<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-2024-330
Date of Submission: 2024-10-06

This report was submitted by a Pharmacist from Frank-Anderson Medical Center concerning patient ANON-PX-3486. The subject is an adult male with a significant medical history including hypertension, seasonal allergies, osteoarthritis, 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 69mg, initiated on 2024-07-11 for Type 2 diabetes and discontinued on 2024-09-11; Atorvastatin administered via the Oral route at a dosage of 131mg, initiated on 2024-07-11 for Hypercholesterolemia and discontinued on 2024-09-11.

On approximately 2024-08-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Hepatotoxicity, Stevens-Johnson syndrome. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed argue and advised girl. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

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

</data>
report_id: ADR-2024-330
report_date: '2024-10-06'
patient_details:
  patient_id: ANON-PX-3486
  gender: Male
  relevant_history:
  - hypertension
  - seasonal allergies
  - osteoarthritis
  - coronary artery disease
suspected_drugs:
- drug_name: Metformin
  dosage: 69mg
  route_of_administration: Topical
  start_date: '2024-07-11'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-09-11'
- drug_name: Atorvastatin
  dosage: 131mg
  route_of_administration: Oral
  start_date: '2024-07-11'
  indication_for_use: Hypercholesterolemia
  end_date: '2024-09-11'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-08-22'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-22'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed argue and advised girl.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-22'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 10
reporting_facility: Frank-Anderson Medical Center
reporter_type: Pharmacist
