➡️ FDA issued safety labeling notification letters to manufacturers of several influenza vaccines (including FLULAVAL, FLUCELVAX, and others from companies like Sanofi, GSK, AstraZeneca, and CSL). These notifications require updating the product labels to include a warning about an increased risk of febrile seizures (fever-induced seizures) in young children, specifically in the first day following vaccination.This is based on postmarketing observational studies (self-controlled case series analyses) from the 2023-2024 and 2024-2025 flu seasons, which found a significantly elevated risk of febrile seizures in children ages 6 months through 4 years (and in some cases up to older preschool ages) on the day after receiving the flu shot.Key points from reports:The risk is small and typically involves a short window (0-1 days post-vaccination).
Febrile seizures are generally benign and self-resolving, though they can be concerning for parents.
This builds on prior CDC observations that some flu seasons have shown a small increased risk of febrile seizures with inactivated influenza vaccines (flu shots), especially when co-administered with certain other vaccines like PCV13 in the past.

The FDA directed updates for multiple major flu vaccines to reflect this in their prescribing information/package inserts. Note that older package inserts may mention febrile seizures in adverse event sections from clinical trials, but the recent FDA action specifically mandates a more prominent warning based on these newer analyses.For the most accurate and up-to-date details, check the official FDA letters (e.g., for specific vaccines like FLULAVAL or FLUCELVAX) or consult a healthcare provider, as vaccine recommendations weigh this small risk against the benefits of flu protection. The CDC also notes febrile seizures as a known but rare consideration with flu vaccines i

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