Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
he vaccinated a 64 year old patient with Fluzone High Dose although the prescribing information says that it is indicated for those 65 and older with no adverse event; Initial information received on 18-Feb-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 64 years old and unknown gender patient who had vaccinated with Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] although the prescribing information says that it is indicated for those 65 and older with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided. On an unknown date, the patient received a unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) (strength, expiry date was unknown) and he vaccinated a 64 year old patient with fluzone high dose although the prescribing information says that it is indicated for those 65 and older with no adverse event (off label use) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. Action taken was not applicable.