Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
fluzone np was given to a 15-month-old patient last 13oct2025 and it was readministered with no reported adverse event; Initial information received on 22-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 15 months old and unknown gender patient who received two dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] in one month with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for influenza immunisation. On 22-Oct-2025 the patient received an extra dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for influenza immunisation, 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. 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.