Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013

Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community—Spain (2008–2018)

“…The AEFIs most commonly reported, which were milder in nature (such as headache, dizziness, myalgia, and malaise), are consistent with those of other studies [33,37,41,44,46,47,[52][53][54] and usually related or accompanied by anxiety symptoms [37,46,55]. On the other hand, the emotional component of the adolescent population (fear, anxiety) when facing vaccination is known [35,56,57], which could have had a negative impact on the vaccination process.…”

“…In our study, the rate for serious AEFIs was also higher in the first three years in the Valencian Community (more than 20 AEFIr per 100,000 doses), although this rate was slightly higher than in other countries [37,47]. However, the exposure by the press could have contributed to this phenomenon [48,49].…”

“…The trend analysis of the AEFI reporting rate from 2008 to 2018 showed a drop with a joinpoint in 2011, and during the first three years (2008)(2009)(2010), the rate was around 100 AEFIr per 100,000 doses, as described in Slovenia [37] and the UK [38],but higher than in other countries in the early years of the vaccination program [33,37,[39][40][41][42][43][44]. However, since 2011, the trend has seen a stabilized period with little APC, and currently, in the Valencian Community, the AEFI reporting rate after HPV immunization is low and consistent with rates of events seen elsewhere and in different regions [43,[45][46][47].…”

Systematic causality assessment of adverse events following HPV vaccines: Analysis of current data from Apulia region (Italy)

“…The overall reporting rate in our study is little lower than Italian estimate as in last AIFA report for 2015 (19 Â 100,000 doses); the rate for serious AEFIs (3.4 Â 100,000 in our study, 2.6 Â 10,000 in Italian estimates) is slightly higher [11]. Results of postmarketing surveillance activities carried out in other countries seem also to show different situations: data from Slovenia collected in 2009-2013 showed a reporting rate of 8.4 Â 100,000 doses; a survey, carried out among Ontario females vaccinated into a school-based program, showed a reporting rate for serious AEFIs of 1.45 Â 100,000 doses, lower than our results; finally, data from VAERS (Vaccine Adverse Events Reporting System), the passive surveillance system cared by FDA in US, are substantially in line with our rate (3.3 serious AEFI Â100.000 doses) [15,16].…”

Post Marketing Surveillance Study of 2nd Dose Quadrivalent Human Papilloma Virus Vaccine in Elementary School Children in Jakarta, Indonesia: Safety Result and Implementation of School-Based HPV Immunization Program

“…This incidence was much lower compared to earlier phase III QHPV clinical trials (9.9% in QHPV vaccine group, age 9-26 years old) (Kohl et al, 2007; MSD Data on File). Data from other school based post licensure/ registry study (2009-2013 in Slovenia) also reported a higher incidence of fever (10%) following immunization with QHPV vaccine (Subelj et al, 2016). The overall pain prevalence in the current study was found to be 59.6%.…”