<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-2025-284
Date of Submission: 2025-08-02

This report was submitted by a Patient from Davis, Lyons and Palmer Medical Center concerning patient ANON-PX-9449. The subject is an adult male with a significant medical history including migraines, atrial fibrillation. 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 445mg, initiated on 2025-06-01 for Gastroesophageal reflux disease and discontinued on 2025-07-29.

On approximately 2025-07-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Pruritus, Diarrhea, Maculopapular Rash, Nausea. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea 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 Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

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. 

Reporter's Narrative Summary: Talk compare determine raise instead. Create voice every camera at sense edge.</data>
report_id: ADR-2025-284
report_date: '2025-08-02'
patient_details:
  patient_id: ANON-PX-9449
  gender: Male
  relevant_history:
  - migraines
  - atrial fibrillation
suspected_drugs:
- drug_name: Omeprazole
  dosage: 445mg
  route_of_administration: Intravenous
  start_date: '2025-06-01'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-07-29'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2025-07-26'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-07-26'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-07-26'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-07-26'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-07-26'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Davis, Lyons and Palmer Medical Center
reporter_type: Patient
notes: Talk compare determine raise instead. Create voice every camera at sense edge.
