<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-2025-125
Date of Submission: 2025-03-26

This report was submitted by a Physician from Webb-Hunter Medical Center concerning patient ANON-PX-2072. The subject is a 77-year-old female with a significant medical history including osteoarthritis, chronic kidney disease, 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 Oral route at a dosage of 456mg, initiated on 2025-01-01 for Gastroesophageal reflux disease and discontinued on 2025-02-28; Metformin (Biguanide) administered via the Topical route at a dosage of 146mg, initiated on 2025-01-01 for Type 2 diabetes and discontinued on 2025-02-28.

On approximately 2025-01-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema, Hepatotoxicity. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed report and advised use. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Mild 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 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Message executive significant nation something. Despite small head leader.</data>
report_id: ADR-2025-125
report_date: '2025-03-26'
patient_details:
  patient_id: ANON-PX-2072
  gender: Female
  relevant_history:
  - osteoarthritis
  - chronic kidney disease
  - atrial fibrillation
  age_at_reaction: 77
suspected_drugs:
- drug_name: Omeprazole
  dosage: 456mg
  route_of_administration: Oral
  start_date: '2025-01-01'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-02-28'
- drug_name: Metformin
  dosage: 146mg
  route_of_administration: Topical
  start_date: '2025-01-01'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-02-28'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-01-30'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-01-30'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed report and advised use.
- symptom_name: Hepatotoxicity
  onset_date: '2025-01-30'
  severity: Mild
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 1
reporting_facility: Webb-Hunter Medical Center
reporter_type: Physician
notes: Message executive significant nation something. Despite small head leader.
