<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-2025-306
Date of Submission: 2025-01-29

This report was submitted by a Nurse from Leblanc, Duffy and Thompson Medical Center concerning patient ANON-PX-2485. The subject is a 30-year-old other with a significant medical history including type 2 diabetes, atrial fibrillation. 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): Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 361mg, initiated on 2024-11-03 for Neuropathic pain with the course ongoing.

On approximately 2025-01-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Angioedema, Anaphylaxis, Stevens-Johnson syndrome. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed save and advised short. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed series and advised Mr. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome 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. 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-2025-306
report_date: '2025-01-29'
patient_details:
  patient_id: ANON-PX-2485
  gender: Other
  relevant_history:
  - type 2 diabetes
  - atrial fibrillation
  age_at_reaction: 30
suspected_drugs:
- drug_name: Gabapentin
  dosage: 361mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-03'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-01-22'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed save and advised short.
- symptom_name: Angioedema
  onset_date: '2025-01-22'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-01-22'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed series and advised Mr.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-01-22'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Leblanc, Duffy and Thompson Medical Center
reporter_type: Nurse
