Symptomtext
an expired dose of Fluzone High-Dose Quadrivalent was administered with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 72 years old female patient who had an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On 27-Oct-2022, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ731AA and expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for Influenza, Immunization. On 27-Oct-2022 the patient developed a non-serious event of an expired dose of fluzone high-dose quadrivalent was administered with no reported adverse event (expired product administered) (Latency: same day). Reporter was requesting efficacy and the need to re-administer. Action taken : not applicable. Outcome: Unknown 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.