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Safety of bivalent human papillomavirus vaccine in the US vaccine adverse event reporting system (VAERS), 2009–2017
Author(s) -
Suragh Tiffany A.,
Lewis Paige,
Arana Jorge,
MbaJonas Adamma,
Li Rongxia,
Stewart Brock,
Shimabukuro Tom T.,
Cano Maria
Publication year - 2018
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.13736
Subject(s) - adverse event reporting system , adverse effect , human papillomavirus , medicine , nausea , human papillomavirus vaccine , bivalent (engine) , cervical cancer , cancer , chemistry , gardasil , organic chemistry , metal
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.