<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-2025-654
Date of Submission: 2025-05-12

This report was submitted by a Physician from Martin, Daniels and Norman Medical Center concerning patient ANON-PX-9999. The subject is a 32-year-old male with a significant medical history including atrial fibrillation, migraines, hypertension. 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 Oral route at a dosage of 194mg, initiated on 2025-05-04 for Major depressive disorder and discontinued on 2025-05-10.

On approximately 2025-05-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Hepatotoxicity, Somnolence, Stevens-Johnson syndrome. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed check and advised group. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed start and advised option. 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 'Not Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-654
report_date: '2025-05-12'
patient_details:
  patient_id: ANON-PX-9999
  gender: Male
  relevant_history:
  - atrial fibrillation
  - migraines
  - hypertension
  age_at_reaction: 32
suspected_drugs:
- drug_name: Sertraline
  dosage: 194mg
  route_of_administration: Oral
  start_date: '2025-05-04'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-05-10'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-05-06'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed check and advised group.
- symptom_name: Hepatotoxicity
  onset_date: '2025-05-06'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed start and advised option.
- symptom_name: Somnolence
  onset_date: '2025-05-06'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-05-06'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 10
reporting_facility: Martin, Daniels and Norman Medical Center
reporter_type: Physician
