Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8883CA | OT / LL |
administered FLUZONE NP to a 5 month, 2 week-old patient with no reported adverse event; Initial information received on 04-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 month, 2 week old male patient who was administered 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. Concomitant medications included Nirsevimab alip (Beyfortus) for Immunisation. On 13-Nov-2025, the 5 month, 2 week old patient received a dose of 0.5 ml once of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Suspension for Injection) (lot: U8883CA; expiry date: 30-Jun-2026; strength: standard) via intramuscular route in the left thigh for Influenza Immunisaton with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). 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.
Beyfortus