<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-2025-771
Date of Submission: 2025-03-24

This report was submitted by a Physician from Ellis-Ray Medical Center concerning patient ANON-PX-5681. The subject is a 53-year-old female with a significant medical history including asthma, 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 Oral route at a dosage of 488mg, initiated on 2025-02-22 for Type 2 diabetes and discontinued on 2025-03-21.

On approximately 2025-03-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Diarrhea, Stevens-Johnson syndrome, Maculopapular Rash. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed news and advised spend. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-771
report_date: '2025-03-24'
patient_details:
  patient_id: ANON-PX-5681
  gender: Female
  relevant_history:
  - asthma
  - osteoarthritis
  age_at_reaction: 53
suspected_drugs:
- drug_name: Metformin
  dosage: 488mg
  route_of_administration: Oral
  start_date: '2025-02-22'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-03-21'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-03-21'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed news and advised spend.
- symptom_name: Diarrhea
  onset_date: '2025-03-21'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-21'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-21'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 3
reporting_facility: Ellis-Ray Medical Center
reporter_type: Physician
