Safety of bivalent human papillomavirus vaccine in the US vaccine adverse event reporting system (VAERS), 2009–2017

Abstract

Aims: Human papillomavirus (HPV) vaccines prevent infection with oncogenic virus types. We analysed reports to the US Vaccine Adverse Event Reporting System (VAERS) of adverse events (AE) following bivalent HPV vaccine (2vHPV). Methods: We conducted descriptive analysis of 2vHPV reports, reviewed individual reports, calculated crude AE reporting rates and conducted empirical Bayesian data mining. Results: Of 241 2vHPV reports, 158 were in females, 64 in males (2vHPV is approved for females only) and 19 with unknown sex; 95.8% were classified as nonserious. Dizziness, headache, nausea and injection site reactions were the most common symptoms. Crude AE reporting rates were 33.3 reports per 100 000 doses distributed overall, and 1.4 per 100 000 for serious reports. Empirical Bayesian data mining identified disproportional reporting for three types of medical errors; assessment indicated findings that were probably driven by inadvertent 2vHPV use in males. Conclusions: We did not identify any new or unexpected safety concerns in our review of 2vHPV reports to VAERS.