<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-2024-560
Date of Submission: 2024-10-24

This report was submitted by a Patient from Wilson-Ross Medical Center concerning patient ANON-PX-8175. The subject is a 51-year-old female with a significant medical history including type 2 diabetes, osteoarthritis, hypertension. 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 administered via the Topical route at a dosage of 234mg, initiated on 2024-08-22 for Gastroesophageal reflux disease and discontinued on 2024-10-12; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 343mg, initiated on 2024-08-22 for Thromboembolism prevention and discontinued on 2024-10-12.

On approximately 2024-09-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Nausea, Angioedema, Vomiting. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed be and advised factor. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate 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 build and advised ago. 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-2024-560
report_date: '2024-10-24'
patient_details:
  patient_id: ANON-PX-8175
  gender: Female
  relevant_history:
  - type 2 diabetes
  - osteoarthritis
  - hypertension
  age_at_reaction: 51
suspected_drugs:
- drug_name: Omeprazole
  dosage: 234mg
  route_of_administration: Topical
  start_date: '2024-08-22'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2024-10-12'
- drug_name: Warfarin
  dosage: 343mg
  route_of_administration: Intravenous
  start_date: '2024-08-22'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2024-10-12'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-09-14'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-09-14'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed be and advised factor.
- symptom_name: Angioedema
  onset_date: '2024-09-14'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-09-14'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed build and advised ago.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 6
reporting_facility: Wilson-Ross Medical Center
reporter_type: Patient
