Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
a patient under 65 years old was administered with FLUZONE HD with no reported adverse event; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult and unknown gender patient under 65 years old and was administered with influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] 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 under the age of 65 years old received influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Influenza (Influenza immunization) with no reported adverse event (product administered to patient of inappropriate age) (same day latency). It was reported that, nurse declined to provide information since she does not know if they are allowed to give out patient information. Nurse also mentioned that they called the patient, who then reported that they are fine. Information on the batch number could not be requested corresponding to the one at time of event occurrence Action taken was not applicable. No additional information available at time of call; caller declined to respond to questions and refuses future follow-up. 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.