Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8470AA | OT |
patient receives two high dose flu vaccines (Fluzone Hd) in one day with no reported adverse event; Initial information received on 27-Feb-2025 (with live follow up process together with CSD: 27-Feb-2025) regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender patient who receives two high dose flu vaccines (fluzone hd) in one day with no reported adverse event after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD]. 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 (lot UT8470AA with expiry date 30-Jun-2025) via unknown route in unknown administration site for Immunization (Immunisation), patient receives two high dose flu vaccines (fluzone hd) in one day with no reported adverse event (extra dose administered). Reportedly: nurse inquired what happens when a patient receives two high dose flu vaccines (Fluzone Hd) in one day. She confirmed that this happened to a patient. Administration of extra doses of tetanus toxoid containing vaccines earlier than the recommend interval can increase the risk for hypersensitivity reactions. - Informed caller that this will be escalated to the business hours team who may contact her for further assistance. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. No follow-up is possible as Reporter cannot be contacted by Sanofi. 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.