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

被引：40

作者：

Leroy, Z. ^{[1
]}

Broder, K. ^{[1
]}

Menschik, D. ^{[2
]}

Shimabukuro, T. ^{[1
]}

Martin, D. ^{[2
]}

机构：

[1] Ctr Dis Control & Prevent, Immunizat Safety Off, Div Hlth Care Qual Promot, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA

[2] US FDA, Off Biostat & Epidemiol, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA

来源：

VACCINE | 2012年 / 30卷 / 11期

关键词：

Febrile seizure; Trivalent influenza vaccine; Vaccine safety; Post-marketing surveillance; IMMUNIZATION;

D O I：

10.1016/j.vaccine.2011.12.042

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

During the 2010-2011 influenza season, the Centers for Disease Control and Prevention and the Food and Drug Administration conducted enhanced vaccine safety monitoring for possible febrile seizures in all trivalent influenza vaccine (TIV) products in the United States using the Vaccine Adverse Event Reporting System (VAERS). We used Empirical Bayesian data mining techniques to assess disproportionate reporting after TIV and reviewed febrile seizure reports in children aged <5 years. On November 23, 2010, the combination of the coding term "febrile convulsion" and the Fluzone (R) TIV product exceeded a predetermined threshold in the VAERS database. By December 10, we confirmed 43 reports of febrile seizure following TIV in children aged 6-23 months. Clinical features of most reports were consistent with typical uncomplicated febrile seizures, and all children recovered. Further epidemiologic assessment of a possible association between TIV and febrile seizures was undertaken in a separate, population-based vaccine safety monitoring system. Published by Elsevier Ltd.

引用

页码：2020 / 2023

页数：4

共 18 条

[1]

[Anonymous], FLUZ VACC SAF FDA CD

[2]

[Anonymous], 2011, REPORTABLE EVENTS TA

[3]

[Anonymous], INVESTIGATION FEBRIL

[4]

[Anonymous], 2011, US NATL VACCINE PLAN

[5] The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine [J].

Barlow, WE ;

Davis, RL ;

Glasser, JW ;

Rhodes, PH ;

Thompson, RS ;

Mullooly, JP ;

Black, SB ;

Shinefield, HR ;

Ward, JI ;

Marcy, SM ;

DeStefano, F ;

Chen, RT ;

Immanuel, V ;

Pearson, JA ;

Vadheim, CM ;

Rebolledo, V ;

Christakis, D ;

Benson, PJ ;

Lewis, N .

NEW ENGLAND JOURNAL OF MEDICINE, 2001, 345 (09) :656-661

[6] Trivalent influenza vaccine and febrile adverse events in Australia, 2010: Clinical features and potential mechanisms [J].

Blyth, C. C. ;

Currie, A. J. ;

Wiertsema, S. P. ;

Conway, N. ;

Kirkham, L. A. S. ;

Fuery, A. ;

Mascaro, F. ;

Geelhoed, G. C. ;

Richmond, P. C. .

VACCINE, 2011, 29 (32) :5107-5113

[7] Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation [J].

Bonhoeffer, J ;

Menkes, J ;

Gold, MS ;

de Souza-Brito, G ;

Fisher, MC ;

Halsey, N ;

Vermeer, P .

VACCINE, 2004, 22 (5-6) :557-562

[8] The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI) [J].

Bonhoeffer, J ;

Kohl, K ;

Chen, R ;

Duclos, P ;

Heijbel, H ;

Heininger, U ;

Jefferson, T ;

Loupi, E .

VACCINE, 2002, 21 (3-4) :298-302

[9]

Centre for Disease Prevention and Control (CDC), REC ADV COMM IMM PRA

[10]

CIOMS Working Group VIII, 2010, PRACT ASP SIGN DET P

← 1 2 →