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

Objective: Describe the Vaccine Safety Datalink's (VSD) Guillain Barre 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 1-42 days 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 42 days 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. Published by Elsevier Ltd.