<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-2025-416
Date of Submission: 2025-07-19

This report was submitted by a Pharmacist from Patel, Rose and Hall Medical Center concerning patient ANON-PX-4993. The subject is a 88-year-old male with a significant medical history including hypertension, atrial fibrillation, chronic kidney disease, seasonal allergies. 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 administered via the Topical route at a dosage of 457mg, initiated on 2025-06-16 for Thromboembolism prevention with the course ongoing.

On approximately 2025-06-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Dizziness, Diarrhea, Hepatotoxicity, Stevens-Johnson syndrome. The Nausea was classified as Severe 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. This necessitated clinical intervention. The documented action was: Prescribed significant and advised set. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed where and advised concern. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed money and advised list. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Severe 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Thing song big high. Resource democratic happy prove. Success matter draw might.</data>
report_id: ADR-2025-416
report_date: '2025-07-19'
patient_details:
  patient_id: ANON-PX-4993
  gender: Male
  relevant_history:
  - hypertension
  - atrial fibrillation
  - chronic kidney disease
  - seasonal allergies
  age_at_reaction: 88
suspected_drugs:
- drug_name: Warfarin
  dosage: 457mg
  route_of_administration: Topical
  start_date: '2025-06-16'
  indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-06-29'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-06-29'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed significant and advised set.
- symptom_name: Diarrhea
  onset_date: '2025-06-29'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed where and advised concern.
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-29'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed money and advised list.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-29'
  severity: Severe
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Patel, Rose and Hall Medical Center
reporter_type: Pharmacist
notes: Thing song big high. Resource democratic happy prove. Success matter draw might.
