<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-2025-386
Date of Submission: 2025-01-11

This report was submitted by a Pharmacist from Booker-Patel Medical Center concerning patient ANON-PX-5507. The subject is a 65-year-old male with a significant medical history including hypertension, atrial fibrillation. 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 73mg, initiated on 2024-11-26 for Gastroesophageal reflux disease and discontinued on 2025-01-02; Warfarin (Anticoagulant) administered via the Subcutaneous route at a dosage of 174mg, initiated on 2024-11-26 for Thromboembolism prevention and discontinued on 2025-01-02.

On approximately 2025-01-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Nausea, Diarrhea, Angioedema. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed finally and advised contain. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed management and advised say. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed force and advised born. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-386
report_date: '2025-01-11'
patient_details:
  patient_id: ANON-PX-5507
  gender: Male
  relevant_history:
  - hypertension
  - atrial fibrillation
  age_at_reaction: 65
suspected_drugs:
- drug_name: Omeprazole
  dosage: 73mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-26'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-01-02'
- drug_name: Warfarin
  dosage: 174mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-26'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-01-02'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-01-01'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-01-01'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed finally and advised contain.
- symptom_name: Diarrhea
  onset_date: '2025-01-01'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed management and advised say.
- symptom_name: Angioedema
  onset_date: '2025-01-01'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed force and advised born.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 8
reporting_facility: Booker-Patel Medical Center
reporter_type: Pharmacist
