<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-2025-799
Date of Submission: 2025-08-05

This report was submitted by a Physician from Compton-Johnson Medical Center concerning patient ANON-PX-9854. The subject is an adult male 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 administered via the Intravenous route at a dosage of 446mg, initiated on 2025-06-20 for Thromboembolism prevention and discontinued on 2025-07-29; Omeprazole administered via the Subcutaneous route at a dosage of 380mg, initiated on 2025-06-20 for Gastroesophageal reflux disease and discontinued on 2025-07-29.

On approximately 2025-07-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Nausea. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 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-2025-799
report_date: '2025-08-05'
patient_details:
  patient_id: ANON-PX-9854
  gender: Male
  relevant_history:
  - type 2 diabetes
  - osteoarthritis
suspected_drugs:
- drug_name: Warfarin
  dosage: 446mg
  route_of_administration: Intravenous
  start_date: '2025-06-20'
  indication_for_use: Thromboembolism prevention
  end_date: '2025-07-29'
- drug_name: Omeprazole
  dosage: 380mg
  route_of_administration: Subcutaneous
  start_date: '2025-06-20'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-07-29'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-07-06'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-07-06'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-07-06'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 7
reporting_facility: Compton-Johnson Medical Center
reporter_type: Physician
