Symptomtext
administered one dose of the expired vaccine with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from other health professional, consumer/non-healthcare professional and physician via Agency (under reference 00786940). This case involves a patient (unknown age and gender) who received one dose of the expired QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) [expired product administered]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received 0.7 mL dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (Total, lot UJ764AA and expiration date: 30-Jun-2021) via unknown route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (same day latency). It was reported "Caller states that they received a shipment of vaccines on 27Sep2021 at 9am, and received an email later that day that the vaccines may have been expired due to being in shipping for too long. The caller states that they have already administered one dose of the vaccine by the time they received the email. Caller informed they have already spoken with customer service and were transferred over to medical information. Caller would like to know how to proceed after administering the expired dose? Caller was unable to provide patient information at this time since they do not have access, they were able to provide vaccine information, administering nurse, and prescribing physician information which is listed below." At 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.