<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-2025-111
Date of Submission: 2025-01-01

This report was submitted by a Pharmacist from Mason LLC Medical Center concerning patient ANON-PX-5449. The subject is a 74-year-old female with a significant medical history including hypertension, migraines, seasonal allergies, 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 Topical route at a dosage of 432mg, initiated on 2024-10-22 for Hypercholesterolemia and discontinued on 2024-12-16.

On approximately 2024-10-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea, Angioedema, Anaphylaxis, Pruritus. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Base participant door carry wind so certainly. Energy modern both too whose positive.</data>
report_id: ADR-2025-111
report_date: '2025-01-01'
patient_details:
  patient_id: ANON-PX-5449
  gender: Female
  relevant_history:
  - hypertension
  - migraines
  - seasonal allergies
  - atrial fibrillation
  age_at_reaction: 74
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 432mg
  route_of_administration: Topical
  start_date: '2024-10-22'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-12-16'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-10-23'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2024-10-23'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-10-23'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-10-23'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-10-23'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Mason LLC Medical Center
reporter_type: Pharmacist
notes: Base participant door carry wind so certainly. Energy modern both too whose
  positive.
