prompt
stringlengths 1.92k
9.98k
| response
stringlengths 714
11k
|
|---|---|
<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-2025-718
Date of Submission: 2025-03-09
This report was submitted by a Patient from Hayes Ltd Medical Center concerning patient ANON-PX-4741. The subject is a 32-year-old female with a significant medical history including seasonal allergies, 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): Omeprazole administered via the Topical route at a dosage of 375mg, initiated on 2025-01-19 for Gastroesophageal reflux disease and discontinued on 2025-03-02; Metformin (Biguanide) administered via the Topical route at a dosage of 230mg, initiated on 2025-01-19 for Type 2 diabetes and discontinued on 2025-03-02.
On approximately 2025-02-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Headache, Stevens-Johnson syndrome, Anaphylaxis, Nausea. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed possible and advised peace. 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 'Recovering'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed ever and advised head. 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 red 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 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-2025-718
report_date: '2025-03-09'
patient_details:
patient_id: ANON-PX-4741
gender: Female
relevant_history:
- seasonal allergies
- type 2 diabetes
- atrial fibrillation
age_at_reaction: 32
suspected_drugs:
- drug_name: Omeprazole
dosage: 375mg
route_of_administration: Topical
start_date: '2025-01-19'
indication_for_use: Gastroesophageal reflux disease
end_date: '2025-03-02'
- drug_name: Metformin
dosage: 230mg
route_of_administration: Topical
start_date: '2025-01-19'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-03-02'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed possible and advised peace.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-27'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed ever and advised head.
- symptom_name: Nausea
onset_date: '2025-02-27'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed red and advised doctor.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Hayes 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-2025-809
Date of Submission: 2025-04-16
This report was submitted by a Other Healthcare Professional from Johnson-Hopkins Medical Center concerning patient ANON-PX-6701. The subject is a 33-year-old female with a significant medical history including type 2 diabetes, 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 (Anticoagulant) administered via the Intramuscular route at a dosage of 361mg, initiated on 2025-03-24 for Thromboembolism prevention and discontinued on 2025-04-10; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 65mg, initiated on 2025-03-24 for Hypothyroidism and discontinued on 2025-04-10.
On approximately 2025-04-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome, Diarrhea, Hepatotoxicity, Maculopapular Rash. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed approach and advised eight. 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'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed value and advised head. 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 expect and advised believe. 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-2025-809
report_date: '2025-04-16'
patient_details:
patient_id: ANON-PX-6701
gender: Female
relevant_history:
- type 2 diabetes
- asthma
- osteoarthritis
- anxiety
age_at_reaction: 33
suspected_drugs:
- drug_name: Warfarin
dosage: 361mg
route_of_administration: Intramuscular
start_date: '2025-03-24'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-04-10'
- drug_name: Levothyroxine
dosage: 65mg
route_of_administration: Intramuscular
start_date: '2025-03-24'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-04-10'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-04-05'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-05'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed approach and advised eight.
- symptom_name: Diarrhea
onset_date: '2025-04-05'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-04-05'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed value and advised head.
- symptom_name: Maculopapular Rash
onset_date: '2025-04-05'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed expect and advised believe.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Johnson-Hopkins 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-2025-608
Date of Submission: 2025-06-01
This report was submitted by a Patient from Mueller, Becker and Ryan Medical Center concerning patient ANON-PX-3978. The subject is a 66-year-old other with a significant medical history including 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): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 232mg, initiated on 2025-05-02 for Pain and inflammation and discontinued on 2025-05-09.
On approximately 2025-05-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Dizziness, Anaphylaxis. 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 Dizziness 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 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. 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-2025-608
report_date: '2025-06-01'
patient_details:
patient_id: ANON-PX-3978
gender: Other
relevant_history:
- osteoarthritis
- chronic kidney disease
age_at_reaction: 66
suspected_drugs:
- drug_name: Ibuprofen
dosage: 232mg
route_of_administration: Intravenous
start_date: '2025-05-02'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-05-09'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-05-08'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-05-08'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-05-08'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Mueller, Becker and Ryan 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-2025-366
Date of Submission: 2025-06-21
This report was submitted by a Nurse from Mckinney Inc Medical Center concerning patient ANON-PX-3028. The subject is an adult male with a significant medical history including hypertension, 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): Amoxicillin administered via the Intravenous route at a dosage of 273mg, initiated on 2025-05-28 for Bacterial infection with the course ongoing.
On approximately 2025-06-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Headache, Stevens-Johnson syndrome. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed medical and advised specific. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe 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 'Not Recovered'. 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'.
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: Listen shake piece. Training two somebody low attention five. Along court mission week wall letter about.</data>
|
report_id: ADR-2025-366
report_date: '2025-06-21'
patient_details:
patient_id: ANON-PX-3028
gender: Male
relevant_history:
- hypertension
- migraines
- atrial fibrillation
suspected_drugs:
- drug_name: Amoxicillin
dosage: 273mg
route_of_administration: Intravenous
start_date: '2025-05-28'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-06-16'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed medical and advised specific.
- symptom_name: Somnolence
onset_date: '2025-06-16'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Headache
onset_date: '2025-06-16'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-16'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Mckinney Inc Medical Center
reporter_type: Nurse
notes: Listen shake piece. Training two somebody low attention five. Along court mission
week wall letter 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-2024-371
Date of Submission: 2024-10-31
This report was submitted by a Pharmacist from Morgan-Hoover Medical Center concerning patient ANON-PX-1107. The subject is a 73-year-old other with a significant medical history including anxiety, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 47mg, initiated on 2024-09-01 for Hypertension with the course ongoing.
On approximately 2024-09-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Hepatotoxicity. 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 Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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: Those group too. Mrs number environmental call.</data>
|
report_id: ADR-2024-371
report_date: '2024-10-31'
patient_details:
patient_id: ANON-PX-1107
gender: Other
relevant_history:
- anxiety
- hypertension
age_at_reaction: 73
suspected_drugs:
- drug_name: Lisinopril
dosage: 47mg
route_of_administration: Topical
start_date: '2024-09-01'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-09-15'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-09-15'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Morgan-Hoover Medical Center
reporter_type: Pharmacist
notes: Those group too. Mrs number environmental call.
|
<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-2024-982
Date of Submission: 2024-11-24
This report was submitted by a Nurse from Hernandez Group Medical Center concerning patient ANON-PX-8756. The subject is a 79-year-old female with a significant medical history including anxiety, migraines, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Oral route at a dosage of 220mg, initiated on 2024-11-08 for Hypothyroidism and discontinued on 2024-11-14; Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 459mg, initiated on 2024-11-08 for Hypercholesterolemia and discontinued on 2024-11-14.
On approximately 2024-11-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea, Angioedema. The Pruritus 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 Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed check and advised six. 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 '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.
Reporter's Narrative Summary: Fire if professional decision after son player. Evidence sea contain level. Garden them down finish dinner.</data>
|
report_id: ADR-2024-982
report_date: '2024-11-24'
patient_details:
patient_id: ANON-PX-8756
gender: Female
relevant_history:
- anxiety
- migraines
- seasonal allergies
age_at_reaction: 79
suspected_drugs:
- drug_name: Levothyroxine
dosage: 220mg
route_of_administration: Oral
start_date: '2024-11-08'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-14'
- drug_name: Atorvastatin
dosage: 459mg
route_of_administration: Intramuscular
start_date: '2024-11-08'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-11-14'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-11-12'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-11-12'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed check and advised six.
- symptom_name: Angioedema
onset_date: '2024-11-12'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 2
reporting_facility: Hernandez Group Medical Center
reporter_type: Nurse
notes: Fire if professional decision after son player. Evidence sea contain level.
Garden them down finish dinner.
|
<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-2024-250
Date of Submission: 2024-09-09
This report was submitted by a Patient from Miller-Sparks Medical Center concerning patient ANON-PX-3702. The subject is a 52-year-old female with a significant medical history including hypertension, asthma, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Topical route at a dosage of 21mg, initiated on 2024-07-04 for Hypercholesterolemia with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Oral route at a dosage of 348mg, initiated on 2024-07-04 for Hypothyroidism with the course ongoing.
On approximately 2024-07-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Pruritus, Diarrhea, Dizziness. 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 'Recovering'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: World stop year million. Woman race carry money represent in. Garden reality training popular beyond tree.</data>
|
report_id: ADR-2024-250
report_date: '2024-09-09'
patient_details:
patient_id: ANON-PX-3702
gender: Female
relevant_history:
- hypertension
- asthma
- atrial fibrillation
age_at_reaction: 52
suspected_drugs:
- drug_name: Atorvastatin
dosage: 21mg
route_of_administration: Topical
start_date: '2024-07-04'
indication_for_use: Hypercholesterolemia
drug_class: Statin
- drug_name: Levothyroxine
dosage: 348mg
route_of_administration: Oral
start_date: '2024-07-04'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-07-15'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-07-15'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-07-15'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-07-15'
severity: Severe
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Miller-Sparks Medical Center
reporter_type: Patient
notes: World stop year million. Woman race carry money represent in. Garden reality
training popular beyond tree.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-633
Date of Submission: 2025-02-27
This report was submitted by a Physician from Brown, Lynch and Walker Medical Center concerning patient ANON-PX-6216. The subject is a 56-year-old male with a significant medical history including seasonal allergies, 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): Lisinopril (ACE inhibitor) administered via the Intramuscular route at a dosage of 490mg, initiated on 2025-02-10 for Hypertension and discontinued on 2025-02-26.
On approximately 2025-02-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Pruritus, Diarrhea. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. 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 'Fatal'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Severe in severity. 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 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: Everyone by important sing there region you. We argue admit foot today loss. Eight card board together seek.</data>
|
report_id: ADR-2025-633
report_date: '2025-02-27'
patient_details:
patient_id: ANON-PX-6216
gender: Male
relevant_history:
- seasonal allergies
- coronary artery disease
- anxiety
age_at_reaction: 56
suspected_drugs:
- drug_name: Lisinopril
dosage: 490mg
route_of_administration: Intramuscular
start_date: '2025-02-10'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-26'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-02-18'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2025-02-18'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-02-18'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-02-18'
severity: Severe
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Brown, Lynch and Walker Medical Center
reporter_type: Physician
notes: Everyone by important sing there region you. We argue admit foot today loss.
Eight card board together seek.
|
<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-2024-898
Date of Submission: 2024-12-06
This report was submitted by a Patient from Chan, Murray and Jackson Medical Center concerning patient ANON-PX-4809. The subject is a 82-year-old female with a significant medical history including 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): Ibuprofen administered via the Intramuscular route at a dosage of 299mg, initiated on 2024-11-04 for Pain and inflammation and discontinued on 2024-11-20; Lisinopril administered via the Subcutaneous route at a dosage of 33mg, initiated on 2024-11-04 for Hypertension and discontinued on 2024-11-20.
On approximately 2024-11-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Anaphylaxis, Stevens-Johnson syndrome. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed per and advised house. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. 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 individual and advised week. 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: It provide impact lawyer mouth. Director more everyone wear affect loss type ago. Probably past new customer.</data>
|
report_id: ADR-2024-898
report_date: '2024-12-06'
patient_details:
patient_id: ANON-PX-4809
gender: Female
relevant_history:
- chronic kidney disease
- asthma
age_at_reaction: 82
suspected_drugs:
- drug_name: Ibuprofen
dosage: 299mg
route_of_administration: Intramuscular
start_date: '2024-11-04'
indication_for_use: Pain and inflammation
end_date: '2024-11-20'
- drug_name: Lisinopril
dosage: 33mg
route_of_administration: Subcutaneous
start_date: '2024-11-04'
indication_for_use: Hypertension
end_date: '2024-11-20'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-11-17'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed per and advised house.
- symptom_name: Anaphylaxis
onset_date: '2024-11-17'
severity: Life-threatening
outcome: Fatal
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-17'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed individual and advised week.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Chan, Murray and Jackson Medical Center
reporter_type: Patient
notes: It provide impact lawyer mouth. Director more everyone wear affect loss type
ago. Probably past new customer.
|
<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-2024-358
Date of Submission: 2024-10-01
This report was submitted by a Physician from Miller, Prince and Lam Medical Center concerning patient ANON-PX-8767. The subject is an adult other with a significant medical history including coronary artery disease, 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): Warfarin administered via the Oral route at a dosage of 473mg, initiated on 2024-07-26 for Thromboembolism prevention and discontinued on 2024-09-22.
On approximately 2024-08-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Anaphylaxis. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed network and advised local. The current patient status regarding this symptom is 'Not 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. 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: May carry meet. Court eat available sound measure.</data>
|
report_id: ADR-2024-358
report_date: '2024-10-01'
patient_details:
patient_id: ANON-PX-8767
gender: Other
relevant_history:
- coronary artery disease
- hypertension
- seasonal allergies
- asthma
suspected_drugs:
- drug_name: Warfarin
dosage: 473mg
route_of_administration: Oral
start_date: '2024-07-26'
indication_for_use: Thromboembolism prevention
end_date: '2024-09-22'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-08-11'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed network and advised local.
- symptom_name: Anaphylaxis
onset_date: '2024-08-11'
severity: Mild
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Miller, Prince and Lam Medical Center
reporter_type: Physician
notes: May carry meet. Court eat available sound measure.
|
<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-2025-840
Date of Submission: 2025-06-06
This report was submitted by a Other Healthcare Professional from Cooper and Sons Medical Center concerning patient ANON-PX-4810. The subject is a 41-year-old male with a significant medical history including asthma, hypertension, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 147mg, initiated on 2025-05-02 for Neuropathic pain and discontinued on 2025-05-25; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 324mg, initiated on 2025-05-02 for Hypothyroidism and discontinued on 2025-05-25.
On approximately 2025-05-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Hepatotoxicity, Headache. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 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 Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Phone industry night happen me. With find health difficult kid picture game.</data>
|
report_id: ADR-2025-840
report_date: '2025-06-06'
patient_details:
patient_id: ANON-PX-4810
gender: Male
relevant_history:
- asthma
- hypertension
- migraines
age_at_reaction: 41
suspected_drugs:
- drug_name: Gabapentin
dosage: 147mg
route_of_administration: Oral
start_date: '2025-05-02'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-05-25'
- drug_name: Levothyroxine
dosage: 324mg
route_of_administration: Topical
start_date: '2025-05-02'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-05-25'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-05-11'
severity: Severe
outcome: Not Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-05-11'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-05-11'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 2
reporting_facility: Cooper and Sons Medical Center
reporter_type: Other Healthcare Professional
notes: Phone industry night happen me. With find health difficult kid picture game.
|
<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-2025-943
Date of Submission: 2025-06-26
This report was submitted by a Patient from Lynch and Sons Medical Center concerning patient ANON-PX-3725. The subject is an adult other with a significant medical history including migraines, seasonal allergies, 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): Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 481mg, initiated on 2025-04-15 for Hypertension and discontinued on 2025-05-20; Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 103mg, initiated on 2025-04-15 for Neuropathic pain and discontinued on 2025-05-20.
On approximately 2025-04-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Nausea 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Audience these those ability police.</data>
|
report_id: ADR-2025-943
report_date: '2025-06-26'
patient_details:
patient_id: ANON-PX-3725
gender: Other
relevant_history:
- migraines
- seasonal allergies
- anxiety
- atrial fibrillation
suspected_drugs:
- drug_name: Lisinopril
dosage: 481mg
route_of_administration: Intravenous
start_date: '2025-04-15'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-05-20'
- drug_name: Gabapentin
dosage: 103mg
route_of_administration: Topical
start_date: '2025-04-15'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-05-20'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-04-28'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Nausea
onset_date: '2025-04-28'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Lynch and Sons Medical Center
reporter_type: Patient
notes: Audience these those ability police.
|
<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-2025-342
Date of Submission: 2025-06-04
This report was submitted by a Other Healthcare Professional from Garrett Ltd Medical Center concerning patient ANON-PX-6148. The subject is a 76-year-old male with a significant medical history including migraines, hypertension, 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 395mg, initiated on 2025-03-23 for Pain and inflammation and discontinued on 2025-05-26; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 412mg, initiated on 2025-03-23 for Hypercholesterolemia and discontinued on 2025-05-26.
On approximately 2025-05-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Anaphylaxis, Hepatotoxicity, Dizziness. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed newspaper and advised seven. 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 'Unknown'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe 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 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-2025-342
report_date: '2025-06-04'
patient_details:
patient_id: ANON-PX-6148
gender: Male
relevant_history:
- migraines
- hypertension
- atrial fibrillation
- seasonal allergies
age_at_reaction: 76
suspected_drugs:
- drug_name: Ibuprofen
dosage: 395mg
route_of_administration: Oral
start_date: '2025-03-23'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-05-26'
- drug_name: Atorvastatin
dosage: 412mg
route_of_administration: Intravenous
start_date: '2025-03-23'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-05-26'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-05-18'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed newspaper and advised seven.
- symptom_name: Anaphylaxis
onset_date: '2025-05-18'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-05-18'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-05-18'
severity: Severe
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Garrett 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-2024-717
Date of Submission: 2024-08-27
This report was submitted by a Physician from Rice, Brooks and Vaughn Medical Center concerning patient ANON-PX-4765. The subject is a 47-year-old male with a significant medical history including asthma, osteoarthritis, 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): Sertraline (SSRI) administered via the Oral route at a dosage of 455mg, initiated on 2024-08-03 for Major depressive disorder with the course ongoing.
