<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-2025-896
Date of Submission: 2025-06-17

This report was submitted by a Patient from Smith, Ellison and Espinoza Medical Center concerning patient ANON-PX-3600. The subject is a 65-year-old other with a significant medical history including osteoarthritis, seasonal allergies, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 166mg, initiated on 2025-05-15 for Major depressive disorder and discontinued on 2025-06-14.

On approximately 2025-06-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Somnolence, Stevens-Johnson syndrome. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed marriage and advised voice. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-896
report_date: '2025-06-17'
patient_details:
  patient_id: ANON-PX-3600
  gender: Other
  relevant_history:
  - osteoarthritis
  - seasonal allergies
  - asthma
  age_at_reaction: 65
suspected_drugs:
- drug_name: Sertraline
  dosage: 166mg
  route_of_administration: Topical
  start_date: '2025-05-15'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-06-14'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-06-13'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-06-13'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-13'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed marriage and advised voice.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 2
reporting_facility: Smith, Ellison and Espinoza Medical Center
reporter_type: Patient
