<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-2025-450
Date of Submission: 2025-05-13

This report was submitted by a Physician from Jackson-Perry Medical Center concerning patient ANON-PX-6857. The subject is a 69-year-old other with a significant medical history including atrial fibrillation, chronic kidney disease, 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): Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 484mg, initiated on 2025-04-11 for Gastroesophageal reflux disease and discontinued on 2025-04-14.

On approximately 2025-04-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Headache, Dizziness, Diarrhea. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Moderate 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. 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 1 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-450
report_date: '2025-05-13'
patient_details:
  patient_id: ANON-PX-6857
  gender: Other
  relevant_history:
  - atrial fibrillation
  - chronic kidney disease
  - coronary artery disease
  age_at_reaction: 69
suspected_drugs:
- drug_name: Omeprazole
  dosage: 484mg
  route_of_administration: Intravenous
  start_date: '2025-04-11'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-04-14'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-14'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-04-14'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-04-14'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-04-14'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 1
reporting_facility: Jackson-Perry Medical Center
reporter_type: Physician
