RT Journal
A1 Klein NP, Hansen J, Chao C, et al
T1 SAfety of quadrivalent human papillomavirus vaccine administered routinely to females
JF Archives of Pediatrics & Adolescent Medicine
JO Archives of Pediatrics & Adolescent Medicine
YR 2012
FD December 1
VO 166
IS 12
SP 1140
OP 1148
DO 10.1001/archpediatrics.2012.1451
UL http://dx.doi.org/10.1001/archpediatrics.2012.1451
AB Objective 
                  To assess the safety of the quadrivalent human papillomavirus vaccine (HPV4) in females following routine administration.Design 
                  In a cohort of vaccinated females, we compared the risk of emergency department visits and hospitalizations during the interval soon after vaccination with risk during a comparison interval more remote from vaccination.Setting 
                  Kaiser Permanente in California.Participants 
                  All females who received the HPV4 vaccine.Main Exposure 
                  One or more doses of HPV4 between August 2006 and March 2008.Main Outcome Measures 
                  Outcomes were emergency department visits and hospitalizations, grouped into predefined diagnostic categories. Within diagnostic groups, we used odds ratios (ORs) to estimate whether each subject had any outcome in postvaccination risk intervals (days 1-60, days 1-14, and day 0), compared with a control interval distant in time from vaccination.Results 
                  One hundred eighty-nine thousand six hundred twenty-nine females received at least 1 dose and 44 001 received 3 HPV4 doses. Fifty categories had significantly elevated ORs during at least 1 risk interval. Medical record review revealed that most diagnoses were present before vaccination or diagnostic workups were initiated at the vaccine visit. Only skin infections during days 1 to 14 (OR, 1.8; 95% CI, 1.3-2.4) and syncope on day of vaccination (OR, 6.0; 95% CI, 3.9-9.2) were noted by an independent Safety Review Committee as likely associations with HPV4.Conclusions 
                  The quadrivalent human papillomavirus vaccine was associated with same-day syncope and skin infections in the 2 weeks after vaccination. This study did not detect evidence of new safety concerns among females 9 to 26 years of age secondary to vaccination with HPV4.