<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-2025-653
Date of Submission: 2025-04-01

This report was submitted by a Physician from Clark Ltd Medical Center concerning patient ANON-PX-8126. The subject is a 82-year-old female with a significant medical history including chronic kidney disease, asthma, migraines. 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 107mg, initiated on 2025-03-14 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-03-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Maculopapular Rash, Stevens-Johnson syndrome, Angioedema. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Herself coach huge research. Them kind investment ground.</data>
report_id: ADR-2025-653
report_date: '2025-04-01'
patient_details:
  patient_id: ANON-PX-8126
  gender: Female
  relevant_history:
  - chronic kidney disease
  - asthma
  - migraines
  age_at_reaction: 82
suspected_drugs:
- drug_name: Omeprazole
  dosage: 107mg
  route_of_administration: Intravenous
  start_date: '2025-03-14'
  indication_for_use: Gastroesophageal reflux disease
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-03-28'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-28'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-28'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-03-28'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 2
reporting_facility: Clark Ltd Medical Center
reporter_type: Physician
notes: Herself coach huge research. Them kind investment ground.
