<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-2025-376
Date of Submission: 2025-03-31

This report was submitted by a Other Healthcare Professional from Manning PLC Medical Center concerning patient ANON-PX-4409. The subject is a 64-year-old female with a significant medical history including chronic kidney disease, atrial fibrillation, osteoarthritis. 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 Oral route at a dosage of 500mg, initiated on 2025-02-28 for Hypercholesterolemia and discontinued on 2025-03-29; Lisinopril administered via the Intramuscular route at a dosage of 350mg, initiated on 2025-02-28 for Hypertension and discontinued on 2025-03-29.

On approximately 2025-03-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Anaphylaxis, Vomiting, Maculopapular Rash, Stevens-Johnson syndrome. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed green and advised fine. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed blue and advised expect. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-376
report_date: '2025-03-31'
patient_details:
  patient_id: ANON-PX-4409
  gender: Female
  relevant_history:
  - chronic kidney disease
  - atrial fibrillation
  - osteoarthritis
  age_at_reaction: 64
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 500mg
  route_of_administration: Oral
  start_date: '2025-02-28'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-03-29'
- drug_name: Lisinopril
  dosage: 350mg
  route_of_administration: Intramuscular
  start_date: '2025-02-28'
  indication_for_use: Hypertension
  end_date: '2025-03-29'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-03-28'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Anaphylaxis
  onset_date: '2025-03-28'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed green and advised fine.
- symptom_name: Vomiting
  onset_date: '2025-03-28'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed blue and advised expect.
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-28'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-28'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 4
reporting_facility: Manning PLC Medical Center
reporter_type: Other Healthcare Professional
