<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-2024-856
Date of Submission: 2024-08-13

This report was submitted by a Patient from Miller, Hernandez and Abbott Medical Center concerning patient ANON-PX-4399. The subject is a 77-year-old female with a significant medical history including anxiety, chronic kidney disease, type 2 diabetes, coronary artery 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 Oral route at a dosage of 430mg, initiated on 2024-06-12 for Gastroesophageal reflux disease and discontinued on 2024-08-11.

On approximately 2024-08-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Somnolence. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed attention and advised phone. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence 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. A Naranjo score of 7 was calculated, 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: Rise window after tell game design. Big whom lead natural send sing time. Current never then include measure visit.</data>
report_id: ADR-2024-856
report_date: '2024-08-13'
patient_details:
  patient_id: ANON-PX-4399
  gender: Female
  relevant_history:
  - anxiety
  - chronic kidney disease
  - type 2 diabetes
  - coronary artery disease
  age_at_reaction: 77
suspected_drugs:
- drug_name: Omeprazole
  dosage: 430mg
  route_of_administration: Oral
  start_date: '2024-06-12'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-08-11'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-07'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed attention and advised phone.
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-07'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-08-07'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 7
reporting_facility: Miller, Hernandez and Abbott Medical Center
reporter_type: Patient
notes: Rise window after tell game design. Big whom lead natural send sing time. Current
  never then include measure visit.
