<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-2025-500
Date of Submission: 2025-07-04

This report was submitted by a Patient from Moreno, Chung and Brown Medical Center concerning patient ANON-PX-9480. The subject is a 34-year-old male with a significant medical history including chronic kidney disease, asthma, 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 administered via the Oral route at a dosage of 465mg, initiated on 2025-04-05 for Neuropathic pain and discontinued on 2025-06-11.

On approximately 2025-06-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Maculopapular Rash, Hepatotoxicity. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed newspaper and advised poor. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, 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. 

Reporter's Narrative Summary: Everything quickly cost position approach. Tv fact probably bank seek score add song. Respond fact card situation.</data>
report_id: ADR-2025-500
report_date: '2025-07-04'
patient_details:
  patient_id: ANON-PX-9480
  gender: Male
  relevant_history:
  - chronic kidney disease
  - asthma
  - migraines
  age_at_reaction: 34
suspected_drugs:
- drug_name: Gabapentin
  dosage: 465mg
  route_of_administration: Oral
  start_date: '2025-04-05'
  indication_for_use: Neuropathic pain
  end_date: '2025-06-11'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-06-03'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-06-03'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed newspaper and advised poor.
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-03'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-03'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 8
reporting_facility: Moreno, Chung and Brown Medical Center
reporter_type: Patient
notes: Everything quickly cost position approach. Tv fact probably bank seek score
  add song. Respond fact card situation.
