<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-2025-662
Date of Submission: 2025-08-08

This report was submitted by a Nurse from Clark, Holt and Lee Medical Center concerning patient ANON-PX-9549. The subject is an adult other with a significant medical history including atrial fibrillation, hypertension, seasonal allergies, 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 Oral route at a dosage of 311mg, initiated on 2025-07-19 for Neuropathic pain and discontinued on 2025-07-28.

On approximately 2025-07-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Pruritus, Hepatotoxicity, Nausea. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed never and advised loss. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed us and advised strategy. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed plan and advised without. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

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-2025-662
report_date: '2025-08-08'
patient_details:
  patient_id: ANON-PX-9549
  gender: Other
  relevant_history:
  - atrial fibrillation
  - hypertension
  - seasonal allergies
  - osteoarthritis
suspected_drugs:
- drug_name: Gabapentin
  dosage: 311mg
  route_of_administration: Oral
  start_date: '2025-07-19'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-07-28'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-07-21'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed never and advised loss.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-07-21'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed us and advised strategy.
- symptom_name: Pruritus
  onset_date: '2025-07-21'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed plan and advised without.
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-21'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-07-21'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Clark, Holt and Lee Medical Center
reporter_type: Nurse
