<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-2024-868
Date of Submission: 2024-08-23

This report was submitted by a Nurse from Caldwell-Kelly Medical Center concerning patient ANON-PX-7494. The subject is a 70-year-old male with a significant medical history including atrial fibrillation, migraines, anxiety. 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 466mg, initiated on 2024-07-10 for Gastroesophageal reflux disease with the course ongoing; Atorvastatin administered via the Intramuscular route at a dosage of 127mg, initiated on 2024-07-10 for Hypercholesterolemia with the course ongoing.

On approximately 2024-07-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. 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 modern and advised speech. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-868
report_date: '2024-08-23'
patient_details:
  patient_id: ANON-PX-7494
  gender: Male
  relevant_history:
  - atrial fibrillation
  - migraines
  - anxiety
  age_at_reaction: 70
suspected_drugs:
- drug_name: Omeprazole
  dosage: 466mg
  route_of_administration: Subcutaneous
  start_date: '2024-07-10'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Atorvastatin
  dosage: 127mg
  route_of_administration: Intramuscular
  start_date: '2024-07-10'
  indication_for_use: Hypercholesterolemia
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-07-19'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-07-19'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed modern and advised speech.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 7
reporting_facility: Caldwell-Kelly Medical Center
reporter_type: Nurse
