<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-2025-294
Date of Submission: 2025-07-17

This report was submitted by a Physician from Schultz, Hudson and Howard Medical Center concerning patient ANON-PX-8590. The subject is a 31-year-old male with a significant medical history including type 2 diabetes, atrial fibrillation, 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): Sertraline administered via the Oral route at a dosage of 484mg, initiated on 2025-06-22 for Major depressive disorder and discontinued on 2025-07-10.

On approximately 2025-07-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Maculopapular Rash. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Life-threatening 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. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-294
report_date: '2025-07-17'
patient_details:
  patient_id: ANON-PX-8590
  gender: Male
  relevant_history:
  - type 2 diabetes
  - atrial fibrillation
  - osteoarthritis
  age_at_reaction: 31
suspected_drugs:
- drug_name: Sertraline
  dosage: 484mg
  route_of_administration: Oral
  start_date: '2025-06-22'
  indication_for_use: Major depressive disorder
  end_date: '2025-07-10'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-07'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-07-07'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-07-07'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Schultz, Hudson and Howard Medical Center
reporter_type: Physician
