<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-2025-627
Date of Submission: 2025-04-07

This report was submitted by a Physician from Lara Group Medical Center concerning patient ANON-PX-9861. The subject is a 45-year-old female with a significant medical history including seasonal allergies, osteoarthritis, asthma, anxiety. 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 215mg, initiated on 2025-01-18 for Gastroesophageal reflux disease and discontinued on 2025-03-11.

On approximately 2025-03-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Dizziness, Nausea, Hepatotoxicity. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed far and advised eye. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. 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-2025-627
report_date: '2025-04-07'
patient_details:
  patient_id: ANON-PX-9861
  gender: Female
  relevant_history:
  - seasonal allergies
  - osteoarthritis
  - asthma
  - anxiety
  age_at_reaction: 45
suspected_drugs:
- drug_name: Omeprazole
  dosage: 215mg
  route_of_administration: Oral
  start_date: '2025-01-18'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-03-11'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-06'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-06'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed far and advised eye.
- symptom_name: Dizziness
  onset_date: '2025-03-06'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-03-06'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-03-06'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 7
reporting_facility: Lara Group Medical Center
reporter_type: Physician
