<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-2025-359
Date of Submission: 2025-07-22

This report was submitted by a Nurse from Bradley PLC Medical Center concerning patient ANON-PX-5507. The subject is a 64-year-old male with a significant medical history including asthma, hypertension. 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 Intramuscular route at a dosage of 444mg, initiated on 2025-05-10 for Hypercholesterolemia and discontinued on 2025-07-20.

On approximately 2025-07-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Anaphylaxis, Somnolence, Pruritus. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed high and advised air. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence 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 Severe in severity. No specific therapeutic intervention was required. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-359
report_date: '2025-07-22'
patient_details:
  patient_id: ANON-PX-5507
  gender: Male
  relevant_history:
  - asthma
  - hypertension
  age_at_reaction: 64
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 444mg
  route_of_administration: Intramuscular
  start_date: '2025-05-10'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-07-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-19'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-07-19'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed high and advised air.
- symptom_name: Anaphylaxis
  onset_date: '2025-07-19'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-07-19'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-07-19'
  severity: Severe
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 6
reporting_facility: Bradley PLC Medical Center
reporter_type: Nurse
