Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States

Human Vaccines and Immunotherapeutics

Volumn 10, Issue 1, 2014, Pages 232-237

  Ojha, Rohit P ^a   Jackson, Bradford E ^b   Tota, Joseph E ^c   Offutt Powell, Tabatha N ^d   Singh, Karan P ^b   Bae, Sejong ^b  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b University of Alabama at Birmingham   (United States)

^c MCGILL UNIVERSITY   (Canada)

^d Delaware Health and Social Services   (United States)

Author keywords

Adverse event; Guillain Barre syndrome; Human papillomavirus; Post marketing surveillance; Safety; Vaccine

Indexed keywords

WART VIRUS VACCINE;

ADULT; ARTICLE; CHILD; CONTROLLED STUDY; DRUG SAFETY; FEMALE; GUILLAIN BARRE SYNDROME; HEALTH CARE PERSONNEL; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 4; LATENT PERIOD; MALE; MEDICAL INFORMATION; PAPILLOMAVIRUS INFECTION; POSTMARKETING SURVEILLANCE; SCHOOL CHILD; SENSITIVITY ANALYSIS; SENSITIVITY AND SPECIFICITY; UNITED STATES; VACCINATION;

EID: 84894486985     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.26292     Document Type: Article

References (37)

1. Yuki N, Hartung HP. Guillain-Barré syndrome. N Engl J Med 2012; 366:2294-304; PMID:22694000; http://dx.doi.org/10.1056/NEJMra1114525
2. Sejvar JJ, Baughman AL, Wise M, Morgan OW. Population incidence of Guillain-Barré syndrome: a systematic review and meta-analysis. Neuroepidemiology 2011; 36:123-33; PMID:21422765; http://dx.doi.org/10.1159/ 000324710
3. Drouet PL, Faivre G, Lamy P, Larcan A. [Guillain-Barré syndrome appearing after an antismallpox vaccination]. Rev Med Nancy 1956; 81:22-6; PMID:13323743
4. Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, Keenlyside RA, Ziegler DW, Retailliau HF, Eddins DL, Bryan JA. Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976 - 1977. Am J Epidemiol 1979; 110:105-23; PMID:463869
5. Stratton KRFA, Rusch E, Clayton EW. Adverse Effects of Vaccines: Evidence and Causality. Washington DC: National Academies Press 2012.
6. Poland GA, Jacobsen SJ. Influenza vaccine, Guillain-Barré syndrome, and chasing zero. Vaccine 2012; 30:5801-3; PMID:22883638; http://dx.doi.org/10.1016/j.vaccine.2012.06.093
7. Kelso JM. Safety of influenza vaccines. Curr Opin Allergy Clin Immunol 2012; 12:383-8; PMID:22766619; http://dx.doi.org/10.1097/ACI.0b013e328354395d
8. Burwen DR, Sandhu SK, MaCurdy TE, Kelman JA, Gibbs JM, Garcia B, Markatou M, Forshee RA, Izurieta HS, Ball R; Safety Surveillance Working Group. Surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2009-2010. Am J Public Health 2012; 102:1921-7; PMID:22970693; http://dx.doi.org/10.2105/AJPH.2011.300510
9. Lehmann HC, Hartung HP, Kieseier BC, Hughes RA. Guillain-Barré syndrome after exposure to influenza virus. Lancet Infect Dis 2010; 10:643-51; PMID:20797646; http://dx.doi.org/10.1016/S1473-3099(10)70140-7
10. Haber P, Sejvar J, Mikaeloff Y, DeStefano F. Vaccines and Guillain-Barré syndrome. Drug Saf 2009; 32:309-23; PMID:19388722; http://dx.doi.org/10.2165/00002018-200932040-00005
11. Salmon DA, Proschan M, Forshee R, Gargiullo P, Bleser W, Burwen DR, Cunningham F, Garman P, Greene SK, Lee GM, et al.; H1N1 GBS Meta-Analysis Working Group. Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis. Lancet 2013; 381:1461-8; PMID:23498095; http://dx.doi.org/10.1016/S0140-6736(12) 62189-8
12. Dodd CN, Romio SA, Black S, Vellozzi C, Andrews N, Sturkenboom M, Zuber P, Hua W, Bonhoeffer J, Buttery J, et al.; Global H1N1 GBS Consortium. International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines. Vaccine 2013; 31:4448-58; PMID:23770307; http://dx.doi.org/10.1016/j.vaccine.2013.06.032
13. Polakowski LL, Sandhu SK, Martin DB, Ball R, Macurdy TE, Franks RL, Gibbs JM, Kropp GF, Avagyan A, Kelman JA, et al. Chart-Confirmed Guillain-Barre Syndrome After 2009 H1N1 Influenza Vaccination Among the Medicare Population, 2009-2010. Am J Epidemiol 2013; (Forthcoming); PMID:23652165; http://dx.doi.org/10.1093/aje/kwt051
14. Wise ME, Viray M, Sejvar JJ, Lewis P, Baughman AL, Connor W, Danila R, Giambrone GP, Hale C, Hogan BC, et al. Guillain-Barre syndrome during the 2009-2010 H1N1 influenza vaccination campaign: population-based surveillance among 45 million Americans. Am J Epidemiol 2012; 175:1110-9; PMID:22582209; http://dx.doi.org/10.1093/aje/kws196