On approximately 2024-08-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity, Diarrhea. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Money start law before drive room area add. Discuss site among. So fast simply strong someone.</data>
|
report_id: ADR-2024-717
report_date: '2024-08-27'
patient_details:
patient_id: ANON-PX-4765
gender: Male
relevant_history:
- asthma
- osteoarthritis
- anxiety
- chronic kidney disease
age_at_reaction: 47
suspected_drugs:
- drug_name: Sertraline
dosage: 455mg
route_of_administration: Oral
start_date: '2024-08-03'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-08-25'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-08-25'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-08-25'
severity: Moderate
outcome: Fatal
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Rice, Brooks and Vaughn Medical Center
reporter_type: Physician
notes: Money start law before drive room area add. Discuss site among. So fast simply
strong someone.
|
<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-2024-123
Date of Submission: 2024-08-15
This report was submitted by a Patient from Mendoza LLC Medical Center concerning patient ANON-PX-6508. The subject is a 51-year-old other with a significant medical history including anxiety, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin administered via the Topical route at a dosage of 294mg, initiated on 2024-05-27 for Type 2 diabetes and discontinued on 2024-08-02; Sertraline (SSRI) administered via the Intramuscular route at a dosage of 347mg, initiated on 2024-05-27 for Major depressive disorder and discontinued on 2024-08-02.
On approximately 2024-06-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Hepatotoxicity. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed physical and advised commercial. 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: Similar TV really trouble great security. Push product home word begin ahead weight.</data>
|
report_id: ADR-2024-123
report_date: '2024-08-15'
patient_details:
patient_id: ANON-PX-6508
gender: Other
relevant_history:
- anxiety
- type 2 diabetes
age_at_reaction: 51
suspected_drugs:
- drug_name: Metformin
dosage: 294mg
route_of_administration: Topical
start_date: '2024-05-27'
indication_for_use: Type 2 diabetes
end_date: '2024-08-02'
- drug_name: Sertraline
dosage: 347mg
route_of_administration: Intramuscular
start_date: '2024-05-27'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-08-02'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-06-09'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-06-09'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed physical and advised commercial.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Mendoza LLC Medical Center
reporter_type: Patient
notes: Similar TV really trouble great security. Push product home word begin ahead
weight.
|
<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-2025-699
Date of Submission: 2025-02-27
This report was submitted by a Physician from Simpson, Reyes and Lee Medical Center concerning patient ANON-PX-6052. The subject is a 33-year-old female with a significant medical history including chronic kidney disease, 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): Levothyroxine administered via the Subcutaneous route at a dosage of 38mg, initiated on 2024-12-21 for Hypothyroidism with the course ongoing.
On approximately 2025-02-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Hepatotoxicity, Headache, Somnolence, Dizziness. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed natural and advised page. 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 avoid and advised among. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness 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 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: Like people civil blue pressure billion. Hundred whole military blood nature. Gun contain they action guy around.</data>
|
report_id: ADR-2025-699
report_date: '2025-02-27'
patient_details:
patient_id: ANON-PX-6052
gender: Female
relevant_history:
- chronic kidney disease
- hypertension
- asthma
age_at_reaction: 33
suspected_drugs:
- drug_name: Levothyroxine
dosage: 38mg
route_of_administration: Subcutaneous
start_date: '2024-12-21'
indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-02-18'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-02-18'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed natural and advised page.
- symptom_name: Headache
onset_date: '2025-02-18'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed avoid and advised among.
- symptom_name: Somnolence
onset_date: '2025-02-18'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-02-18'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 3
reporting_facility: Simpson, Reyes and Lee Medical Center
reporter_type: Physician
notes: Like people civil blue pressure billion. Hundred whole military blood nature.
Gun contain they action guy around.
|
<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-2024-508
Date of Submission: 2024-08-28
This report was submitted by a Other Healthcare Professional from Stone-Adams Medical Center concerning patient ANON-PX-9086. The subject is an adult other with a significant medical history including chronic kidney disease, 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 Topical route at a dosage of 455mg, initiated on 2024-08-17 for Hypertension and discontinued on 2024-08-26; Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 40mg, initiated on 2024-08-17 for Bacterial infection and discontinued on 2024-08-26.
On approximately 2024-08-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema, Nausea. 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 Angioedema was classified as Severe 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 'Unknown'.
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-2024-508
report_date: '2024-08-28'
patient_details:
patient_id: ANON-PX-9086
gender: Other
relevant_history:
- chronic kidney disease
- osteoarthritis
- coronary artery disease
suspected_drugs:
- drug_name: Lisinopril
dosage: 455mg
route_of_administration: Topical
start_date: '2024-08-17'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-08-26'
- drug_name: Amoxicillin
dosage: 40mg
route_of_administration: Topical
start_date: '2024-08-17'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-08-26'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-08-25'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-08-25'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-08-25'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Stone-Adams 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-2025-431
Date of Submission: 2025-02-24
This report was submitted by a Physician from Sherman Ltd Medical Center concerning patient ANON-PX-4171. The subject is a 77-year-old other with a significant medical history including chronic kidney disease, 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): Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 452mg, initiated on 2025-01-18 for Bacterial infection and discontinued on 2025-02-18; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 214mg, initiated on 2025-01-18 for Hypertension and discontinued on 2025-02-18.
On approximately 2025-02-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Nausea, Angioedema, Pruritus. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed product and advised fish. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-431
report_date: '2025-02-24'
patient_details:
patient_id: ANON-PX-4171
gender: Other
relevant_history:
- chronic kidney disease
- type 2 diabetes
- asthma
age_at_reaction: 77
suspected_drugs:
- drug_name: Amoxicillin
dosage: 452mg
route_of_administration: Intramuscular
start_date: '2025-01-18'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-02-18'
- drug_name: Lisinopril
dosage: 214mg
route_of_administration: Intravenous
start_date: '2025-01-18'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-18'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-02-13'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-13'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-02-13'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-02-13'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed product and advised fish.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Sherman Ltd 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-2024-208
Date of Submission: 2024-10-06
This report was submitted by a Physician from Russo-Bennett Medical Center concerning patient ANON-PX-6800. The subject is a 43-year-old female 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): Sertraline (SSRI) administered via the Oral route at a dosage of 69mg, initiated on 2024-09-08 for Major depressive disorder with the course ongoing; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 155mg, initiated on 2024-09-08 for Pain and inflammation with the course ongoing.
On approximately 2024-09-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome. 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 Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 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: Bank economy million five. Laugh dinner government less east near campaign.</data>
|
report_id: ADR-2024-208
report_date: '2024-10-06'
patient_details:
patient_id: ANON-PX-6800
gender: Female
relevant_history:
- atrial fibrillation
- seasonal allergies
age_at_reaction: 43
suspected_drugs:
- drug_name: Sertraline
dosage: 69mg
route_of_administration: Oral
start_date: '2024-09-08'
indication_for_use: Major depressive disorder
drug_class: SSRI
- drug_name: Ibuprofen
dosage: 155mg
route_of_administration: Intramuscular
start_date: '2024-09-08'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-09-24'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-24'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 8
reporting_facility: Russo-Bennett Medical Center
reporter_type: Physician
notes: Bank economy million five. Laugh dinner government less east near campaign.
|
<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-2024-127
Date of Submission: 2024-12-17
This report was submitted by a Nurse from Eaton-Dorsey Medical Center concerning patient ANON-PX-4933. The subject is an adult female with a significant medical history including coronary artery disease, osteoarthritis, atrial fibrillation, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Intravenous route at a dosage of 269mg, initiated on 2024-11-27 for Hypercholesterolemia with the course ongoing; Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 221mg, initiated on 2024-11-27 for Hypertension with the course ongoing.
On approximately 2024-12-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Maculopapular Rash, Hepatotoxicity, Dizziness. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed not and advised admit. 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 'Fatal'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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: Ability security kitchen up. Necessary or again stay.</data>
|
report_id: ADR-2024-127
report_date: '2024-12-17'
patient_details:
patient_id: ANON-PX-4933
gender: Female
relevant_history:
- coronary artery disease
- osteoarthritis
- atrial fibrillation
- seasonal allergies
suspected_drugs:
- drug_name: Atorvastatin
dosage: 269mg
route_of_administration: Intravenous
start_date: '2024-11-27'
indication_for_use: Hypercholesterolemia
drug_class: Statin
- drug_name: Lisinopril
dosage: 221mg
route_of_administration: Subcutaneous
start_date: '2024-11-27'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-12-13'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed not and advised admit.
- symptom_name: Maculopapular Rash
onset_date: '2024-12-13'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-12-13'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-12-13'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Eaton-Dorsey Medical Center
reporter_type: Nurse
notes: Ability security kitchen up. Necessary or again stay.
|
<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-2025-652
Date of Submission: 2025-01-18
This report was submitted by a Other Healthcare Professional from Payne, Morse and Garcia Medical Center concerning patient ANON-PX-4082. The subject is a 84-year-old male with a significant medical history including migraines, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 347mg, initiated on 2024-11-08 for Type 2 diabetes and discontinued on 2025-01-12.
On approximately 2024-12-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome, Headache. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed player and advised outside. The current patient status regarding this symptom is 'Not 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 'Recovering'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 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.
</data>
|
report_id: ADR-2025-652
report_date: '2025-01-18'
patient_details:
patient_id: ANON-PX-4082
gender: Male
relevant_history:
- migraines
- asthma
age_at_reaction: 84
suspected_drugs:
- drug_name: Metformin
dosage: 347mg
route_of_administration: Intramuscular
start_date: '2024-11-08'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2025-01-12'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-12-21'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed player and advised outside.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-21'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-21'
severity: Severe
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 1
reporting_facility: Payne, Morse and Garcia 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-2025-810
Date of Submission: 2025-01-01
This report was submitted by a Patient from Ward-Davis Medical Center concerning patient ANON-PX-7418. The subject is a 88-year-old female with a significant medical history including osteoarthritis, 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 (ACE inhibitor) administered via the Intramuscular route at a dosage of 210mg, initiated on 2024-12-20 for Hypertension with the course ongoing.
On approximately 2024-12-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Hepatotoxicity, Headache, Nausea, Stevens-Johnson syndrome. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed care and advised class. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed answer and advised want. 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: Ten include whatever wall fly peace. Into however set choose last mother tax.</data>
|
report_id: ADR-2025-810
report_date: '2025-01-01'
patient_details:
patient_id: ANON-PX-7418
gender: Female
relevant_history:
- osteoarthritis
- chronic kidney disease
- coronary artery disease
age_at_reaction: 88
suspected_drugs:
- drug_name: Lisinopril
dosage: 210mg
route_of_administration: Intramuscular
start_date: '2024-12-20'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-12-25'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-12-25'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2024-12-25'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed care and advised class.
- symptom_name: Nausea
onset_date: '2024-12-25'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-12-25'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed answer and advised want.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Ward-Davis Medical Center
reporter_type: Patient
notes: Ten include whatever wall fly peace. Into however set choose last mother tax.
|
<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-2025-799
Date of Submission: 2025-07-02
This report was submitted by a Pharmacist from Harrison, Cohen and Garza Medical Center concerning patient ANON-PX-4542. The subject is a 81-year-old other with a significant medical history including 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): Warfarin administered via the Intramuscular route at a dosage of 305mg, initiated on 2025-06-20 for Thromboembolism prevention with the course ongoing.
On approximately 2025-06-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Nausea. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea 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 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Our red miss focus our these nation. Home behind item might. Work model control western moment.</data>
|
report_id: ADR-2025-799
report_date: '2025-07-02'
patient_details:
patient_id: ANON-PX-4542
gender: Other
relevant_history:
- migraines
- coronary artery disease
age_at_reaction: 81
suspected_drugs:
- drug_name: Warfarin
dosage: 305mg
route_of_administration: Intramuscular
start_date: '2025-06-20'
indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-06-30'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-06-30'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 7
reporting_facility: Harrison, Cohen and Garza Medical Center
reporter_type: Pharmacist
notes: Our red miss focus our these nation. Home behind item might. Work model control
western moment.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-294
Date of Submission: 2025-07-22
This report was submitted by a Patient from Casey LLC Medical Center concerning patient ANON-PX-1267. The subject is a 22-year-old other with a significant medical history including type 2 diabetes, 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): Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 151mg, initiated on 2025-04-30 for Neuropathic pain and discontinued on 2025-06-21; Warfarin administered via the Intravenous route at a dosage of 167mg, initiated on 2025-04-30 for Thromboembolism prevention and discontinued on 2025-06-21.
On approximately 2025-05-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Dizziness. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The 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. 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-2025-294
report_date: '2025-07-22'
patient_details:
patient_id: ANON-PX-1267
gender: Other
relevant_history:
- type 2 diabetes
- coronary artery disease
age_at_reaction: 22
suspected_drugs:
- drug_name: Gabapentin
dosage: 151mg
route_of_administration: Oral
start_date: '2025-04-30'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-06-21'
- drug_name: Warfarin
dosage: 167mg
route_of_administration: Intravenous
start_date: '2025-04-30'
indication_for_use: Thromboembolism prevention
end_date: '2025-06-21'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-31'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-05-31'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Casey LLC Medical Center
reporter_type: Patient
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-703
Date of Submission: 2025-03-06
This report was submitted by a Patient from Collins-Roberson Medical Center concerning patient ANON-PX-9493. The subject is a 51-year-old female with a significant medical history including seasonal allergies, 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): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 312mg, initiated on 2025-02-24 for Gastroesophageal reflux disease with the course ongoing; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 350mg, initiated on 2025-02-24 for Neuropathic pain with the course ongoing.
On approximately 2025-02-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Stevens-Johnson syndrome, Somnolence, Vomiting, Maculopapular Rash. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed have and advised coach. 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 'Fatal'. The Somnolence 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 Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed claim and advised expect. 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 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: One trip important top. Discover country late west same need.</data>
|
report_id: ADR-2025-703
report_date: '2025-03-06'
patient_details:
patient_id: ANON-PX-9493
gender: Female
relevant_history:
- seasonal allergies
- type 2 diabetes
- asthma
age_at_reaction: 51
suspected_drugs:
- drug_name: Omeprazole
dosage: 312mg
route_of_administration: Topical
start_date: '2025-02-24'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Gabapentin
dosage: 350mg
route_of_administration: Subcutaneous
start_date: '2025-02-24'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-02-26'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed have and advised coach.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-26'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-02-26'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-26'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed claim and advised expect.
- symptom_name: Maculopapular Rash
onset_date: '2025-02-26'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Collins-Roberson Medical Center
reporter_type: Patient
notes: One trip important top. Discover country late west same need.
|
<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-2025-640
Date of Submission: 2025-06-15
This report was submitted by a Other Healthcare Professional from Sullivan-Cross Medical Center concerning patient ANON-PX-1588. The subject is an adult male with a significant medical history including chronic kidney disease, atrial fibrillation. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Intravenous route at a dosage of 456mg, initiated on 2025-05-01 for Hypercholesterolemia and discontinued on 2025-06-11; Gabapentin administered via the Subcutaneous route at a dosage of 207mg, initiated on 2025-05-01 for Neuropathic pain and discontinued on 2025-06-11.
On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Vomiting, Diarrhea. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed child and advised phone. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as 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 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Hour western never sign. Group win church their teach.</data>
|
report_id: ADR-2025-640
report_date: '2025-06-15'
patient_details:
patient_id: ANON-PX-1588
gender: Male
relevant_history:
- chronic kidney disease
- atrial fibrillation
suspected_drugs:
- drug_name: Atorvastatin
dosage: 456mg
route_of_administration: Intravenous
start_date: '2025-05-01'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-06-11'
- drug_name: Gabapentin
dosage: 207mg
route_of_administration: Subcutaneous
start_date: '2025-05-01'
indication_for_use: Neuropathic pain
end_date: '2025-06-11'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-06-07'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed child and advised phone.
- symptom_name: Vomiting
onset_date: '2025-06-07'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-06-07'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 6
reporting_facility: Sullivan-Cross Medical Center
reporter_type: Other Healthcare Professional
notes: Hour western never sign. Group win church their teach.
|
<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-2025-482
Date of Submission: 2025-06-01
This report was submitted by a Pharmacist from Colon and Sons Medical Center concerning patient ANON-PX-9077. The subject is a 76-year-old other with a significant medical history including 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): Ibuprofen (NSAID) administered via the Oral route at a dosage of 78mg, initiated on 2025-04-09 for Pain and inflammation with the course ongoing.
On approximately 2025-05-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Vomiting, Anaphylaxis, Dizziness. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed happy and advised major. 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 'Recovered'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Dizziness 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.
</data>
|
report_id: ADR-2025-482
report_date: '2025-06-01'
patient_details:
patient_id: ANON-PX-9077
gender: Other
relevant_history:
- coronary artery disease
- osteoarthritis
age_at_reaction: 76
suspected_drugs:
- drug_name: Ibuprofen
dosage: 78mg
route_of_administration: Oral
start_date: '2025-04-09'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-05-10'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed happy and advised major.
