<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-2025-100
Date of Submission: 2025-04-20

This report was submitted by a Nurse from Evans LLC Medical Center concerning patient ANON-PX-6716. The subject is an adult other 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 Topical route at a dosage of 495mg, initiated on 2025-04-05 for Hypercholesterolemia and discontinued on 2025-04-15.

On approximately 2025-04-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Pruritus, Vomiting. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed stage and advised small. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

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-2025-100
report_date: '2025-04-20'
patient_details:
  patient_id: ANON-PX-6716
  gender: Other
  relevant_history:
  - type 2 diabetes
  - atrial fibrillation
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 495mg
  route_of_administration: Topical
  start_date: '2025-04-05'
  indication_for_use: Hypercholesterolemia
  end_date: '2025-04-15'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-04-08'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-04-08'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed stage and advised small.
- symptom_name: Vomiting
  onset_date: '2025-04-08'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Evans LLC Medical Center
reporter_type: Nurse
