<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-2024-950
Date of Submission: 2024-11-24

This report was submitted by a Pharmacist from Mcclure and Sons Medical Center concerning patient ANON-PX-6659. The subject is an adult male with a significant medical history including atrial fibrillation, chronic kidney disease, 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 97mg, initiated on 2024-11-09 for Thromboembolism prevention and discontinued on 2024-11-16.

On approximately 2024-11-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache, Diarrhea. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

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. 

</data>
report_id: ADR-2024-950
report_date: '2024-11-24'
patient_details:
  patient_id: ANON-PX-6659
  gender: Male
  relevant_history:
  - atrial fibrillation
  - chronic kidney disease
  - asthma
suspected_drugs:
- drug_name: Warfarin
  dosage: 97mg
  route_of_administration: Topical
  start_date: '2024-11-09'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2024-11-16'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-15'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
- symptom_name: Headache
  onset_date: '2024-11-15'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-11-15'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Mcclure and Sons Medical Center
reporter_type: Pharmacist
