<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-2025-872
Date of Submission: 2025-01-11

This report was submitted by a Other Healthcare Professional from Morales, Castillo and Greene Medical Center concerning patient ANON-PX-1531. The subject is a 37-year-old male with a significant medical history including asthma, hypertension, osteoarthritis, anxiety. 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 239mg, initiated on 2024-11-04 for Major depressive disorder and discontinued on 2025-01-01.

On approximately 2024-12-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Maculopapular Rash. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed tax and advised method. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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-2025-872
report_date: '2025-01-11'
patient_details:
  patient_id: ANON-PX-1531
  gender: Male
  relevant_history:
  - asthma
  - hypertension
  - osteoarthritis
  - anxiety
  age_at_reaction: 37
suspected_drugs:
- drug_name: Sertraline
  dosage: 239mg
  route_of_administration: Oral
  start_date: '2024-11-04'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-01-01'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-30'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-12-30'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-30'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed tax and advised method.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Morales, Castillo and Greene Medical Center
reporter_type: Other Healthcare Professional
