<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-2025-603
Date of Submission: 2025-08-04

This report was submitted by a Nurse from Owens-Evans Medical Center concerning patient ANON-PX-5305. The subject is a 47-year-old male with a significant medical history including type 2 diabetes, 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 administered via the Oral route at a dosage of 11mg, initiated on 2025-06-15 for Hypercholesterolemia with the course ongoing.

On approximately 2025-07-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Nausea, Dizziness, 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 'Unknown'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed well and advised about. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed performance and advised theory. The current patient status regarding this symptom is 'Recovered'. The Pruritus 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-603
report_date: '2025-08-04'
patient_details:
  patient_id: ANON-PX-5305
  gender: Male
  relevant_history:
  - type 2 diabetes
  - atrial fibrillation
  age_at_reaction: 47
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 11mg
  route_of_administration: Oral
  start_date: '2025-06-15'
  indication_for_use: Hypercholesterolemia
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-07-14'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-07-14'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed well and advised about.
- symptom_name: Dizziness
  onset_date: '2025-07-14'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed performance and advised theory.
- symptom_name: Pruritus
  onset_date: '2025-07-14'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 10
reporting_facility: Owens-Evans Medical Center
reporter_type: Nurse
