Does the H1N1-09 vaccine cause febrile seizures in toddlers?

Answer 1

According to a recent release (January 2011) from VAERS (Vaccine Adverse Event Reporting System) there is a slight trend toward an increase in the reports of febrile seizures in infants and toddlers that follow the TIV (trivalent influenza vaccines) vaccinations (like the 2010-2011 flu vaccine). A definite connection vs. coincidental findings has not yet been made, however, it is being watched closely. The VAERS report (see also links below) includes the following information:

Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. These reported febrile seizures have primarily been seen in children younger than 2 years of age. Data from VAERS are preliminary and serve as a sign or indication that further investigation is warranted. Further investigations are under

way to assess whether there could be an association between influenza vaccination and febrile seizures, or if other factors could be involved.

FDA and CDC have seen no increase in VAERS reports of febrile seizures in people older than 2 years of age following vaccination with TIV, and no increase after live attenuated influenza vaccine (FluMist, the nasal spray vaccine). In the cases reported, all children recovered and no lasting effects have been seen.

The risk of severe influenza illness is higher among young children, especially children under 2 years of age. Approximately 9 out of 10,000 children 6-23 months of age require hospitalization each season for reasons related to influenza. Flu vaccine is the best way to protect against becoming ill with the flu.

Recommendations for the use of flu vaccine in children have not changed. CDC recommends that all persons ages 6 months and older receive a flu vaccine each year.

All providers of health care in the US are required to report specific incidences of adverse events after vaccination whether determined to be due to or only occurring with or after the vaccine to the VAERS reporting system, so that all possible problems are being evaluated in real time. The guidance to providers of healthcare for reporting are:

The National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report any adverse event that is listed by the vaccine manufacturer as being a contraindication (reason for not giving the child any further doses of the vaccine). The NCVIA also requires healthcare providers to report any adverse event that is listed in the Vaccine Adverse Event Reporting System (VAERS) Table of Reportable Events Following Vaccination if that event occurs within a specified time period after the child is vaccinated.

Healthcare providers are encouraged to report other clinically significant adverse events that follow immunization to VAERS even if they are unsure whether the event was caused by vaccine.

Febrile seizures occur in response to illnesses that cause fever. The CDC provides the following information:

'Febrile' means 'relating to a fever.' In some children, having a fever can bring on a seizure. During a febrile seizure, a child often has spasms or jerking movements-large or small-and may lose consciousness. Febrile seizures usually last only a minute or two. They are most common with fevers reaching 102°F (38.9°C) or higher but can also occur at lower temperatures or when a fever is going back down.

Febrile seizures can happen with any condition that causes a fever, including typical childhood illnesses like a cold, the flu, an ear infection, or roseola.

The CDC also provides this guidance in interpreting the VAERS data:

VAERS cannot usually determine cause-and-effect. VAERS accepts all reports without regard to whether or not the event was caused by the vaccine. The report of an adverse event to VAERS does not mean that a vaccine caused the event. It only indicates that the event occurred sometime after administration of the vaccine. Proof that the event was caused by the vaccine is NOT required in order for VAERS to accept the report.

Remember that these vaccines contain all the same ingredients and are made the same way as seasonal influenza vaccinations have been for decades of use. The only difference is the type of flu viruses each year included in the vaccines. There has not been a significant relationship made between increased febrile seizures after vaccinations found over all these years of use, although for the sake of safety it is always being monitored and evaluated.

The American Academy of Pediatrics has not changed their recommendations for flu vaccinations in children and still encourage their use.

See related links below.