at a dosage of 321mg, initiated on 2024-07-02 for Type 2 diabetes with the course ongoing.
On approximately 2024-09-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema, Pruritus, Somnolence. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed gun and advised hundred. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate 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 documented action was: Prescribed environment and advised result. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed structure and advised help. 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-259
report_date: '2024-09-08'
patient_details:
patient_id: ANON-PX-8336
gender: Female
relevant_history:
- type 2 diabetes
- seasonal allergies
age_at_reaction: 37
suspected_drugs:
- drug_name: Ibuprofen
dosage: 95mg
route_of_administration: Topical
start_date: '2024-07-02'
indication_for_use: Pain and inflammation
drug_class: NSAID
- drug_name: Metformin
dosage: 321mg
route_of_administration: Oral
start_date: '2024-07-02'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-09-03'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed gun and advised hundred.
- symptom_name: Angioedema
onset_date: '2024-09-03'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-09-03'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed environment and advised result.
- symptom_name: Somnolence
onset_date: '2024-09-03'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed structure and advised help.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Madden, Welch and Hubbard 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-2025-788
Date of Submission: 2025-06-11
This report was submitted by a Other Healthcare Professional from Garner LLC Medical Center concerning patient ANON-PX-1784. The subject is a 59-year-old male with a significant medical history including seasonal allergies, type 2 diabetes, 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 Intravenous route at a dosage of 169mg, initiated on 2025-04-03 for Type 2 diabetes with the course ongoing; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 105mg, initiated on 2025-04-03 for Hypertension with the course ongoing.
On approximately 2025-04-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Pruritus, Vomiting, Stevens-Johnson syndrome. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed prepare and advised exactly. 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 study and advised than. 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: Say education social we no management particularly really. Push address story offer.</data>
|
report_id: ADR-2025-788
report_date: '2025-06-11'
patient_details:
patient_id: ANON-PX-1784
gender: Male
relevant_history:
- seasonal allergies
- type 2 diabetes
- anxiety
- atrial fibrillation
age_at_reaction: 59
suspected_drugs:
- drug_name: Metformin
dosage: 169mg
route_of_administration: Intravenous
start_date: '2025-04-03'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
- drug_name: Lisinopril
dosage: 105mg
route_of_administration: Intravenous
start_date: '2025-04-03'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-04-22'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-22'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-04-22'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed prepare and advised exactly.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-22'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed study and advised than.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Garner LLC Medical Center
reporter_type: Other Healthcare Professional
notes: Say education social we no management particularly really. Push address story
offer.
|
<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-2025-424
Date of Submission: 2025-04-13
This report was submitted by a Pharmacist from Garcia, Gordon and Green Medical Center concerning patient ANON-PX-1438. The subject is a 53-year-old other with a significant medical history including hypertension, 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): Atorvastatin administered via the Oral route at a dosage of 270mg, initiated on 2025-01-22 for Hypercholesterolemia and discontinued on 2025-03-31.
On approximately 2025-03-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Vomiting. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed professor and advised job. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Mild 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 2 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: Like third spend participant fight build head. Continue hair best treat bag.</data>
|
report_id: ADR-2025-424
report_date: '2025-04-13'
patient_details:
patient_id: ANON-PX-1438
gender: Other
relevant_history:
- hypertension
- seasonal allergies
- anxiety
- osteoarthritis
age_at_reaction: 53
suspected_drugs:
- drug_name: Atorvastatin
dosage: 270mg
route_of_administration: Oral
start_date: '2025-01-22'
indication_for_use: Hypercholesterolemia
end_date: '2025-03-31'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-03-29'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed professor and advised job.
- symptom_name: Vomiting
onset_date: '2025-03-29'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 2
reporting_facility: Garcia, Gordon and Green Medical Center
reporter_type: Pharmacist
notes: Like third spend participant fight build head. Continue hair best treat bag.
|
<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-2025-982
Date of Submission: 2025-02-05
This report was submitted by a Pharmacist from Garcia, Wade and Swanson Medical Center concerning patient ANON-PX-8329. The subject is a 73-year-old other with a significant medical history including seasonal allergies, 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 71mg, initiated on 2024-12-14 for Hypertension and discontinued on 2025-02-04.
On approximately 2024-12-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Maculopapular Rash. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed system and advised ago. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed themselves and advised wife. 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.
Reporter's Narrative Summary: Near agency send culture focus. Minute democratic born example toward nor close. Now third state product free among ten. West compare yourself unit organization various simple.</data>
|
report_id: ADR-2025-982
report_date: '2025-02-05'
patient_details:
patient_id: ANON-PX-8329
gender: Other
relevant_history:
- seasonal allergies
- migraines
age_at_reaction: 73
suspected_drugs:
- drug_name: Lisinopril
dosage: 71mg
route_of_administration: Intramuscular
start_date: '2024-12-14'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-04'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-12-31'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed system and advised ago.
- symptom_name: Maculopapular Rash
onset_date: '2024-12-31'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed themselves and advised wife.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Garcia, Wade and Swanson Medical Center
reporter_type: Pharmacist
notes: Near agency send culture focus. Minute democratic born example toward nor close.
Now third state product free among ten. West compare yourself unit organization
various simple.
|
<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-2025-508
Date of Submission: 2025-06-13
This report was submitted by a Other Healthcare Professional from Ortiz, Harris and Davis Medical Center concerning patient ANON-PX-5499. The subject is a 29-year-old male 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): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 139mg, initiated on 2025-05-03 for Thromboembolism prevention and discontinued on 2025-05-30.
On approximately 2025-05-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea. The Stevens-Johnson syndrome 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 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. 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-2025-508
report_date: '2025-06-13'
patient_details:
patient_id: ANON-PX-5499
gender: Male
relevant_history:
- chronic kidney disease
- coronary artery disease
age_at_reaction: 29
suspected_drugs:
- drug_name: Warfarin
dosage: 139mg
route_of_administration: Subcutaneous
start_date: '2025-05-03'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-05-30'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-06'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-05-06'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Ortiz, Harris and Davis 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-2025-927
Date of Submission: 2025-08-12
This report was submitted by a Patient from Phillips Ltd Medical Center concerning patient ANON-PX-4473. The subject is a 56-year-old male with a significant medical history including 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 Topical route at a dosage of 489mg, initiated on 2025-07-15 for Hypertension and discontinued on 2025-07-25; Metformin (Biguanide) administered via the Topical route at a dosage of 364mg, initiated on 2025-07-15 for Type 2 diabetes and discontinued on 2025-07-25.
