Febrile seizures after 2010–2011 influenza vaccine in young children, United States: A vaccine safety signal from the vaccine adverse event reporting system

Leroy, Zanie; Broder, Karen R.; Menschik, David; Shimabukuro, Tom T.; Martín, David

doi:10.1016/j.vaccine.2011.12.042

Cited by 41 publications

(24 citation statements)

References 12 publications

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“…Factors that might contribute to this temporal trend include: increases in the size and complexity of the immunization schedule over time [21], with more opportunity for vaccination errors; increased awareness of medical errors [2]; stimulated reporting to VAERS [30][31][32] and other unrecognized factors. In 2004, a large increase in vaccination error reports involved a specific new influenza vaccine, which had a more narrow age indication compared to other IIV3s in use at that time.…”

Section: Discussionmentioning

confidence: 99%

Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000–2013

Hibbs

Moro

Lewis

et al. 2015

Vaccine

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Section: Discussionmentioning

confidence: 99%

Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000–2013

Hibbs

Moro

Lewis

et al. 2015

Vaccine

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“…Given the known underreporting of adverse events to VAERS, these findings were concerning enough for CDC to suspend its recommendation for RotaShield ® vaccination and initiate further investigation [64]; shortly thereafter the vaccine was withdrawn from the market by the manufacturer [65]. More recently, VAERS detected disproportional reporting for febrile seizures in young children following an inactivated influenza vaccine during the 2010-2011 influenza season [58,59]. Clinical review of the VAERS reports indicated the cases were typical of uncomplicated febrile seizures and all children fully recovered.…”

Section: Closing Thoughtsmentioning

confidence: 99%

Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)

Shimabukuro

Nguyen

Martín

et al. 2015

Vaccine

485

517

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The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination.

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“…Surveillance among children receiving U.S.-licensed influenza vaccines during the 2010-11 influenza season subsequently detected safety concerns for febrile seizures in young children following receipt of IIV3 (289,290). Further assessment through a VSD study determined that risk for febrile seizures was increased in children aged 6 months-4 years from the day of vaccination until the day after (risk window: day 0-1).…”

Section: Safety Of Inactivated Influenza Vaccines Childrenmentioning

confidence: 99%