- symptom_name: Vomiting
onset_date: '2025-05-10'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-05-10'
severity: Moderate
outcome: Recovered
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-05-10'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 9
reporting_facility: Colon and Sons 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-2025-913
Date of Submission: 2025-08-09
This report was submitted by a Physician from Campbell and Sons Medical Center concerning patient ANON-PX-3680. The subject is a 27-year-old male with a significant medical history including type 2 diabetes, 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 Oral route at a dosage of 251mg, initiated on 2025-05-24 for Hypothyroidism with the course ongoing.
On approximately 2025-06-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea, Angioedema. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed top and advised hard. 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 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Member brother unit boy. Show against throughout less do face. Wife social senior return group.</data>
|
report_id: ADR-2025-913
report_date: '2025-08-09'
patient_details:
patient_id: ANON-PX-3680
gender: Male
relevant_history:
- type 2 diabetes
- coronary artery disease
age_at_reaction: 27
suspected_drugs:
- drug_name: Levothyroxine
dosage: 251mg
route_of_administration: Oral
start_date: '2025-05-24'
indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-06-24'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-06-24'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed top and advised hard.
- symptom_name: Angioedema
onset_date: '2025-06-24'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 1
reporting_facility: Campbell and Sons Medical Center
reporter_type: Physician
notes: Member brother unit boy. Show against throughout less do face. Wife social
senior return group.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-554
Date of Submission: 2025-07-03
This report was submitted by a Physician from Allen Inc Medical Center concerning patient ANON-PX-8329. The subject is an adult other with a significant medical history including 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): Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 241mg, initiated on 2025-04-26 for Neuropathic pain with the course ongoing; Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 194mg, initiated on 2025-04-26 for Hypertension with the course ongoing.
On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Maculopapular Rash, Vomiting, Hepatotoxicity, Headache. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed professional and advised home. 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 Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed leg and advised along. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-554
report_date: '2025-07-03'
patient_details:
patient_id: ANON-PX-8329
gender: Other
relevant_history:
- osteoarthritis
- seasonal allergies
suspected_drugs:
- drug_name: Gabapentin
dosage: 241mg
route_of_administration: Intramuscular
start_date: '2025-04-26'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
- drug_name: Lisinopril
dosage: 194mg
route_of_administration: Subcutaneous
start_date: '2025-04-26'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-06-07'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed professional and advised home.
- symptom_name: Maculopapular Rash
onset_date: '2025-06-07'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-06-07'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed leg and advised along.
- symptom_name: Hepatotoxicity
onset_date: '2025-06-07'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2025-06-07'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Allen Inc 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-2024-378
Date of Submission: 2024-11-16
This report was submitted by a Physician from Freeman, Villanueva and Harper Medical Center concerning patient ANON-PX-4015. The subject is a 32-year-old female with a significant medical history including coronary artery disease, migraines, 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 303mg, initiated on 2024-09-02 for Hypothyroidism and discontinued on 2024-10-21; Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 369mg, initiated on 2024-09-02 for Hypertension and discontinued on 2024-10-21.
On approximately 2024-10-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Dizziness, Maculopapular Rash. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed bring and advised full. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed firm and advised fire. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: While defense treat. Foot section sport.</data>
|
report_id: ADR-2024-378
report_date: '2024-11-16'
patient_details:
patient_id: ANON-PX-4015
gender: Female
relevant_history:
- coronary artery disease
- migraines
- chronic kidney disease
age_at_reaction: 32
suspected_drugs:
- drug_name: Levothyroxine
dosage: 303mg
route_of_administration: Topical
start_date: '2024-09-02'
indication_for_use: Hypothyroidism
end_date: '2024-10-21'
- drug_name: Lisinopril
dosage: 369mg
route_of_administration: Subcutaneous
start_date: '2024-09-02'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-10-21'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-10-04'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-10-04'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed bring and advised full.
- symptom_name: Maculopapular Rash
onset_date: '2024-10-04'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed firm and advised fire.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 8
reporting_facility: Freeman, Villanueva and Harper Medical Center
reporter_type: Physician
notes: While defense treat. Foot section sport.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-865
Date of Submission: 2025-01-13
This report was submitted by a Physician from Mitchell-Valdez Medical Center concerning patient ANON-PX-1117. The subject is an adult other with a significant medical history including osteoarthritis, 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 Subcutaneous route at a dosage of 410mg, initiated on 2024-12-30 for Gastroesophageal reflux disease and discontinued on 2025-01-07; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 103mg, initiated on 2024-12-30 for Bacterial infection and discontinued on 2025-01-07.
On approximately 2025-01-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache. 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 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 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: Office friend hit interesting talk.</data>
|
report_id: ADR-2025-865
report_date: '2025-01-13'
patient_details:
patient_id: ANON-PX-1117
gender: Other
relevant_history:
- osteoarthritis
- type 2 diabetes
- seasonal allergies
suspected_drugs:
- drug_name: Omeprazole
dosage: 410mg
route_of_administration: Subcutaneous
start_date: '2024-12-30'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-01-07'
- drug_name: Amoxicillin
dosage: 103mg
route_of_administration: Subcutaneous
start_date: '2024-12-30'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-01-07'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-01-03'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-01-03'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 1
reporting_facility: Mitchell-Valdez Medical Center
reporter_type: Physician
notes: Office friend hit interesting talk.
|
<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: 2025-05-02
This report was submitted by a Nurse from Guzman Inc Medical Center concerning patient ANON-PX-8359. The subject is a 84-year-old other with a significant medical history including chronic kidney disease, 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 Intravenous route at a dosage of 8mg, initiated on 2025-02-17 for Major depressive disorder and discontinued on 2025-04-09; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 366mg, initiated on 2025-02-17 for Hypertension and discontinued on 2025-04-09.
On approximately 2025-04-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Hepatotoxicity. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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: Appear heart resource reach break movie write stand.</data>
|
report_id: ADR-2025-627
report_date: '2025-05-02'
patient_details:
patient_id: ANON-PX-8359
gender: Other
relevant_history:
- chronic kidney disease
- seasonal allergies
- asthma
age_at_reaction: 84
suspected_drugs:
- drug_name: Sertraline
dosage: 8mg
route_of_administration: Intravenous
start_date: '2025-02-17'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-04-09'
- drug_name: Lisinopril
dosage: 366mg
route_of_administration: Intravenous
start_date: '2025-02-17'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-04-09'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-04-09'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-04-09'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Guzman Inc Medical Center
reporter_type: Nurse
notes: Appear heart resource reach break movie write stand.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-427
Date of Submission: 2025-01-18
This report was submitted by a Nurse from Bowers, Armstrong and Chavez Medical Center concerning patient ANON-PX-3858. The subject is a 19-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 (SSRI) administered via the Subcutaneous route at a dosage of 28mg, initiated on 2024-10-25 for Major depressive disorder with the course ongoing.
On approximately 2024-12-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Nausea, Somnolence, Vomiting. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed then and advised really. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed cold and advised she. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed ask and advised green. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Edge within exist value democratic carry view not. Week spring I whole behavior individual he. Cause she century performance may. Campaign play responsibility wrong age practice.</data>
|
report_id: ADR-2025-427
report_date: '2025-01-18'
patient_details:
patient_id: ANON-PX-3858
gender: Male
relevant_history:
- coronary artery disease
- type 2 diabetes
age_at_reaction: 19
suspected_drugs:
- drug_name: Sertraline
dosage: 28mg
route_of_administration: Subcutaneous
start_date: '2024-10-25'
indication_for_use: Major depressive disorder
drug_class: SSRI
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-12-02'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-12-02'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed then and advised really.
- symptom_name: Somnolence
onset_date: '2024-12-02'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed cold and advised she.
- symptom_name: Vomiting
onset_date: '2024-12-02'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed ask and advised green.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Bowers, Armstrong and Chavez Medical Center
reporter_type: Nurse
notes: Edge within exist value democratic carry view not. Week spring I whole behavior
individual he. Cause she century performance may. Campaign play responsibility wrong
age practice.
|
<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-2024-934
Date of Submission: 2024-11-29
This report was submitted by a Patient from Johnson-Welch Medical Center concerning patient ANON-PX-1157. The subject is a 80-year-old male with a significant medical history including osteoarthritis, 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): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 286mg, initiated on 2024-10-31 for Hypertension with the course ongoing.
On approximately 2024-11-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Hepatotoxicity, Headache, Dizziness, Vomiting. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed born and advised movie. The current patient status regarding this symptom is 'Not 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 Dizziness was classified as Severe 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. 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.
Reporter's Narrative Summary: Stay report successful. Price ago play leader career exactly. Child consider situation student my like.</data>
|
report_id: ADR-2024-934
report_date: '2024-11-29'
patient_details:
patient_id: ANON-PX-1157
gender: Male
relevant_history:
- osteoarthritis
- coronary artery disease
- chronic kidney disease
age_at_reaction: 80
suspected_drugs:
- drug_name: Lisinopril
dosage: 286mg
route_of_administration: Topical
start_date: '2024-10-31'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-11-19'
severity: Moderate
outcome: Not Recovered
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2024-11-19'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed born and advised movie.
- symptom_name: Headache
onset_date: '2024-11-19'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-11-19'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-11-19'
severity: Life-threatening
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Johnson-Welch Medical Center
reporter_type: Patient
notes: Stay report successful. Price ago play leader career exactly. Child consider
situation student my like.
|
<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-2025-472
Date of Submission: 2025-02-20
This report was submitted by a Patient from Molina-Harris Medical Center concerning patient ANON-PX-3069. The subject is an adult female with a significant medical history including hypertension, type 2 diabetes, 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): Amoxicillin administered via the Intravenous route at a dosage of 464mg, initiated on 2024-11-23 for Bacterial infection with the course ongoing.
On approximately 2025-01-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Hepatotoxicity. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed enjoy and advised rate. 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 Hepatotoxicity 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 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: Job prove local be side tough.</data>
|
report_id: ADR-2025-472
report_date: '2025-02-20'
patient_details:
patient_id: ANON-PX-3069
gender: Female
relevant_history:
- hypertension
- type 2 diabetes
- coronary artery disease
- seasonal allergies
suspected_drugs:
- drug_name: Amoxicillin
dosage: 464mg
route_of_administration: Intravenous
start_date: '2024-11-23'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-01-11'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed enjoy and advised rate.
- symptom_name: Dizziness
onset_date: '2025-01-11'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-01-11'
severity: Moderate
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 4
reporting_facility: Molina-Harris Medical Center
reporter_type: Patient
notes: Job prove local be side tough.
|
<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-2025-411
Date of Submission: 2025-04-08
This report was submitted by a Pharmacist from Burns, Matthews and Gray Medical Center concerning patient ANON-PX-2871. The subject is a 73-year-old female with a significant medical history including coronary artery disease, type 2 diabetes, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Topical route at a dosage of 301mg, initiated on 2025-01-17 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-02-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Nausea, Hepatotoxicity, Somnolence. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed peace and advised never. 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 Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Mild 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 yeah and advised should. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Like everything among. Teach Republican rate about card white. Build call skin nearly whose contain agreement.</data>
|
report_id: ADR-2025-411
report_date: '2025-04-08'
patient_details:
patient_id: ANON-PX-2871
gender: Female
relevant_history:
- coronary artery disease
- type 2 diabetes
- hypertension
age_at_reaction: 73
suspected_drugs:
- drug_name: Omeprazole
dosage: 301mg
route_of_administration: Topical
start_date: '2025-01-17'
indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-02-08'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed peace and advised never.
- symptom_name: Headache
onset_date: '2025-02-08'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-02-08'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-02-08'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-02-08'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed yeah and advised should.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 9
reporting_facility: Burns, Matthews and Gray Medical Center
reporter_type: Pharmacist
notes: Like everything among. Teach Republican rate about card white. Build call skin
nearly whose contain agreement.
|
<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-2024-661
Date of Submission: 2024-08-15
This report was submitted by a Physician from Payne-Savage Medical Center concerning patient ANON-PX-1076. The subject is an adult other with a significant medical history including chronic kidney disease, atrial fibrillation, anxiety, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intravenous route at a dosage of 485mg, initiated on 2024-06-19 for Gastroesophageal reflux disease and discontinued on 2024-07-13.
On approximately 2024-06-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Nausea. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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: Represent message green statement. Prevent operation important trip into.</data>
|
report_id: ADR-2024-661
report_date: '2024-08-15'
patient_details:
patient_id: ANON-PX-1076
gender: Other
relevant_history:
- chronic kidney disease
- atrial fibrillation
- anxiety
- coronary artery disease
suspected_drugs:
- drug_name: Omeprazole
dosage: 485mg
route_of_administration: Intravenous
start_date: '2024-06-19'
indication_for_use: Gastroesophageal reflux disease
end_date: '2024-07-13'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-06-21'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Nausea
onset_date: '2024-06-21'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Payne-Savage Medical Center
reporter_type: Physician
notes: Represent message green statement. Prevent operation important trip into.
|
<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-2025-558
Date of Submission: 2025-06-23
This report was submitted by a Nurse from Robertson-Zuniga Medical Center concerning patient ANON-PX-7978. The subject is an adult male with a significant medical history including seasonal allergies, 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): Levothyroxine administered via the Intravenous route at a dosage of 368mg, initiated on 2025-03-25 for Hypothyroidism and discontinued on 2025-06-14; Atorvastatin administered via the Oral route at a dosage of 334mg, initiated on 2025-03-25 for Hypercholesterolemia and discontinued on 2025-06-14.
On approximately 2025-06-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Stevens-Johnson syndrome, Diarrhea, Pruritus, Somnolence. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed face and advised mention. 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 black and advised wall. 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 'Unknown'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as 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 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Light he tend girl beyond eat behavior tonight. Question per idea body administration society.</data>
|
report_id: ADR-2025-558
report_date: '2025-06-23'
patient_details:
patient_id: ANON-PX-7978
gender: Male
relevant_history:
- seasonal allergies
- asthma
- anxiety
- chronic kidney disease
suspected_drugs:
- drug_name: Levothyroxine
dosage: 368mg
route_of_administration: Intravenous
start_date: '2025-03-25'
indication_for_use: Hypothyroidism
end_date: '2025-06-14'
- drug_name: Atorvastatin
dosage: 334mg
route_of_administration: Oral
start_date: '2025-03-25'
indication_for_use: Hypercholesterolemia
end_date: '2025-06-14'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2025-06-11'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed face and advised mention.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-11'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed black and advised wall.
- symptom_name: Diarrhea
onset_date: '2025-06-11'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-06-11'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-06-11'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Robertson-Zuniga Medical Center
reporter_type: Nurse
notes: Light he tend girl beyond eat behavior tonight. Question per idea body administration
society.
|
<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-2024-420
Date of Submission: 2024-09-29
This report was submitted by a Physician from Blevins, Murphy and King Medical Center concerning patient ANON-PX-3067. The subject is a 30-year-old male with a significant medical history including atrial fibrillation, chronic kidney 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 administered via the Subcutaneous route at a dosage of 162mg, initiated on 2024-07-31 for Type 2 diabetes and discontinued on 2024-09-15.
On approximately 2024-09-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Stevens-Johnson syndrome, Hepatotoxicity. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed especially and advised southern. The current patient status regarding this symptom is 'Recovering'. 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 Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Write road you yes education fall. Move event person reflect wait seven.</data>
|
report_id: ADR-2024-420
report_date: '2024-09-29'
patient_details:
patient_id: ANON-PX-3067
gender: Male
relevant_history:
- atrial fibrillation
- chronic kidney disease
- osteoarthritis
age_at_reaction: 30
suspected_drugs:
- drug_name: Metformin
dosage: 162mg
route_of_administration: Subcutaneous
start_date: '2024-07-31'
indication_for_use: Type 2 diabetes
end_date: '2024-09-15'
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-09-11'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed especially and advised southern.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-11'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-09-11'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Blevins, Murphy and King Medical Center
reporter_type: Physician
notes: Write road you yes education fall. Move event person reflect wait seven.
|
<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-2025-663
Date of Submission: 2025-02-10
This report was submitted by a Other Healthcare Professional from Cameron, Orr and Oliver Medical Center concerning patient ANON-PX-1323. The subject is a 50-year-old female with a significant medical history including atrial fibrillation, type 2 diabetes, seasonal allergies, 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): Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 464mg, initiated on 2024-12-04 for Hypothyroidism and discontinued on 2025-01-26.
On approximately 2025-01-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, 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 'Fatal'. The Pruritus 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Everything total tend military. Interesting place sit degree magazine term bad. Against event scientist media I agreement.</data>
|
report_id: ADR-2025-663
report_date: '2025-02-10'
patient_details:
patient_id: ANON-PX-1323
gender: Female
relevant_history:
- atrial fibrillation
- type 2 diabetes
- seasonal allergies
- anxiety
age_at_reaction: 50
suspected_drugs:
- drug_name: Levothyroxine
dosage: 464mg
route_of_administration: Topical
start_date: '2024-12-04'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-01-26'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-01-17'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-01-17'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Cameron, Orr and Oliver Medical Center
reporter_type: Other Healthcare Professional
notes: Everything total tend military. Interesting place sit degree magazine term
bad. Against event scientist media I agreement.
|
<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-2025-111
Date of Submission: 2025-04-23
This report was submitted by a Nurse from Taylor-Cameron Medical Center concerning patient ANON-PX-5808. The subject is a 90-year-old female with a significant medical history including seasonal allergies, chronic kidney disease, 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): Lisinopril administered via the Oral route at a dosage of 125mg, initiated on 2025-04-12 for Hypertension with the course ongoing.
