Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case involves a 77-years-old male patient who received an expired INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were given to the patient. On 03-Nov-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (once), (suspension for injection, lot UJ507AC, expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to expired vaccine used (latency: same day). It was reported "The medical Information agent confirmed the spelling of demographics with the caller for accuracy. The caller reported that her facility orders Fluzone Quad directly from Sanofi and in their shipment of 2021-2022 product they received vials of 2020-2021. The caller reported that some staff and residents were administered the expired product and she wants to know what to do. A nurse reporting a medication error described as 20-staff members and 7-Residents received expired doses of FLUZONE QUADRIVALENT MDV from 2020-2021 year after receiving these 6-vials of the FLUZONE QUADRIVALENT MDV in the current years flu vaccine shipment. The nurse reported that the 20-staff members received the dose since the end of Oct2021; that the information on the staff members are not known, at the time of this report; that the staff has had no reports of adverse issues since dosing; that the 6-Residents received their dose on 03Nov2021; that the information for the residents is known to the reporter; that the residents have had no reports of adverse issues since dosing. The nurse reported that the doses came shipped to their central supply; that then the vaccines were distributed and placed in the vaccine refrigerators through the facility; that she is not the person that receives the vaccines from shipping and that she does not have the packaging slips or boxes due to it is handled with central supply; that when their staff is administering a vaccine the expiration date is not noted prior to administration; that the expiration date is not documented but just the LOT number; that the staff is not looking at the expiration date when administering; and that a nurse, yesterday, saw the expiration date to be expired after vaccinating residents." At time of reporting, no adverse event 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 Regulatory Authority. 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. This case is linked to cases 2021SA369738, 2021SA369789, 2021SA370183, 2021SA370209, 2021SA369806 and 2021SA371632 (CLUSTERS).