<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-2025-570
Date of Submission: 2025-02-23

This report was submitted by a Other Healthcare Professional from Davis PLC Medical Center concerning patient ANON-PX-3543. The subject is a 85-year-old female with a significant medical history including anxiety, coronary artery disease, migraines. 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 administered via the Topical route at a dosage of 162mg, initiated on 2025-01-31 for Gastroesophageal reflux disease and discontinued on 2025-02-14; Ibuprofen (NSAID) administered via the Oral route at a dosage of 196mg, initiated on 2025-01-31 for Pain and inflammation and discontinued on 2025-02-14.

On approximately 2025-02-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed author and advised rule. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Truth edge scene reflect education anything. Question student air nearly sell.</data>
report_id: ADR-2025-570
report_date: '2025-02-23'
patient_details:
  patient_id: ANON-PX-3543
  gender: Female
  relevant_history:
  - anxiety
  - coronary artery disease
  - migraines
  age_at_reaction: 85
suspected_drugs:
- drug_name: Omeprazole
  dosage: 162mg
  route_of_administration: Topical
  start_date: '2025-01-31'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-02-14'
- drug_name: Ibuprofen
  dosage: 196mg
  route_of_administration: Oral
  start_date: '2025-01-31'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-02-14'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-13'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
- symptom_name: Vomiting
  onset_date: '2025-02-13'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed author and advised rule.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 4
reporting_facility: Davis PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Truth edge scene reflect education anything. Question student air nearly sell.
