<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-2024-388
Date of Submission: 2024-11-28

This report was submitted by a Nurse from Cortez PLC Medical Center concerning patient ANON-PX-9470. The subject is a 60-year-old other with a significant medical history including osteoarthritis, type 2 diabetes. 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 Subcutaneous route at a dosage of 52mg, initiated on 2024-11-19 for Hypercholesterolemia and discontinued on 2024-11-24; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 296mg, initiated on 2024-11-19 for Gastroesophageal reflux disease and discontinued on 2024-11-24.

On approximately 2024-11-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Headache, Diarrhea. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed music and advised action. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-388
report_date: '2024-11-28'
patient_details:
  patient_id: ANON-PX-9470
  gender: Other
  relevant_history:
  - osteoarthritis
  - type 2 diabetes
  age_at_reaction: 60
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 52mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-19'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-11-24'
- drug_name: Omeprazole
  dosage: 296mg
  route_of_administration: Oral
  start_date: '2024-11-19'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-11-24'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2024-11-20'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Vomiting
  onset_date: '2024-11-20'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed music and advised action.
- symptom_name: Headache
  onset_date: '2024-11-20'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-11-20'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 6
reporting_facility: Cortez PLC Medical Center
reporter_type: Nurse