On approximately 2025-04-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed simply and advised act. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: North toward hand east finally. Ask book level include. Production five program. Others financial bar management.</data>
|
report_id: ADR-2025-111
report_date: '2025-04-23'
patient_details:
patient_id: ANON-PX-5808
gender: Female
relevant_history:
- seasonal allergies
- chronic kidney disease
- coronary artery disease
- atrial fibrillation
age_at_reaction: 90
suspected_drugs:
- drug_name: Lisinopril
dosage: 125mg
route_of_administration: Oral
start_date: '2025-04-12'
indication_for_use: Hypertension
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-17'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed simply and advised act.
- symptom_name: Somnolence
onset_date: '2025-04-17'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 10
reporting_facility: Taylor-Cameron Medical Center
reporter_type: Nurse
notes: North toward hand east finally. Ask book level include. Production five program.
Others financial bar management.
|
<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-2024-579
Date of Submission: 2024-11-30
This report was submitted by a Physician from Lang PLC Medical Center concerning patient ANON-PX-8644. The subject is a 71-year-old male with a significant medical history including migraines, chronic kidney disease, asthma, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 424mg, initiated on 2024-09-13 for Hypercholesterolemia with the course ongoing; Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 37mg, initiated on 2024-09-13 for Hypertension with the course ongoing.
On approximately 2024-11-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema, Nausea, Vomiting. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. 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 herself and advised watch. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed current and advised end. The current patient status regarding this symptom is 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Treatment debate note million. Response sea down on. Or mention onto concern.</data>
|
report_id: ADR-2024-579
report_date: '2024-11-30'
patient_details:
patient_id: ANON-PX-8644
gender: Male
relevant_history:
- migraines
- chronic kidney disease
- asthma
- type 2 diabetes
age_at_reaction: 71
suspected_drugs:
- drug_name: Atorvastatin
dosage: 424mg
route_of_administration: Subcutaneous
start_date: '2024-09-13'
indication_for_use: Hypercholesterolemia
drug_class: Statin
- drug_name: Lisinopril
dosage: 37mg
route_of_administration: Subcutaneous
start_date: '2024-09-13'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-11-11'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-11-11'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed herself and advised watch.
- symptom_name: Nausea
onset_date: '2024-11-11'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-11-11'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed current and advised end.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Lang PLC Medical Center
reporter_type: Physician
notes: Treatment debate note million. Response sea down on. Or mention onto concern.
|
<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-2025-138
Date of Submission: 2025-01-19
This report was submitted by a Other Healthcare Professional from Evans LLC Medical Center concerning patient ANON-PX-6411. The subject is an adult female with a significant medical history including anxiety, migraines, 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): Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 362mg, initiated on 2024-12-25 for Hypothyroidism and discontinued on 2025-01-16; Amoxicillin administered via the Topical route at a dosage of 427mg, initiated on 2024-12-25 for Bacterial infection and discontinued on 2025-01-16.
On approximately 2025-01-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Dizziness, Vomiting, Diarrhea. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed per and advised catch. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed paper and advised herself. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed recent and advised you. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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: Cultural employee learn before. Term enough feeling institution save.</data>
|
report_id: ADR-2025-138
report_date: '2025-01-19'
patient_details:
patient_id: ANON-PX-6411
gender: Female
relevant_history:
- anxiety
- migraines
- coronary artery disease
- seasonal allergies
suspected_drugs:
- drug_name: Levothyroxine
dosage: 362mg
route_of_administration: Topical
start_date: '2024-12-25'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-01-16'
- drug_name: Amoxicillin
dosage: 427mg
route_of_administration: Topical
start_date: '2024-12-25'
indication_for_use: Bacterial infection
end_date: '2025-01-16'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-01-09'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed per and advised catch.
- symptom_name: Somnolence
onset_date: '2025-01-09'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-01-09'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed paper and advised herself.
- symptom_name: Vomiting
onset_date: '2025-01-09'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed recent and advised you.
- symptom_name: Diarrhea
onset_date: '2025-01-09'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Evans LLC Medical Center
reporter_type: Other Healthcare Professional
notes: Cultural employee learn before. Term enough feeling institution save.
|
<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-2025-235
Date of Submission: 2025-02-07
This report was submitted by a Nurse from Porter Inc Medical Center concerning patient ANON-PX-5744. The subject is a 19-year-old male with a significant medical history including atrial fibrillation, type 2 diabetes, 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 Oral route at a dosage of 132mg, initiated on 2024-12-18 for Thromboembolism prevention with the course ongoing.
On approximately 2025-02-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Dizziness. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed author and advised peace. 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 various and advised item. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Collection tough understand station interest where. Lead ready budget within lead dog.</data>
|
report_id: ADR-2025-235
report_date: '2025-02-07'
patient_details:
patient_id: ANON-PX-5744
gender: Male
relevant_history:
- atrial fibrillation
- type 2 diabetes
- migraines
- hypertension
age_at_reaction: 19
suspected_drugs:
- drug_name: Warfarin
dosage: 132mg
route_of_administration: Oral
start_date: '2024-12-18'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-02-04'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed author and advised peace.
- symptom_name: Dizziness
onset_date: '2025-02-04'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed various and advised item.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 1
reporting_facility: Porter Inc Medical Center
reporter_type: Nurse
notes: Collection tough understand station interest where. Lead ready budget within
lead dog.
|
<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: 2025-01-06
This report was submitted by a Patient from Johnson-Martinez Medical Center concerning patient ANON-PX-3331. The subject is an adult other with a significant medical history including type 2 diabetes, 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 administered via the Oral route at a dosage of 108mg, initiated on 2024-11-13 for Hypothyroidism and discontinued on 2024-12-21; Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 75mg, initiated on 2024-11-13 for Bacterial infection and discontinued on 2024-12-21.
On approximately 2024-12-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea, Anaphylaxis. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Boy near ability want ever office. Night son high answer under. Century stage task fish senior step.</data>
|
report_id: ADR-2025-306
report_date: '2025-01-06'
patient_details:
patient_id: ANON-PX-3331
gender: Other
relevant_history:
- type 2 diabetes
- hypertension
suspected_drugs:
- drug_name: Levothyroxine
dosage: 108mg
route_of_administration: Oral
start_date: '2024-11-13'
indication_for_use: Hypothyroidism
end_date: '2024-12-21'
- drug_name: Amoxicillin
dosage: 75mg
route_of_administration: Intravenous
start_date: '2024-11-13'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-12-21'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-12-15'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-12-15'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-12-15'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Johnson-Martinez Medical Center
reporter_type: Patient
notes: Boy near ability want ever office. Night son high answer under. Century stage
task fish senior step.
|
<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: 2025-08-12
This report was submitted by a Other Healthcare Professional from Murray-Boyd Medical Center concerning patient ANON-PX-5445. The subject is an adult other with a significant medical history including type 2 diabetes, anxiety, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 264mg, initiated on 2025-07-20 for Bacterial infection and discontinued on 2025-07-31.
On approximately 2025-07-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Diarrhea. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The 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 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: Step research school entire process watch. Use between forward wait yeah nation. With many what person film I.</data>
|
report_id: ADR-2025-575
report_date: '2025-08-12'
patient_details:
patient_id: ANON-PX-5445
gender: Other
relevant_history:
- type 2 diabetes
- anxiety
- migraines
suspected_drugs:
- drug_name: Amoxicillin
dosage: 264mg
route_of_administration: Intramuscular
start_date: '2025-07-20'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-07-31'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-07-24'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Somnolence
onset_date: '2025-07-24'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-07-24'
severity: Mild
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Murray-Boyd Medical Center
reporter_type: Other Healthcare Professional
notes: Step research school entire process watch. Use between forward wait yeah nation.
With many what person film I.
|
<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-2025-759
Date of Submission: 2025-05-04
This report was submitted by a Nurse from Hart Ltd Medical Center concerning patient ANON-PX-6130. The subject is a 90-year-old other with a significant medical history including migraines, 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): Gabapentin administered via the Intramuscular route at a dosage of 189mg, initiated on 2025-03-08 for Neuropathic pain with the course ongoing; Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 358mg, initiated on 2025-03-08 for Type 2 diabetes with the course ongoing.
On approximately 2025-04-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Stevens-Johnson syndrome, Angioedema, Dizziness. The Nausea 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 Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed medical and advised house. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Ago decision activity election strategy special. Gun could man born. Forget vote place start thank.</data>
|
report_id: ADR-2025-759
report_date: '2025-05-04'
patient_details:
patient_id: ANON-PX-6130
gender: Other
relevant_history:
- migraines
- seasonal allergies
- asthma
- chronic kidney disease
age_at_reaction: 90
suspected_drugs:
- drug_name: Gabapentin
dosage: 189mg
route_of_administration: Intramuscular
start_date: '2025-03-08'
indication_for_use: Neuropathic pain
- drug_name: Metformin
dosage: 358mg
route_of_administration: Subcutaneous
start_date: '2025-03-08'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-04-25'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-04-25'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed medical and advised house.
- symptom_name: Angioedema
onset_date: '2025-04-25'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-04-25'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 3
reporting_facility: Hart Ltd Medical Center
reporter_type: Nurse
notes: Ago decision activity election strategy special. Gun could man born. Forget
vote place start thank.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-384
Date of Submission: 2024-10-20
This report was submitted by a Physician from Brown-Duncan Medical Center concerning patient ANON-PX-1459. The subject is a 60-year-old male with a significant medical history including chronic kidney disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole administered via the Intravenous route at a dosage of 472mg, initiated on 2024-09-17 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2024-09-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Pruritus, Anaphylaxis, Somnolence. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed in and advised general. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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-2024-384
report_date: '2024-10-20'
patient_details:
patient_id: ANON-PX-1459
gender: Male
relevant_history:
- chronic kidney disease
- hypertension
age_at_reaction: 60
suspected_drugs:
- drug_name: Omeprazole
dosage: 472mg
route_of_administration: Intravenous
start_date: '2024-09-17'
indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-09-19'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed in and advised general.
- symptom_name: Angioedema
onset_date: '2024-09-19'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-09-19'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-09-19'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Somnolence
onset_date: '2024-09-19'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 3
reporting_facility: Brown-Duncan 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-2024-961
Date of Submission: 2024-08-19
This report was submitted by a Nurse from Lewis PLC Medical Center concerning patient ANON-PX-2356. The subject is a 77-year-old female with a significant medical history including anxiety, type 2 diabetes, 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): Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 197mg, initiated on 2024-06-17 for Hypertension with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 408mg, initiated on 2024-06-17 for Hypothyroidism with the course ongoing.
On approximately 2024-08-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Dizziness. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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-2024-961
report_date: '2024-08-19'
patient_details:
patient_id: ANON-PX-2356
gender: Female
relevant_history:
- anxiety
- type 2 diabetes
- asthma
- osteoarthritis
age_at_reaction: 77
suspected_drugs:
- drug_name: Lisinopril
dosage: 197mg
route_of_administration: Intravenous
start_date: '2024-06-17'
indication_for_use: Hypertension
drug_class: ACE inhibitor
- drug_name: Levothyroxine
dosage: 408mg
route_of_administration: Topical
start_date: '2024-06-17'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-08-06'
severity: Severe
outcome: Recovered
intervention_required: true
- symptom_name: Dizziness
onset_date: '2024-08-06'
severity: Severe
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Lewis 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-2024-982
Date of Submission: 2024-08-29
This report was submitted by a Patient from Rhodes-Lane Medical Center concerning patient ANON-PX-3571. The subject is a 51-year-old male with a significant medical history including type 2 diabetes, anxiety, atrial fibrillation, 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 administered via the Subcutaneous route at a dosage of 432mg, initiated on 2024-06-28 for Hypothyroidism with the course ongoing.
On approximately 2024-07-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Nausea. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed beautiful and advised must. 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 right and advised market. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-982
report_date: '2024-08-29'
patient_details:
patient_id: ANON-PX-3571
gender: Male
relevant_history:
- type 2 diabetes
- anxiety
- atrial fibrillation
- hypertension
age_at_reaction: 51
suspected_drugs:
- drug_name: Levothyroxine
dosage: 432mg
route_of_administration: Subcutaneous
start_date: '2024-06-28'
indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-07-24'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed beautiful and advised must.
- symptom_name: Nausea
onset_date: '2024-07-24'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed right and advised market.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Rhodes-Lane 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-2024-974
Date of Submission: 2024-11-15
This report was submitted by a Physician from Orr, Bell and Wolf Medical Center concerning patient ANON-PX-4008. The subject is a 34-year-old other with a significant medical history including osteoarthritis, migraines, 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): Atorvastatin (Statin) administered via the Intramuscular route at a dosage of 385mg, initiated on 2024-09-20 for Hypercholesterolemia and discontinued on 2024-10-21.
On approximately 2024-09-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Dizziness. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed marriage and advised commercial. 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 free and advised party. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-974
report_date: '2024-11-15'
patient_details:
patient_id: ANON-PX-4008
gender: Other
relevant_history:
- osteoarthritis
- migraines
- chronic kidney disease
age_at_reaction: 34
suspected_drugs:
- drug_name: Atorvastatin
dosage: 385mg
route_of_administration: Intramuscular
start_date: '2024-09-20'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-10-21'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-09-26'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed marriage and advised commercial.
- symptom_name: Dizziness
onset_date: '2024-09-26'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed free and advised party.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Orr, Bell and Wolf 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-2024-427
Date of Submission: 2024-08-31
This report was submitted by a Physician from Hernandez-Hatfield Medical Center concerning patient ANON-PX-9527. The subject is a 39-year-old male with a significant medical history including migraines, 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): Sertraline (SSRI) administered via the Intramuscular route at a dosage of 181mg, initiated on 2024-07-03 for Major depressive disorder and discontinued on 2024-08-28.
On approximately 2024-08-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, 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 'Fatal'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-427
report_date: '2024-08-31'
patient_details:
patient_id: ANON-PX-9527
gender: Male
relevant_history:
- migraines
- hypertension
- chronic kidney disease
age_at_reaction: 39
suspected_drugs:
- drug_name: Sertraline
dosage: 181mg
route_of_administration: Intramuscular
start_date: '2024-07-03'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-08-28'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-08-27'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2024-08-27'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 8
reporting_facility: Hernandez-Hatfield 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-2025-777
Date of Submission: 2025-06-13
This report was submitted by a Patient from Massey LLC Medical Center concerning patient ANON-PX-3759. The subject is a 67-year-old female with a significant medical history including 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 (Anticoagulant) administered via the Topical route at a dosage of 153mg, initiated on 2025-05-24 for Thromboembolism prevention and discontinued on 2025-06-10.
On approximately 2025-05-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Pruritus, Diarrhea, Maculopapular Rash, Headache. The Hepatotoxicity 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 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 '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'. The Headache 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 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: Year window last idea door use own. Western local result quickly sense red. Exactly find break language.</data>
|
report_id: ADR-2025-777
report_date: '2025-06-13'
patient_details:
patient_id: ANON-PX-3759
gender: Female
relevant_history:
- type 2 diabetes
- osteoarthritis
age_at_reaction: 67
suspected_drugs:
- drug_name: Warfarin
dosage: 153mg
route_of_administration: Topical
start_date: '2025-05-24'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-06-10'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-05-25'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-05-25'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-05-25'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-05-25'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2025-05-25'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 6
reporting_facility: Massey LLC Medical Center
reporter_type: Patient
notes: Year window last idea door use own. Western local result quickly sense red.
Exactly find break language.
|
<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: 2025-08-05
This report was submitted by a Patient from Jones Group Medical Center concerning patient ANON-PX-9696. The subject is a 60-year-old male with a significant medical history including migraines, seasonal allergies, 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): Gabapentin administered via the Intravenous route at a dosage of 16mg, initiated on 2025-07-16 for Neuropathic pain and discontinued on 2025-07-26.
On approximately 2025-07-21, 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Activity else sense by cover me at.</data>
|
report_id: ADR-2025-746
report_date: '2025-08-05'
patient_details:
patient_id: ANON-PX-9696
gender: Male
relevant_history:
- migraines
- seasonal allergies
- hypertension
- atrial fibrillation
age_at_reaction: 60
suspected_drugs:
- drug_name: Gabapentin
dosage: 16mg
route_of_administration: Intravenous
start_date: '2025-07-16'
indication_for_use: Neuropathic pain
end_date: '2025-07-26'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-07-21'
severity: Moderate
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-07-21'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2025-07-21'
severity: Mild
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 9
reporting_facility: Jones Group Medical Center
reporter_type: Patient
notes: Activity else sense by cover me at.
|
<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-2024-326
Date of Submission: 2024-12-30
This report was submitted by a Other Healthcare Professional from Sharp and Sons Medical Center concerning patient ANON-PX-1509. The subject is an adult female with a significant medical history including osteoarthritis, type 2 diabetes, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin administered via the Intravenous route at a dosage of 19mg, initiated on 2024-10-15 for Bacterial infection and discontinued on 2024-12-07.
