<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-2025-321
Date of Submission: 2025-06-11

This report was submitted by a Patient from Pruitt, Malone and Rodriguez Medical Center concerning patient ANON-PX-6503. The subject is a 71-year-old female with a significant medical history including anxiety, migraines, atrial fibrillation, 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 (Biguanide) administered via the Subcutaneous route at a dosage of 31mg, initiated on 2025-04-01 for Type 2 diabetes and discontinued on 2025-05-30.

On approximately 2025-05-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Hepatotoxicity, Maculopapular Rash, Dizziness, Somnolence. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed suddenly and advised form. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed serious and advised order. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, 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. 

Reporter's Narrative Summary: School player plant enough. Summer southern sing program shake measure structure billion. American certainly accept fill discuss security.</data>
report_id: ADR-2025-321
report_date: '2025-06-11'
patient_details:
  patient_id: ANON-PX-6503
  gender: Female
  relevant_history:
  - anxiety
  - migraines
  - atrial fibrillation
  - coronary artery disease
  age_at_reaction: 71
suspected_drugs:
- drug_name: Metformin
  dosage: 31mg
  route_of_administration: Subcutaneous
  start_date: '2025-04-01'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-05-30'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-05-03'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed suddenly and advised form.
- symptom_name: Hepatotoxicity
  onset_date: '2025-05-03'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed serious and advised order.
- symptom_name: Maculopapular Rash
  onset_date: '2025-05-03'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-05-03'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-05-03'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 8
reporting_facility: Pruitt, Malone and Rodriguez Medical Center
reporter_type: Patient
notes: School player plant enough. Summer southern sing program shake measure structure
  billion. American certainly accept fill discuss security.
