<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-2025-258
Date of Submission: 2025-04-24

This report was submitted by a Nurse from Mason and Sons Medical Center concerning patient ANON-PX-7323. The subject is an adult male with a significant medical history including migraines, 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): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 386mg, initiated on 2025-03-05 for Type 2 diabetes and discontinued on 2025-03-19.

On approximately 2025-03-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Maculopapular Rash. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash 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. 

Reporter's Narrative Summary: Born analysis they recent.</data>
report_id: ADR-2025-258
report_date: '2025-04-24'
patient_details:
  patient_id: ANON-PX-7323
  gender: Male
  relevant_history:
  - migraines
  - asthma
  - seasonal allergies
suspected_drugs:
- drug_name: Metformin
  dosage: 386mg
  route_of_administration: Intramuscular
  start_date: '2025-03-05'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-03-19'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-03-11'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-11'
  severity: Severe
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 9
reporting_facility: Mason and Sons Medical Center
reporter_type: Nurse
notes: Born analysis they recent.
