<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-2025-400
Date of Submission: 2025-02-14

This report was submitted by a Pharmacist from Clay, Nichols and Christensen Medical Center concerning patient ANON-PX-2369. The subject is a 73-year-old male with a significant medical history including chronic kidney disease, type 2 diabetes, anxiety, osteoarthritis. 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 Intramuscular route at a dosage of 388mg, initiated on 2025-01-21 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-01-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Maculopapular Rash, Nausea, Stevens-Johnson syndrome. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. 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 since and advised hold. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild 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 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: Continue current prove. Single see small positive little happy. Late stop everybody cell item.</data>
report_id: ADR-2025-400
report_date: '2025-02-14'
patient_details:
  patient_id: ANON-PX-2369
  gender: Male
  relevant_history:
  - chronic kidney disease
  - type 2 diabetes
  - anxiety
  - osteoarthritis
  age_at_reaction: 73
suspected_drugs:
- drug_name: Omeprazole
  dosage: 388mg
  route_of_administration: Intramuscular
  start_date: '2025-01-21'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-01-23'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-01-23'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-01-23'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed since and advised hold.
- symptom_name: Nausea
  onset_date: '2025-01-23'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-01-23'
  severity: Mild
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 6
reporting_facility: Clay, Nichols and Christensen Medical Center
reporter_type: Pharmacist
notes: Continue current prove. Single see small positive little happy. Late stop everybody
  cell item.
