<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-2025-219
Date of Submission: 2025-04-01

This report was submitted by a Nurse from Wright LLC Medical Center concerning patient ANON-PX-6495. The subject is a 33-year-old female with a significant medical history including anxiety, atrial fibrillation, migraines. 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 Subcutaneous route at a dosage of 355mg, initiated on 2025-02-02 for Major depressive disorder and discontinued on 2025-03-19.

On approximately 2025-02-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence, Headache, Stevens-Johnson syndrome, Dizziness. The Hepatotoxicity was classified as Severe 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. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache 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 Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed leg and advised executive. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Moderate 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. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-219
report_date: '2025-04-01'
patient_details:
  patient_id: ANON-PX-6495
  gender: Female
  relevant_history:
  - anxiety
  - atrial fibrillation
  - migraines
  age_at_reaction: 33
suspected_drugs:
- drug_name: Sertraline
  dosage: 355mg
  route_of_administration: Subcutaneous
  start_date: '2025-02-02'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-03-19'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-25'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-25'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Headache
  onset_date: '2025-02-25'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-02-25'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed leg and advised executive.
- symptom_name: Dizziness
  onset_date: '2025-02-25'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Wright LLC Medical Center
reporter_type: Nurse
