<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-2024-717
Date of Submission: 2024-08-27

This report was submitted by a Physician from Rice, Brooks and Vaughn Medical Center concerning patient ANON-PX-4765. The subject is a 47-year-old male with a significant medical history including asthma, osteoarthritis, anxiety, chronic kidney disease. 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 455mg, initiated on 2024-08-03 for Major depressive disorder with the course ongoing.

On approximately 2024-08-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity, Diarrhea. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

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

Reporter's Narrative Summary: Money start law before drive room area add. Discuss site among. So fast simply strong someone.</data>
report_id: ADR-2024-717
report_date: '2024-08-27'
patient_details:
  patient_id: ANON-PX-4765
  gender: Male
  relevant_history:
  - asthma
  - osteoarthritis
  - anxiety
  - chronic kidney disease
  age_at_reaction: 47
suspected_drugs:
- drug_name: Sertraline
  dosage: 455mg
  route_of_administration: Oral
  start_date: '2024-08-03'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-25'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-25'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-08-25'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Rice, Brooks and Vaughn Medical Center
reporter_type: Physician
notes: Money start law before drive room area add. Discuss site among. So fast simply
  strong someone.
