<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-2024-859
Date of Submission: 2024-10-22

This report was submitted by a Physician from Lopez, Bryan and Allen Medical Center concerning patient ANON-PX-2324. The subject is an adult female with a significant medical history including type 2 diabetes, osteoarthritis, 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 Intramuscular route at a dosage of 500mg, initiated on 2024-09-13 for Gastroesophageal reflux disease with the course ongoing; Ibuprofen administered via the Subcutaneous route at a dosage of 120mg, initiated on 2024-09-13 for Pain and inflammation with the course ongoing.

On approximately 2024-09-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea, Angioedema. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-859
report_date: '2024-10-22'
patient_details:
  patient_id: ANON-PX-2324
  gender: Female
  relevant_history:
  - type 2 diabetes
  - osteoarthritis
  - chronic kidney disease
suspected_drugs:
- drug_name: Omeprazole
  dosage: 500mg
  route_of_administration: Intramuscular
  start_date: '2024-09-13'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Ibuprofen
  dosage: 120mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-13'
  indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-09-25'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-09-25'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-09-25'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Lopez, Bryan and Allen Medical Center
reporter_type: Physician
