<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-2024-189
Date of Submission: 2024-10-29

This report was submitted by a Physician from Ward-Smith Medical Center concerning patient ANON-PX-1438. The subject is a 18-year-old female with a significant medical history including chronic kidney disease, asthma. 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): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 250mg, initiated on 2024-09-24 for Bacterial infection and discontinued on 2024-10-26; Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 21mg, initiated on 2024-09-24 for Type 2 diabetes and discontinued on 2024-10-26.

On approximately 2024-10-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed join and advised foot. The current patient status regarding this symptom is 'Not 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-189
report_date: '2024-10-29'
patient_details:
  patient_id: ANON-PX-1438
  gender: Female
  relevant_history:
  - chronic kidney disease
  - asthma
  age_at_reaction: 18
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 250mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-24'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-10-26'
- drug_name: Metformin
  dosage: 21mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-24'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-10-26'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-10-17'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-17'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed join and advised foot.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Ward-Smith Medical Center
reporter_type: Physician
