Article

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

Immunization Safety Office, Division of Health Care Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Vaccine (Impact Factor: 3.49). 03/2012; 30(11):2020-3. DOI: 10.1016/j.vaccine.2011.12.042
Source: PubMed

ABSTRACT 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(®) 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.

0 Bookmarks
 · 
59 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Seizures are a commonly encountered condition within the emergency department and, because of this, can engender complacency on the part of the physicians and staff. Unfortunately, there is significant associated morbidity and mortality with seizures, and they should never be regarded as routine. This point is particularly important with respect to seizures in pediatric patients. The aim of this review is to provide a current view of the various issues that make pediatric seizures unique and to help elucidate emergent evaluation and management strategies.
    Emergency medicine clinics of North America 08/2013; 31(3):733-54. · 0.96 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Post-licensure surveillance of adverse events following vaccination or prescription drug use often relies on electronic healthcare data to efficiently detect and evaluate safety signals. The accuracy of seizure-related diagnosis codes in identifying true incident seizure events in vaccine safety studies are influenced by factors such as clinical setting of diagnosis and age. To date, most studies of post-vaccination seizure have focused on pediatric populations. More information is needed on how well seizure can be identified in adults and children using algorithms that rely on electronic healthcare data. This validation study was part of a larger safety study of influenza vaccination during the 2009-2010 and 2010-2011 influenza seasons. Children and adults receiving influenza vaccination were drawn from an administrative claims database of a large United States healthcare insurer. Potential seizure events were identified using an algorithm of ICD-9 diagnosis codes associated with an emergency department (ED) visit or hospitalization within pre-specified risk windows following influenza vaccination. Seizure events were confirmed through medical record review. The positive predictive value (PPV) of the algorithm was calculated within each diagnostic setting and stratified by age group, ICD-9 code group, and sex. Review confirmed 113 out of 176 potential seizure events. The PPVs were higher in the ED setting (93.9%) than in the inpatient setting (38.3%). The PPVs by age varied within the ED setting (98.2% in <7 years, 76.9% in 7-24 years, 92% in ≥25 years) and within the inpatient setting (64.7% in <7 years, 33.3% in 7-24 years, 32.3% in ≥25 years). Our algorithm for identification of seizure events using claims data had a high level of accuracy in the emergency department setting in young children and older adults and a lower, but acceptable, level of accuracy in older children and young adults.
    Vaccine 10/2013; · 3.49 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Vaccine administration is the second leading cause of febrile seizures (FS). FS occurrence in children is a serious concern because it leads to public apprehension of vaccinations. This review discusses the clinical implications of FS, its potential link to vaccinations and its impact on official recommendations for vaccinations in children. Vaccines such as the pertussis antigen-containing vaccine, the measles-containing vaccine and the influenza vaccine have been linked to FS. However, FS events are very rare and are not usually associated with downstream complications or severe neurologic diseases. Considering their significant health benefits, vaccinations have not been restricted in the pediatric population. Nevertheless, vaccine-induced FS could be a problem, particularly in genetically predisposed children. Therefore, post-marketing surveillance studies are required to accurately assess the incidence of FS and identify individuals who are particularly susceptible to FS after vaccination.
    Expert Review of Vaccines 08/2013; 12(8):885-92. · 4.22 Impact Factor