Safety of bivalent human papillomavirus vaccine in the U.S. Vaccine Adverse Event Reporting System (VAERS), 2009-2017
Menée aux Etats-Unis à partir de l'analyse des rapports du "Vaccine Adverse Event Reporting System" concernant 241 personnes vaccinées sur la période 2009-2017, cette étude identifie les événements indésirables associés à un vaccin (Cervarix) contre les papillomavirus humains de type 16 et 18
Background : Human papillomavirus (HPV) vaccines prevent infection with oncogenic virus types. We analyzed reports to the U.S. 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 non-serious. 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 were likely 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.