<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-2024-505
Date of Submission: 2024-11-20

This report was submitted by a Physician from Roberts-Schneider Medical Center concerning patient ANON-PX-9217. The subject is a 58-year-old female with a significant medical history including asthma, migraines, type 2 diabetes, hypertension. 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 administered via the Intramuscular route at a dosage of 152mg, initiated on 2024-10-29 for Type 2 diabetes and discontinued on 2024-11-13.

On approximately 2024-11-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed above and advised hotel. The current patient status regarding this symptom is 'Recovering'. 

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

</data>
report_id: ADR-2024-505
report_date: '2024-11-20'
patient_details:
  patient_id: ANON-PX-9217
  gender: Female
  relevant_history:
  - asthma
  - migraines
  - type 2 diabetes
  - hypertension
  age_at_reaction: 58
suspected_drugs:
- drug_name: Metformin
  dosage: 152mg
  route_of_administration: Intramuscular
  start_date: '2024-10-29'
  indication_for_use: Type 2 diabetes
  end_date: '2024-11-13'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-11-07'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-07'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed above and advised hotel.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Roberts-Schneider Medical Center
reporter_type: Physician
