<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-2025-898
Date of Submission: 2025-05-21

This report was submitted by a Nurse from Arellano-Harrison Medical Center concerning patient ANON-PX-3918. The subject is a 24-year-old male with a significant medical history including atrial fibrillation, type 2 diabetes. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities. 

Current medication review revealed the following suspected agent(s): Metformin administered via the Oral route at a dosage of 175mg, initiated on 2025-04-21 for Type 2 diabetes and discontinued on 2025-05-14.

On approximately 2025-05-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Angioedema. The Hepatotoxicity was classified as Severe 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 documented action was: Prescribed peace and advised under. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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: Situation side mouth. Peace subject analysis somebody apply moment interview. Note project animal live citizen which science. Never fast somebody realize bit radio gas identify.</data>
report_id: ADR-2025-898
report_date: '2025-05-21'
patient_details:
  patient_id: ANON-PX-3918
  gender: Male
  relevant_history:
  - atrial fibrillation
  - type 2 diabetes
  age_at_reaction: 24
suspected_drugs:
- drug_name: Metformin
  dosage: 175mg
  route_of_administration: Oral
  start_date: '2025-04-21'
  indication_for_use: Type 2 diabetes
  end_date: '2025-05-14'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-05-05'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-05-05'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed peace and advised under.
- symptom_name: Angioedema
  onset_date: '2025-05-05'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Arellano-Harrison Medical Center
reporter_type: Nurse
notes: Situation side mouth. Peace subject analysis somebody apply moment interview.
  Note project animal live citizen which science. Never fast somebody realize bit
  radio gas identify.
