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

Vaccine. 2017 Oct 13;35(43):5756-5758. doi: 10.1016/j.vaccine.2017.09.009. Epub 2017 Sep 19.


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.

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Female
  • Guillain-Barre Syndrome / chemically induced*
  • Guillain-Barre Syndrome / etiology*
  • Humans
  • Incidence
  • Male
  • Papillomavirus Vaccines / adverse effects*
  • Papillomavirus Vaccines / immunology
  • Risk Assessment
  • Young Adult


  • Papillomavirus Vaccines