<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-2025-175
Date of Submission: 2025-04-23

This report was submitted by a Other Healthcare Professional from Evans-Wilson Medical Center concerning patient ANON-PX-8851. The subject is a 70-year-old other 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 (Proton-pump inhibitor) administered via the Topical route at a dosage of 340mg, initiated on 2025-03-21 for Gastroesophageal reflux disease and discontinued on 2025-04-22.

On approximately 2025-04-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Stevens-Johnson syndrome, Angioedema, Nausea, Anaphylaxis. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed respond and advised cold. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed land and advised evening. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly 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-2025-175
report_date: '2025-04-23'
patient_details:
  patient_id: ANON-PX-8851
  gender: Other
  relevant_history:
  - chronic kidney disease
  - hypertension
  age_at_reaction: 70
suspected_drugs:
- drug_name: Omeprazole
  dosage: 340mg
  route_of_administration: Topical
  start_date: '2025-03-21'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-04-22'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-04-19'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed respond and advised cold.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-19'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed land and advised evening.
- symptom_name: Angioedema
  onset_date: '2025-04-19'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-04-19'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-04-19'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 10
reporting_facility: Evans-Wilson Medical Center
reporter_type: Other Healthcare Professional
