<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-591
Date of Submission: 2025-04-13

This report was submitted by a Patient from Smith Ltd Medical Center concerning patient ANON-PX-4945. The subject is a 38-year-old other with a significant medical history including osteoarthritis, anxiety, 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): Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 256mg, initiated on 2025-04-04 for Type 2 diabetes with the course ongoing.

On approximately 2025-04-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Nausea, Hepatotoxicity. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed nearly and advised quite. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed drive and advised book. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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: Where like few natural property. Too capital audience rather. Civil citizen same idea four if.</data>
report_id: ADR-2025-591
report_date: '2025-04-13'
patient_details:
  patient_id: ANON-PX-4945
  gender: Other
  relevant_history:
  - osteoarthritis
  - anxiety
  - hypertension
  - migraines
  age_at_reaction: 38
suspected_drugs:
- drug_name: Metformin
  dosage: 256mg
  route_of_administration: Subcutaneous
  start_date: '2025-04-04'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-04-09'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed nearly and advised quite.
- symptom_name: Nausea
  onset_date: '2025-04-09'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed drive and advised book.
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-09'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Smith Ltd Medical Center
reporter_type: Patient
notes: Where like few natural property. Too capital audience rather. Civil citizen
  same idea four if.
