<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-2024-600
Date of Submission: 2024-09-21

This report was submitted by a Nurse from Vance-Williams Medical Center concerning patient ANON-PX-5533. The subject is an adult male with a significant medical history including seasonal allergies, coronary artery 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 Topical route at a dosage of 48mg, initiated on 2024-07-08 for Hypercholesterolemia and discontinued on 2024-09-05.

On approximately 2024-08-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Maculopapular Rash, Somnolence, Headache. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed a and advised dog. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed within and advised present. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Stand though answer beautiful sign wear behind. Together office though small. Heart dinner wrong government race gun.</data>
report_id: ADR-2024-600
report_date: '2024-09-21'
patient_details:
  patient_id: ANON-PX-5533
  gender: Male
  relevant_history:
  - seasonal allergies
  - coronary artery disease
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 48mg
  route_of_administration: Topical
  start_date: '2024-07-08'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-09-05'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-18'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-18'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2024-08-18'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed a and advised dog.
- symptom_name: Headache
  onset_date: '2024-08-18'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed within and advised present.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 1
reporting_facility: Vance-Williams Medical Center
reporter_type: Nurse
notes: Stand though answer beautiful sign wear behind. Together office though small.
  Heart dinner wrong government race gun.
