<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-2024-427
Date of Submission: 2024-08-31

This report was submitted by a Physician from Hernandez-Hatfield Medical Center concerning patient ANON-PX-9527. The subject is a 39-year-old male with a significant medical history including migraines, hypertension, 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 Intramuscular route at a dosage of 181mg, initiated on 2024-07-03 for Major depressive disorder and discontinued on 2024-08-28.

On approximately 2024-08-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Pruritus. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Moderate 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-427
report_date: '2024-08-31'
patient_details:
  patient_id: ANON-PX-9527
  gender: Male
  relevant_history:
  - migraines
  - hypertension
  - chronic kidney disease
  age_at_reaction: 39
suspected_drugs:
- drug_name: Sertraline
  dosage: 181mg
  route_of_administration: Intramuscular
  start_date: '2024-07-03'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-08-28'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-27'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-08-27'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 8
reporting_facility: Hernandez-Hatfield Medical Center
reporter_type: Physician
