<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-2025-504
Date of Submission: 2025-04-02

This report was submitted by a Nurse from Larsen Ltd Medical Center concerning patient ANON-PX-9101. The subject is an adult female with a significant medical history including anxiety, osteoarthritis, chronic kidney 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 Intravenous route at a dosage of 336mg, initiated on 2025-03-20 for Type 2 diabetes and discontinued on 2025-04-01.

On approximately 2025-03-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Maculopapular Rash. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed simply and advised possible. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-504
report_date: '2025-04-02'
patient_details:
  patient_id: ANON-PX-9101
  gender: Female
  relevant_history:
  - anxiety
  - osteoarthritis
  - chronic kidney disease
suspected_drugs:
- drug_name: Metformin
  dosage: 336mg
  route_of_administration: Intravenous
  start_date: '2025-03-20'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-04-01'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2025-03-30'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-30'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed simply and advised possible.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 8
reporting_facility: Larsen Ltd Medical Center
reporter_type: Nurse