On approximately 2025-07-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Somnolence. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed thus and advised customer. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed nor and advised sign. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Nature contain civil these.</data>
|
report_id: ADR-2025-927
report_date: '2025-08-12'
patient_details:
patient_id: ANON-PX-4473
gender: Male
relevant_history:
- asthma
- type 2 diabetes
age_at_reaction: 56
suspected_drugs:
- drug_name: Lisinopril
dosage: 489mg
route_of_administration: Topical
start_date: '2025-07-15'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-07-25'
- drug_name: Metformin
dosage: 364mg
route_of_administration: Topical
start_date: '2025-07-15'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-07-25'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-07-24'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed thus and advised customer.
- symptom_name: Somnolence
onset_date: '2025-07-24'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed nor and advised sign.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 9
reporting_facility: Phillips Ltd Medical Center
reporter_type: Patient
notes: Nature contain civil these.
|
<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-2024-530
Date of Submission: 2024-09-03
This report was submitted by a Pharmacist from Dorsey, Thomas and Maynard Medical Center concerning patient ANON-PX-2685. The subject is an adult female with a significant medical history including migraines, 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): Ibuprofen (NSAID) administered via the Oral route at a dosage of 94mg, initiated on 2024-08-26 for Pain and inflammation and discontinued on 2024-09-02; Warfarin (Anticoagulant) administered via the Oral route at a dosage of 358mg, initiated on 2024-08-26 for Thromboembolism prevention and discontinued on 2024-09-02.
On approximately 2024-08-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Nausea, Maculopapular Rash, Headache, Anaphylaxis. The Dizziness 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 Moderate 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 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 area and advised relationship. The current patient status regarding this symptom is 'Recovering'. 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 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: Identify popular simply seven check onto. Culture something season likely. Whether ball particular sense many.</data>
|
report_id: ADR-2024-530
report_date: '2024-09-03'
patient_details:
patient_id: ANON-PX-2685
gender: Female
relevant_history:
- migraines
- atrial fibrillation
- seasonal allergies
suspected_drugs:
- drug_name: Ibuprofen
dosage: 94mg
route_of_administration: Oral
start_date: '2024-08-26'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-09-02'
- drug_name: Warfarin
dosage: 358mg
route_of_administration: Oral
start_date: '2024-08-26'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-09-02'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-08-30'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-08-30'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-30'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2024-08-30'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed area and advised relationship.
- symptom_name: Anaphylaxis
onset_date: '2024-08-30'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 9
reporting_facility: Dorsey, Thomas and Maynard Medical Center
reporter_type: Pharmacist
notes: Identify popular simply seven check onto. Culture something season likely.
Whether ball particular sense many.
|
<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-2024-836
Date of Submission: 2024-12-02
This report was submitted by a Patient from Mills, Carter and Rocha Medical Center concerning patient ANON-PX-6737. The subject is an adult 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): Metformin (Biguanide) administered via the Topical route at a dosage of 409mg, initiated on 2024-11-22 for Type 2 diabetes and discontinued on 2024-11-26; Omeprazole administered via the Subcutaneous route at a dosage of 101mg, initiated on 2024-11-22 for Gastroesophageal reflux disease and discontinued on 2024-11-26.
On approximately 2024-11-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Maculopapular Rash, Vomiting. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed knowledge and advised off. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Severe 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 '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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Lose early miss central might. Model speech exactly across. Rest threat pick.</data>
|
report_id: ADR-2024-836
report_date: '2024-12-02'
patient_details:
patient_id: ANON-PX-6737
gender: Other
relevant_history:
- atrial fibrillation
- seasonal allergies
suspected_drugs:
- drug_name: Metformin
dosage: 409mg
route_of_administration: Topical
start_date: '2024-11-22'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-11-26'
- drug_name: Omeprazole
dosage: 101mg
route_of_administration: Subcutaneous
start_date: '2024-11-22'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-11-26'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-11-23'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed knowledge and advised off.
- symptom_name: Maculopapular Rash
onset_date: '2024-11-23'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-11-23'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Mills, Carter and Rocha Medical Center
reporter_type: Patient
notes: Lose early miss central might. Model speech exactly across. Rest threat pick.
|
<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-2025-790
Date of Submission: 2025-01-16
This report was submitted by a Patient from Sloan Ltd Medical Center concerning patient ANON-PX-3645. The subject is a 18-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): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 468mg, initiated on 2024-11-16 for Pain and inflammation with the course ongoing.
On approximately 2025-01-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Maculopapular Rash. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. 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 '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-790
report_date: '2025-01-16'
patient_details:
patient_id: ANON-PX-3645
gender: Other
relevant_history:
- osteoarthritis
- asthma
age_at_reaction: 18
suspected_drugs:
- drug_name: Ibuprofen
dosage: 468mg
route_of_administration: Intravenous
start_date: '2024-11-16'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-01-10'
severity: Life-threatening
outcome: Fatal
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-01-10'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 2
reporting_facility: Sloan 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-2025-866
Date of Submission: 2025-05-31
This report was submitted by a Pharmacist from Brown and Sons Medical Center concerning patient ANON-PX-2513. The subject is a 89-year-old other with a significant medical history including chronic kidney 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): Metformin (Biguanide) administered via the Intravenous route at a dosage of 435mg, initiated on 2025-03-15 for Type 2 diabetes and discontinued on 2025-05-08.
On approximately 2025-04-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Vomiting, Anaphylaxis, Angioedema, Maculopapular Rash. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed question and advised drug. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis 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 Severe in severity. This necessitated clinical intervention. 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 '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Me behind care exist design report. Peace school wide certain present people prevent book. My least organization never camera pretty.</data>
|
report_id: ADR-2025-866
report_date: '2025-05-31'
patient_details:
patient_id: ANON-PX-2513
gender: Other
relevant_history:
- chronic kidney disease
- hypertension
- seasonal allergies
age_at_reaction: 89
suspected_drugs:
- drug_name: Metformin
dosage: 435mg
route_of_administration: Intravenous
start_date: '2025-03-15'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-05-08'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-04-03'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Vomiting
onset_date: '2025-04-03'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed question and advised drug.
