<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-2025-669
Date of Submission: 2025-08-03

This report was submitted by a Physician from Mcmillan-Becker Medical Center concerning patient ANON-PX-3458. The subject is a 90-year-old male with a significant medical history including coronary artery disease, hypertension, 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): Warfarin (Anticoagulant) administered via the Topical route at a dosage of 288mg, initiated on 2025-06-02 for Thromboembolism prevention and discontinued on 2025-08-01.

On approximately 2025-06-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Hepatotoxicity, Angioedema. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed local and advised development. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed stage and advised investment. The current patient status regarding this symptom is 'Recovering'. 

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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-669
report_date: '2025-08-03'
patient_details:
  patient_id: ANON-PX-3458
  gender: Male
  relevant_history:
  - coronary artery disease
  - hypertension
  - asthma
  age_at_reaction: 90
suspected_drugs:
- drug_name: Warfarin
  dosage: 288mg
  route_of_administration: Topical
  start_date: '2025-06-02'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-08-01'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-06-25'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-25'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed local and advised development.
- symptom_name: Angioedema
  onset_date: '2025-06-25'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed stage and advised investment.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 9
reporting_facility: Mcmillan-Becker Medical Center
reporter_type: Physician
