<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-2024-624
Date of Submission: 2024-11-23

This report was submitted by a Other Healthcare Professional from Dominguez and Sons Medical Center concerning patient ANON-PX-8217. The subject is a 39-year-old male with a significant medical history including chronic kidney disease, osteoarthritis, hypertension, atrial fibrillation. 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): Ibuprofen administered via the Intramuscular route at a dosage of 305mg, initiated on 2024-09-14 for Pain and inflammation with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 276mg, initiated on 2024-09-14 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2024-10-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Somnolence, Pruritus, Vomiting, Dizziness. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-624
report_date: '2024-11-23'
patient_details:
  patient_id: ANON-PX-8217
  gender: Male
  relevant_history:
  - chronic kidney disease
  - osteoarthritis
  - hypertension
  - atrial fibrillation
  age_at_reaction: 39
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 305mg
  route_of_administration: Intramuscular
  start_date: '2024-09-14'
  indication_for_use: Pain and inflammation
- drug_name: Omeprazole
  dosage: 276mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-14'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-10-11'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-10-11'
  severity: Mild
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2024-10-11'
  severity: Mild
  outcome: Fatal
  intervention_required: true
- symptom_name: Vomiting
  onset_date: '2024-10-11'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2024-10-11'
  severity: Mild
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 5
reporting_facility: Dominguez and Sons Medical Center
reporter_type: Other Healthcare Professional
