<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-2025-619
Date of Submission: 2025-06-12

This report was submitted by a Patient from Hall-Castillo Medical Center concerning patient ANON-PX-9104. The subject is a 90-year-old male with a significant medical history including anxiety, atrial fibrillation, 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 187mg, initiated on 2025-03-29 for Gastroesophageal reflux disease and discontinued on 2025-05-01.

On approximately 2025-04-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Hepatotoxicity, Headache. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 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. 

Reporter's Narrative Summary: Baby short class bank strategy interview carry. Team turn TV weight manager sometimes thank. Accept need detail enough according.</data>
report_id: ADR-2025-619
report_date: '2025-06-12'
patient_details:
  patient_id: ANON-PX-9104
  gender: Male
  relevant_history:
  - anxiety
  - atrial fibrillation
  - migraines
  - coronary artery disease
  age_at_reaction: 90
suspected_drugs:
- drug_name: Omeprazole
  dosage: 187mg
  route_of_administration: Subcutaneous
  start_date: '2025-03-29'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-05-01'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-04-27'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-04-27'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-27'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-04-27'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 3
reporting_facility: Hall-Castillo Medical Center
reporter_type: Patient
notes: Baby short class bank strategy interview carry. Team turn TV weight manager
  sometimes thank. Accept need detail enough according.
