<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-2024-388
Date of Submission: 2024-08-24

This report was submitted by a Physician from Madden, Garcia and Carpenter Medical Center concerning patient ANON-PX-6494. The subject is a 29-year-old female with a significant medical history including type 2 diabetes, 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 Subcutaneous route at a dosage of 273mg, initiated on 2024-07-12 for Type 2 diabetes with the course ongoing.

On approximately 2024-07-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Maculopapular Rash, Diarrhea. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed I and advised need. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed after and advised born. The current patient status regarding this symptom is 'Recovered'. 

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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Phone study either still product throughout. Agency fish her remain ten nation along.</data>
report_id: ADR-2024-388
report_date: '2024-08-24'
patient_details:
  patient_id: ANON-PX-6494
  gender: Female
  relevant_history:
  - type 2 diabetes
  - osteoarthritis
  age_at_reaction: 29
suspected_drugs:
- drug_name: Metformin
  dosage: 273mg
  route_of_administration: Subcutaneous
  start_date: '2024-07-12'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-07-27'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-07-27'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed I and advised need.
- symptom_name: Diarrhea
  onset_date: '2024-07-27'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed after and advised born.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 8
reporting_facility: Madden, Garcia and Carpenter Medical Center
reporter_type: Physician
notes: Phone study either still product throughout. Agency fish her remain ten nation
  along.
