<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-2025-360
Date of Submission: 2025-03-30

This report was submitted by a Physician from Robertson Inc Medical Center concerning patient ANON-PX-3911. The subject is a 56-year-old male with a significant medical history including anxiety, migraines, asthma. 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 127mg, initiated on 2025-01-23 for Type 2 diabetes and discontinued on 2025-02-27.

On approximately 2025-02-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Angioedema. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed local and advised here. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: New strategy his month girl think. Effect step institution drop woman night relate participant. Race level site cause.</data>
report_id: ADR-2025-360
report_date: '2025-03-30'
patient_details:
  patient_id: ANON-PX-3911
  gender: Male
  relevant_history:
  - anxiety
  - migraines
  - asthma
  age_at_reaction: 56
suspected_drugs:
- drug_name: Metformin
  dosage: 127mg
  route_of_administration: Topical
  start_date: '2025-01-23'
  indication_for_use: Type 2 diabetes
  end_date: '2025-02-27'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-02-23'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-02-23'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-02-23'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed local and advised here.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Robertson Inc Medical Center
reporter_type: Physician
notes: New strategy his month girl think. Effect step institution drop woman night
  relate participant. Race level site cause.
