<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-2025-900
Date of Submission: 2025-02-14

This report was submitted by a Patient from Smith-Allen Medical Center concerning patient ANON-PX-8724. The subject is a 18-year-old other with a significant medical history including atrial fibrillation, hypertension, chronic kidney disease. 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 162mg, initiated on 2024-11-30 for Neuropathic pain and discontinued on 2025-01-24.

On approximately 2024-12-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Stevens-Johnson syndrome, Nausea, Somnolence. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed attention and advised understand. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed quickly and advised affect. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence 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. 

Reporter's Narrative Summary: Safe we rise institution commercial find sort. Popular since indicate catch painting field note.</data>
report_id: ADR-2025-900
report_date: '2025-02-14'
patient_details:
  patient_id: ANON-PX-8724
  gender: Other
  relevant_history:
  - atrial fibrillation
  - hypertension
  - chronic kidney disease
  age_at_reaction: 18
suspected_drugs:
- drug_name: Gabapentin
  dosage: 162mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-30'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-24'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-26'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed attention and advised understand.
- symptom_name: Dizziness
  onset_date: '2024-12-26'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-26'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed quickly and advised affect.
- symptom_name: Nausea
  onset_date: '2024-12-26'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-12-26'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Smith-Allen Medical Center
reporter_type: Patient
notes: Safe we rise institution commercial find sort. Popular since indicate catch
  painting field note.
