<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-2025-912
Date of Submission: 2025-06-04

This report was submitted by a Pharmacist from Sanchez LLC Medical Center concerning patient ANON-PX-9489. The subject is a 81-year-old male with a significant medical history including anxiety, osteoarthritis, coronary artery disease, chronic kidney disease. 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 (SSRI) administered via the Topical route at a dosage of 481mg, initiated on 2025-03-16 for Major depressive disorder and discontinued on 2025-04-29; Warfarin administered via the Intravenous route at a dosage of 148mg, initiated on 2025-03-16 for Thromboembolism prevention and discontinued on 2025-04-29.

On approximately 2025-04-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Dizziness. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 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. 

</data>
report_id: ADR-2025-912
report_date: '2025-06-04'
patient_details:
  patient_id: ANON-PX-9489
  gender: Male
  relevant_history:
  - anxiety
  - osteoarthritis
  - coronary artery disease
  - chronic kidney disease
  age_at_reaction: 81
suspected_drugs:
- drug_name: Sertraline
  dosage: 481mg
  route_of_administration: Topical
  start_date: '2025-03-16'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-04-29'
- drug_name: Warfarin
  dosage: 148mg
  route_of_administration: Intravenous
  start_date: '2025-03-16'
  indication_for_use: Thromboembolism prevention
  end_date: '2025-04-29'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-08'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-04-08'
  severity: Severe
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 7
reporting_facility: Sanchez LLC Medical Center
reporter_type: Pharmacist
