<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-2025-719
Date of Submission: 2025-06-01

This report was submitted by a Other Healthcare Professional from Sullivan-Trujillo Medical Center concerning patient ANON-PX-6874. The subject is a 65-year-old other with a significant medical history including 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 Intravenous route at a dosage of 182mg, initiated on 2025-04-21 for Gastroesophageal reflux disease and discontinued on 2025-05-25; Ibuprofen (NSAID) administered via the Topical route at a dosage of 369mg, initiated on 2025-04-21 for Pain and inflammation and discontinued on 2025-05-25.

On approximately 2025-04-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Hepatotoxicity. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed item and advised participant. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

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

</data>
report_id: ADR-2025-719
report_date: '2025-06-01'
patient_details:
  patient_id: ANON-PX-6874
  gender: Other
  relevant_history:
  - migraines
  - coronary artery disease
  age_at_reaction: 65
suspected_drugs:
- drug_name: Omeprazole
  dosage: 182mg
  route_of_administration: Intravenous
  start_date: '2025-04-21'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-05-25'
- drug_name: Ibuprofen
  dosage: 369mg
  route_of_administration: Topical
  start_date: '2025-04-21'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-05-25'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-04-22'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed item and advised participant.
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-22'
  severity: Mild
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Sullivan-Trujillo Medical Center
reporter_type: Other Healthcare Professional
