<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-2025-415
Date of Submission: 2025-07-06

This report was submitted by a Patient from Garcia, Martinez and Church Medical Center concerning patient ANON-PX-7159. The subject is a 22-year-old other with a significant medical history including coronary artery disease, anxiety, seasonal allergies, 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): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 254mg, initiated on 2025-05-17 for Gastroesophageal reflux disease and discontinued on 2025-07-04.

On approximately 2025-06-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Hepatotoxicity. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-415
report_date: '2025-07-06'
patient_details:
  patient_id: ANON-PX-7159
  gender: Other
  relevant_history:
  - coronary artery disease
  - anxiety
  - seasonal allergies
  - chronic kidney disease
  age_at_reaction: 22
suspected_drugs:
- drug_name: Omeprazole
  dosage: 254mg
  route_of_administration: Oral
  start_date: '2025-05-17'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-07-04'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-06-28'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-28'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 6
reporting_facility: Garcia, Martinez and Church Medical Center
reporter_type: Patient
