Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
getting 2 doses of flu vaccine with no reported adverse event; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient received 2 doses of 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 received an unknown dose 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 unknown route in unknown administration site for influenza. On an unknown date, the patient received an extra dose 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 unknown route in unknown administration site for influenza, with no reported adverse event (extra dose administered) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, Nurse supervisor called to ask for possible side effects if a high dose flu vaccine was administered twice at one given time. Caller was not able to provide its brand name but said that the manufacturer was Sanofi and they were assuming that it was Fluzone HD. Caller cannot yet guarantee if a patient was administered or not but they still wanted to get information about possible side effects. 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.