<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-2024-542
Date of Submission: 2024-09-15

This report was submitted by a Other Healthcare Professional from Harris, Hodges and Green Medical Center concerning patient ANON-PX-7046. The subject is an adult male with a significant medical history including asthma, coronary artery disease, hypertension, migraines. 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 administered via the Topical route at a dosage of 287mg, initiated on 2024-06-20 for Type 2 diabetes and discontinued on 2024-09-12.

On approximately 2024-09-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema, Stevens-Johnson syndrome. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-542
report_date: '2024-09-15'
patient_details:
  patient_id: ANON-PX-7046
  gender: Male
  relevant_history:
  - asthma
  - coronary artery disease
  - hypertension
  - migraines
suspected_drugs:
- drug_name: Metformin
  dosage: 287mg
  route_of_administration: Topical
  start_date: '2024-06-20'
  indication_for_use: Type 2 diabetes
  end_date: '2024-09-12'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-09-01'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-09-01'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-09-01'
  severity: Mild
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 8
reporting_facility: Harris, Hodges and Green Medical Center
reporter_type: Other Healthcare Professional
