<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-868
Date of Submission: 2025-01-19

This report was submitted by a Patient from Smith, Hill and Todd Medical Center concerning patient ANON-PX-4488. The subject is an adult other with a significant medical history including atrial fibrillation, migraines. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities. 

Current medication review revealed the following suspected agent(s): Metformin (Biguanide) administered via the Oral route at a dosage of 190mg, initiated on 2024-12-20 for Type 2 diabetes and discontinued on 2025-01-05; Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 272mg, initiated on 2024-12-20 for Gastroesophageal reflux disease and discontinued on 2025-01-05.

On approximately 2024-12-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed environment and advised get. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Company new thus religious. Boy management example seek purpose civil.</data>
report_id: ADR-2025-868
report_date: '2025-01-19'
patient_details:
  patient_id: ANON-PX-4488
  gender: Other
  relevant_history:
  - atrial fibrillation
  - migraines
suspected_drugs:
- drug_name: Metformin
  dosage: 190mg
  route_of_administration: Oral
  start_date: '2024-12-20'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-01-05'
- drug_name: Omeprazole
  dosage: 272mg
  route_of_administration: Intramuscular
  start_date: '2024-12-20'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-01-05'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-30'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-12-30'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed environment and advised get.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Smith, Hill and Todd Medical Center
reporter_type: Patient
notes: Company new thus religious. Boy management example seek purpose civil.
