<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-2024-727
Date of Submission: 2024-10-24

This report was submitted by a Physician from Huang-Montgomery Medical Center concerning patient ANON-PX-1229. The subject is an adult female with a significant medical history including seasonal allergies, anxiety, 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 Topical route at a dosage of 411mg, initiated on 2024-09-08 for Gastroesophageal reflux disease and discontinued on 2024-10-20; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 442mg, initiated on 2024-09-08 for Pain and inflammation and discontinued on 2024-10-20.

On approximately 2024-09-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Somnolence. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Paper until these allow fact relationship. Age affect what now let. Edge born father.</data>
report_id: ADR-2024-727
report_date: '2024-10-24'
patient_details:
  patient_id: ANON-PX-1229
  gender: Female
  relevant_history:
  - seasonal allergies
  - anxiety
  - chronic kidney disease
suspected_drugs:
- drug_name: Omeprazole
  dosage: 411mg
  route_of_administration: Topical
  start_date: '2024-09-08'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-10-20'
- drug_name: Ibuprofen
  dosage: 442mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-08'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-10-20'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-09-18'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-09-18'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Huang-Montgomery Medical Center
reporter_type: Physician
notes: Paper until these allow fact relationship. Age affect what now let. Edge born
  father.
