<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-2024-267
Date of Submission: 2024-09-05

This report was submitted by a Pharmacist from Burns, Gonzales and Roberts Medical Center concerning patient ANON-PX-1967. The subject is a 41-year-old female with a significant medical history including anxiety, 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 Intravenous route at a dosage of 419mg, initiated on 2024-08-13 for Gastroesophageal reflux disease and discontinued on 2024-08-31.

On approximately 2024-08-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Headache, Stevens-Johnson syndrome. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

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. 

</data>
report_id: ADR-2024-267
report_date: '2024-09-05'
patient_details:
  patient_id: ANON-PX-1967
  gender: Female
  relevant_history:
  - anxiety
  - coronary artery disease
  age_at_reaction: 41
suspected_drugs:
- drug_name: Omeprazole
  dosage: 419mg
  route_of_administration: Intravenous
  start_date: '2024-08-13'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-08-31'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-08-21'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
- symptom_name: Headache
  onset_date: '2024-08-21'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-21'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Burns, Gonzales and Roberts Medical Center
reporter_type: Pharmacist
