[Safety of the bivalent human papillomavirus vaccine--results following administration of more than 192,000 doses].
OBJECTIVE
To study the safety profile of the bivalent human papillomavirus (HPV) vaccine following administration of a first dose to 192,119 13-16-year-old girls in the context of a catch-up campaign.


METHODS
Descriptive.


METHODS
The safety of the HPV campaign underwent surveillance in three ways: via a spontaneous reporting system, whereby anyone could report a possible undesirable effect; following completion and validation a diagnosis was made and the causal relationship with the vaccination assessed. Secondly, general healthcare service (GGD) physicians reported effects that occurred during the vaccination sessions. Thirdly, we conducted a questionnaire survey of frequent possible side effects, in which we asked about effects that occurred up to 1 week after the vaccine.


RESULTS
446 reports were received via the spontaneous reporting system (degree of reporting: 23.2:10,000). 16% of reports were mainly local effects; 84% were systemic effects, including 8 severe effects. 157 girls consulted their general practitioner or went to a hospital (degree of reporting: 8:10,000). 59% of the reports were of a side effect; in 41% a concurrent event was coincidental. There were 638 reports during the vaccination sessions (degree of reporting 45:10,000). The largest number were vasovegetative effects, including fainting or near-fainting (n = 569; degree of reporting: 40:10,000). The degree of reporting of tightness of the chest or skin effects was 2:10,000. The assistance of a general practitioner or ambulance was summoned for 10 girls (degree of reporting: 0.7:10,000). The questionnaire study (response 68.7%; n = 3646) showed that 92.1% of the girls had local effects. In 1.6% these symptoms were severe. Systemic effects occurred in 91.7%; 0.7% had fever (>or= 39.5 degrees C). 1.5% of girls called for medical assistance.


CONCLUSIONS
During intensive surveillance of safety of the HPV campaign, no unexpected or serious side effects with a causal relationship with the vaccination occurred following administration of 192,119 doses. In accordance with data from foreign studies, side effects may be common, but are in general mild and short-lived.
van der Maas
Nicoline A T
NA
Rijksinstituut voor Volksgezondheid en Milieu, Centrum Infectieziektebestrijding, Bilthoven, The Netherlands. nicoline.van.der.maas@rivm.nl
Kemmeren
Jeanet M
JM
de Melker
Hester E
HE
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D009426:Netherlands; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control / Q000821:virology; D014611:Vaccination / Q000592:standards
D053918:Papillomavirus Vaccines