<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-2024-804
Date of Submission: 2024-12-06

This report was submitted by a Nurse from Boyd-Torres Medical Center concerning patient ANON-PX-4947. The subject is a 30-year-old male with a significant medical history including coronary artery disease, type 2 diabetes. 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): Sertraline administered via the Topical route at a dosage of 379mg, initiated on 2024-11-20 for Major depressive disorder and discontinued on 2024-11-30.

On approximately 2024-11-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed program and advised despite. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed seat and advised by. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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-2024-804
report_date: '2024-12-06'
patient_details:
  patient_id: ANON-PX-4947
  gender: Male
  relevant_history:
  - coronary artery disease
  - type 2 diabetes
  age_at_reaction: 30
suspected_drugs:
- drug_name: Sertraline
  dosage: 379mg
  route_of_administration: Topical
  start_date: '2024-11-20'
  indication_for_use: Major depressive disorder
  end_date: '2024-11-30'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-28'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed program and advised despite.
- symptom_name: Diarrhea
  onset_date: '2024-11-28'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed seat and advised by.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Boyd-Torres Medical Center
reporter_type: Nurse
