Adverse events following immunization in Ontario's female school-based HPV program.

Abstract Background In September 2007, a school-based human papillomavirus (HPV) vaccination program targeting grade 8 girls (approximately 13 years old) and delivered by public health was implemented in Ontario, Canada. We assessed reports of adverse events following immunization (AEFI) from the school-based program as part of quadrivalent HPV (HPV4) vaccine safety surveillance and to contribute to a comprehensive HPV vaccine program evaluation. Methods AEFIs following HPV4 vaccine (Gardasil ® ) administered between September 1, 2007 and December 31, 2011 were extracted from the province's reportable disease system. Confirmed AEFI reports among females 12–15 years old (i.e. assumed to have received vaccine through the program) were included. Events were grouped according to provincial AEFI case definitions. Rates were calculated using doses distributed as the denominator. Results Between 2007 and 2011, 133 confirmed AEFIs were reported while 691,994 HPV4 vaccine doses were distributed in the school-based program. The overall reporting rate was 19.2 HPV4 AEFI per 100,000 doses distributed. Annual reporting rates decreased from 30.0 to 18.3 per 100,000 doses distributed. Frequently reported events included ‘allergic reaction—dermatologic/mucosa’ (25%), ‘rash’ (22%), and ‘local/injection site reaction’ (20%); 26% of reports had a non-specific event of ‘other severe/unusual events’ selected. Ten serious AEFIs were reported (7.5% of reports) including 2 anaphylaxis, 2 seizures, 1 thrombocytopenia and 1 death. Further review found that the reports of anaphylaxis did not meet the Brighton anaphylaxis definition and the death was attributed to a preexisting cardiac condition. Conclusions Overall these findings are consistent with the safety profile of HPV4 vaccine from pre-licensure clinical trials and post-marketing surveillance reports and importantly, no new safety signals were identified, especially no reports of VTE in this younger female population. Continued assessment of HPV4 AEFI surveillance data may be important to detect and investigate safety signals.