Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015

Vaccine
Jorge AranaT Shimabukuro

Abstract

The Food and Drug Administration (FDA) approved quadrivalent human papillomavirus vaccine (4vHPV) for use in females and males aged 9-26 years, since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS), a US spontaneous reporting system, in females and males who received 4vHPV vaccination. We searched VAERS for US reports of adverse events (AEs) following 4vHPV from January 2009 through December 2015. Signs and symptoms were coded using Medical Dictionary for Regulatory Activities (MedDRA). We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reports. Clinicians reviewed available information, including medical records, and reports of selected pre-specified conditions. VAERS received 19,760 reports following 4vHPV; 60.2% in females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports were non-serious; dizziness, syncope and injection site reactions were commonly reported in both males and females. Headache, fatigue and nausea were commonly reported serious AEs. More than 60 million 4vHPV doses were distributed during the study period. Crude AE reporting rates were 327 reports per million 4vHPV doses distr...Continue Reading

Citations

Sep 20, 2018·British Journal of Clinical Pharmacology·Tiffany A SuraghMaria Cano
Jan 25, 2019·Human Vaccines & Immunotherapeutics·Robert A Bednarczyk
May 16, 2019·Euro Surveillance : Bulletin Européen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin·Daniel WardAnders Hviid
Apr 8, 2020·Frontiers in Microbiology·Sarah GeogheganPaul A Offit
Aug 9, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Mona MarinHuong Q McLean
Oct 8, 2021·Human Vaccines & Immunotherapeutics·Mugen UjiieShinya Tsuzuki
Nov 20, 2019·Pediatrics·Tom T ShimabukuroMaria V Cano

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