<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-2025-473
Date of Submission: 2025-01-22

This report was submitted by a Patient from Baker, Morris and Dodson Medical Center concerning patient ANON-PX-6879. The subject is a 77-year-old female with a significant medical history including migraines, coronary artery 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 administered via the Subcutaneous route at a dosage of 55mg, initiated on 2024-11-18 for Thromboembolism prevention and discontinued on 2024-12-25; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 58mg, initiated on 2024-11-18 for Gastroesophageal reflux disease and discontinued on 2024-12-25.

On approximately 2024-11-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea, Pruritus, Angioedema, Nausea. 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 Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed month and advised husband. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed those and advised level. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. 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-2025-473
report_date: '2025-01-22'
patient_details:
  patient_id: ANON-PX-6879
  gender: Female
  relevant_history:
  - migraines
  - coronary artery disease
  age_at_reaction: 77
suspected_drugs:
- drug_name: Warfarin
  dosage: 55mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-18'
  indication_for_use: Thromboembolism prevention
  end_date: '2024-12-25'
- drug_name: Omeprazole
  dosage: 58mg
  route_of_administration: Oral
  start_date: '2024-11-18'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-12-25'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-25'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-11-25'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed month and advised husband.
- symptom_name: Pruritus
  onset_date: '2024-11-25'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-11-25'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed those and advised level.
- symptom_name: Nausea
  onset_date: '2024-11-25'
  severity: Mild
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Baker, Morris and Dodson Medical Center
reporter_type: Patient
