OBJECTIVES

This study assessed human papillomavirus vaccines (HPV) related adverse events (AE) reported to the Vaccine Adverse Events Reporting System (VAERS) from 2010-2019 by gender and age.

METHODS

We searched VAERS AE reports after receipt of an HPV vaccine from January 1, 2010, to October 14, 2019. We included patients ages 9-45 years old. Serious AEs were classified as resulting in death, life-threatening, hospitalization, emergency room visit, and disability. Descriptive statistics, including reporting rates to characterize AEs by severity status, were conducted. Proportional reporting ratios (PRR) were calculated for reported preferred terms to assess for disproportionately higher reporting of AEs after HPV vaccination. Signal criteria for disproportionality were set at PRR≥2 and the number of reports≥3.

RESULTS

VAERS received a total of 93,780 reports, 30,920 (33.0%) for males and 62,860 (67.0%) for females in the period of analysis. Significant gender and age differences were found for those administered an HPV vaccine (p<0.001). Of those reports, 4,643 mentioned a serious AE; 3,763 (19%) for females and 880 (9%) for males (p<0.001). Disproportionality reporting signals were found for females and disability (PRR [95%CI] = 2.38 [2.21-2.56]) but not for males (PRR [95%CI] = 1.5 [1.21-1.85]). Signals were detected for all age groups and disability, 9-25 years (PRR [95%CI] = 2.14 [2.01-2.28]) and 26-45 years (PRR [95%CI] = 2.01 [1.41-2.86]). No signals were found for other serious adverse events across age and gender groups.

CONCLUSIONS

This review identified differences in AEs across gender and age groups of patients receiving an HPV vaccine. Potential safety signals were found for serious adverse events of disability among females and all ages. Further clinical studies are needed to understand the heterogeneity of AEs reported across gender and age subgroups.