<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-2025-165
Date of Submission: 2025-05-23

This report was submitted by a Other Healthcare Professional from Warren-Humphrey Medical Center concerning patient ANON-PX-7672. The subject is a 85-year-old female with a significant medical history including atrial fibrillation, anxiety, 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): Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 254mg, initiated on 2025-03-05 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-05-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness, Angioedema, Nausea. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed pressure and advised final. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed require and advised officer. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed miss and advised now. The current patient status regarding this symptom is 'Unknown'. 

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-2025-165
report_date: '2025-05-23'
patient_details:
  patient_id: ANON-PX-7672
  gender: Female
  relevant_history:
  - atrial fibrillation
  - anxiety
  - osteoarthritis
  - type 2 diabetes
  age_at_reaction: 85
suspected_drugs:
- drug_name: Omeprazole
  dosage: 254mg
  route_of_administration: Intravenous
  start_date: '2025-03-05'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-05-09'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed pressure and advised final.
- symptom_name: Dizziness
  onset_date: '2025-05-09'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-05-09'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed require and advised officer.
- symptom_name: Nausea
  onset_date: '2025-05-09'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed miss and advised now.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 4
reporting_facility: Warren-Humphrey Medical Center
reporter_type: Other Healthcare Professional
