<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-2024-306
Date of Submission: 2024-08-30

This report was submitted by a Pharmacist from Gordon PLC Medical Center concerning patient ANON-PX-4936. The subject is a 83-year-old other with a significant medical history including type 2 diabetes, seasonal allergies, atrial fibrillation, 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): Metformin (Biguanide) administered via the Topical route at a dosage of 482mg, initiated on 2024-07-30 for Type 2 diabetes and discontinued on 2024-08-20.

On approximately 2024-08-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Headache, Vomiting, Somnolence. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed player and advised follow. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed through and advised drop. 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. 

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report_id: ADR-2024-306
report_date: '2024-08-30'
patient_details:
  patient_id: ANON-PX-4936
  gender: Other
  relevant_history:
  - type 2 diabetes
  - seasonal allergies
  - atrial fibrillation
  - osteoarthritis
  age_at_reaction: 83
suspected_drugs:
- drug_name: Metformin
  dosage: 482mg
  route_of_administration: Topical
  start_date: '2024-07-30'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-08-20'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-17'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed player and advised follow.
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-17'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-08-17'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Vomiting
  onset_date: '2024-08-17'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-08-17'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed through and advised drop.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 9
reporting_facility: Gordon PLC Medical Center
reporter_type: Pharmacist
notes: Develop wife drive different test put. Business analysis Republican structure
  American husband. Reveal program tax Mr.
