<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-2024-464
Date of Submission: 2024-09-06

This report was submitted by a Nurse from Graves, Brown and Sullivan Medical Center concerning patient ANON-PX-7831. The subject is a 23-year-old male with a significant medical history including seasonal allergies, atrial fibrillation. 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 Topical route at a dosage of 148mg, initiated on 2024-08-06 for Neuropathic pain and discontinued on 2024-09-05.

On approximately 2024-08-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Diarrhea. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed series and advised past. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: It bring factor understand score establish power. Know stay Republican reduce purpose material. Church parent eat fire. Save carry whole special.</data>
report_id: ADR-2024-464
report_date: '2024-09-06'
patient_details:
  patient_id: ANON-PX-7831
  gender: Male
  relevant_history:
  - seasonal allergies
  - atrial fibrillation
  age_at_reaction: 23
suspected_drugs:
- drug_name: Gabapentin
  dosage: 148mg
  route_of_administration: Topical
  start_date: '2024-08-06'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2024-09-05'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-18'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-08-18'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-08-18'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed series and advised past.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Graves, Brown and Sullivan Medical Center
reporter_type: Nurse
notes: It bring factor understand score establish power. Know stay Republican reduce
  purpose material. Church parent eat fire. Save carry whole special.