On approximately 2024-10-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Diarrhea. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed both and advised should. 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 sport and advised party. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-326
report_date: '2024-12-30'
patient_details:
patient_id: ANON-PX-1509
gender: Female
relevant_history:
- osteoarthritis
- type 2 diabetes
- anxiety
suspected_drugs:
- drug_name: Amoxicillin
dosage: 19mg
route_of_administration: Intravenous
start_date: '2024-10-15'
indication_for_use: Bacterial infection
end_date: '2024-12-07'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-10-18'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed both and advised should.
- symptom_name: Diarrhea
onset_date: '2024-10-18'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed sport and advised party.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 4
reporting_facility: Sharp 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-2025-210
Date of Submission: 2025-04-18
This report was submitted by a Other Healthcare Professional from Black Ltd Medical Center concerning patient ANON-PX-3317. The subject is a 37-year-old male with a significant medical history including type 2 diabetes, 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): Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 438mg, initiated on 2025-02-18 for Gastroesophageal reflux disease with the course ongoing; Amoxicillin administered via the Intramuscular route at a dosage of 372mg, initiated on 2025-02-18 for Bacterial infection with the course ongoing.
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, Diarrhea. 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'. The Diarrhea was classified as Life-threatening 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 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: West recognize along them identify medical. Imagine attention throughout price. Organization must job character sense toward.</data>
|
report_id: ADR-2025-210
report_date: '2025-04-18'
patient_details:
patient_id: ANON-PX-3317
gender: Male
relevant_history:
- type 2 diabetes
- migraines
- anxiety
age_at_reaction: 37
suspected_drugs:
- drug_name: Omeprazole
dosage: 438mg
route_of_administration: Intravenous
start_date: '2025-02-18'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Amoxicillin
dosage: 372mg
route_of_administration: Intramuscular
start_date: '2025-02-18'
indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-03-06'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-03-06'
severity: Life-threatening
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 9
reporting_facility: Black Ltd Medical Center
reporter_type: Other Healthcare Professional
notes: West recognize along them identify medical. Imagine attention throughout price.
Organization must job character sense toward.
|
<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-2024-946
Date of Submission: 2024-09-24
This report was submitted by a Other Healthcare Professional from Parker, Ramirez and Davis Medical Center concerning patient ANON-PX-8083. The subject is a 23-year-old female with a significant medical history including 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): Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 487mg, initiated on 2024-07-14 for Bacterial infection with the course ongoing; Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 339mg, initiated on 2024-07-14 for Hypertension with the course ongoing.
On approximately 2024-07-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Vomiting, Stevens-Johnson syndrome, Dizziness, Diarrhea. The Headache 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 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed present and advised these. 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 'Not Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2024-946
report_date: '2024-09-24'
patient_details:
patient_id: ANON-PX-8083
gender: Female
relevant_history:
- type 2 diabetes
- anxiety
- atrial fibrillation
age_at_reaction: 23
suspected_drugs:
- drug_name: Amoxicillin
dosage: 487mg
route_of_administration: Intramuscular
start_date: '2024-07-14'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
- drug_name: Lisinopril
dosage: 339mg
route_of_administration: Oral
start_date: '2024-07-14'
indication_for_use: Hypertension
drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Headache
onset_date: '2024-07-30'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-07-30'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-07-30'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-07-30'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed present and advised these.
- symptom_name: Diarrhea
onset_date: '2024-07-30'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 7
reporting_facility: Parker, Ramirez 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-2025-133
Date of Submission: 2025-07-08
This report was submitted by a Nurse from Sanchez LLC Medical Center concerning patient ANON-PX-2083. The subject is a 63-year-old female 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): Metformin administered via the Intravenous route at a dosage of 32mg, initiated on 2025-04-09 for Type 2 diabetes and discontinued on 2025-06-06; Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 16mg, initiated on 2025-04-09 for Hypertension and discontinued on 2025-06-06.
On approximately 2025-05-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome, Somnolence, Diarrhea, Headache. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed walk and advised arm. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed according and advised late. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed lay and advised including. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed form and advised author. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-133
report_date: '2025-07-08'
patient_details:
patient_id: ANON-PX-2083
gender: Female
relevant_history:
- osteoarthritis
- asthma
age_at_reaction: 63
suspected_drugs:
- drug_name: Metformin
dosage: 32mg
route_of_administration: Intravenous
start_date: '2025-04-09'
indication_for_use: Type 2 diabetes
end_date: '2025-06-06'
- drug_name: Lisinopril
dosage: 16mg
route_of_administration: Oral
start_date: '2025-04-09'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-06-06'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-05-22'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-05-22'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed walk and advised arm.
- symptom_name: Somnolence
onset_date: '2025-05-22'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed according and advised late.
- symptom_name: Diarrhea
onset_date: '2025-05-22'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed lay and advised including.
- symptom_name: Headache
onset_date: '2025-05-22'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed form and advised author.
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 9
reporting_facility: Sanchez 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-2025-120
Date of Submission: 2025-02-20
This report was submitted by a Patient from Simon, Watson and Holmes Medical Center concerning patient ANON-PX-7931. The subject is an adult female with a significant medical history including chronic kidney disease, atrial fibrillation, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 223mg, initiated on 2024-12-27 for Hypertension and discontinued on 2025-02-01; Gabapentin administered via the Topical route at a dosage of 211mg, initiated on 2024-12-27 for Neuropathic pain and discontinued on 2025-02-01.
On approximately 2024-12-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Pruritus, Anaphylaxis. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed woman and advised face. 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 throw and advised PM. 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 'Unknown'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Trade because old traditional better order. Start appear official pattern article board.</data>
|
report_id: ADR-2025-120
report_date: '2025-02-20'
patient_details:
patient_id: ANON-PX-7931
gender: Female
relevant_history:
- chronic kidney disease
- atrial fibrillation
- seasonal allergies
suspected_drugs:
- drug_name: Lisinopril
dosage: 223mg
route_of_administration: Subcutaneous
start_date: '2024-12-27'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-01'
- drug_name: Gabapentin
dosage: 211mg
route_of_administration: Topical
start_date: '2024-12-27'
indication_for_use: Neuropathic pain
end_date: '2025-02-01'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-12-29'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed woman and advised face.
- symptom_name: Pruritus
onset_date: '2024-12-29'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed throw and advised PM.
- symptom_name: Anaphylaxis
onset_date: '2024-12-29'
severity: Severe
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Simon, Watson and Holmes Medical Center
reporter_type: Patient
notes: Trade because old traditional better order. Start appear official pattern article
board.
|
<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-2024-331
Date of Submission: 2024-09-07
This report was submitted by a Physician from Butler PLC Medical Center concerning patient ANON-PX-5863. The subject is an adult male with a significant medical history including chronic kidney 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): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 293mg, initiated on 2024-07-14 for Hypertension and discontinued on 2024-09-06; Ibuprofen administered via the Intramuscular route at a dosage of 469mg, initiated on 2024-07-14 for Pain and inflammation and discontinued on 2024-09-06.
On approximately 2024-09-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Somnolence, Nausea, Vomiting, Angioedema. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed show and advised child. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Angioedema 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. 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-2024-331
report_date: '2024-09-07'
patient_details:
patient_id: ANON-PX-5863
gender: Male
relevant_history:
- chronic kidney disease
- osteoarthritis
suspected_drugs:
- drug_name: Lisinopril
dosage: 293mg
route_of_administration: Oral
start_date: '2024-07-14'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2024-09-06'
- drug_name: Ibuprofen
dosage: 469mg
route_of_administration: Intramuscular
start_date: '2024-07-14'
indication_for_use: Pain and inflammation
end_date: '2024-09-06'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-09-02'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
- symptom_name: Somnolence
onset_date: '2024-09-02'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed show and advised child.
- symptom_name: Nausea
onset_date: '2024-09-02'
severity: Life-threatening
outcome: Unknown
intervention_required: true
- symptom_name: Vomiting
onset_date: '2024-09-02'
severity: Moderate
outcome: Recovering
intervention_required: true
- symptom_name: Angioedema
onset_date: '2024-09-02'
severity: Mild
outcome: Unknown
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Butler PLC 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-2024-874
Date of Submission: 2024-09-12
This report was submitted by a Pharmacist from Green-Wells Medical Center concerning patient ANON-PX-7501. The subject is a 46-year-old male with a significant medical history including coronary artery disease, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 285mg, initiated on 2024-07-17 for Bacterial infection and discontinued on 2024-08-30; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 396mg, initiated on 2024-07-17 for Neuropathic pain and discontinued on 2024-08-30.
On approximately 2024-07-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Vomiting, Maculopapular Rash. 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 Moderate in severity. No specific therapeutic intervention was required. 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 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Two seek glass section. Friend about do.</data>
|
report_id: ADR-2024-874
report_date: '2024-09-12'
patient_details:
patient_id: ANON-PX-7501
gender: Male
relevant_history:
- coronary artery disease
- seasonal allergies
age_at_reaction: 46
suspected_drugs:
- drug_name: Amoxicillin
dosage: 285mg
route_of_administration: Intravenous
start_date: '2024-07-17'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-08-30'
- drug_name: Gabapentin
dosage: 396mg
route_of_administration: Subcutaneous
start_date: '2024-07-17'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-08-30'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-07-18'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-07-18'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2024-07-18'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Green-Wells Medical Center
reporter_type: Pharmacist
notes: Two seek glass section. Friend about do.
|
<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-2024-724
Date of Submission: 2024-10-19
This report was submitted by a Patient from Berry, Chavez and Johnson Medical Center concerning patient ANON-PX-3249. The subject is an adult 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): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 419mg, initiated on 2024-09-29 for Bacterial infection and discontinued on 2024-10-08; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 72mg, initiated on 2024-09-29 for Neuropathic pain and discontinued on 2024-10-08.
On approximately 2024-10-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Diarrhea, Somnolence, Vomiting. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. 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 tell and advised likely. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed machine and advised Democrat. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed land and advised stand. The current patient status regarding this symptom is 'Fatal'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Watch wall show front. Cold character argue least north.</data>
|
report_id: ADR-2024-724
report_date: '2024-10-19'
patient_details:
patient_id: ANON-PX-3249
gender: Male
relevant_history:
- asthma
- type 2 diabetes
suspected_drugs:
- drug_name: Amoxicillin
dosage: 419mg
route_of_administration: Subcutaneous
start_date: '2024-09-29'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-10-08'
- drug_name: Gabapentin
dosage: 72mg
route_of_administration: Subcutaneous
start_date: '2024-09-29'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-10-08'
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2024-10-02'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Diarrhea
onset_date: '2024-10-02'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed tell and advised likely.
- symptom_name: Somnolence
onset_date: '2024-10-02'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed machine and advised Democrat.
- symptom_name: Vomiting
onset_date: '2024-10-02'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed land and advised stand.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 7
reporting_facility: Berry, Chavez and Johnson Medical Center
reporter_type: Patient
notes: Watch wall show front. Cold character argue least north.
|
<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-2024-357
Date of Submission: 2024-11-26
This report was submitted by a Patient from Adams Group Medical Center concerning patient ANON-PX-8850. The subject is an adult other with a significant medical history including atrial fibrillation, seasonal allergies, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 46mg, initiated on 2024-10-24 for Major depressive disorder and discontinued on 2024-11-21.
On approximately 2024-11-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Anaphylaxis, Somnolence, Stevens-Johnson syndrome, Angioedema. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed talk and advised also. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed fly and advised war. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema 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 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: Lot run radio send everybody community. Personal college chair. Truth rule son special nation us.</data>
|
report_id: ADR-2024-357
report_date: '2024-11-26'
patient_details:
patient_id: ANON-PX-8850
gender: Other
relevant_history:
- atrial fibrillation
- seasonal allergies
- osteoarthritis
- coronary artery disease
suspected_drugs:
- drug_name: Sertraline
dosage: 46mg
route_of_administration: Topical
start_date: '2024-10-24'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2024-11-21'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-11-18'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed talk and advised also.
- symptom_name: Anaphylaxis
onset_date: '2024-11-18'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed fly and advised war.
- symptom_name: Somnolence
onset_date: '2024-11-18'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-18'
severity: Moderate
outcome: Not Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-11-18'
severity: Moderate
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 9
reporting_facility: Adams Group Medical Center
reporter_type: Patient
notes: Lot run radio send everybody community. Personal college chair. Truth rule
son special nation us.
|
<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-2025-149
Date of Submission: 2025-02-24
This report was submitted by a Other Healthcare Professional from Petersen, Wilson and Frazier Medical Center concerning patient ANON-PX-2592. The subject is a 33-year-old male with a significant medical history including hypertension, type 2 diabetes, 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): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 134mg, initiated on 2025-01-07 for Bacterial infection and discontinued on 2025-02-12; Ibuprofen (NSAID) administered via the Topical route at a dosage of 339mg, initiated on 2025-01-07 for Pain and inflammation and discontinued on 2025-02-12.
On approximately 2025-01-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Nausea. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. 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 '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: Particularly whose whether spend instead candidate. Instead agent mission him. White food stay cultural the the.</data>
|
report_id: ADR-2025-149
report_date: '2025-02-24'
patient_details:
patient_id: ANON-PX-2592
gender: Male
relevant_history:
- hypertension
- type 2 diabetes
- coronary artery disease
- atrial fibrillation
age_at_reaction: 33
suspected_drugs:
- drug_name: Amoxicillin
dosage: 134mg
route_of_administration: Topical
start_date: '2025-01-07'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-02-12'
- drug_name: Ibuprofen
dosage: 339mg
route_of_administration: Topical
start_date: '2025-01-07'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-02-12'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2025-01-10'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-01-10'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Petersen, Wilson and Frazier Medical Center
reporter_type: Other Healthcare Professional
notes: Particularly whose whether spend instead candidate. Instead agent mission him.
White food stay cultural the the.
|
<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-2025-814
Date of Submission: 2025-03-09
This report was submitted by a Patient from Mitchell PLC Medical Center concerning patient ANON-PX-3811. The subject is a 64-year-old female with a significant medical history including atrial fibrillation, 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): Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 458mg, initiated on 2025-02-09 for Neuropathic pain and discontinued on 2025-03-01; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 339mg, initiated on 2025-02-09 for Bacterial infection and discontinued on 2025-03-01.
On approximately 2025-02-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Maculopapular Rash. 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'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-814
report_date: '2025-03-09'
patient_details:
patient_id: ANON-PX-3811
gender: Female
relevant_history:
- atrial fibrillation
- seasonal allergies
- chronic kidney disease
age_at_reaction: 64
suspected_drugs:
- drug_name: Gabapentin
dosage: 458mg
route_of_administration: Intravenous
start_date: '2025-02-09'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-03-01'
- drug_name: Amoxicillin
dosage: 339mg
route_of_administration: Intramuscular
start_date: '2025-02-09'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2025-03-01'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-02-12'
severity: Mild
outcome: Unknown
intervention_required: false
- symptom_name: Somnolence
onset_date: '2025-02-12'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Maculopapular Rash
onset_date: '2025-02-12'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 6
reporting_facility: Mitchell 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-2025-666
Date of Submission: 2025-04-06
This report was submitted by a Physician from Ramirez Inc Medical Center concerning patient ANON-PX-7013. The subject is a 89-year-old male with a significant medical history including osteoarthritis, type 2 diabetes, 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 Topical route at a dosage of 177mg, initiated on 2025-02-25 for Pain and inflammation with the course ongoing.
On approximately 2025-03-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea, Maculopapular Rash. 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 Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed song and advised teacher. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed worry and advised thousand. 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-2025-666
report_date: '2025-04-06'
patient_details:
patient_id: ANON-PX-7013
gender: Male
relevant_history:
- osteoarthritis
- type 2 diabetes
- hypertension
age_at_reaction: 89
suspected_drugs:
- drug_name: Ibuprofen
dosage: 177mg
route_of_administration: Topical
start_date: '2025-02-25'
indication_for_use: Pain and inflammation
drug_class: NSAID
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-03-21'
severity: Life-threatening
outcome: Recovered
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-03-21'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed song and advised teacher.
- symptom_name: Maculopapular Rash
onset_date: '2025-03-21'
severity: Mild
outcome: Recovering
intervention_required: true
intervention_details: Prescribed worry and advised thousand.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Ramirez Inc 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-2025-350
Date of Submission: 2025-07-11
This report was submitted by a Other Healthcare Professional from Hodge, Lopez and Johnson Medical Center concerning patient ANON-PX-2456. The subject is a 76-year-old male with a significant medical history including asthma, 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): Metformin administered via the Intramuscular route at a dosage of 402mg, initiated on 2025-06-09 for Type 2 diabetes and discontinued on 2025-06-24.
On approximately 2025-06-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed decade and advised yard. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed idea and advised kid. 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-2025-350
report_date: '2025-07-11'
patient_details:
patient_id: ANON-PX-2456
gender: Male
relevant_history:
- asthma
- osteoarthritis
- seasonal allergies
age_at_reaction: 76
suspected_drugs:
- drug_name: Metformin
dosage: 402mg
route_of_administration: Intramuscular
start_date: '2025-06-09'
indication_for_use: Type 2 diabetes
end_date: '2025-06-24'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-06-23'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed decade and advised yard.
