<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-2024-836
Date of Submission: 2024-12-02

This report was submitted by a Patient from Mills, Carter and Rocha Medical Center concerning patient ANON-PX-6737. The subject is an adult other with a significant medical history including atrial fibrillation, seasonal allergies. 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 409mg, initiated on 2024-11-22 for Type 2 diabetes and discontinued on 2024-11-26; Omeprazole administered via the Subcutaneous route at a dosage of 101mg, initiated on 2024-11-22 for Gastroesophageal reflux disease and discontinued on 2024-11-26.

On approximately 2024-11-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Maculopapular Rash, Vomiting. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed knowledge and advised off. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe 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 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Lose early miss central might. Model speech exactly across. Rest threat pick.</data>
report_id: ADR-2024-836
report_date: '2024-12-02'
patient_details:
  patient_id: ANON-PX-6737
  gender: Other
  relevant_history:
  - atrial fibrillation
  - seasonal allergies
suspected_drugs:
- drug_name: Metformin
  dosage: 409mg
  route_of_administration: Topical
  start_date: '2024-11-22'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-11-26'
- drug_name: Omeprazole
  dosage: 101mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-22'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2024-11-26'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-11-23'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed knowledge and advised off.
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-23'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-11-23'
  severity: Severe
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 6
reporting_facility: Mills, Carter and Rocha Medical Center
reporter_type: Patient
notes: Lose early miss central might. Model speech exactly across. Rest threat pick.
