<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-2025-575
Date of Submission: 2025-04-25

This report was submitted by a Nurse from Spence-Fitzgerald Medical Center concerning patient ANON-PX-8282. The subject is an adult male with a significant medical history including type 2 diabetes, seasonal allergies, atrial fibrillation, asthma. 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 Topical route at a dosage of 366mg, initiated on 2025-04-13 for Gastroesophageal reflux disease with the course ongoing; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 471mg, initiated on 2025-04-13 for Neuropathic pain with the course ongoing.

On approximately 2025-04-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Dizziness. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed action and advised sea. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

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-2025-575
report_date: '2025-04-25'
patient_details:
  patient_id: ANON-PX-8282
  gender: Male
  relevant_history:
  - type 2 diabetes
  - seasonal allergies
  - atrial fibrillation
  - asthma
suspected_drugs:
- drug_name: Omeprazole
  dosage: 366mg
  route_of_administration: Topical
  start_date: '2025-04-13'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Gabapentin
  dosage: 471mg
  route_of_administration: Subcutaneous
  start_date: '2025-04-13'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-16'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed action and advised sea.
- symptom_name: Somnolence
  onset_date: '2025-04-16'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2025-04-16'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Spence-Fitzgerald Medical Center
reporter_type: Nurse
