<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-2025-398
Date of Submission: 2025-06-26

This report was submitted by a Patient from Smith, Gonzalez and Ruiz Medical Center concerning patient ANON-PX-3618. The subject is an adult female with a significant medical history including hypertension, type 2 diabetes, 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 administered via the Intravenous route at a dosage of 328mg, initiated on 2025-04-05 for Neuropathic pain with the course ongoing; Metformin (Biguanide) administered via the Intravenous route at a dosage of 208mg, initiated on 2025-04-05 for Type 2 diabetes with the course ongoing.

On approximately 2025-05-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Pruritus, Diarrhea. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly 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: West kid friend draw home their. Woman free customer detail. Question evening account doctor.</data>
report_id: ADR-2025-398
report_date: '2025-06-26'
patient_details:
  patient_id: ANON-PX-3618
  gender: Female
  relevant_history:
  - hypertension
  - type 2 diabetes
  - osteoarthritis
suspected_drugs:
- drug_name: Gabapentin
  dosage: 328mg
  route_of_administration: Intravenous
  start_date: '2025-04-05'
  indication_for_use: Neuropathic pain
- drug_name: Metformin
  dosage: 208mg
  route_of_administration: Intravenous
  start_date: '2025-04-05'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-05-03'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-05-03'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2025-05-03'
  severity: Mild
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 10
reporting_facility: Smith, Gonzalez and Ruiz Medical Center
reporter_type: Patient
notes: West kid friend draw home their. Woman free customer detail. Question evening
  account doctor.
