<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-2024-651
Date of Submission: 2024-09-23

This report was submitted by a Physician from Ramsey, Lee and Lopez Medical Center concerning patient ANON-PX-6352. The subject is a 58-year-old other with a significant medical history including asthma, anxiety, migraines, chronic kidney 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 171mg, initiated on 2024-08-26 for Gastroesophageal reflux disease and discontinued on 2024-09-12.

On approximately 2024-09-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Hepatotoxicity, Headache, Anaphylaxis. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed add and advised someone. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Mild 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 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Strategy then after inside.</data>
report_id: ADR-2024-651
report_date: '2024-09-23'
patient_details:
  patient_id: ANON-PX-6352
  gender: Other
  relevant_history:
  - asthma
  - anxiety
  - migraines
  - chronic kidney disease
  age_at_reaction: 58
suspected_drugs:
- drug_name: Omeprazole
  dosage: 171mg
  route_of_administration: Intravenous
  start_date: '2024-08-26'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-09-12'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-09-12'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-12'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed add and advised someone.
- symptom_name: Headache
  onset_date: '2024-09-12'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-09-12'
  severity: Mild
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 9
reporting_facility: Ramsey, Lee and Lopez Medical Center
reporter_type: Physician
notes: Strategy then after inside.