- symptom_name: Angioedema
onset_date: '2025-06-23'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed idea and advised kid.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Hodge, Lopez and Johnson 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-2025-669
Date of Submission: 2025-08-07
This report was submitted by a Other Healthcare Professional from Salinas PLC Medical Center concerning patient ANON-PX-8143. The subject is a 78-year-old female with a significant medical history including osteoarthritis, asthma, 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): Amoxicillin administered via the Subcutaneous route at a dosage of 490mg, initiated on 2025-07-23 for Bacterial infection with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 78mg, initiated on 2025-07-23 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-07-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed key and advised resource. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed always and advised policy. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Party organization almost street.</data>
|
report_id: ADR-2025-669
report_date: '2025-08-07'
patient_details:
patient_id: ANON-PX-8143
gender: Female
relevant_history:
- osteoarthritis
- asthma
- hypertension
- atrial fibrillation
age_at_reaction: 78
suspected_drugs:
- drug_name: Amoxicillin
dosage: 490mg
route_of_administration: Subcutaneous
start_date: '2025-07-23'
indication_for_use: Bacterial infection
- drug_name: Omeprazole
dosage: 78mg
route_of_administration: Intravenous
start_date: '2025-07-23'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-07-29'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed key and advised resource.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-29'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed always and advised policy.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Salinas PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Party organization almost street.
|
<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-2024-550
Date of Submission: 2024-11-06
This report was submitted by a Nurse from Alvarez PLC Medical Center concerning patient ANON-PX-6707. The subject is a 72-year-old female with a significant medical history including migraines, 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): Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 275mg, initiated on 2024-10-10 for Pain and inflammation and discontinued on 2024-11-05; Levothyroxine (Thyroid hormone) administered via the Oral route at a dosage of 400mg, initiated on 2024-10-10 for Hypothyroidism and discontinued on 2024-11-05.
On approximately 2024-11-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Anaphylaxis, Stevens-Johnson syndrome. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Prevent nature majority how sense strong. Spring however upon me.</data>
|
report_id: ADR-2024-550
report_date: '2024-11-06'
patient_details:
patient_id: ANON-PX-6707
gender: Female
relevant_history:
- migraines
- atrial fibrillation
- anxiety
age_at_reaction: 72
suspected_drugs:
- drug_name: Ibuprofen
dosage: 275mg
route_of_administration: Intramuscular
start_date: '2024-10-10'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-11-05'
- drug_name: Levothyroxine
dosage: 400mg
route_of_administration: Oral
start_date: '2024-10-10'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-05'
adverse_reactions:
- symptom_name: Somnolence
onset_date: '2024-11-02'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2024-11-02'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-02'
severity: Mild
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Alvarez PLC Medical Center
reporter_type: Nurse
notes: Prevent nature majority how sense strong. Spring however upon me.
|
<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-2025-112
Date of Submission: 2025-04-12
This report was submitted by a Nurse from Smith-Smith Medical Center concerning patient ANON-PX-2799. The subject is a 83-year-old male with a significant medical history including coronary artery disease, anxiety, chronic kidney disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 322mg, initiated on 2025-03-29 for Thromboembolism prevention and discontinued on 2025-04-03; Ibuprofen administered via the Intravenous route at a dosage of 466mg, initiated on 2025-03-29 for Pain and inflammation and discontinued on 2025-04-03.
On approximately 2025-04-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Vomiting, Somnolence, Diarrhea, Anaphylaxis. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed minute and advised whole. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed home and advised doctor. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed sing and advised child. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed per and advised you. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed adult and advised drug. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-112
report_date: '2025-04-12'
patient_details:
patient_id: ANON-PX-2799
gender: Male
relevant_history:
- coronary artery disease
- anxiety
- chronic kidney disease
- hypertension
age_at_reaction: 83
suspected_drugs:
- drug_name: Warfarin
dosage: 322mg
route_of_administration: Intramuscular
start_date: '2025-03-29'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-04-03'
- drug_name: Ibuprofen
dosage: 466mg
route_of_administration: Intravenous
start_date: '2025-03-29'
indication_for_use: Pain and inflammation
end_date: '2025-04-03'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-04-03'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed minute and advised whole.
- symptom_name: Vomiting
onset_date: '2025-04-03'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed home and advised doctor.
- symptom_name: Somnolence
onset_date: '2025-04-03'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed sing and advised child.
- symptom_name: Diarrhea
onset_date: '2025-04-03'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed per and advised you.
- symptom_name: Anaphylaxis
onset_date: '2025-04-03'
severity: Mild
outcome: Fatal
intervention_required: true
intervention_details: Prescribed adult and advised drug.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Smith-Smith 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-2025-296
Date of Submission: 2025-07-11
This report was submitted by a Patient from Jenkins Inc Medical Center concerning patient ANON-PX-1911. The subject is an adult other with a significant medical history including migraines, atrial fibrillation, seasonal allergies, 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 administered via the Intravenous route at a dosage of 483mg, initiated on 2025-06-27 for Type 2 diabetes and discontinued on 2025-07-09.
On approximately 2025-07-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Headache, Pruritus, Somnolence, Vomiting. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed action and advised evening. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. 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 administration and advised about. 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'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed police and advised reveal. 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: Discussion former learn them one major tax now. Rule provide bag recent pick.</data>
|
report_id: ADR-2025-296
report_date: '2025-07-11'
patient_details:
patient_id: ANON-PX-1911
gender: Other
relevant_history:
- migraines
- atrial fibrillation
- seasonal allergies
- anxiety
suspected_drugs:
- drug_name: Metformin
dosage: 483mg
route_of_administration: Intravenous
start_date: '2025-06-27'
indication_for_use: Type 2 diabetes
end_date: '2025-07-09'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-07-05'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed action and advised evening.
- symptom_name: Headache
onset_date: '2025-07-05'
severity: Life-threatening
outcome: Fatal
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-07-05'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed administration and advised about.
- symptom_name: Somnolence
onset_date: '2025-07-05'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-07-05'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed police and advised reveal.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Jenkins Inc Medical Center
reporter_type: Patient
notes: Discussion former learn them one major tax now. Rule provide bag recent 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-2025-225
Date of Submission: 2025-07-27
This report was submitted by a Patient from Johnston Inc Medical Center concerning patient ANON-PX-3699. The subject is an adult other with a significant medical history including migraines, 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): Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 375mg, initiated on 2025-06-03 for Thromboembolism prevention and discontinued on 2025-07-10; Ibuprofen (NSAID) administered via the Topical route at a dosage of 362mg, initiated on 2025-06-03 for Pain and inflammation and discontinued on 2025-07-10.
On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Headache. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed reflect and advised chance. 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: To PM relationship. Hear organization purpose family arm arm.</data>
|
report_id: ADR-2025-225
report_date: '2025-07-27'
patient_details:
patient_id: ANON-PX-3699
gender: Other
relevant_history:
- migraines
- coronary artery disease
- seasonal allergies
suspected_drugs:
- drug_name: Warfarin
dosage: 375mg
route_of_administration: Intramuscular
start_date: '2025-06-03'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-07-10'
- drug_name: Ibuprofen
dosage: 362mg
route_of_administration: Topical
start_date: '2025-06-03'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-07-10'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-06-07'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2025-06-07'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2025-06-07'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed reflect and advised chance.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Johnston Inc Medical Center
reporter_type: Patient
notes: To PM relationship. Hear organization purpose family arm 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-2025-586
Date of Submission: 2025-08-11
This report was submitted by a Nurse from Turner-Sanchez Medical Center concerning patient ANON-PX-2447. The subject is a 45-year-old male with a significant medical history including hypertension, 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 401mg, initiated on 2025-07-29 for Neuropathic pain with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 296mg, initiated on 2025-07-29 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-07-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed personal and advised probably. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed since and advised prove. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Hear over try spend. Field this moment difference window bar some. Adult property coach doctor.</data>
|
report_id: ADR-2025-586
report_date: '2025-08-11'
patient_details:
patient_id: ANON-PX-2447
gender: Male
relevant_history:
- hypertension
- anxiety
- atrial fibrillation
age_at_reaction: 45
suspected_drugs:
- drug_name: Gabapentin
dosage: 401mg
route_of_administration: Topical
start_date: '2025-07-29'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
- drug_name: Omeprazole
dosage: 296mg
route_of_administration: Oral
start_date: '2025-07-29'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-07-31'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed personal and advised probably.
- symptom_name: Somnolence
onset_date: '2025-07-31'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed since and advised prove.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 8
reporting_facility: Turner-Sanchez Medical Center
reporter_type: Nurse
notes: Hear over try spend. Field this moment difference window bar some. Adult property
coach doctor.
|
<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-2025-437
Date of Submission: 2025-01-01
This report was submitted by a Physician from Phillips, Payne and Morrison Medical Center concerning patient ANON-PX-8095. The subject is a 32-year-old male with a significant medical history including atrial fibrillation, asthma, 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): Atorvastatin administered via the Intramuscular route at a dosage of 52mg, initiated on 2024-10-10 for Hypercholesterolemia and discontinued on 2024-12-27.
On approximately 2024-12-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Angioedema. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed single and advised center. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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'.
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: Gas she risk answer. Thousand one experience station. Commercial management finish certainly.</data>
|
report_id: ADR-2025-437
report_date: '2025-01-01'
patient_details:
patient_id: ANON-PX-8095
gender: Male
relevant_history:
- atrial fibrillation
- asthma
- hypertension
- anxiety
age_at_reaction: 32
suspected_drugs:
- drug_name: Atorvastatin
dosage: 52mg
route_of_administration: Intramuscular
start_date: '2024-10-10'
indication_for_use: Hypercholesterolemia
end_date: '2024-12-27'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-12-25'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed single and advised center.
- symptom_name: Headache
onset_date: '2024-12-25'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-12-25'
severity: Moderate
outcome: Not Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Phillips, Payne and Morrison Medical Center
reporter_type: Physician
notes: Gas she risk answer. Thousand one experience station. Commercial management
finish certainly.
|
<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-2024-589
Date of Submission: 2024-09-03
This report was submitted by a Patient from Fowler PLC Medical Center concerning patient ANON-PX-2169. The subject is a 34-year-old female with a significant medical history including hypertension, chronic kidney disease, asthma, seasonal allergies. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Topical route at a dosage of 222mg, initiated on 2024-07-26 for Hypercholesterolemia and discontinued on 2024-07-27.
On approximately 2024-07-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Vomiting, Somnolence, Maculopapular Rash. The Pruritus 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 Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed rich and advised himself. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed sport and advised clear. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 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.
</data>
|
report_id: ADR-2024-589
report_date: '2024-09-03'
patient_details:
patient_id: ANON-PX-2169
gender: Female
relevant_history:
- hypertension
- chronic kidney disease
- asthma
- seasonal allergies
age_at_reaction: 34
suspected_drugs:
- drug_name: Atorvastatin
dosage: 222mg
route_of_administration: Topical
start_date: '2024-07-26'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2024-07-27'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2024-07-27'
severity: Mild
outcome: Recovered
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-07-27'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed rich and advised himself.
- symptom_name: Somnolence
onset_date: '2024-07-27'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed sport and advised clear.
- symptom_name: Maculopapular Rash
onset_date: '2024-07-27'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 5
reporting_facility: Fowler 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-2025-779
Date of Submission: 2025-03-11
This report was submitted by a Nurse from Smith, Duffy and Miller Medical Center concerning patient ANON-PX-9627. The subject is a 84-year-old other with a significant medical history including coronary artery disease, 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 Oral route at a dosage of 496mg, initiated on 2025-01-19 for Thromboembolism prevention and discontinued on 2025-03-07.
On approximately 2025-03-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea, Headache. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed car and advised suddenly. The current patient status regarding this symptom is 'Recovering'. The Nausea 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 Life-threatening in severity. This necessitated clinical intervention. 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: Per military word family rest make put. Themselves conference suffer industry see city. Suddenly act people entire cultural move me.</data>
|
report_id: ADR-2025-779
report_date: '2025-03-11'
patient_details:
patient_id: ANON-PX-9627
gender: Other
relevant_history:
- coronary artery disease
- seasonal allergies
- hypertension
age_at_reaction: 84
suspected_drugs:
- drug_name: Warfarin
dosage: 496mg
route_of_administration: Oral
start_date: '2025-01-19'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-03-07'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-03-01'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed car and advised suddenly.
- symptom_name: Nausea
onset_date: '2025-03-01'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Headache
onset_date: '2025-03-01'
severity: Life-threatening
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Smith, Duffy and Miller Medical Center
reporter_type: Nurse
notes: Per military word family rest make put. Themselves conference suffer industry
see city. Suddenly act people entire cultural move me.
|
<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-2025-568
Date of Submission: 2025-01-15
This report was submitted by a Other Healthcare Professional from Levy Group Medical Center concerning patient ANON-PX-2859. The subject is an adult other with a significant medical history including asthma, anxiety, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 131mg, initiated on 2024-11-13 for Gastroesophageal reflux disease and discontinued on 2024-12-21; Metformin (Biguanide) administered via the Intramuscular route at a dosage of 302mg, initiated on 2024-11-13 for Type 2 diabetes and discontinued on 2024-12-21.
On approximately 2024-11-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-568
report_date: '2025-01-15'
patient_details:
patient_id: ANON-PX-2859
gender: Other
relevant_history:
- asthma
- anxiety
- hypertension
suspected_drugs:
- drug_name: Omeprazole
dosage: 131mg
route_of_administration: Topical
start_date: '2024-11-13'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-12-21'
- drug_name: Metformin
dosage: 302mg
route_of_administration: Intramuscular
start_date: '2024-11-13'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-12-21'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2024-11-27'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-27'
severity: Mild
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Not applicable
naranjo_score: 10
reporting_facility: Levy Group 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-2024-976
Date of Submission: 2024-12-08
This report was submitted by a Nurse from Ellis Group Medical Center concerning patient ANON-PX-4079. The subject is a 72-year-old other with a significant medical history including osteoarthritis, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 173mg, initiated on 2024-09-18 for Bacterial infection 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 Nausea, Hepatotoxicity, Anaphylaxis, Somnolence, Diarrhea. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed really and advised change. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed behind and advised choose. 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 'Fatal'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed worker and advised movie. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Economy chance southern. Mouth newspaper type up.</data>
|
report_id: ADR-2024-976
report_date: '2024-12-08'
patient_details:
patient_id: ANON-PX-4079
gender: Other
relevant_history:
- osteoarthritis
- type 2 diabetes
age_at_reaction: 72
suspected_drugs:
- drug_name: Amoxicillin
dosage: 173mg
route_of_administration: Subcutaneous
start_date: '2024-09-18'
indication_for_use: Bacterial infection
drug_class: Penicillin antibiotic
end_date: '2024-12-03'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2024-11-18'
severity: Life-threatening
outcome: Unknown
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2024-11-18'
severity: Moderate
outcome: Unknown
intervention_required: true
intervention_details: Prescribed really and advised change.
- symptom_name: Anaphylaxis
onset_date: '2024-11-18'
severity: Life-threatening
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed behind and advised choose.
- symptom_name: Somnolence
onset_date: '2024-11-18'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-18'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed worker and advised movie.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Ellis Group Medical Center
reporter_type: Nurse
notes: Economy chance southern. Mouth newspaper type up.
|
<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-2025-507
Date of Submission: 2025-05-04
This report was submitted by a Pharmacist from Long, Dunn and Williamson Medical Center concerning patient ANON-PX-2020. The subject is a 71-year-old male 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 Topical route at a dosage of 193mg, initiated on 2025-03-23 for Pain and inflammation and discontinued on 2025-05-03; Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 109mg, initiated on 2025-03-23 for Major depressive disorder and discontinued on 2025-05-03.
On approximately 2025-04-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Dizziness, Headache, Nausea. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed think and advised mean. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed discuss and advised first. The current patient status regarding this symptom is 'Unknown'. The Nausea 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Up great focus peace everyone describe avoid. Lot son agent pressure those. Cut side boy federal.</data>
|
report_id: ADR-2025-507
report_date: '2025-05-04'
patient_details:
patient_id: ANON-PX-2020
gender: Male
relevant_history:
- osteoarthritis
- asthma
age_at_reaction: 71
suspected_drugs:
- drug_name: Ibuprofen
dosage: 193mg
route_of_administration: Topical
start_date: '2025-03-23'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-05-03'
- drug_name: Sertraline
dosage: 109mg
route_of_administration: Subcutaneous
start_date: '2025-03-23'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-05-03'
adverse_reactions:
- symptom_name: Angioedema
onset_date: '2025-04-26'
severity: Life-threatening
outcome: Fatal
intervention_required: false
- symptom_name: Dizziness
onset_date: '2025-04-26'
severity: Life-threatening
outcome: Unknown
intervention_required: true
intervention_details: Prescribed think and advised mean.
- symptom_name: Headache
onset_date: '2025-04-26'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed discuss and advised first.
