Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 2 | — | OT |
received a second Fluzone dose almost 2 weeks too early, with no reported adverse event; Initial information received on 02-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old female patient who received a second Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] dose almost 2 weeks too early, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 31-Oct-2025 she also received 0.5ml (dose 1) of Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown strength and expiry datw with an unknown batch number via unknown route in unknown administration site for immunisation. On 16-Nov-2025, the patient received 0.5ml (dose 2) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown strength) lot U8889DA and expiry date 30-Jun-2026 via intramuscular route in the left vastus lateralis for immunisation, almost 2 weeks too early, with no reported adverse event (inappropriate schedule of product administration) (Latency Same day). It was reported that, "This second dose was later determined to be an invalid dose, because it was given almost 2 weeks too early.The patient was administered a first dose of Fluzone on 31-Oct-2025 and was supposed to return a month later to receive the second dose." 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.