<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-2025-136
Date of Submission: 2025-08-06

This report was submitted by a Pharmacist from Valdez Group Medical Center concerning patient ANON-PX-5172. The subject is a 36-year-old female with a significant medical history including type 2 diabetes, asthma, hypertension, coronary artery disease. 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 Intravenous route at a dosage of 299mg, initiated on 2025-05-20 for Neuropathic pain and discontinued on 2025-07-20; Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 369mg, initiated on 2025-05-20 for Gastroesophageal reflux disease and discontinued on 2025-07-20.

On approximately 2025-06-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Pruritus, Vomiting. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed discuss and advised others. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed travel and advised why. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Enter us consider. Major ability to play.</data>
report_id: ADR-2025-136
report_date: '2025-08-06'
patient_details:
  patient_id: ANON-PX-5172
  gender: Female
  relevant_history:
  - type 2 diabetes
  - asthma
  - hypertension
  - coronary artery disease
  age_at_reaction: 36
suspected_drugs:
- drug_name: Gabapentin
  dosage: 299mg
  route_of_administration: Intravenous
  start_date: '2025-05-20'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-07-20'
- drug_name: Omeprazole
  dosage: 369mg
  route_of_administration: Topical
  start_date: '2025-05-20'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-07-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-03'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed discuss and advised others.
- symptom_name: Pruritus
  onset_date: '2025-06-03'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-06-03'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed travel and advised why.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 9
reporting_facility: Valdez Group Medical Center
reporter_type: Pharmacist
notes: Enter us consider. Major ability to play.
