<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-2025-440
Date of Submission: 2025-01-14

This report was submitted by a Patient from Bass Ltd Medical Center concerning patient ANON-PX-1421. The subject is a 80-year-old other with a significant medical history including chronic kidney disease, anxiety, 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 267mg, initiated on 2024-10-25 for Hypercholesterolemia and discontinued on 2024-12-26.

On approximately 2024-11-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Diarrhea. The Headache was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed strategy and advised better. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-440
report_date: '2025-01-14'
patient_details:
  patient_id: ANON-PX-1421
  gender: Other
  relevant_history:
  - chronic kidney disease
  - anxiety
  - atrial fibrillation
  age_at_reaction: 80
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 267mg
  route_of_administration: Topical
  start_date: '2024-10-25'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-12-26'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-11-13'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2024-11-13'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed strategy and advised better.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 3
reporting_facility: Bass Ltd Medical Center
reporter_type: Patient
