<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-2025-649
Date of Submission: 2025-07-12

This report was submitted by a Physician from Moore, Serrano and Monroe Medical Center concerning patient ANON-PX-6643. The subject is a 30-year-old female with a significant medical history including chronic kidney disease, migraines, atrial fibrillation. 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 321mg, initiated on 2025-05-21 for Major depressive disorder and discontinued on 2025-07-02.

On approximately 2025-06-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Nausea. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed example and advised attack. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 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. 

Reporter's Narrative Summary: Agreement paper kid discuss do small. Environment themselves should case south analysis past positive. Yes so away want material discuss standard.</data>
report_id: ADR-2025-649
report_date: '2025-07-12'
patient_details:
  patient_id: ANON-PX-6643
  gender: Female
  relevant_history:
  - chronic kidney disease
  - migraines
  - atrial fibrillation
  age_at_reaction: 30
suspected_drugs:
- drug_name: Sertraline
  dosage: 321mg
  route_of_administration: Topical
  start_date: '2025-05-21'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-07-02'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-30'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-30'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed example and advised attack.
- symptom_name: Nausea
  onset_date: '2025-06-30'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 3
reporting_facility: Moore, Serrano and Monroe Medical Center
reporter_type: Physician
notes: Agreement paper kid discuss do small. Environment themselves should case south
  analysis past positive. Yes so away want material discuss standard.
