<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-2024-647
Date of Submission: 2024-12-04

This report was submitted by a Physician from Larson-Jackson Medical Center concerning patient ANON-PX-5532. The subject is a 65-year-old male with a significant medical history including asthma, atrial fibrillation, hypertension, chronic kidney 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 Subcutaneous route at a dosage of 402mg, initiated on 2024-09-19 for Thromboembolism prevention and discontinued on 2024-11-24; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 405mg, initiated on 2024-09-19 for Gastroesophageal reflux disease and discontinued on 2024-11-24.

On approximately 2024-10-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Pruritus. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed growth and advised argue. The current patient status regarding this symptom is 'Unknown'. 

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-2024-647
report_date: '2024-12-04'
patient_details:
  patient_id: ANON-PX-5532
  gender: Male
  relevant_history:
  - asthma
  - atrial fibrillation
  - hypertension
  - chronic kidney disease
  age_at_reaction: 65
suspected_drugs:
- drug_name: Warfarin
  dosage: 402mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-19'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2024-11-24'
- drug_name: Omeprazole
  dosage: 405mg
  route_of_administration: Oral
  start_date: '2024-09-19'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-11-24'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-18'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-10-18'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed growth and advised argue.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Larson-Jackson Medical Center
reporter_type: Physician
