<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-2025-777
Date of Submission: 2025-06-13

This report was submitted by a Patient from Massey LLC Medical Center concerning patient ANON-PX-3759. The subject is a 67-year-old female with a significant medical history including type 2 diabetes, osteoarthritis. 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 153mg, initiated on 2025-05-24 for Thromboembolism prevention and discontinued on 2025-06-10.

On approximately 2025-05-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Pruritus, Diarrhea, Maculopapular Rash, Headache. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Year window last idea door use own. Western local result quickly sense red. Exactly find break language.</data>
report_id: ADR-2025-777
report_date: '2025-06-13'
patient_details:
  patient_id: ANON-PX-3759
  gender: Female
  relevant_history:
  - type 2 diabetes
  - osteoarthritis
  age_at_reaction: 67
suspected_drugs:
- drug_name: Warfarin
  dosage: 153mg
  route_of_administration: Topical
  start_date: '2025-05-24'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-06-10'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-05-25'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-05-25'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-05-25'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-05-25'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-05-25'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 6
reporting_facility: Massey LLC Medical Center
reporter_type: Patient
notes: Year window last idea door use own. Western local result quickly sense red.
  Exactly find break language.
