Active surveillance evaluation of anti-HPV vaccine adverse events in Umbria region

Abstract

The study is a part of the "Active surveillance of adverse events following HPV vaccination" project conducted in order to actively register all common adverse events in girls 9-26 years after anti-HPV vaccination. It is a multicenter cohort study which included 12 Regions and 87 local health authorities, coordinated by the National Centre for Epidemiology, Surveillance and Health Promotion (CNESPS) ISS. We included all adolescents, 12 years old, actively contacted for HPV vaccination, as well as all women aged 9-26 years who recived, in the period under review, the same vaccination at the local health authorities in Spoleto. Out of 147 girls enrolled in the program, only 102 have reported the diary filled after the first vaccine dose, 62 and 88 respectively after the second and third dose. The filled diaries shown that adverse events, if any, have occurred almost exclusively during the first 5 days of vaccination, with a strong prevalence of local reactions (erythema, pain and swelling at the injection site) followed by headache and muscles pain. Even though the results show a high number of reported adverse events, mainly due to the detection method (active surveillance), they are mild or moderate in almost all the cases. This is in line with that seen in previous trials.