Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: Cohort study

BMJ (Online)

Volumn 347, Issue 7930, 2013, Pages

  Arnheim Dahlström, Lisen ^a   Pasternak, Björn ^b   Svanström, Henrik ^b   Sparén, Pär ^a   Hviid, Anders ^b  

^a KAROLINSKA INSTITUTE   (Sweden)

^b STATENS SERUM INSTITUT   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

WART VIRUS VACCINE;

ADOLESCENT; ADVERSE OUTCOME; ARTICLE; AUTOIMMUNE DISEASE; BEHCET DISEASE; CHILD; COHORT ANALYSIS; CONTROLLED STUDY; DENMARK; DRUG SAFETY; EDUCATIONAL STATUS; EPILEPSY; FEMALE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PARALYSIS; PRIORITY JOURNAL; RAYNAUD PHENOMENON; RISK ASSESSMENT; RISK FACTOR; SCHOOL CHILD; SENSITIVITY ANALYSIS; SOCIAL STATUS; SWEDEN; VACCINATION; VACCINE FAILURE; VENOUS THROMBOEMBOLISM;

ADOLESCENT; AUTOIMMUNE DISEASES; CHILD; COHORT STUDIES; DENMARK; FEMALE; HUMANS; INCIDENCE; NERVOUS SYSTEM DISEASES; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; RISK FACTORS; SWEDEN; VENOUS THROMBOEMBOLISM;

EID: 84886603337     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.f5906     Document Type: Article

References (28)

1. Medical Products Agency. Vaccination against human papillomavirus (HPV) vaccine Gardasil and Cervarix. 2012. [In Swedish.] www.lakemedelsverket.se/ OVRIGA-SIDOR/HPV-vaccinering/.
2. Wraith DC, Goldman M, Lambert PH. Vaccination and autoimmune disease: what is the evidence? Lancet 2003;362:1659-66. (Pubitemid 37443537)
3. Siegrist CA. Autoimmune diseases after adolescent or adult immunization: what should we expect? CMAJ 2007;177:1352-4.
4. Trim K, Nagji N, Elit L, Roy K. Parental knowledge, attitudes, and behaviours towards human papillomavirus vaccination for their children: a systematic review from 2001 to 2011. Obstet Gynecol Int 2012;2012:921236.
5. Laz TH, Rahman M, Berenson AB. An update on human papillomavirus vaccine uptake among 11-17 year old girls in the United States: national health interview survey, 2010. Vaccine 2012;30:3534-40.
6. Nohynek H, Jokinen J, Partinen M, Vaarala O, Kirjavainen T, Sundman J, et al. AS03 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland. PLoS One 2012;7:e33536.
7. Medical Products Agency. Occurrence of narcolepsy with cataplexy among children and adolescents in relation to the H1N1 pandemic and Pandemrix vaccinations. Secondary occurrence of narcolepsy with cataplexy among children and adolescents in relation to the H1N1 pandemic and Pandemrix vaccinations 2011. www.lakemedelsverket.se/upload/nyheter/2011/Fallinventeringsrapport- pandermrix-110630.pdf.
8. Salmon DA, Proschan M, Forshee R, Gargiullo P, Bleser W, Burwen DR, et al. Association between Guillain-Barre syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis. Lancet 2013;381:1461-8.
9. Lu B, Kumar A, Castellsague X, Giuliano AR. Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review and meta-analysis. BMC Infect Dis 2011;11:13.
10. Van Klooster TM, Kemmeren JM, van der Maas NA, de Melker HE. Reported adverse events in girls aged 13-16 years after vaccination with the human papillomavirus (HPV)-16/18 vaccine in the Netherlands. Vaccine 2011;29:4601-7.
11. Block SL, Brown DR, Chatterjee A, Gold MA, Sings HL, Meibohm A, et al. Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine. Pediatr Infect Disease J 2010;29:95-101.
12. Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, et al. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin 2009;5:332-40.
13. Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009;302:750-7.
14. Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine 2011;29:8279-84.
15. Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med 2012;271:193-203.
16. Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med 2012:166:1140-8.
17. Callreus T, Svanstrom H, Nielsen NM, Poulsen S, Valentiner-Branth P, Hviid A. Human papillomavirus immunisation of adolescent girls and anticipated reporting of immune-mediated adverse events. Vaccine 2009;27:2954-8.
18. Ludvigsson JF, Otterblad-Olausson P, Pettersson BU, Ekbom A. The Swedish personal identity number: possibilities and pitfalls in healthcare and medical research. Eur J Epidemiol 2009;24:659-67.
19. Pedersen CB, Gotzsche H, Moller JO, Mortensen PB. The Danish Civil Registration System. A cohort of eight million persons. Dan Med Bull 2006;53:441-9. (Pubitemid 44816920)
20. Hviid A. Postlicensure epidemiology of childhood vaccination: the Danish experience. Expert Rev Vaccines 2006;5:641-9. (Pubitemid 46021046)
21. Kildemoes HW, Sorensen HT, Hallas J. The Danish National Prescription Registry. Scand J Public Health 2011;39:38-41.
22. Leval A, Herweijer E, Ploner A, Eloranta S, Fridman Simard S, Dillner J, et al. Quadrivalent HPV-vaccine effectiveness on genital warts: a population-based study in over 2.2 million women including dose evaluation. J Natl Cancer Inst 2013 (in press).
23. Wettermark B, Hammar N, Fored CM, Leimanis A, Otterblad Olausson P, Bergman U, et al. The new Swedish Prescribed Drug Register-opportunities for pharmacoepidemiological research and experience from the first six months. Pharmacoepidemiol Drug Safety 2007;16:726-35. (Pubitemid 47180362)
24. Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health 2011;39:30-3.
25. Ludvigsson JF, Andersson E, Ekbom A, Feychting M, Kim JL, Reuterwall C, et al. External review and validation of the Swedish national inpatient register. BMC Public Health 2011;11:450.
26. Chao C, Jacobsen SJ. Evaluation of autoimmune safety signal in observational vaccine safety studies. Hum Vaccin Immunother 2012;8:1302-4.
27. Rasmussen TA, Jorgensen MR, Bjerrum S, Jensen-Fangel S, Stovring H, Ostergaard L, et al. Use of population based background rates of disease to assess vaccine safety in childhood and mass immunisation in Denmark: nationwide population based cohort study. BMJ 2012;345:e5823.
28. Farrington CP, Nash J, Miller E. Case series analysis of adverse reactions to vaccines: a comparative evaluation. Am J Epidemiol 1996;143:1165-73. (Pubitemid 26158114)