Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Oct 13;35(43):5756-5758.
doi: 10.1016/j.vaccine.2017.09.009. Epub 2017 Sep 19.

Risk of Guillain-Barré Syndrome following quadrivalent human papillomavirus vaccine in the Vaccine Safety Datalink

Julianne Gee  1 , Lakshmi Sukumaran  2 , Eric Weintraub  2 ; Vaccine Safety Datalink Team  2
Affiliations

Risk of Guillain-Barré Syndrome following quadrivalent human papillomavirus vaccine in the Vaccine Safety Datalink

Julianne Gee et al. Vaccine. .

Abstract

Objective: Describe the Vaccine Safety Datalink's (VSD) Guillain Barré Syndrome (GBS) surveillance following quadrivalent HPV vaccine (4vHPV) from 2006 through 2015.

Methods: Among 4vHPV vaccinated persons aged 9-26, ICD-9 coded GBS was identified in VSD's electronic data. Medical records were reviewed and adjudicated to confirm GBS. We calculated incidence rates of confirmed GBS within 1-42days following 4vHPV with a one-sided 95% confidence interval.

Results: Following 2,773,185 4vHPV doses, we confirmed 1 case of GBS in a male and no cases among females. The incidence rate of medical record confirmed GBS within 42days following 4vHPV vaccine was 0.36 cases per million 4vHPV doses administered (1-sided 95% CI 1.71), which was less than the background rate.

Conclusion: We found no evidence of an increased risk of GBS following 4vHPV. With an upper 95% confidence limit, we estimate that, if an increased risk exists, we would expect at most 1.08 additional cases of GBS per million people vaccinated with 4vHPV.

Keywords: Guillain Barré Syndrome; Human papillomavirus vaccine; Vaccine Safety.

PubMed Disclaimer

References

    1. Sejvar JJ, Kohl KS, Gidudu J, Amato A, Bakshi N, Baxter R, et al. Guillain-Barre syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2011;29:599–612. - PubMed
    1. Shui IM, Rett MD, Weintraub E, Marcy M, Amato AA, Sheikh SI, et al. Vaccine Safety Datalink Research T. Guillain-Barre syndrome incidence in a large United States cohort (2000–2009). Neuroepidemiology 2012;39:109–15. - PubMed
    1. Vellozzi C, Iqbal S, Stewart B, Tokars J, DeStefano F. Cumulative risk of Guillain-Barre syndrome among vaccinated and unvaccinated populations during the 2009 H1N1 influenza pandemic. Am J Public Health 2014;104:696–701. - PMC - PubMed
    1. Yuki N, Hartung HP. Guillain-Barre syndrome. N Engl J Med 2012;366:2294–304. - PubMed
    1. Hardy TA, Blum S, McCombe PA, Reddel SW. Guillain-barre syndrome: modern theories of etiology. Curr Allergy Asthma Rep 2011;11:197–204. - PubMed

Substances