Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | — | OT |
an extra dose of FLUZONE NP was administration with no reported adverse event; Initial information received on 08-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months old female patient who was administered an extra dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Dec-2025, the patient received 0.5mL (dose 3) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8873KA, expiry date 30-Jun-2026, frequency once and strength standard) via intramuscular route in the left thigh, on 05-Sep-2025, she also received an unknown dose (dose 1) and on 10-Oct-2025 she also received an unknwon dose (dose 2) (unknown batch number, expiry date and strength) via unknown route in unknown administration site for Immunisation and an extra dose (dose 3) of was administered with no reported adverse event (extra dose administered) (latency same day). It was reported "nurse sought guidance following the administration of an extra dose of Fluzone NP. They explained that the patient received a first dose at six months old on 05-Sep-2025, a second dose one month later on 10-Oct-2025, and a third dose on 05-Dec-2025 (third dose was an extra dose)". Action taken was unknown. 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.