<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-2025-586
Date of Submission: 2025-08-11

This report was submitted by a Nurse from Turner-Sanchez Medical Center concerning patient ANON-PX-2447. The subject is a 45-year-old male with a significant medical history including hypertension, anxiety, 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 401mg, initiated on 2025-07-29 for Neuropathic pain with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 296mg, initiated on 2025-07-29 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-07-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed personal and advised probably. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed since and advised prove. The current patient status regarding this symptom is 'Recovered'. 

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: Hear over try spend. Field this moment difference window bar some. Adult property coach doctor.</data>
report_id: ADR-2025-586
report_date: '2025-08-11'
patient_details:
  patient_id: ANON-PX-2447
  gender: Male
  relevant_history:
  - hypertension
  - anxiety
  - atrial fibrillation
  age_at_reaction: 45
suspected_drugs:
- drug_name: Gabapentin
  dosage: 401mg
  route_of_administration: Topical
  start_date: '2025-07-29'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
- drug_name: Omeprazole
  dosage: 296mg
  route_of_administration: Oral
  start_date: '2025-07-29'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-31'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed personal and advised probably.
- symptom_name: Somnolence
  onset_date: '2025-07-31'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed since and advised prove.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 8
reporting_facility: Turner-Sanchez Medical Center
reporter_type: Nurse
notes: Hear over try spend. Field this moment difference window bar some. Adult property
  coach doctor.
