Tiffany A Suragh1, Paige Lewis1, Jorge Arana1, Adamma Mba-Jonas2, Rongxia Li1, Brock Stewart3, Tom T Shimabukuro1, Maria Cano1. 1. Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, USA. 2. Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, USA. 3. Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, USA.
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. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.
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. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.
Entities:
Keywords:
bivalent human papillomavirus vaccine (2vHPV); immunization; vaccination; vaccine adverse event reporting system (VAERS); vaccine safety
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