<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-2024-503
Date of Submission: 2024-12-04

This report was submitted by a Physician from Garcia, Reynolds and Bradford Medical Center concerning patient ANON-PX-4262. The subject is an adult other with a significant medical history including seasonal allergies, asthma, migraines, anxiety. 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 Intravenous route at a dosage of 463mg, initiated on 2024-11-24 for Type 2 diabetes and discontinued on 2024-12-02.

On approximately 2024-11-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Vomiting, Stevens-Johnson syndrome. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 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 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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-2024-503
report_date: '2024-12-04'
patient_details:
  patient_id: ANON-PX-4262
  gender: Other
  relevant_history:
  - seasonal allergies
  - asthma
  - migraines
  - anxiety
suspected_drugs:
- drug_name: Metformin
  dosage: 463mg
  route_of_administration: Intravenous
  start_date: '2024-11-24'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-12-02'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-11-29'
  severity: Mild
  outcome: Recovering
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2024-11-29'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-11-29'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-29'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Garcia, Reynolds and Bradford Medical Center
reporter_type: Physician
