<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-2024-478
Date of Submission: 2024-08-28

This report was submitted by a Physician from Torres and Sons Medical Center concerning patient ANON-PX-7326. The subject is an adult male with a significant medical history including hypertension, osteoarthritis, type 2 diabetes, migraines. 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 370mg, initiated on 2024-06-28 for Neuropathic pain and discontinued on 2024-08-24.

On approximately 2024-08-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Hepatotoxicity, Nausea, Stevens-Johnson syndrome, Somnolence. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. 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 'Unknown'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed realize and advised off. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-478
report_date: '2024-08-28'
patient_details:
  patient_id: ANON-PX-7326
  gender: Male
  relevant_history:
  - hypertension
  - osteoarthritis
  - type 2 diabetes
  - migraines
suspected_drugs:
- drug_name: Gabapentin
  dosage: 370mg
  route_of_administration: Oral
  start_date: '2024-06-28'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2024-08-24'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-08-16'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-16'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-08-16'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-16'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-08-16'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed realize and advised off.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Torres and Sons Medical Center
reporter_type: Physician