- symptom_name: Anaphylaxis
onset_date: '2025-04-03'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-04-03'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-04-03'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Brown and Sons Medical Center
reporter_type: Pharmacist
notes: Me behind care exist design report. Peace school wide certain present people
prevent book. My least organization never camera pretty.
|
<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: 2024-12-07
This report was submitted by a Pharmacist from Henry-Shaw Medical Center concerning patient ANON-PX-6394. The subject is an adult other with a significant medical history including type 2 diabetes, 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): Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 184mg, initiated on 2024-10-30 for Pain and inflammation and discontinued on 2024-12-06.
On approximately 2024-11-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash, Headache. The Somnolence was classified as Mild 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. This necessitated clinical intervention. The documented action was: Prescribed least and advised west. 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 '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: Question your high recently letter brother best left. Few relationship let million reach well. Character station attorney consider force specific painting.</data>
|
report_id: ADR-2024-489
report_date: '2024-12-07'
patient_details:
patient_id: ANON-PX-6394
gender: Other
relevant_history:
- type 2 diabetes
- chronic kidney disease
- migraines
- seasonal allergies
suspected_drugs:
- drug_name: Ibuprofen
dosage: 184mg
route_of_administration: Intramuscular
start_date: '2024-10-30'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-12-06'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-11-29'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-29'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed least and advised west.
- symptom_name: Headache
onset_date: '2024-11-29'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Henry-Shaw Medical Center
reporter_type: Pharmacist
notes: Question your high recently letter brother best left. Few relationship let
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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-2025-615
Date of Submission: 2025-08-12
This report was submitted by a Pharmacist from Ashley-Gallagher Medical Center concerning patient ANON-PX-4668. The subject is an adult female with a significant medical history including asthma, 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 Intravenous route at a dosage of 231mg, initiated on 2025-06-13 for Pain and inflammation and discontinued on 2025-08-10.
On approximately 2025-07-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Headache. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache 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. 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: Upon five call anyone identify. Even along window fear its. Generation go cover hold response.</data>
|
report_id: ADR-2025-615
report_date: '2025-08-12'
patient_details:
patient_id: ANON-PX-4668
gender: Female
relevant_history:
- asthma
- seasonal allergies
- type 2 diabetes
suspected_drugs:
- drug_name: Ibuprofen
dosage: 231mg
route_of_administration: Intravenous
start_date: '2025-06-13'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-08-10'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-07-20'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-07-20'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2025-07-20'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Ashley-Gallagher Medical Center
reporter_type: Pharmacist
notes: Upon five call anyone identify. Even along window fear its. Generation go cover
hold response.
|
<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: 2025-08-04
This report was submitted by a Other Healthcare Professional from Arroyo Ltd Medical Center concerning patient ANON-PX-3547. The subject is a 68-year-old female with a significant medical history including chronic kidney disease, 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): Atorvastatin administered via the Subcutaneous route at a dosage of 258mg, initiated on 2025-06-27 for Hypercholesterolemia with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 342mg, initiated on 2025-06-27 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-07-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Anaphylaxis. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed consumer and advised this. The current patient status regarding this symptom is 'Recovered'. 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 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-2025-741
report_date: '2025-08-04'
patient_details:
patient_id: ANON-PX-3547
gender: Female
relevant_history:
- chronic kidney disease
- coronary artery disease
- anxiety
age_at_reaction: 68
suspected_drugs:
- drug_name: Atorvastatin
dosage: 258mg
route_of_administration: Subcutaneous
start_date: '2025-06-27'
indication_for_use: Hypercholesterolemia
- drug_name: Omeprazole
dosage: 342mg
route_of_administration: Topical
start_date: '2025-06-27'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-30'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed consumer and advised this.
- symptom_name: Anaphylaxis
onset_date: '2025-07-30'
severity: Mild
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Arroyo Ltd 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-2024-271
Date of Submission: 2024-10-12
This report was submitted by a Nurse from Smith LLC Medical Center concerning patient ANON-PX-7277. The subject is an adult female with a significant medical history including asthma, anxiety, atrial fibrillation, 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): Gabapentin administered via the Oral route at a dosage of 107mg, initiated on 2024-09-18 for Neuropathic pain with the course ongoing; Ibuprofen administered via the Topical route at a dosage of 214mg, initiated on 2024-09-18 for Pain and inflammation with the course ongoing.
On approximately 2024-09-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed game and advised appear. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed old and advised send. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-271
report_date: '2024-10-12'
patient_details:
patient_id: ANON-PX-7277
gender: Female
relevant_history:
- asthma
- anxiety
- atrial fibrillation
- type 2 diabetes
suspected_drugs:
- drug_name: Gabapentin
dosage: 107mg
route_of_administration: Oral
start_date: '2024-09-18'
indication_for_use: Neuropathic pain
- drug_name: Ibuprofen
dosage: 214mg
route_of_administration: Topical
start_date: '2024-09-18'
indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-09-20'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed game and advised appear.
- symptom_name: Nausea
onset_date: '2024-09-20'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed old and advised send.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Smith LLC 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-2024-561
Date of Submission: 2024-10-22
This report was submitted by a Pharmacist from Michael-Stewart Medical Center concerning patient ANON-PX-8391. The subject is a 74-year-old other with a significant medical history including chronic kidney disease, asthma, 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): Atorvastatin administered via the Intramuscular route at a dosage of 231mg, initiated on 2024-09-24 for Hypercholesterolemia with the course ongoing.
On approximately 2024-10-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Angioedema. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed beautiful and advised how. The current patient status regarding this symptom is 'Fatal'. The Angioedema 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Free under chance far remain year key. Dinner option tax campaign office establish huge with. Chair glass Congress speak particularly item that main. Character down specific.</data>
|
report_id: ADR-2024-561
report_date: '2024-10-22'
patient_details:
patient_id: ANON-PX-8391
gender: Other
relevant_history:
- chronic kidney disease
- asthma
- migraines
- hypertension
age_at_reaction: 74
suspected_drugs:
- drug_name: Atorvastatin
dosage: 231mg
route_of_administration: Intramuscular
start_date: '2024-09-24'
indication_for_use: Hypercholesterolemia
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-10-12'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed beautiful and advised how.
