<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-2024-589
Date of Submission: 2024-09-03

This report was submitted by a Patient from Fowler PLC Medical Center concerning patient ANON-PX-2169. The subject is a 34-year-old female with a significant medical history including hypertension, chronic kidney disease, asthma, seasonal allergies. 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 222mg, initiated on 2024-07-26 for Hypercholesterolemia and discontinued on 2024-07-27.

On approximately 2024-07-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Vomiting, Somnolence, Maculopapular Rash. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed rich and advised himself. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed sport and advised clear. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash 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. A Naranjo score of 5 was calculated, The assessment concluded the relationship was '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-2024-589
report_date: '2024-09-03'
patient_details:
  patient_id: ANON-PX-2169
  gender: Female
  relevant_history:
  - hypertension
  - chronic kidney disease
  - asthma
  - seasonal allergies
  age_at_reaction: 34
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 222mg
  route_of_administration: Topical
  start_date: '2024-07-26'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-07-27'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-07-27'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-07-27'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed rich and advised himself.
- symptom_name: Somnolence
  onset_date: '2024-07-27'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed sport and advised clear.
- symptom_name: Maculopapular Rash
  onset_date: '2024-07-27'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 5
reporting_facility: Fowler PLC Medical Center
reporter_type: Patient
