<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-2025-396
Date of Submission: 2025-06-28

This report was submitted by a Patient from Mcintyre LLC Medical Center concerning patient ANON-PX-5354. The subject is a 18-year-old female with a significant medical history including atrial fibrillation, 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): Metformin (Biguanide) administered via the Topical route at a dosage of 360mg, initiated on 2025-06-03 for Type 2 diabetes with the course ongoing; Gabapentin administered via the Subcutaneous route at a dosage of 359mg, initiated on 2025-06-03 for Neuropathic pain with the course ongoing.

On approximately 2025-06-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed throughout and advised within. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-396
report_date: '2025-06-28'
patient_details:
  patient_id: ANON-PX-5354
  gender: Female
  relevant_history:
  - atrial fibrillation
  - coronary artery disease
  age_at_reaction: 18
suspected_drugs:
- drug_name: Metformin
  dosage: 360mg
  route_of_administration: Topical
  start_date: '2025-06-03'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
- drug_name: Gabapentin
  dosage: 359mg
  route_of_administration: Subcutaneous
  start_date: '2025-06-03'
  indication_for_use: Neuropathic pain
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-06-26'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed throughout and advised within.
- symptom_name: Headache
  onset_date: '2025-06-26'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 9
reporting_facility: Mcintyre LLC Medical Center
reporter_type: Patient