- symptom_name: Angioedema
onset_date: '2024-10-12'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Michael-Stewart Medical Center
reporter_type: Pharmacist
notes: Free under chance far remain year key. Dinner option tax campaign office establish
huge with. Chair glass Congress speak particularly item that main. Character down
specific.
|
<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-2025-780
Date of Submission: 2025-08-08
This report was submitted by a Patient from Martinez-Brewer Medical Center concerning patient ANON-PX-1846. The subject is a 22-year-old male with a significant medical history including migraines, 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 93mg, initiated on 2025-06-22 for Gastroesophageal reflux disease and discontinued on 2025-08-04; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 452mg, initiated on 2025-06-22 for Thromboembolism prevention and discontinued on 2025-08-04.
On approximately 2025-08-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Dizziness, Hepatotoxicity, Maculopapular Rash. 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 Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed realize and advised spring. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed method and advised way. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed peace and advised still. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-780
report_date: '2025-08-08'
patient_details:
patient_id: ANON-PX-1846
gender: Male
relevant_history:
- migraines
- atrial fibrillation
age_at_reaction: 22
suspected_drugs:
- drug_name: Omeprazole
dosage: 93mg
route_of_administration: Subcutaneous
start_date: '2025-06-22'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-08-04'
- drug_name: Warfarin
dosage: 452mg
route_of_administration: Intravenous
start_date: '2025-06-22'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-08-04'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-08-03'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-08-03'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed realize and advised spring.
- symptom_name: Hepatotoxicity
onset_date: '2025-08-03'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed method and advised way.
- symptom_name: Maculopapular Rash
onset_date: '2025-08-03'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed peace and advised still.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 3
reporting_facility: Martinez-Brewer 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-2024-166
Date of Submission: 2024-11-28
This report was submitted by a Patient from Chapman Group Medical Center concerning patient ANON-PX-7145. The subject is an adult other with a significant medical history including osteoarthritis, asthma, chronic kidney 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): Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 174mg, initiated on 2024-11-09 for Bacterial infection and discontinued on 2024-11-18; Sertraline (SSRI) administered via the Intravenous route at a dosage of 494mg, initiated on 2024-11-09 for Major depressive disorder and discontinued on 2024-11-18.
On approximately 2024-11-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed boy and advised result. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild 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 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: Professional seat nearly TV environmental. Mention maybe stage coach add magazine. Shoulder grow something write condition. Benefit name politics contain.</data>
|
report_id: ADR-2024-166
report_date: '2024-11-28'
patient_details:
patient_id: ANON-PX-7145
gender: Other
relevant_history:
- osteoarthritis
- asthma
- chronic kidney disease
- type 2 diabetes
suspected_drugs:
- drug_name: Amoxicillin
dosage: 174mg
route_of_administration: Intravenous
start_date: '2024-11-09'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-11-18'
- drug_name: Sertraline
dosage: 494mg
route_of_administration: Intravenous
start_date: '2024-11-09'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-11-18'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-11-16'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed boy and advised result.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-16'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Chapman Group Medical Center
reporter_type: Patient
notes: Professional seat nearly TV environmental. Mention maybe stage coach add magazine.
Shoulder grow something write condition. Benefit name politics contain.
|
<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-2024-496
Date of Submission: 2024-09-21
This report was submitted by a Other Healthcare Professional from Ellis, Allison and Page Medical Center concerning patient ANON-PX-6464. The subject is a 78-year-old other 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): Amoxicillin administered via the Intravenous route at a dosage of 455mg, initiated on 2024-08-05 for Bacterial infection with the course ongoing.
On approximately 2024-08-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Anaphylaxis, Stevens-Johnson syndrome, Nausea, Vomiting. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis 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 'Recovered'. The Nausea 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 Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is '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-2024-496
report_date: '2024-09-21'
patient_details:
patient_id: ANON-PX-6464
gender: Other
relevant_history:
- hypertension
- asthma
age_at_reaction: 78
suspected_drugs:
- drug_name: Amoxicillin
dosage: 455mg
route_of_administration: Intravenous
start_date: '2024-08-05'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-08-08'
severity: Life-threatening
outcome: Fatal
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2024-08-08'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-08'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-08-08'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-08-08'
severity: Mild
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 10
reporting_facility: Ellis, Allison and Page 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-2025-890
Date of Submission: 2025-03-19
This report was submitted by a Pharmacist from Martinez, Spencer and Davis Medical Center concerning patient ANON-PX-1314. The subject is an adult female with a significant medical history including 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): Levothyroxine administered via the Intramuscular route at a dosage of 160mg, initiated on 2025-02-15 for Hypothyroidism with the course ongoing.
On approximately 2025-03-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed that and advised authority. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Fish more since arm training owner spend. Rock maintain writer side. Inside degree bring image opportunity others.</data>
|
report_id: ADR-2025-890
report_date: '2025-03-19'
patient_details:
patient_id: ANON-PX-1314
gender: Female
relevant_history:
- type 2 diabetes
- atrial fibrillation
suspected_drugs:
- drug_name: Levothyroxine
dosage: 160mg
route_of_administration: Intramuscular
start_date: '2025-02-15'
indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-03-13'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-03-13'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed that and advised authority.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Martinez, Spencer and Davis Medical Center
reporter_type: Pharmacist
notes: Fish more since arm training owner spend. Rock maintain writer side. Inside
degree bring image opportunity others.
|
<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-2024-385
Date of Submission: 2024-09-08
This report was submitted by a Nurse from Bishop and Sons Medical Center concerning patient ANON-PX-2663. The subject is a 37-year-old female with a significant medical history including 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 330mg, initiated on 2024-06-25 for Pain and inflammation and discontinued on 2024-09-02; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 374mg, initiated on 2024-06-25 for Thromboembolism prevention and discontinued on 2024-09-02.
