<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-2024-431
Date of Submission: 2024-10-25

This report was submitted by a Physician from Haas PLC Medical Center concerning patient ANON-PX-2451. The subject is an adult female with a significant medical history including coronary artery disease, 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 Intravenous route at a dosage of 413mg, initiated on 2024-08-07 for Type 2 diabetes and discontinued on 2024-10-11.

On approximately 2024-09-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Maculopapular Rash, Diarrhea. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Life-threatening 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 5 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. 

</data>
report_id: ADR-2024-431
report_date: '2024-10-25'
patient_details:
  patient_id: ANON-PX-2451
  gender: Female
  relevant_history:
  - coronary artery disease
  - osteoarthritis
suspected_drugs:
- drug_name: Metformin
  dosage: 413mg
  route_of_administration: Intravenous
  start_date: '2024-08-07'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-10-11'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-09-20'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-09-20'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-20'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2024-09-20'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 5
reporting_facility: Haas PLC Medical Center
reporter_type: Physician
