<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-2025-841
Date of Submission: 2025-07-23

This report was submitted by a Nurse from Morrow, Bennett and Brown Medical Center concerning patient ANON-PX-1137. The subject is a 41-year-old male with a significant medical history including atrial fibrillation, 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): Gabapentin administered via the Topical route at a dosage of 199mg, initiated on 2025-05-12 for Neuropathic pain with the course ongoing.

On approximately 2025-05-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Maculopapular Rash, Diarrhea, Stevens-Johnson syndrome, Angioedema. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed simply and advised you. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-841
report_date: '2025-07-23'
patient_details:
  patient_id: ANON-PX-1137
  gender: Male
  relevant_history:
  - atrial fibrillation
  - type 2 diabetes
  age_at_reaction: 41
suspected_drugs:
- drug_name: Gabapentin
  dosage: 199mg
  route_of_administration: Topical
  start_date: '2025-05-12'
  indication_for_use: Neuropathic pain
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-05-31'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed simply and advised you.
- symptom_name: Maculopapular Rash
  onset_date: '2025-05-31'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-05-31'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-05-31'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-05-31'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 1
reporting_facility: Morrow, Bennett and Brown Medical Center
reporter_type: Nurse
