Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8817KA | OT |
gave an extra Fluzone NP shot, She got one dose of FLUZONE NP back in September and got second dose of the same today with no reported adverse event; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 61 years old female patient who gave an extra INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] shot, she got one dose of fluzone NP back in september and got second dose of the same today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or ''no other immunizations'': No other immunizations On 12-Sep-2025, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (lot UT8817KA) via unknown route in unknown administration site; then On 21-Oct-2025 the patient received an extra dose of 0.5 ml of same vaccine (Frequency: once, Strength: standard) (lot-U8881AA, expiry date: 30-Jun-2026) via intramuscular route in the left arm; for Influenza (Influenza immunization); with no reported adverse event (extra dose administered) (latency- same day). It was reported, ''Medical assistant is asking for guidance after they gave an extra Fluzone NP shot given to patient, or if there is anything that would affect her. Treatment: No''. 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.