<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-2025-265
Date of Submission: 2025-06-14

This report was submitted by a Physician from Mcdaniel-Gonzalez Medical Center concerning patient ANON-PX-6026. The subject is a 55-year-old male with a significant medical history including coronary artery disease, migraines, atrial fibrillation, anxiety. 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 Intravenous route at a dosage of 300mg, initiated on 2025-04-19 for Major depressive disorder and discontinued on 2025-06-09.

On approximately 2025-06-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema, Headache. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. 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-2025-265
report_date: '2025-06-14'
patient_details:
  patient_id: ANON-PX-6026
  gender: Male
  relevant_history:
  - coronary artery disease
  - migraines
  - atrial fibrillation
  - anxiety
  age_at_reaction: 55
suspected_drugs:
- drug_name: Sertraline
  dosage: 300mg
  route_of_administration: Intravenous
  start_date: '2025-04-19'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-06-09'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-01'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-06-01'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-06-01'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Mcdaniel-Gonzalez Medical Center
reporter_type: Physician
