Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
pre-assessed as an off-label use as per local labelling due to use of unapproved alternative injection site patient may have received possibly fluzone hd in the gluteal area before with no reported ae; Initial information received on 10-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age female patient who had use of unapproved alternative injection site patient may have received possibly influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] in the gluteal area before with no reported ae (adverse event) which was pre-assessed as an off-label use as per local labelling. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Poliomyelitis. Concomitant medications included COVID-19 vaccine for Immunisation. On an unknown date, the patient received a dose of suspect influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number, dose, strength and expiry not reported) via unknown route in gluteal muscle as Immunization that had use of unapproved alternative injection site with no reported ae (adverse event) which was pre-assessed as an off-label use as per local labelling (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. It was reported "A nurse is asking for guidance on administering FLUZONE HD in an alternate site to a senior resident that has Polio Syndrome, which has diminished usable tissue in the deltoid. She has been told that historically, the patient has gotten COVID and flu vaccines in the gluteal muscle instead, and they are supposed to administer FLUZONE HD next week. She is asking if they can give that injection in the gluteal muscle, and she is aware there may be an effect on a nerve. Caller mentioned that she believes the patient may have received (unspecified) COVID vaccine and possibly FLUZONE HD in the gluteal area before. There is no further information available, as she states it was in the past and at a different facility." Action taken: not applicable.
Polio
COVID-19 vaccine