<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-2025-805
Date of Submission: 2025-01-15

This report was submitted by a Patient from Gonzalez and Sons Medical Center concerning patient ANON-PX-4056. The subject is an adult male with a significant medical history including asthma, anxiety, migraines, type 2 diabetes. 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 135mg, initiated on 2024-11-02 for Gastroesophageal reflux disease and discontinued on 2025-01-04.

On approximately 2024-11-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed other and advised floor. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-805
report_date: '2025-01-15'
patient_details:
  patient_id: ANON-PX-4056
  gender: Male
  relevant_history:
  - asthma
  - anxiety
  - migraines
  - type 2 diabetes
suspected_drugs:
- drug_name: Omeprazole
  dosage: 135mg
  route_of_administration: Oral
  start_date: '2024-11-02'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-01-04'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-11-12'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-12'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed other and advised floor.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 2
reporting_facility: Gonzalez and Sons Medical Center
reporter_type: Patient
