<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-2024-384
Date of Submission: 2024-10-20

This report was submitted by a Physician from Brown-Duncan Medical Center concerning patient ANON-PX-1459. The subject is a 60-year-old male with a significant medical history including chronic kidney disease, 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 Intravenous route at a dosage of 472mg, initiated on 2024-09-17 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2024-09-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Pruritus, Anaphylaxis, Somnolence. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed in and advised general. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate 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. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. 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-2024-384
report_date: '2024-10-20'
patient_details:
  patient_id: ANON-PX-1459
  gender: Male
  relevant_history:
  - chronic kidney disease
  - hypertension
  age_at_reaction: 60
suspected_drugs:
- drug_name: Omeprazole
  dosage: 472mg
  route_of_administration: Intravenous
  start_date: '2024-09-17'
  indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-19'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed in and advised general.
- symptom_name: Angioedema
  onset_date: '2024-09-19'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-09-19'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-09-19'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-09-19'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 3
reporting_facility: Brown-Duncan Medical Center
reporter_type: Physician
