<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-2025-693
Date of Submission: 2025-04-04

This report was submitted by a Patient from Collins PLC Medical Center concerning patient ANON-PX-4973. The subject is a 41-year-old female with a significant medical history including hypertension, atrial fibrillation, osteoarthritis. 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 404mg, initiated on 2025-01-29 for Neuropathic pain and discontinued on 2025-03-24.

On approximately 2025-03-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Hepatotoxicity, Angioedema, Headache, Stevens-Johnson syndrome. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed agree and advised paper. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed woman and advised little. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed throughout and advised always. The current patient status regarding this symptom is 'Not Recovered'. 

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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-693
report_date: '2025-04-04'
patient_details:
  patient_id: ANON-PX-4973
  gender: Female
  relevant_history:
  - hypertension
  - atrial fibrillation
  - osteoarthritis
  age_at_reaction: 41
suspected_drugs:
- drug_name: Gabapentin
  dosage: 404mg
  route_of_administration: Subcutaneous
  start_date: '2025-01-29'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-03-24'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-03-17'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed agree and advised paper.
- symptom_name: Hepatotoxicity
  onset_date: '2025-03-17'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed woman and advised little.
- symptom_name: Angioedema
  onset_date: '2025-03-17'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-03-17'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-17'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed throughout and advised always.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 7
reporting_facility: Collins PLC Medical Center
reporter_type: Patient
