<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-2024-841
Date of Submission: 2024-10-11

This report was submitted by a Patient from James Inc Medical Center concerning patient ANON-PX-1425. The subject is a 65-year-old male with a significant medical history including seasonal allergies, 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 (Biguanide) administered via the Subcutaneous route at a dosage of 180mg, initiated on 2024-09-03 for Type 2 diabetes and discontinued on 2024-10-04.

On approximately 2024-09-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Angioedema. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-841
report_date: '2024-10-11'
patient_details:
  patient_id: ANON-PX-1425
  gender: Male
  relevant_history:
  - seasonal allergies
  - migraines
  age_at_reaction: 65
suspected_drugs:
- drug_name: Metformin
  dosage: 180mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-03'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-10-04'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-09-23'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-09-23'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: James Inc Medical Center
reporter_type: Patient
