<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-2025-486
Date of Submission: 2025-05-01

This report was submitted by a Physician from Douglas, Terry and Mcconnell Medical Center concerning patient ANON-PX-8104. The subject is a 29-year-old male with a significant medical history including osteoarthritis, coronary artery disease, hypertension, chronic kidney 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 administered via the Oral route at a dosage of 154mg, initiated on 2025-02-04 for Gastroesophageal reflux disease and discontinued on 2025-03-24.

On approximately 2025-03-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 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. 

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report_id: ADR-2025-486
report_date: '2025-05-01'
patient_details:
  patient_id: ANON-PX-8104
  gender: Male
  relevant_history:
  - osteoarthritis
  - coronary artery disease
  - hypertension
  - chronic kidney disease
  age_at_reaction: 29
suspected_drugs:
- drug_name: Omeprazole
  dosage: 154mg
  route_of_administration: Oral
  start_date: '2025-02-04'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-03-24'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-22'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-03-22'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 2
reporting_facility: Douglas, Terry and Mcconnell Medical Center
reporter_type: Physician
notes: Others month act year. Agency listen difficult quite goal draw three. Science
  under ago kind important set.
