<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-2025-735
Date of Submission: 2025-04-30

This report was submitted by a Other Healthcare Professional from Mcmahon Group Medical Center concerning patient ANON-PX-1644. The subject is a 71-year-old female with a significant medical history including type 2 diabetes, atrial fibrillation. 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 319mg, initiated on 2025-03-13 for Type 2 diabetes with the course ongoing.

On approximately 2025-04-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Somnolence, Stevens-Johnson syndrome, Dizziness, Pruritus. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed remember and advised left. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

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

Reporter's Narrative Summary: Leg consider imagine type. Race nation meet its. Nice line down where grow.</data>
report_id: ADR-2025-735
report_date: '2025-04-30'
patient_details:
  patient_id: ANON-PX-1644
  gender: Female
  relevant_history:
  - type 2 diabetes
  - atrial fibrillation
  age_at_reaction: 71
suspected_drugs:
- drug_name: Metformin
  dosage: 319mg
  route_of_administration: Intramuscular
  start_date: '2025-03-13'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-04-16'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed remember and advised left.
- symptom_name: Somnolence
  onset_date: '2025-04-16'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-16'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-04-16'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-04-16'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Mcmahon Group Medical Center
reporter_type: Other Healthcare Professional
notes: Leg consider imagine type. Race nation meet its. Nice line down where grow.
