<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-2024-549
Date of Submission: 2024-09-25

This report was submitted by a Other Healthcare Professional from Butler, Novak and James Medical Center concerning patient ANON-PX-5870. The subject is a 52-year-old male with a significant medical history including coronary artery disease, anxiety, hypertension, atrial fibrillation. 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): Atorvastatin (Statin) administered via the Oral route at a dosage of 191mg, initiated on 2024-08-20 for Hypercholesterolemia and discontinued on 2024-09-22.

On approximately 2024-09-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Hepatotoxicity, Headache, Maculopapular Rash. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-549
report_date: '2024-09-25'
patient_details:
  patient_id: ANON-PX-5870
  gender: Male
  relevant_history:
  - coronary artery disease
  - anxiety
  - hypertension
  - atrial fibrillation
  age_at_reaction: 52
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 191mg
  route_of_administration: Oral
  start_date: '2024-08-20'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-09-22'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-09-22'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-22'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-09-22'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-22'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 10
reporting_facility: Butler, Novak and James Medical Center
reporter_type: Other Healthcare Professional
