Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
expired FLUZONE NP was administered with no reported adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age and gender patient who got administered expired Influenza usp trival a-b subvirion no preservative vaccine [Fluzone] NP with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an expired dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Influenza (immunization) with no reported adverse event (expired product administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. Action taken- not applicable. 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.