A nationwide epidemiological survey of adolescent patients with diverse symptoms similar to those following human papillomavirus vaccination: background prevalence and incidence for considering vaccine safety in Japan.

Background Since June 2013, Japan has suspended proactive recommendation of human papillomavirus (HPV) vaccination due to self-reported diverse symptoms, including pain and motor dysfunction, as possible serious adverse events following immunization. Although these symptoms may be seen in adolescents without HPV vaccination, their frequency taking into account disease severity has not been examined. Methods A two-stage, descriptive, nationwide epidemiological survey was conducted in 2016 with a 6-month targeted period from July 1 to December 31, 2015 to estimate the prevalence and incidence of diverse symptoms among Japanese adolescents without HPV vaccination. Participants were 11,037 medical departments in hospitals selected nationwide by stratified random sampling. Eligible patients had to satisfy four criteria: (1) aged 12-18 years upon visiting hospital; (2) having at least one of four symptoms/disorders (pain or sensory dysfunction, motor dysfunction, autonomic dysfunction, or cognitive impairment); (3) symptoms/disorders persisting for at least three months; and (4) both criteria (2) and (3) influence attendance at school or work. We further extracted patients with diverse symptoms similar to those after HPV vaccination while considering opinions of doctors in charge. Results Estimated 6-month period prevalence of diverse symptoms among girls aged 12-18 years without HPV vaccination was 20.2 per 100,000. Annual incidence was estimated to be 7.3 per 100,000. Conclusion Adolescent Japanese girls without HPV vaccination also visited hospitals with diverse symptoms similar to those following HPV vaccination. Our findings predicted the medical demands for diverse symptoms that are temporally associated with but not caused by vaccination of Japanese adolescents.