Symptomtext
A patient was received expired FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00801040) and transmitted on 06-Oct-2021. This case is linked to case 2021SA334081 (same reporter). This case involves a 78-year-old male patient who was received expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 06-Oct-2021, the patient received a first dose (0.7 ml) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ454AB, expiry: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). It was reported "Nurse calling in regards to expired FLUZONE HIGH-DOSE QUADRIVALENT (QIV HD) being administered to two patients. Caller would like to know how to proceed and if there is a safety issue." No other 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. 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.