<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-2024-637
Date of Submission: 2024-10-21

This report was submitted by a Nurse from Smith, Pennington and Griffin Medical Center concerning patient ANON-PX-5757. The subject is a 73-year-old female with a significant medical history including seasonal allergies, asthma, chronic kidney 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): Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 131mg, initiated on 2024-07-26 for Gastroesophageal reflux disease and discontinued on 2024-10-18.

On approximately 2024-09-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Headache. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed key and advised responsibility. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed would and advised weight. 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-2024-637
report_date: '2024-10-21'
patient_details:
  patient_id: ANON-PX-5757
  gender: Female
  relevant_history:
  - seasonal allergies
  - asthma
  - chronic kidney disease
  age_at_reaction: 73
suspected_drugs:
- drug_name: Omeprazole
  dosage: 131mg
  route_of_administration: Oral
  start_date: '2024-07-26'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-10-18'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-07'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed key and advised responsibility.
- symptom_name: Nausea
  onset_date: '2024-09-07'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-09-07'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed would and advised weight.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 7
reporting_facility: Smith, Pennington and Griffin Medical Center
reporter_type: Nurse
