<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-536
Date of Submission: 2025-04-09

This report was submitted by a Pharmacist from Brown, Dunlap and Huber Medical Center concerning patient ANON-PX-8338. The subject is a 81-year-old male with a significant medical history including type 2 diabetes, seasonal allergies, 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): Ibuprofen administered via the Topical route at a dosage of 327mg, initiated on 2025-02-28 for Pain and inflammation and discontinued on 2025-03-20; Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 404mg, initiated on 2025-02-28 for Gastroesophageal reflux disease and discontinued on 2025-03-20.

On approximately 2025-03-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed him and advised drug. 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 east and advised money. 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: Either now picture drop big end. Seat chance finally help drive fall. National air job know perhaps situation mission.</data>
report_id: ADR-2025-536
report_date: '2025-04-09'
patient_details:
  patient_id: ANON-PX-8338
  gender: Male
  relevant_history:
  - type 2 diabetes
  - seasonal allergies
  - hypertension
  - anxiety
  age_at_reaction: 81
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 327mg
  route_of_administration: Topical
  start_date: '2025-02-28'
  indication_for_use: Pain and inflammation
  end_date: '2025-03-20'
- drug_name: Omeprazole
  dosage: 404mg
  route_of_administration: Topical
  start_date: '2025-02-28'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-03-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-03-15'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed him and advised drug.
- symptom_name: Headache
  onset_date: '2025-03-15'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed east and advised money.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Brown, Dunlap and Huber Medical Center
reporter_type: Pharmacist
notes: Either now picture drop big end. Seat chance finally help drive fall. National
  air job know perhaps situation mission.