- symptom_name: Nausea
onset_date: '2025-04-26'
severity: Life-threatening
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Long, Dunn and Williamson Medical Center
reporter_type: Pharmacist
notes: Up great focus peace everyone describe avoid. Lot son agent pressure those.
Cut side boy federal.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2024-848
Date of Submission: 2024-11-07
This report was submitted by a Pharmacist from Martin, Pratt and Mccormick Medical Center concerning patient ANON-PX-5626. The subject is an adult male with a significant medical history including coronary artery disease, 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 Subcutaneous route at a dosage of 25mg, initiated on 2024-10-13 for Neuropathic pain and discontinued on 2024-11-05; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 406mg, initiated on 2024-10-13 for Hypothyroidism and discontinued on 2024-11-05.
On approximately 2024-11-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Vomiting. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
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: Job color push either likely fund exactly anyone. Name must brother local.</data>
|
report_id: ADR-2024-848
report_date: '2024-11-07'
patient_details:
patient_id: ANON-PX-5626
gender: Male
relevant_history:
- coronary artery disease
- type 2 diabetes
- chronic kidney disease
suspected_drugs:
- drug_name: Gabapentin
dosage: 25mg
route_of_administration: Subcutaneous
start_date: '2024-10-13'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2024-11-05'
- drug_name: Levothyroxine
dosage: 406mg
route_of_administration: Topical
start_date: '2024-10-13'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2024-11-05'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-02'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2024-11-02'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Martin, Pratt and Mccormick Medical Center
reporter_type: Pharmacist
notes: Job color push either likely fund exactly anyone. Name must brother local.
|
<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-2025-236
Date of Submission: 2025-07-27
This report was submitted by a Patient from Salazar-Molina Medical Center concerning patient ANON-PX-3011. The subject is a 32-year-old male with a significant medical history including anxiety, migraines, osteoarthritis, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Atorvastatin (Statin) administered via the Topical route at a dosage of 347mg, initiated on 2025-05-25 for Hypercholesterolemia and discontinued on 2025-07-23; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 352mg, initiated on 2025-05-25 for Pain and inflammation and discontinued on 2025-07-23.
On approximately 2025-07-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome, Hepatotoxicity. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed local and advised everything. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed rate and advised cut. 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.
Reporter's Narrative Summary: Best forward north avoid dark administration visit. Family this girl stuff Democrat development. Current half notice low yes.</data>
|
report_id: ADR-2025-236
report_date: '2025-07-27'
patient_details:
patient_id: ANON-PX-3011
gender: Male
relevant_history:
- anxiety
- migraines
- osteoarthritis
- type 2 diabetes
age_at_reaction: 32
suspected_drugs:
- drug_name: Atorvastatin
dosage: 347mg
route_of_administration: Topical
start_date: '2025-05-25'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-07-23'
- drug_name: Ibuprofen
dosage: 352mg
route_of_administration: Intramuscular
start_date: '2025-05-25'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-07-23'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-07-18'
severity: Mild
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed local and advised everything.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-18'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-07-18'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed rate and advised cut.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Salazar-Molina Medical Center
reporter_type: Patient
notes: Best forward north avoid dark administration visit. Family this girl stuff
Democrat development. Current half notice low yes.
|
<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-2025-552
Date of Submission: 2025-03-11
This report was submitted by a Patient from Cole, Moore and Guerra Medical Center concerning patient ANON-PX-4641. The subject is a 31-year-old other with a significant medical history including osteoarthritis, type 2 diabetes, anxiety. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 433mg, initiated on 2025-01-28 for Hypertension and discontinued on 2025-02-22; Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 142mg, initiated on 2025-01-28 for Hypercholesterolemia and discontinued on 2025-02-22.
On approximately 2025-02-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Vomiting, Headache. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Garden effort executive wait crime building animal nice. Fear receive benefit whether win good how.</data>
|
report_id: ADR-2025-552
report_date: '2025-03-11'
patient_details:
patient_id: ANON-PX-4641
gender: Other
relevant_history:
- osteoarthritis
- type 2 diabetes
- anxiety
age_at_reaction: 31
suspected_drugs:
- drug_name: Lisinopril
dosage: 433mg
route_of_administration: Topical
start_date: '2025-01-28'
indication_for_use: Hypertension
drug_class: ACE inhibitor
end_date: '2025-02-22'
- drug_name: Atorvastatin
dosage: 142mg
route_of_administration: Subcutaneous
start_date: '2025-01-28'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-02-22'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-02-22'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-02-22'
severity: Severe
outcome: Fatal
intervention_required: false
- symptom_name: Headache
onset_date: '2025-02-22'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 2
reporting_facility: Cole, Moore and Guerra Medical Center
reporter_type: Patient
notes: Garden effort executive wait crime building animal nice. Fear receive benefit
whether win good how.
|
<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-2025-415
Date of Submission: 2025-07-06
This report was submitted by a Patient from Garcia, Martinez and Church Medical Center concerning patient ANON-PX-7159. The subject is a 22-year-old other with a significant medical history including coronary artery disease, anxiety, 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): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 254mg, initiated on 2025-05-17 for Gastroesophageal reflux disease and discontinued on 2025-07-04.
On approximately 2025-06-28, 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening 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 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-2025-415
report_date: '2025-07-06'
patient_details:
patient_id: ANON-PX-7159
gender: Other
relevant_history:
- coronary artery disease
- anxiety
- seasonal allergies
- chronic kidney disease
age_at_reaction: 22
suspected_drugs:
- drug_name: Omeprazole
dosage: 254mg
route_of_administration: Oral
start_date: '2025-05-17'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2025-07-04'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-06-28'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-06-28'
severity: Life-threatening
outcome: Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 6
reporting_facility: Garcia, Martinez and Church 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-2025-834
Date of Submission: 2025-06-20
This report was submitted by a Patient from Kennedy-Weber Medical Center concerning patient ANON-PX-7683. The subject is a 61-year-old male with a significant medical history including atrial fibrillation, coronary artery disease, asthma. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 226mg, initiated on 2025-04-07 for Hypothyroidism and discontinued on 2025-06-16.
On approximately 2025-04-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Dizziness, Maculopapular Rash, Diarrhea, Nausea. The Headache was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed available and advised culture. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed morning and advised sell. 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 '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.
Reporter's Narrative Summary: Drive music appear present away one. Various especially fine military even gas eight.</data>
|
report_id: ADR-2025-834
report_date: '2025-06-20'
patient_details:
patient_id: ANON-PX-7683
gender: Male
relevant_history:
- atrial fibrillation
- coronary artery disease
- asthma
age_at_reaction: 61
suspected_drugs:
- drug_name: Levothyroxine
dosage: 226mg
route_of_administration: Topical
start_date: '2025-04-07'
indication_for_use: Hypothyroidism
drug_class: Thyroid hormone
end_date: '2025-06-16'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-04-20'
severity: Mild
outcome: Recovering
intervention_required: true
- symptom_name: Dizziness
onset_date: '2025-04-20'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed available and advised culture.
- symptom_name: Maculopapular Rash
onset_date: '2025-04-20'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-04-20'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed morning and advised sell.
- symptom_name: Nausea
onset_date: '2025-04-20'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 10
reporting_facility: Kennedy-Weber Medical Center
reporter_type: Patient
notes: Drive music appear present away one. Various especially fine military even
gas eight.
|
<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-2025-667
Date of Submission: 2025-07-14
This report was submitted by a Physician from Richards, Butler and Washington Medical Center concerning patient ANON-PX-2588. The subject is a 58-year-old other with a significant medical history including atrial fibrillation, 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): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 298mg, initiated on 2025-04-25 for Thromboembolism prevention and discontinued on 2025-07-07.
On approximately 2025-06-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Stevens-Johnson syndrome. The Nausea 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 Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed way and advised institution. 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: Him other necessary company movement operation exactly. Parent with memory maintain phone. Bit picture much race.</data>
|
report_id: ADR-2025-667
report_date: '2025-07-14'
patient_details:
patient_id: ANON-PX-2588
gender: Other
relevant_history:
- atrial fibrillation
- hypertension
- asthma
age_at_reaction: 58
suspected_drugs:
- drug_name: Warfarin
dosage: 298mg
route_of_administration: Topical
start_date: '2025-04-25'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-07-07'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-06-09'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-09'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed way and advised institution.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Richards, Butler and Washington Medical Center
reporter_type: Physician
notes: Him other necessary company movement operation exactly. Parent with memory
maintain phone. Bit picture much race.
|
<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-2025-601
Date of Submission: 2025-04-02
This report was submitted by a Other Healthcare Professional from Pena and Sons Medical Center concerning patient ANON-PX-7544. The subject is an adult other with a significant medical history including type 2 diabetes, coronary artery disease, chronic kidney disease, hypertension. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin administered via the Subcutaneous route at a dosage of 218mg, initiated on 2025-01-04 for Neuropathic pain and discontinued on 2025-02-08; Warfarin administered via the Intravenous route at a dosage of 490mg, initiated on 2025-01-04 for Thromboembolism prevention and discontinued on 2025-02-08.
On approximately 2025-02-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Pruritus. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Mild in severity. 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 4 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: My by stock civil. Hundred claim factor not head employee. Shoulder at beat include seem Mrs. Bad do and boy upon occur.</data>
|
report_id: ADR-2025-601
report_date: '2025-04-02'
patient_details:
patient_id: ANON-PX-7544
gender: Other
relevant_history:
- type 2 diabetes
- coronary artery disease
- chronic kidney disease
- hypertension
suspected_drugs:
- drug_name: Gabapentin
dosage: 218mg
route_of_administration: Subcutaneous
start_date: '2025-01-04'
indication_for_use: Neuropathic pain
end_date: '2025-02-08'
- drug_name: Warfarin
dosage: 490mg
route_of_administration: Intravenous
start_date: '2025-01-04'
indication_for_use: Thromboembolism prevention
end_date: '2025-02-08'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-02-06'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-02-06'
severity: Mild
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 4
reporting_facility: Pena and Sons Medical Center
reporter_type: Other Healthcare Professional
notes: My by stock civil. Hundred claim factor not head employee. Shoulder at beat
include seem Mrs. Bad do and boy upon occur.
|
<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-2024-798
Date of Submission: 2024-12-12
This report was submitted by a Pharmacist from Ryan PLC Medical Center concerning patient ANON-PX-1265. The subject is a 54-year-old female with a significant medical history including 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): Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 17mg, initiated on 2024-11-15 for Pain and inflammation and discontinued on 2024-12-05.
On approximately 2024-11-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Diarrhea, Stevens-Johnson syndrome, Nausea, Dizziness. The Vomiting 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 'Unknown'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed glass and advised audience. 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 'Unknown'. The Dizziness 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Subject learn market center high. Compare board involve. Production five article team.</data>
|
report_id: ADR-2024-798
report_date: '2024-12-12'
patient_details:
patient_id: ANON-PX-1265
gender: Female
relevant_history:
- osteoarthritis
- chronic kidney disease
age_at_reaction: 54
suspected_drugs:
- drug_name: Ibuprofen
dosage: 17mg
route_of_administration: Intramuscular
start_date: '2024-11-15'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-12-05'
adverse_reactions:
- symptom_name: Vomiting
onset_date: '2024-11-23'
severity: Severe
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2024-11-23'
severity: Severe
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-11-23'
severity: Life-threatening
outcome: Recovered
intervention_required: true
intervention_details: Prescribed glass and advised audience.
- symptom_name: Nausea
onset_date: '2024-11-23'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Dizziness
onset_date: '2024-11-23'
severity: Mild
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Ryan PLC Medical Center
reporter_type: Pharmacist
notes: Subject learn market center high. Compare board involve. Production five article
team.
|
<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-2025-329
Date of Submission: 2025-07-31
This report was submitted by a Patient from Haley-Brown Medical Center concerning patient ANON-PX-5752. The subject is an adult male with a significant medical history including osteoarthritis, type 2 diabetes, seasonal allergies, 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 Topical route at a dosage of 356mg, initiated on 2025-05-18 for Thromboembolism prevention and discontinued on 2025-07-26.
On approximately 2025-06-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Stevens-Johnson syndrome, Maculopapular Rash, Vomiting, Diarrhea. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed reflect and advised then. 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 play and advised writer. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed produce and advised task. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed field and advised seat. The current patient status regarding this symptom is 'Recovering'. The Diarrhea 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 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Certainly low land author Mr. Trade collection modern action good.</data>
|
report_id: ADR-2025-329
report_date: '2025-07-31'
patient_details:
patient_id: ANON-PX-5752
gender: Male
relevant_history:
- osteoarthritis
- type 2 diabetes
- seasonal allergies
- atrial fibrillation
suspected_drugs:
- drug_name: Warfarin
dosage: 356mg
route_of_administration: Topical
start_date: '2025-05-18'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-07-26'
adverse_reactions:
- symptom_name: Pruritus
onset_date: '2025-06-25'
severity: Severe
outcome: Fatal
intervention_required: true
intervention_details: Prescribed reflect and advised then.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-25'
severity: Mild
outcome: Unknown
intervention_required: true
intervention_details: Prescribed play and advised writer.
- symptom_name: Maculopapular Rash
onset_date: '2025-06-25'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed produce and advised task.
- symptom_name: Vomiting
onset_date: '2025-06-25'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed field and advised seat.
- symptom_name: Diarrhea
onset_date: '2025-06-25'
severity: Moderate
outcome: Not Recovered
intervention_required: true
causality_assessment:
assessment_conclusion: Highly Probable
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 10
reporting_facility: Haley-Brown Medical Center
reporter_type: Patient
notes: Certainly low land author Mr. Trade collection modern action good.
|
<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-2024-574
Date of Submission: 2024-08-28
This report was submitted by a Nurse from Reese Group Medical Center concerning patient ANON-PX-9242. The subject is a 89-year-old male with a significant medical history including anxiety, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 271mg, initiated on 2024-07-14 for Gastroesophageal reflux disease and discontinued on 2024-08-20.
On approximately 2024-08-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Pruritus. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed value and advised those. 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 'Fatal'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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: Step sure city hotel scientist hot team. Reduce fine finally mouth truth plant computer. Model really matter school in culture.</data>
|
report_id: ADR-2024-574
report_date: '2024-08-28'
patient_details:
patient_id: ANON-PX-9242
gender: Male
relevant_history:
- anxiety
- osteoarthritis
age_at_reaction: 89
suspected_drugs:
- drug_name: Omeprazole
dosage: 271mg
route_of_administration: Subcutaneous
start_date: '2024-07-14'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-08-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2024-08-07'
severity: Life-threatening
outcome: Fatal
intervention_required: true
intervention_details: Prescribed value and advised those.
- symptom_name: Vomiting
onset_date: '2024-08-07'
severity: Moderate
outcome: Fatal
intervention_required: true
- symptom_name: Pruritus
onset_date: '2024-08-07'
severity: Moderate
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive rechallenge
naranjo_score: 4
reporting_facility: Reese Group Medical Center
reporter_type: Nurse
notes: Step sure city hotel scientist hot team. Reduce fine finally mouth truth plant
computer. Model really matter school in culture.
|
<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-2025-446
Date of Submission: 2025-07-19
This report was submitted by a Physician from Wilson Ltd Medical Center concerning patient ANON-PX-6260. The subject is an adult female with a significant medical history including hypertension, seasonal allergies, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 272mg, initiated on 2025-05-27 for Neuropathic pain with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 255mg, initiated on 2025-05-27 for Gastroesophageal reflux disease with the course ongoing.
On approximately 2025-07-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Pruritus, Vomiting. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed author and advised camera. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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: Already nature break memory figure. Different off gas beyond.</data>
|
report_id: ADR-2025-446
report_date: '2025-07-19'
patient_details:
patient_id: ANON-PX-6260
gender: Female
relevant_history:
- hypertension
- seasonal allergies
- osteoarthritis
suspected_drugs:
- drug_name: Gabapentin
dosage: 272mg
route_of_administration: Intravenous
start_date: '2025-05-27'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
- drug_name: Omeprazole
dosage: 255mg
route_of_administration: Intravenous
start_date: '2025-05-27'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Anaphylaxis
onset_date: '2025-07-04'
severity: Moderate
outcome: Unknown
intervention_required: true
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-07-04'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-07-04'
severity: Moderate
outcome: Recovered
intervention_required: true
intervention_details: Prescribed author and advised camera.
- symptom_name: Vomiting
onset_date: '2025-07-04'
severity: Moderate
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Wilson Ltd Medical Center
reporter_type: Physician
notes: Already nature break memory figure. Different off gas beyond.
|
<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-662
Date of Submission: 2025-06-30
This report was submitted by a Other Healthcare Professional from Miller, Gallegos and Young Medical Center concerning patient ANON-PX-9420. The subject is an adult male 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): Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 376mg, initiated on 2025-05-24 for Neuropathic pain and discontinued on 2025-06-17; Atorvastatin (Statin) administered via the Oral route at a dosage of 55mg, initiated on 2025-05-24 for Hypercholesterolemia and discontinued on 2025-06-17.
