<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-2025-225
Date of Submission: 2025-02-16

This report was submitted by a Other Healthcare Professional from Guzman, Shepherd and Brooks Medical Center concerning patient ANON-PX-2698. The subject is a 62-year-old male with a significant medical history including coronary artery disease, 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): Atorvastatin (Statin) administered via the Oral route at a dosage of 104mg, initiated on 2025-01-10 for Hypercholesterolemia with the course ongoing.

On approximately 2025-02-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Anaphylaxis. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed environment and advised during. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed must and advised PM. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 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-2025-225
report_date: '2025-02-16'
patient_details:
  patient_id: ANON-PX-2698
  gender: Male
  relevant_history:
  - coronary artery disease
  - chronic kidney disease
  age_at_reaction: 62
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 104mg
  route_of_administration: Oral
  start_date: '2025-01-10'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-02-08'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed environment and advised during.
- symptom_name: Vomiting
  onset_date: '2025-02-08'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed must and advised PM.
- symptom_name: Anaphylaxis
  onset_date: '2025-02-08'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Guzman, Shepherd and Brooks Medical Center
reporter_type: Other Healthcare Professional