On approximately 2024-09-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Somnolence, Dizziness, Anaphylaxis. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 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 Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed speak and advised join. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. 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: Tend course customer level. Night north record. Here public rock size size market trade.</data>
|
report_id: ADR-2024-385
report_date: '2024-09-08'
patient_details:
patient_id: ANON-PX-2663
gender: Female
relevant_history:
- asthma
- type 2 diabetes
age_at_reaction: 37
suspected_drugs:
- drug_name: Ibuprofen
dosage: 330mg
route_of_administration: Topical
start_date: '2024-06-25'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-09-02'
- drug_name: Warfarin
dosage: 374mg
route_of_administration: Intravenous
start_date: '2024-06-25'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-09-02'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-09-01'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-09-01'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-09-01'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Dizziness
onset_date: '2024-09-01'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed speak and advised join.
- symptom_name: Anaphylaxis
onset_date: '2024-09-01'
severity: Life-threatening
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Bishop and Sons Medical Center
reporter_type: Nurse
notes: Tend course customer level. Night north record. Here public rock size size
market trade.
|
<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-2025-896
Date of Submission: 2025-06-17
This report was submitted by a Patient from Smith, Ellison and Espinoza Medical Center concerning patient ANON-PX-3600. The subject is a 65-year-old other with a significant medical history including osteoarthritis, seasonal allergies, 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 Topical route at a dosage of 166mg, initiated on 2025-05-15 for Major depressive disorder and discontinued on 2025-06-14.
On approximately 2025-06-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Somnolence, Stevens-Johnson syndrome. The Dizziness 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 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. This necessitated clinical intervention. The documented action was: Prescribed marriage and advised voice. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-896
report_date: '2025-06-17'
patient_details:
patient_id: ANON-PX-3600
gender: Other
relevant_history:
- osteoarthritis
- seasonal allergies
- asthma
age_at_reaction: 65
suspected_drugs:
- drug_name: Sertraline
dosage: 166mg
route_of_administration: Topical
start_date: '2025-05-15'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-06-14'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-06-13'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-06-13'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-13'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed marriage and advised voice.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 2
reporting_facility: Smith, Ellison and Espinoza 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-2025-916
Date of Submission: 2025-03-15
This report was submitted by a Other Healthcare Professional from Bowman, Nelson and Camacho Medical Center concerning patient ANON-PX-3507. The subject is a 90-year-old male with a significant medical history including type 2 diabetes, asthma, coronary artery 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): Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 266mg, initiated on 2024-12-16 for Hypercholesterolemia and discontinued on 2025-02-05; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 19mg, initiated on 2024-12-16 for Bacterial infection and discontinued on 2025-02-05.
On approximately 2025-01-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Stevens-Johnson syndrome. The Pruritus 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 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 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.
Reporter's Narrative Summary: Again natural two sell occur. Painting present politics control word democratic hope window.</data>
|
report_id: ADR-2025-916
report_date: '2025-03-15'
patient_details:
patient_id: ANON-PX-3507
gender: Male
relevant_history:
- type 2 diabetes
- asthma
- coronary artery disease
- atrial fibrillation
age_at_reaction: 90
suspected_drugs:
- drug_name: Atorvastatin
dosage: 266mg
route_of_administration: Intramuscular
start_date: '2024-12-16'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-02-05'
- drug_name: Amoxicillin
dosage: 19mg
route_of_administration: Intramuscular
start_date: '2024-12-16'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-02-05'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-01-09'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-09'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 8
reporting_facility: Bowman, Nelson and Camacho Medical Center
reporter_type: Other Healthcare Professional
notes: Again natural two sell occur. Painting present politics control word democratic
hope 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-2025-936
Date of Submission: 2025-02-20
This report was submitted by a Patient from Jones Ltd Medical Center concerning patient ANON-PX-4666. The subject is a 42-year-old male with a significant medical history including anxiety, osteoarthritis, atrial fibrillation, 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): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 321mg, initiated on 2024-12-28 for Major depressive disorder and discontinued on 2025-01-29; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 373mg, initiated on 2024-12-28 for Neuropathic pain and discontinued on 2025-01-29.
On approximately 2025-01-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Anaphylaxis, Angioedema, Somnolence, Headache. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed what and advised black. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis 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. 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 Congress and advised the. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed same and advised always. The current patient status regarding this symptom is '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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-936
report_date: '2025-02-20'
patient_details:
patient_id: ANON-PX-4666
gender: Male
relevant_history:
- anxiety
- osteoarthritis
- atrial fibrillation
- type 2 diabetes
age_at_reaction: 42
suspected_drugs:
- drug_name: Sertraline
dosage: 321mg
route_of_administration: Subcutaneous
start_date: '2024-12-28'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-01-29'
- drug_name: Gabapentin
dosage: 373mg
route_of_administration: Intravenous
start_date: '2024-12-28'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-01-29'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-01-04'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed what and advised black.
- symptom_name: Anaphylaxis
onset_date: '2025-01-04'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-01-04'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-01-04'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed Congress and advised the.
- symptom_name: Headache
onset_date: '2025-01-04'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed same and advised always.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Jones 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-2024-115
Date of Submission: 2024-10-21
This report was submitted by a Nurse from Wiggins Group Medical Center concerning patient ANON-PX-3697. The subject is a 69-year-old male with a significant medical history including 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): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 380mg, initiated on 2024-10-04 for Hypertension and discontinued on 2024-10-19; Ibuprofen (NSAID) administered via the Oral route at a dosage of 16mg, initiated on 2024-10-04 for Pain and inflammation and discontinued on 2024-10-19.
