Symptomtext
she accidentally administered a dose of FLUZONE HIGH-DOSE QUADRIVALENT to a patient from a box that was in the refrigerator from last year, with no adverse event; Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a nurse via Agency Inquiry Number: 00782410). This case involves a 71- years old female patient who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On 23-Sep-2021, the patient received a first 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ552AA and expiry date not provided via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported "Nurse stated that she accidentally administered a dose of FLUZONE HIGH-DOSE QUADRIVALENT to a patient from a box that was in the refrigerator from last year. Caller asked how to proceed and whether or not she could have the patient come back in today to be revaccinated." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.