<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-2024-208
Date of Submission: 2024-10-06

This report was submitted by a Physician from Russo-Bennett Medical Center concerning patient ANON-PX-6800. The subject is a 43-year-old female with a significant medical history including atrial fibrillation, seasonal allergies. 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 69mg, initiated on 2024-09-08 for Major depressive disorder with the course ongoing; Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 155mg, initiated on 2024-09-08 for Pain and inflammation with the course ongoing.

On approximately 2024-09-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 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 '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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Bank economy million five. Laugh dinner government less east near campaign.</data>
report_id: ADR-2024-208
report_date: '2024-10-06'
patient_details:
  patient_id: ANON-PX-6800
  gender: Female
  relevant_history:
  - atrial fibrillation
  - seasonal allergies
  age_at_reaction: 43
suspected_drugs:
- drug_name: Sertraline
  dosage: 69mg
  route_of_administration: Oral
  start_date: '2024-09-08'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
- drug_name: Ibuprofen
  dosage: 155mg
  route_of_administration: Intramuscular
  start_date: '2024-09-08'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-24'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-09-24'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 8
reporting_facility: Russo-Bennett Medical Center
reporter_type: Physician
notes: Bank economy million five. Laugh dinner government less east near campaign.
