<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-2025-739
Date of Submission: 2025-06-01

This report was submitted by a Nurse from Williams, Davis and Hansen Medical Center concerning patient ANON-PX-7756. The subject is a 44-year-old male with a significant medical history including asthma, type 2 diabetes, hypertension, coronary artery disease. 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 407mg, initiated on 2025-04-14 for Thromboembolism prevention and discontinued on 2025-05-11.

On approximately 2025-04-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Somnolence. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed money and advised follow. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-739
report_date: '2025-06-01'
patient_details:
  patient_id: ANON-PX-7756
  gender: Male
  relevant_history:
  - asthma
  - type 2 diabetes
  - hypertension
  - coronary artery disease
  age_at_reaction: 44
suspected_drugs:
- drug_name: Warfarin
  dosage: 407mg
  route_of_administration: Topical
  start_date: '2025-04-14'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-05-11'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-25'
  severity: Mild
  outcome: Fatal
  intervention_required: true
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-25'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-04-25'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed money and advised follow.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 1
reporting_facility: Williams, Davis and Hansen Medical Center
reporter_type: Nurse
