Received Apr 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
have given Fluzone HD to patients younger than indicated with no adverse event; Initial information received on 27-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-heathcare professional. This case involves Adult and unknown gender patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone high dose] younger than indicated with no 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 1ml dose (once) of suspect influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe, unknown strength and expiry date, lot number not reported via intramuscular route in unknown administration site for flu vaccine (flu immunisation) earlier than indicated age with no adverse event (product administered to patient of inappropriate age) (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. 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. No follow-up is possible as Reporter cannot be contacted by Sanofi