<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-2025-979
Date of Submission: 2025-07-26

This report was submitted by a Pharmacist from Beck-Thomas Medical Center concerning patient ANON-PX-1548. The subject is a 79-year-old male with a significant medical history including seasonal allergies, anxiety. 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 Subcutaneous route at a dosage of 477mg, initiated on 2025-06-04 for Type 2 diabetes with the course ongoing.

On approximately 2025-07-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Somnolence, Dizziness. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness 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. A Naranjo score of 6 was calculated, 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: Lose voice southern more near ok tax. Smile side benefit radio write. Recognize pull stock last above free.</data>
report_id: ADR-2025-979
report_date: '2025-07-26'
patient_details:
  patient_id: ANON-PX-1548
  gender: Male
  relevant_history:
  - seasonal allergies
  - anxiety
  age_at_reaction: 79
suspected_drugs:
- drug_name: Metformin
  dosage: 477mg
  route_of_administration: Subcutaneous
  start_date: '2025-06-04'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-07-14'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-07-14'
  severity: Mild
  outcome: Recovered
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2025-07-14'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2025-07-14'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 6
reporting_facility: Beck-Thomas Medical Center
reporter_type: Pharmacist
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