On approximately 2024-10-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Hepatotoxicity, Nausea, Diarrhea, Stevens-Johnson syndrome. The Headache 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 'Not 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 Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate 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 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: Must sport face leader organization should. Believe life you environmental often.</data>
|
report_id: ADR-2024-115
report_date: '2024-10-21'
patient_details:
patient_id: ANON-PX-3697
gender: Male
relevant_history:
- atrial fibrillation
- chronic kidney disease
- seasonal allergies
age_at_reaction: 69
suspected_drugs:
- drug_name: Lisinopril
dosage: 380mg
route_of_administration: Topical
start_date: '2024-10-04'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-10-19'
- drug_name: Ibuprofen
dosage: 16mg
route_of_administration: Oral
start_date: '2024-10-04'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-10-19'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-10-18'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-10-18'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-10-18'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-10-18'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-10-18'
severity: Moderate
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Wiggins Group Medical Center
reporter_type: Nurse
notes: Must sport face leader organization should. Believe life you environmental
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-2024-571
Date of Submission: 2024-11-13
This report was submitted by a Other Healthcare Professional from Nelson Ltd Medical Center concerning patient ANON-PX-4103. The subject is a 63-year-old other with a significant medical history including type 2 diabetes, seasonal allergies, 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): Sertraline administered via the Intramuscular route at a dosage of 338mg, initiated on 2024-08-16 for Major depressive disorder and discontinued on 2024-10-24; Omeprazole administered via the Intramuscular route at a dosage of 66mg, initiated on 2024-08-16 for Gastroesophageal reflux disease and discontinued on 2024-10-24.
On approximately 2024-08-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Diarrhea, Maculopapular Rash, Headache. 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 Diarrhea 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 bag and advised focus. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed who and advised although. 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: Lot stop everybody behind another try throw almost. Car land final mean almost I. Spring shake participant wonder yet professional. At before put.</data>
|
report_id: ADR-2024-571
report_date: '2024-11-13'
patient_details:
patient_id: ANON-PX-4103
gender: Other
relevant_history:
- type 2 diabetes
- seasonal allergies
- chronic kidney disease
- migraines
age_at_reaction: 63
suspected_drugs:
- drug_name: Sertraline
dosage: 338mg
route_of_administration: Intramuscular
start_date: '2024-08-16'
indication_for_use: Major depressive disorder
end_date: '2024-10-24'
- drug_name: Omeprazole
dosage: 66mg
route_of_administration: Intramuscular
start_date: '2024-08-16'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-10-24'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-08-23'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-08-23'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-08-23'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed bag and advised focus.
- symptom_name: Headache
onset_date: '2024-08-23'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed who and advised although.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Nelson Ltd Medical Center
reporter_type: Other Healthcare Professional
notes: Lot stop everybody behind another try throw almost. Car land final mean almost
I. Spring shake participant wonder yet professional. At before put.
|
<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-2024-816
Date of Submission: 2024-11-30
This report was submitted by a Patient from Horn and Sons Medical Center concerning patient ANON-PX-9723. The subject is a 24-year-old other with a significant medical history including asthma, 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): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 105mg, initiated on 2024-11-14 for Thromboembolism prevention and discontinued on 2024-11-26; Levothyroxine (Thyroid hormone) administered via the Intravenous route at a dosage of 356mg, initiated on 2024-11-14 for Hypothyroidism and discontinued on 2024-11-26.
On approximately 2024-11-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Angioedema, Maculopapular Rash. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema 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. This necessitated clinical intervention. The documented action was: Prescribed interest and advised knowledge. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-816
report_date: '2024-11-30'
patient_details:
patient_id: ANON-PX-9723
gender: Other
relevant_history:
- asthma
- anxiety
- chronic kidney disease
age_at_reaction: 24
suspected_drugs:
- drug_name: Warfarin
dosage: 105mg
route_of_administration: Subcutaneous
start_date: '2024-11-14'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-11-26'
- drug_name: Levothyroxine
dosage: 356mg
route_of_administration: Intravenous
start_date: '2024-11-14'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-26'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-11-17'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-11-17'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-11-17'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed interest and advised knowledge.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 2
reporting_facility: Horn and Sons 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-2024-886
Date of Submission: 2024-12-27
This report was submitted by a Other Healthcare Professional from Harris PLC Medical Center concerning patient ANON-PX-9432. The subject is an adult female with a significant medical history including seasonal allergies, osteoarthritis, 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): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 118mg, initiated on 2024-11-05 for Hypertension and discontinued on 2024-12-03.
On approximately 2024-11-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea, Vomiting, Anaphylaxis. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed firm and advised population. 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 'Not Recovered'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed position and advised else. 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 'Fatal'.
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: Instead child ahead at shake direction tell side. President see no front program part push relationship. Continue job how ago successful animal.</data>
|
report_id: ADR-2024-886
report_date: '2024-12-27'
patient_details:
patient_id: ANON-PX-9432
gender: Female
relevant_history:
- seasonal allergies
- osteoarthritis
- chronic kidney disease
- asthma
suspected_drugs:
- drug_name: Lisinopril
dosage: 118mg
route_of_administration: Subcutaneous
start_date: '2024-11-05'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-12-03'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-11-18'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed firm and advised population.
- symptom_name: Nausea
onset_date: '2024-11-18'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-11-18'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed position and advised else.
- symptom_name: Anaphylaxis
onset_date: '2024-11-18'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Harris PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Instead child ahead at shake direction tell side. President see no front program
part push relationship. Continue job how ago successful animal.
|
<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: 2025-03-03
This report was submitted by a Other Healthcare Professional from Mathis, Spencer and Peterson Medical Center concerning patient ANON-PX-5953. The subject is an adult other with a significant medical history including coronary artery disease, 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): Sertraline administered via the Oral route at a dosage of 391mg, initiated on 2025-01-03 for Major depressive disorder with the course ongoing.
On approximately 2025-02-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Anaphylaxis, Vomiting. 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 Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed culture and advised environmental. The current patient status regarding this symptom is 'Unknown'. The Vomiting 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 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: News finish back worker me audience receive. The teach study build same thank. Participant improve young whose significant raise. Call contain role animal color change official.</data>
|
report_id: ADR-2025-709
report_date: '2025-03-03'
patient_details:
patient_id: ANON-PX-5953
gender: Other
relevant_history:
- coronary artery disease
- migraines
- type 2 diabetes
suspected_drugs:
- drug_name: Sertraline
dosage: 391mg
route_of_administration: Oral
start_date: '2025-01-03'
indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-02-07'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-02-07'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed culture and advised environmental.
- symptom_name: Vomiting
onset_date: '2025-02-07'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Mathis, Spencer and Peterson Medical Center
reporter_type: Other Healthcare Professional
notes: News finish back worker me audience receive. The teach study build same thank.
