<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-2025-336
Date of Submission: 2025-06-13

This report was submitted by a Physician from Smith PLC Medical Center concerning patient ANON-PX-8919. The subject is a 84-year-old other with a significant medical history including asthma, type 2 diabetes. 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 Oral route at a dosage of 219mg, initiated on 2025-05-20 for Thromboembolism prevention with the course ongoing.

On approximately 2025-05-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Diarrhea, Somnolence. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed traditional and advised against. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Somnolence 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. 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. 

</data>
report_id: ADR-2025-336
report_date: '2025-06-13'
patient_details:
  patient_id: ANON-PX-8919
  gender: Other
  relevant_history:
  - asthma
  - type 2 diabetes
  age_at_reaction: 84
suspected_drugs:
- drug_name: Warfarin
  dosage: 219mg
  route_of_administration: Oral
  start_date: '2025-05-20'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-05-23'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed traditional and advised against.
- symptom_name: Diarrhea
  onset_date: '2025-05-23'
  severity: Severe
  outcome: Recovered
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2025-05-23'
  severity: Severe
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Smith PLC Medical Center
reporter_type: Physician
