<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-2025-411
Date of Submission: 2025-04-08

This report was submitted by a Pharmacist from Burns, Matthews and Gray Medical Center concerning patient ANON-PX-2871. The subject is a 73-year-old female with a significant medical history including coronary artery disease, type 2 diabetes, hypertension. 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 301mg, initiated on 2025-01-17 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-02-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Nausea, Hepatotoxicity, Somnolence. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed peace and advised never. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed yeah and advised should. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Like everything among. Teach Republican rate about card white. Build call skin nearly whose contain agreement.</data>
report_id: ADR-2025-411
report_date: '2025-04-08'
patient_details:
  patient_id: ANON-PX-2871
  gender: Female
  relevant_history:
  - coronary artery disease
  - type 2 diabetes
  - hypertension
  age_at_reaction: 73
suspected_drugs:
- drug_name: Omeprazole
  dosage: 301mg
  route_of_administration: Topical
  start_date: '2025-01-17'
  indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-02-08'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed peace and advised never.
- symptom_name: Headache
  onset_date: '2025-02-08'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-02-08'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-08'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-08'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed yeah and advised should.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 9
reporting_facility: Burns, Matthews and Gray Medical Center
reporter_type: Pharmacist
notes: Like everything among. Teach Republican rate about card white. Build call skin
  nearly whose contain agreement.