Participant improve young whose significant raise. Call contain role animal color
change official.
|
<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-2025-248
Date of Submission: 2025-06-22
This report was submitted by a Physician from Arroyo-Malone Medical Center concerning patient ANON-PX-7695. The subject is a 67-year-old male with a significant medical history including 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): Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 185mg, initiated on 2025-05-31 for Thromboembolism prevention and discontinued on 2025-06-05; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 317mg, initiated on 2025-05-31 for Bacterial infection and discontinued on 2025-06-05.
On approximately 2025-06-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Vomiting, Somnolence. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 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 Life-threatening in severity. This necessitated clinical intervention. 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 '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: With some Mr bar evening safe garden meet. Including book stock glass cover more.</data>
|
report_id: ADR-2025-248
report_date: '2025-06-22'
patient_details:
patient_id: ANON-PX-7695
gender: Male
relevant_history:
- seasonal allergies
- hypertension
age_at_reaction: 67
suspected_drugs:
- drug_name: Warfarin
dosage: 185mg
route_of_administration: Subcutaneous
start_date: '2025-05-31'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-06-05'
- drug_name: Amoxicillin
dosage: 317mg
route_of_administration: Subcutaneous
start_date: '2025-05-31'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-06-05'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-03'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2025-06-03'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-06-03'
severity: Life-threatening
outcome: Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2025-06-03'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Arroyo-Malone Medical Center
reporter_type: Physician
notes: With some Mr bar evening safe garden meet. Including book stock glass cover
more.
|
<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-2024-958
Date of Submission: 2024-09-22
This report was submitted by a Patient from Nicholson, Johnson and Flynn Medical Center concerning patient ANON-PX-1780. The subject is an adult female 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): Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 394mg, initiated on 2024-08-18 for Thromboembolism prevention and discontinued on 2024-09-11.
On approximately 2024-08-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Nausea, Maculopapular Rash, Vomiting. The Headache was classified as Mild in severity. This necessitated clinical intervention. 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 I and advised gas. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed dream and advised partner. The current patient status regarding this symptom is 'Recovered'. The Vomiting 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 5 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-2024-958
report_date: '2024-09-22'
patient_details:
patient_id: ANON-PX-1780
gender: Female
relevant_history:
- migraines
- hypertension
suspected_drugs:
- drug_name: Warfarin
dosage: 394mg
route_of_administration: Intravenous
start_date: '2024-08-18'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2024-09-11'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-08-28'
severity: Mild
outcome: Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-08-28'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed I and advised gas.
- symptom_name: Nausea
onset_date: '2024-08-28'
severity: Mild
outcome: Not Recovered
intervention_required: true
- symptom_name: Maculopapular Rash
onset_date: '2024-08-28'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed dream and advised partner.
- symptom_name: Vomiting
onset_date: '2024-08-28'
severity: Mild
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Nicholson, Johnson and Flynn 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-2025-666
Date of Submission: 2025-08-02
This report was submitted by a Other Healthcare Professional from Moreno, Randolph and Prince Medical Center concerning patient ANON-PX-5669. The subject is a 38-year-old female with a significant medical history including seasonal allergies, 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): Levothyroxine administered via the Topical route at a dosage of 218mg, initiated on 2025-07-21 for Hypothyroidism and discontinued on 2025-07-30.
On approximately 2025-07-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Hepatotoxicity, 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 Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. 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 'Not 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'.
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: Board to cost young game fast. Where throw Congress behavior why.</data>
|
report_id: ADR-2025-666
report_date: '2025-08-02'
patient_details:
patient_id: ANON-PX-5669
gender: Female
relevant_history:
- seasonal allergies
- asthma
- coronary artery disease
age_at_reaction: 38
suspected_drugs:
- drug_name: Levothyroxine
dosage: 218mg
route_of_administration: Topical
start_date: '2025-07-21'
indication_for_use: Hypothyroidism
end_date: '2025-07-30'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-23'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-07-23'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-07-23'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-07-23'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Moreno, Randolph and Prince Medical Center
reporter_type: Other Healthcare Professional
notes: Board to cost young game fast. Where throw Congress behavior why.
|
<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-2025-627
Date of Submission: 2025-04-07
This report was submitted by a Physician from Lara Group Medical Center concerning patient ANON-PX-9861. The subject is a 45-year-old female with a significant medical history including seasonal allergies, osteoarthritis, 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): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 215mg, initiated on 2025-01-18 for Gastroesophageal reflux disease and discontinued on 2025-03-11.
On approximately 2025-03-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Dizziness, Nausea, Hepatotoxicity. 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 Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed far and advised eye. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 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 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-627
report_date: '2025-04-07'
patient_details:
patient_id: ANON-PX-9861
gender: Female
relevant_history:
- seasonal allergies
- osteoarthritis
- asthma
- anxiety
age_at_reaction: 45
suspected_drugs:
- drug_name: Omeprazole
dosage: 215mg
route_of_administration: Oral
start_date: '2025-01-18'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-03-11'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-06'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-03-06'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed far and advised eye.
- symptom_name: Dizziness
onset_date: '2025-03-06'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-03-06'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-03-06'
severity: Severe
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Lara Group 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-2024-727
Date of Submission: 2024-10-24
This report was submitted by a Physician from Huang-Montgomery Medical Center concerning patient ANON-PX-1229. The subject is an adult female with a significant medical history including seasonal allergies, 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): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 411mg, initiated on 2024-09-08 for Gastroesophageal reflux disease and discontinued on 2024-10-20; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 442mg, initiated on 2024-09-08 for Pain and inflammation and discontinued on 2024-10-20.
On approximately 2024-09-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Somnolence. The Diarrhea 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 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. 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: Paper until these allow fact relationship. Age affect what now let. Edge born father.</data>
|
report_id: ADR-2024-727
report_date: '2024-10-24'
patient_details:
patient_id: ANON-PX-1229
gender: Female
relevant_history:
- seasonal allergies
- anxiety
- chronic kidney disease
suspected_drugs:
- drug_name: Omeprazole
dosage: 411mg
route_of_administration: Topical
start_date: '2024-09-08'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-10-20'
- drug_name: Ibuprofen
dosage: 442mg
route_of_administration: Subcutaneous
start_date: '2024-09-08'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-10-20'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-09-18'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-09-18'
severity: Life-threatening
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Huang-Montgomery Medical Center
reporter_type: Physician
notes: Paper until these allow fact relationship. Age affect what now let. Edge born
father.
|
<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-2025-553
Date of Submission: 2025-03-07
This report was submitted by a Pharmacist from Rodriguez-Garrett Medical Center concerning patient ANON-PX-1482. The subject is a 72-year-old male with a significant medical history including asthma, 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): Amoxicillin administered via the Subcutaneous route at a dosage of 404mg, initiated on 2025-02-17 for Bacterial infection and discontinued on 2025-03-03; Metformin (Biguanide) administered via the Intravenous route at a dosage of 77mg, initiated on 2025-02-17 for Type 2 diabetes and discontinued on 2025-03-03.
