<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-2025-194
Date of Submission: 2025-01-05

This report was submitted by a Patient from Bennett-Morris Medical Center concerning patient ANON-PX-4202. The subject is an adult other with a significant medical history including anxiety, asthma, migraines, 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 Intramuscular route at a dosage of 283mg, initiated on 2024-11-08 for Neuropathic pain and discontinued on 2025-01-02.

On approximately 2024-12-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome, Angioedema, Anaphylaxis. The Hepatotoxicity was classified as Severe 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. This necessitated clinical intervention. The documented action was: Prescribed few and advised yes. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-194
report_date: '2025-01-05'
patient_details:
  patient_id: ANON-PX-4202
  gender: Other
  relevant_history:
  - anxiety
  - asthma
  - migraines
  - osteoarthritis
suspected_drugs:
- drug_name: Gabapentin
  dosage: 283mg
  route_of_administration: Intramuscular
  start_date: '2024-11-08'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-02'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-24'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-24'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed few and advised yes.
- symptom_name: Angioedema
  onset_date: '2024-12-24'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-12-24'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Bennett-Morris Medical Center
reporter_type: Patient
