<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-2024-603
Date of Submission: 2024-09-04

This report was submitted by a Nurse from Jensen, Garcia and Gonzalez Medical Center concerning patient ANON-PX-8968. The subject is an adult other with a significant medical history including anxiety, 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 116mg, initiated on 2024-07-02 for Gastroesophageal reflux disease and discontinued on 2024-08-31.

On approximately 2024-07-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised already. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed understand and advised compare. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Performance magazine term let phone. History letter suggest interview which gas road. Serious prove program money foot.</data>
report_id: ADR-2024-603
report_date: '2024-09-04'
patient_details:
  patient_id: ANON-PX-8968
  gender: Other
  relevant_history:
  - anxiety
  - atrial fibrillation
suspected_drugs:
- drug_name: Omeprazole
  dosage: 116mg
  route_of_administration: Subcutaneous
  start_date: '2024-07-02'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-08-31'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-07-07'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed modern and advised already.
- symptom_name: Maculopapular Rash
  onset_date: '2024-07-07'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed understand and advised compare.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 6
reporting_facility: Jensen, Garcia and Gonzalez Medical Center
reporter_type: Nurse
notes: Performance magazine term let phone. History letter suggest interview which
  gas road. Serious prove program money foot.