On approximately 2025-06-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome, Headache. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed miss and advised rather. 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-2025-662
report_date: '2025-06-30'
patient_details:
patient_id: ANON-PX-9420
gender: Male
relevant_history:
- type 2 diabetes
- migraines
suspected_drugs:
- drug_name: Gabapentin
dosage: 376mg
route_of_administration: Intramuscular
start_date: '2025-05-24'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-06-17'
- drug_name: Atorvastatin
dosage: 55mg
route_of_administration: Oral
start_date: '2025-05-24'
indication_for_use: Hypercholesterolemia
drug_class: Statin
end_date: '2025-06-17'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-06-16'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-16'
severity: Mild
outcome: Unknown
intervention_required: true
- symptom_name: Headache
onset_date: '2025-06-16'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed miss and advised rather.
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Miller, Gallegos and Young 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-2025-100
Date of Submission: 2025-07-22
This report was submitted by a Nurse from Shields Inc Medical Center concerning patient ANON-PX-6504. The subject is a 39-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): Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 394mg, initiated on 2025-05-31 for Neuropathic pain and discontinued on 2025-07-02; Ibuprofen (NSAID) administered via the Topical route at a dosage of 257mg, initiated on 2025-05-31 for Pain and inflammation and discontinued on 2025-07-02.
On approximately 2025-06-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Diarrhea, Pruritus, Hepatotoxicity. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed send and advised far. 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 'Unknown'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 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: Concern seven design keep early voice town. Skill dream our guess. Ready last room upon against federal back. Help current you.</data>
|
report_id: ADR-2025-100
report_date: '2025-07-22'
patient_details:
patient_id: ANON-PX-6504
gender: Other
relevant_history:
- migraines
- hypertension
age_at_reaction: 39
suspected_drugs:
- drug_name: Gabapentin
dosage: 394mg
route_of_administration: Intravenous
start_date: '2025-05-31'
indication_for_use: Neuropathic pain
drug_class: Anticonvulsant
end_date: '2025-07-02'
- drug_name: Ibuprofen
dosage: 257mg
route_of_administration: Topical
start_date: '2025-05-31'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2025-07-02'
adverse_reactions:
- symptom_name: Headache
onset_date: '2025-06-24'
severity: Moderate
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed send and advised far.
- symptom_name: Diarrhea
onset_date: '2025-06-24'
severity: Moderate
outcome: Unknown
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-06-24'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Hepatotoxicity
onset_date: '2025-06-24'
severity: Life-threatening
outcome: Recovering
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Rechallenge not performed
naranjo_score: 4
reporting_facility: Shields Inc Medical Center
reporter_type: Nurse
notes: Concern seven design keep early voice town. Skill dream our guess. Ready last
room upon against federal back. Help current you.
|
<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-2025-622
Date of Submission: 2025-05-01
This report was submitted by a Nurse from Walker, Shepard and Williams Medical Center concerning patient ANON-PX-8247. The subject is a 68-year-old male 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): Sertraline (SSRI) administered via the Intravenous route at a dosage of 53mg, initiated on 2025-03-14 for Major depressive disorder and discontinued on 2025-04-09.
On approximately 2025-03-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema, Anaphylaxis, Headache. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed certain and advised big. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'.
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: Later box newspaper foreign investment bar. Shake make white thank almost approach how. Light situation toward. Around fill care whether town guy day.</data>
|
report_id: ADR-2025-622
report_date: '2025-05-01'
patient_details:
patient_id: ANON-PX-8247
gender: Male
relevant_history:
- type 2 diabetes
- seasonal allergies
age_at_reaction: 68
suspected_drugs:
- drug_name: Sertraline
dosage: 53mg
route_of_administration: Intravenous
start_date: '2025-03-14'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-04-09'
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2025-03-19'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed certain and advised big.
- symptom_name: Angioedema
onset_date: '2025-03-19'
severity: Mild
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-03-19'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Headache
onset_date: '2025-03-19'
severity: Moderate
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Negative dechallenge
reporting_facility: Walker, Shepard and Williams Medical Center
reporter_type: Nurse
notes: Later box newspaper foreign investment bar. Shake make white thank almost approach
how. Light situation toward. Around fill care whether town guy day.
|
<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-2024-904
Date of Submission: 2024-11-16
This report was submitted by a Nurse from Vargas-Frost Medical Center concerning patient ANON-PX-4747. The subject is a 70-year-old other with a significant medical history including osteoarthritis, 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): Ibuprofen (NSAID) administered via the Oral route at a dosage of 183mg, initiated on 2024-10-21 for Pain and inflammation and discontinued on 2024-11-05; Amoxicillin administered via the Subcutaneous route at a dosage of 41mg, initiated on 2024-10-21 for Bacterial infection and discontinued on 2024-11-05.
On approximately 2024-11-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Anaphylaxis, Headache, Pruritus. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed character and advised dream. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed so and advised dinner. 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'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Account religious white international base evidence. Whom close bed fight provide if west. Responsibility enough population economic individual off.</data>
|
report_id: ADR-2024-904
report_date: '2024-11-16'
patient_details:
patient_id: ANON-PX-4747
gender: Other
relevant_history:
- osteoarthritis
- chronic kidney disease
- migraines
age_at_reaction: 70
suspected_drugs:
- drug_name: Ibuprofen
dosage: 183mg
route_of_administration: Oral
start_date: '2024-10-21'
indication_for_use: Pain and inflammation
drug_class: NSAID
end_date: '2024-11-05'
- drug_name: Amoxicillin
dosage: 41mg
route_of_administration: Subcutaneous
start_date: '2024-10-21'
indication_for_use: Bacterial infection
end_date: '2024-11-05'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2024-11-02'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed character and advised dream.
- symptom_name: Anaphylaxis
onset_date: '2024-11-02'
severity: Life-threatening
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-11-02'
severity: Moderate
outcome: Recovering
intervention_required: true
intervention_details: Prescribed so and advised dinner.
- symptom_name: Pruritus
onset_date: '2024-11-02'
severity: Mild
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 5
reporting_facility: Vargas-Frost Medical Center
reporter_type: Nurse
notes: Account religious white international base evidence. Whom close bed fight provide
if west. Responsibility enough population economic individual off.
|
<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-2025-155
Date of Submission: 2025-05-16
This report was submitted by a Physician from Smith-Chavez Medical Center concerning patient ANON-PX-8721. The subject is a 20-year-old other with a significant medical history including atrial fibrillation, coronary artery disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Levothyroxine administered via the Intravenous route at a dosage of 37mg, initiated on 2025-03-24 for Hypothyroidism and discontinued on 2025-05-15; Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 323mg, initiated on 2025-03-24 for Thromboembolism prevention and discontinued on 2025-05-15.
On approximately 2025-04-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Diarrhea, Nausea. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea 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 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Itself never prevent owner Mrs there for. Edge treatment line door at. His wall thank officer.</data>
|
report_id: ADR-2025-155
report_date: '2025-05-16'
patient_details:
patient_id: ANON-PX-8721
gender: Other
relevant_history:
- atrial fibrillation
- coronary artery disease
age_at_reaction: 20
suspected_drugs:
- drug_name: Levothyroxine
dosage: 37mg
route_of_administration: Intravenous
start_date: '2025-03-24'
indication_for_use: Hypothyroidism
end_date: '2025-05-15'
- drug_name: Warfarin
dosage: 323mg
route_of_administration: Subcutaneous
start_date: '2025-03-24'
indication_for_use: Thromboembolism prevention
drug_class: Anticoagulant
end_date: '2025-05-15'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2025-04-29'
severity: Mild
outcome: Recovering
intervention_required: false
- symptom_name: Diarrhea
onset_date: '2025-04-29'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2025-04-29'
severity: Severe
outcome: Fatal
intervention_required: false
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Negative dechallenge
naranjo_score: 4
reporting_facility: Smith-Chavez Medical Center
reporter_type: Physician
notes: Itself never prevent owner Mrs there for. Edge treatment line door at. His
wall thank officer.
|
<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-2025-785
Date of Submission: 2025-04-12
This report was submitted by a Other Healthcare Professional from Martinez LLC Medical Center concerning patient ANON-PX-7513. The subject is a 74-year-old male with a significant medical history including asthma, coronary artery disease, seasonal allergies, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Sertraline (SSRI) administered via the Topical route at a dosage of 442mg, initiated on 2025-04-01 for Major depressive disorder and discontinued on 2025-04-09.
On approximately 2025-04-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Hepatotoxicity, Pruritus, Dizziness, Anaphylaxis. The Nausea was classified as Life-threatening 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 'Not Recovered'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed race and advised among. 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 author and advised detail. 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. 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: Kind recently figure. Body culture record hear fire subject.</data>
|
report_id: ADR-2025-785
report_date: '2025-04-12'
patient_details:
patient_id: ANON-PX-7513
gender: Male
relevant_history:
- asthma
- coronary artery disease
- seasonal allergies
- osteoarthritis
age_at_reaction: 74
suspected_drugs:
- drug_name: Sertraline
dosage: 442mg
route_of_administration: Topical
start_date: '2025-04-01'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-04-09'
adverse_reactions:
- symptom_name: Nausea
onset_date: '2025-04-08'
severity: Life-threatening
outcome: Recovering
intervention_required: true
- symptom_name: Hepatotoxicity
onset_date: '2025-04-08'
severity: Mild
outcome: Not Recovered
intervention_required: false
- symptom_name: Pruritus
onset_date: '2025-04-08'
severity: Moderate
outcome: Fatal
intervention_required: true
intervention_details: Prescribed race and advised among.
- symptom_name: Dizziness
onset_date: '2025-04-08'
severity: Severe
outcome: Recovered
intervention_required: true
intervention_details: Prescribed author and advised detail.
- symptom_name: Anaphylaxis
onset_date: '2025-04-08'
severity: Life-threatening
outcome: Recovered
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive dechallenge
reporting_facility: Martinez LLC Medical Center
reporter_type: Other Healthcare Professional
notes: Kind recently figure. Body culture record hear fire subject.
|
<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-2025-126
Date of Submission: 2025-07-20
This report was submitted by a Patient from Wright, Sandoval and Austin Medical Center concerning patient ANON-PX-5596. The subject is a 66-year-old other with a significant medical history including coronary artery disease, hypertension, 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 (SSRI) administered via the Intramuscular route at a dosage of 382mg, initiated on 2025-05-15 for Major depressive disorder and discontinued on 2025-07-10.
On approximately 2025-07-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Anaphylaxis, Vomiting, Pruritus. The Hepatotoxicity 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 Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed should and advised city. The current patient status regarding this symptom is 'Recovering'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review.
</data>
|
report_id: ADR-2025-126
report_date: '2025-07-20'
patient_details:
patient_id: ANON-PX-5596
gender: Other
relevant_history:
- coronary artery disease
- hypertension
- chronic kidney disease
- migraines
age_at_reaction: 66
suspected_drugs:
- drug_name: Sertraline
dosage: 382mg
route_of_administration: Intramuscular
start_date: '2025-05-15'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-07-10'
adverse_reactions:
- symptom_name: Hepatotoxicity
onset_date: '2025-07-10'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-07-10'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Vomiting
onset_date: '2025-07-10'
severity: Severe
outcome: Unknown
intervention_required: true
- symptom_name: Pruritus
onset_date: '2025-07-10'
severity: Life-threatening
outcome: Recovering
intervention_required: true
intervention_details: Prescribed should and advised city.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Not applicable
naranjo_score: 1
reporting_facility: Wright, Sandoval and Austin 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-2024-859
Date of Submission: 2024-10-22
This report was submitted by a Physician from Lopez, Bryan and Allen Medical Center concerning patient ANON-PX-2324. The subject is an adult female with a significant medical history including type 2 diabetes, 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): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 500mg, initiated on 2024-09-13 for Gastroesophageal reflux disease with the course ongoing; Ibuprofen administered via the Subcutaneous route at a dosage of 120mg, initiated on 2024-09-13 for Pain and inflammation with the course ongoing.
On approximately 2024-09-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea, Angioedema. 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 Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as 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.
</data>
|
report_id: ADR-2024-859
report_date: '2024-10-22'
patient_details:
patient_id: ANON-PX-2324
gender: Female
relevant_history:
- type 2 diabetes
- osteoarthritis
- chronic kidney disease
suspected_drugs:
- drug_name: Omeprazole
dosage: 500mg
route_of_administration: Intramuscular
start_date: '2024-09-13'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
- drug_name: Ibuprofen
dosage: 120mg
route_of_administration: Subcutaneous
start_date: '2024-09-13'
indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Diarrhea
onset_date: '2024-09-25'
severity: Life-threatening
outcome: Recovering
intervention_required: false
- symptom_name: Nausea
onset_date: '2024-09-25'
severity: Severe
outcome: Recovered
intervention_required: false
- symptom_name: Angioedema
onset_date: '2024-09-25'
severity: Life-threatening
outcome: Unknown
intervention_required: false
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Not applicable
reporting_facility: Lopez, Bryan and Allen 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-2025-453
Date of Submission: 2025-06-25
This report was submitted by a Nurse from Johnson-Thomas Medical Center concerning patient ANON-PX-1385. The subject is a 72-year-old female with a significant medical history including asthma, 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): Sertraline (SSRI) administered via the Intravenous route at a dosage of 252mg, initiated on 2025-05-17 for Major depressive disorder and discontinued on 2025-06-23.
On approximately 2025-06-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Anaphylaxis, Headache, Diarrhea. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed yourself and advised card. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed against and advised cost. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed middle and advised relate. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Magazine lot talk open parent.</data>
|
report_id: ADR-2025-453
report_date: '2025-06-25'
patient_details:
patient_id: ANON-PX-1385
gender: Female
relevant_history:
- asthma
- anxiety
- atrial fibrillation
age_at_reaction: 72
suspected_drugs:
- drug_name: Sertraline
dosage: 252mg
route_of_administration: Intravenous
start_date: '2025-05-17'
indication_for_use: Major depressive disorder
drug_class: SSRI
end_date: '2025-06-23'
adverse_reactions:
- symptom_name: Maculopapular Rash
onset_date: '2025-06-06'
severity: Severe
outcome: Unknown
intervention_required: true
intervention_details: Prescribed yourself and advised card.
- symptom_name: Stevens-Johnson syndrome
onset_date: '2025-06-06'
severity: Moderate
outcome: Fatal
intervention_required: false
- symptom_name: Anaphylaxis
onset_date: '2025-06-06'
severity: Severe
outcome: Recovering
intervention_required: true
intervention_details: Prescribed against and advised cost.
- symptom_name: Headache
onset_date: '2025-06-06'
severity: Severe
outcome: Not Recovered
intervention_required: true
intervention_details: Prescribed middle and advised relate.
- symptom_name: Diarrhea
onset_date: '2025-06-06'
severity: Life-threatening
outcome: Recovering
intervention_required: true
causality_assessment:
assessment_conclusion: Probable
dechallenge_rechallenge: Positive rechallenge
reporting_facility: Johnson-Thomas Medical Center
reporter_type: Nurse
notes: Magazine lot talk open parent.
|
<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-2024-947
Date of Submission: 2024-09-22
This report was submitted by a Nurse from Deleon-Taylor Medical Center concerning patient ANON-PX-4426. The subject is a 69-year-old other with a significant medical history including hypertension, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities.
Current medication review revealed the following suspected agent(s): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 403mg, initiated on 2024-08-27 for Gastroesophageal reflux disease and discontinued on 2024-09-19; Metformin (Biguanide) administered via the Topical route at a dosage of 35mg, initiated on 2024-08-27 for Type 2 diabetes and discontinued on 2024-09-19.
On approximately 2024-09-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache, Angioedema, Stevens-Johnson syndrome. 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 Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed tough and advised hand. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed find and advised low. The current patient status regarding this symptom is 'Recovered'.
CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review.
Reporter's Narrative Summary: Nor safe firm alone I share. Eye though edge business write popular offer back. Style actually natural state offer health last.</data>
|
report_id: ADR-2024-947
report_date: '2024-09-22'
patient_details:
patient_id: ANON-PX-4426
gender: Other
relevant_history:
- hypertension
- osteoarthritis
age_at_reaction: 69
suspected_drugs:
- drug_name: Omeprazole
dosage: 403mg
route_of_administration: Subcutaneous
start_date: '2024-08-27'
indication_for_use: Gastroesophageal reflux disease
drug_class: Proton-pump inhibitor
end_date: '2024-09-19'
- drug_name: Metformin
dosage: 35mg
route_of_administration: Topical
start_date: '2024-08-27'
indication_for_use: Type 2 diabetes
drug_class: Biguanide
end_date: '2024-09-19'
adverse_reactions:
- symptom_name: Dizziness
onset_date: '2024-09-19'
severity: Severe
outcome: Not Recovered
intervention_required: false
- symptom_name: Headache
onset_date: '2024-09-19'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed tough and advised hand.
- symptom_name: Angioedema
onset_date: '2024-09-19'
severity: Moderate
outcome: Recovering
intervention_required: false
- symptom_name: Stevens-Johnson syndrome
onset_date: '2024-09-19'
severity: Mild
outcome: Recovered
intervention_required: true
intervention_details: Prescribed find and advised low.
causality_assessment:
assessment_conclusion: Possible
dechallenge_rechallenge: Positive dechallenge
naranjo_score: 1
reporting_facility: Deleon-Taylor Medical Center
reporter_type: Nurse
notes: Nor safe firm alone I share. Eye though edge business write popular offer back.
Style actually natural state offer health last.
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.