<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-2025-842
Date of Submission: 2025-02-13

This report was submitted by a Patient from Ponce-Frost Medical Center concerning patient ANON-PX-2930. The subject is an adult male with a significant medical history including migraines, coronary artery disease. 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 Subcutaneous route at a dosage of 61mg, initiated on 2024-12-20 for Type 2 diabetes and discontinued on 2024-12-30.

On approximately 2024-12-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Vomiting, Headache, Hepatotoxicity, Anaphylaxis. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed behind and advised kind. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed fall and advised fine. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-842
report_date: '2025-02-13'
patient_details:
  patient_id: ANON-PX-2930
  gender: Male
  relevant_history:
  - migraines
  - coronary artery disease
suspected_drugs:
- drug_name: Metformin
  dosage: 61mg
  route_of_administration: Subcutaneous
  start_date: '2024-12-20'
  indication_for_use: Type 2 diabetes
  end_date: '2024-12-30'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-29'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed behind and advised kind.
- symptom_name: Vomiting
  onset_date: '2024-12-29'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-12-29'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-29'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed fall and advised fine.
- symptom_name: Anaphylaxis
  onset_date: '2024-12-29'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 9
reporting_facility: Ponce-Frost Medical Center
reporter_type: Patient
