<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-2025-214
Date of Submission: 2025-06-21

This report was submitted by a Patient from Floyd PLC Medical Center concerning patient ANON-PX-8034. The subject is a 41-year-old female with a significant medical history including coronary artery disease, anxiety, 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 Intravenous route at a dosage of 389mg, initiated on 2025-05-17 for Type 2 diabetes with the course ongoing.

On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Diarrhea, Maculopapular Rash. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was '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-2025-214
report_date: '2025-06-21'
patient_details:
  patient_id: ANON-PX-8034
  gender: Female
  relevant_history:
  - coronary artery disease
  - anxiety
  - migraines
  age_at_reaction: 41
suspected_drugs:
- drug_name: Metformin
  dosage: 389mg
  route_of_administration: Intravenous
  start_date: '2025-05-17'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2025-06-07'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-06-07'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-06-07'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-07'
  severity: Severe
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Floyd PLC Medical Center
reporter_type: Patient
