<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-2025-571
Date of Submission: 2025-04-09

This report was submitted by a Physician from Massey Group Medical Center concerning patient ANON-PX-3747. The subject is a 88-year-old other with a significant medical history including seasonal allergies, 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 Topical route at a dosage of 42mg, initiated on 2025-02-24 for Type 2 diabetes with the course ongoing.

On approximately 2025-03-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Stevens-Johnson syndrome. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed population and advised become. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed thing and advised mother. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-571
report_date: '2025-04-09'
patient_details:
  patient_id: ANON-PX-3747
  gender: Other
  relevant_history:
  - seasonal allergies
  - type 2 diabetes
  age_at_reaction: 88
suspected_drugs:
- drug_name: Metformin
  dosage: 42mg
  route_of_administration: Topical
  start_date: '2025-02-24'
  indication_for_use: Type 2 diabetes
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-03-31'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed population and advised become.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-31'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed thing and advised mother.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 5
reporting_facility: Massey Group Medical Center
reporter_type: Physician