On approximately 2025-03-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash, Headache, Stevens-Johnson syndrome. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed resource and advised teacher. The current patient status regarding this symptom is 'Unknown'. 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 Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild 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 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: Must message plan condition agency. Modern hour agent loss boy tax western thousand.</data>
|
report_id: ADR-2025-553
report_date: '2025-03-07'
patient_details:
patient_id: ANON-PX-1482
gender: Male
relevant_history:
- asthma
- seasonal allergies
- coronary artery disease
age_at_reaction: 72
suspected_drugs:
- drug_name: Amoxicillin
dosage: 404mg
route_of_administration: Subcutaneous
start_date: '2025-02-17'
indication_for_use: Bacterial infection
end_date: '2025-03-03'
- drug_name: Metformin
dosage: 77mg
route_of_administration: Intravenous
start_date: '2025-02-17'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-03-03'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-03-03'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed resource and advised teacher.
- symptom_name: Maculopapular Rash
onset_date: '2025-03-03'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-03-03'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-03'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 4
reporting_facility: Rodriguez-Garrett Medical Center
reporter_type: Pharmacist
notes: Must message plan condition agency. Modern hour agent loss boy tax western
thousand.
|
<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-2025-746
Date of Submission: 2025-04-04
This report was submitted by a Nurse from Aguilar LLC Medical Center concerning patient ANON-PX-1430. The subject is an adult other with a significant medical history including atrial fibrillation, hypertension, 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): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 247mg, initiated on 2025-01-30 for Gastroesophageal reflux disease and discontinued on 2025-02-18.
On approximately 2025-02-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Somnolence, Angioedema, Anaphylaxis. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed along and advised population. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. 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 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: Tree evidence term. Partner American song choose song serve.</data>
|
report_id: ADR-2025-746
report_date: '2025-04-04'
patient_details:
patient_id: ANON-PX-1430
gender: Other
relevant_history:
- atrial fibrillation
- hypertension
- type 2 diabetes
suspected_drugs:
- drug_name: Omeprazole
dosage: 247mg
route_of_administration: Intramuscular
start_date: '2025-01-30'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-02-18'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-02-09'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed along and advised population.
- symptom_name: Somnolence
onset_date: '2025-02-09'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Angioedema
onset_date: '2025-02-09'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Anaphylaxis
onset_date: '2025-02-09'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 2
reporting_facility: Aguilar LLC Medical Center
reporter_type: Nurse
notes: Tree evidence term. Partner American song choose song serve.
|
<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-2024-624
Date of Submission: 2024-11-23
This report was submitted by a Other Healthcare Professional from Dominguez and Sons Medical Center concerning patient ANON-PX-8217. The subject is a 39-year-old male with a significant medical history including chronic kidney disease, osteoarthritis, hypertension, 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): Ibuprofen administered via the Intramuscular route at a dosage of 305mg, initiated on 2024-09-14 for Pain and inflammation with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 276mg, initiated on 2024-09-14 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2024-10-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Somnolence, Pruritus, Vomiting, Dizziness. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Mild 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 current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. 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 '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-624
report_date: '2024-11-23'
patient_details:
patient_id: ANON-PX-8217
gender: Male
relevant_history:
- chronic kidney disease
- osteoarthritis
- hypertension
- atrial fibrillation
age_at_reaction: 39
suspected_drugs:
- drug_name: Ibuprofen
dosage: 305mg
route_of_administration: Intramuscular
start_date: '2024-09-14'
indication_for_use: Pain and inflammation
- drug_name: Omeprazole
dosage: 276mg
route_of_administration: Subcutaneous
start_date: '2024-09-14'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-10-11'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-10-11'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-10-11'
severity: Mild
outcome: Fatal
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-10-11'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Dizziness
onset_date: '2024-10-11'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 5
reporting_facility: Dominguez and Sons 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-2024-791
Date of Submission: 2024-08-21
This report was submitted by a Pharmacist from Guzman-Williams Medical Center concerning patient ANON-PX-1976. The subject is a 32-year-old other with a significant medical history including anxiety, seasonal allergies, 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): Lisinopril administered via the Oral route at a dosage of 191mg, initiated on 2024-06-22 for Hypertension with the course ongoing; Ibuprofen administered via the Intramuscular route at a dosage of 322mg, initiated on 2024-06-22 for Pain and inflammation with the course ongoing.
On approximately 2024-08-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Angioedema, Diarrhea. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed capital and advised machine. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed high and advised deal. 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 '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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Sign serious despite develop. Oil prepare beautiful white small attention perhaps. Put ahead mouth note reveal Mrs.</data>
|
report_id: ADR-2024-791
report_date: '2024-08-21'
patient_details:
patient_id: ANON-PX-1976
gender: Other
relevant_history:
- anxiety
- seasonal allergies
- osteoarthritis
- chronic kidney disease
age_at_reaction: 32
suspected_drugs:
- drug_name: Lisinopril
dosage: 191mg
route_of_administration: Oral
start_date: '2024-06-22'
indication_for_use: Hypertension
- drug_name: Ibuprofen
dosage: 322mg
route_of_administration: Intramuscular
start_date: '2024-06-22'
indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-08-15'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed capital and advised machine.
- symptom_name: Angioedema
onset_date: '2024-08-15'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed high and advised deal.
- symptom_name: Diarrhea
onset_date: '2024-08-15'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 5
reporting_facility: Guzman-Williams Medical Center
reporter_type: Pharmacist
notes: Sign serious despite develop. Oil prepare beautiful white small attention perhaps.
Put ahead mouth note reveal Mrs.
|
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