<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-2025-546
Date of Submission: 2025-04-09

This report was submitted by a Nurse from Vaughn-Figueroa Medical Center concerning patient ANON-PX-1510. The subject is an adult female with a significant medical history including atrial fibrillation, anxiety. 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 Intramuscular route at a dosage of 377mg, initiated on 2025-03-10 for Gastroesophageal reflux disease and discontinued on 2025-04-04.

On approximately 2025-03-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed support and advised every. The current patient status regarding this symptom is 'Fatal'. 

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-2025-546
report_date: '2025-04-09'
patient_details:
  patient_id: ANON-PX-1510
  gender: Female
  relevant_history:
  - atrial fibrillation
  - anxiety
suspected_drugs:
- drug_name: Omeprazole
  dosage: 377mg
  route_of_administration: Intramuscular
  start_date: '2025-03-10'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-04-04'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-03-14'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-03-14'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed support and advised every.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 7
reporting_facility: Vaughn-Figueroa Medical Center
reporter_type: Nurse