15. Greene SK, Rett M, Weintraub ES, Li L, Yin R, Amato AA, Ho DT, Sheikh SI, Fireman BH, Daley MF, et al. Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010. Am J Epidemiol 2012; 175:1100-9; PMID:22582210; http://dx.doi.org/10.1093/aje/kws195
16. Tokars JI, Lewis P, DeStefano F, Wise M, Viray M, Morgan O, Gargiullo P, Vellozzi C. The risk of Guillain-Barré syndrome associated with influenza A (H1N1) 2009 monovalent vaccine and 2009-2010 seasonal influenza vaccines: results from self-controlled analyses. Pharmacoepidemiol Drug Saf 2012; 21:546-52; PMID:22407672; http://dx.doi.org/10.1002/pds.3220
17. De Wals P, Deceuninck G, Toth E, Boulianne N, Brunet D, Boucher RM, Landry M, De Serres G. Risk of Guillain-Barré syndrome following H1N1 influenza vaccination in Quebec. JAMA 2012; 308:175-81; PMID:22782419; http://dx.doi.org/10.1001/jama.2012.7342
18. Yih WK, Lee GM, Lieu TA, Ball R, Kulldorff M, Rett M, Wahl PM, McMahill-Walraven CN, Platt R, Salmon DA. Surveillance for adverse events following receipt of pandemic 2009 H1N1 vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) System, 2009-2010. Am J Epidemiol 2012; 175:1120-8; PMID:22582207; http://dx.doi.org/10.1093/aje/kws197
19. Yin JK, Khandaker G, Rashid H, Heron L, Ridda I, Booy R. Immunogenicity and safety of pandemic influenza A (H1N1) 2009 vaccine: systematic review and meta-analysis. Influenza Other Respi Viruses 2011; 5:299-305; PMID:21668694; http://dx.doi.org/10.1111/j.1750-2659.2011.00229.x
20. Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007; 56(RR-2):1-24; PMID:17380109
21. Centers for Disease Control and Prevention (CDC). FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2010; 59:630-2; PMID:20508594
22. Souayah N, Michas-Martin PA, Nasar A, Krivitskaya N, Yacoub HA, Khan H, Qureshi AI. Guillain-Barré syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006-2009. Vaccine 2011; 29:886-9; PMID:20869467; http://dx.doi.org/10.1016/j.vaccine.2010.09.020
23. Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009; 302:750-7; PMID:19690307; http://dx.doi.org/10.1001/jama.2009.1201
24. Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, Kulldorff M, Lewis E, Fireman B, Daley MF, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine 2011; 29:8279-84; PMID:21907257; http://dx.doi.org/10.1016/j.vaccine.2011.08.106
25. Slade BA, Gee J, Broder KR, Vellozzi C. Comment on the contribution by Souayah et al., "Guillain-Barré syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006-2009". Vaccine 2011; 29:865-6; PMID:21111783; http://dx.doi.org/10.1016/j.vaccine.2010.11.031
26. Centers for Disease Control and Prevention. Vaccine Adverse Event Reporting System. Available from: http://vaershhsgov/data/index Accessed March 7, 2013.
27. Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, Chen RT. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 2004; 23:287-94; PMID:15071280; http://dx.doi.org/10.1097/00006454-200404000-00002
28. Stratton KR, Howe CJ, Johnson RB. Adverse Events Associated with Childhood Vaccines:Evidence Bearing on Causality. Washington DC: National Academy Press, 1994.
29. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001; 10:483-6; PMID:11828828; http://dx.doi.org/10. 1002/pds.677
30. Lash TL, Fox MP, Fink AK. Applying quantitative bias analysis to epidemiologic data. New York, NY: Springer Science+Business Media, LLC, 2009.
31. Sejvar JJ, Kohl KS, Gidudu J, Amato A, Bakshi N, Baxter R, Burwen DR, Cornblath DR, Cleerbout J, Edwards KM, et al.; Brighton Collaboration GBS Working Group. Guillain-Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2011; 29:599-612; PMID:20600491; http://dx.doi.org/10.1016/j.vaccine.2010.06.003
32. Kohl KS, Magnus M, Ball R, Halsey N, Shadomy S, Farley TA. Applicability, reliability, sensitivity, and specificity of six Brighton Collaboration standardized case definitions for adverse events following immunization. Vaccine 2008; 26:6349-60; PMID:18805456; http://dx.doi.org/10.1016/j.vaccine.2008.09. 002
33. Greenland S. Interpreting time-related trends in effect estimates. J Chronic Dis 1987; 40(Suppl 2):17S-24S; PMID:3667863; http://dx.doi.org/10.1016/ S0021-9681(87)80005-X
34. Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf 2004; 13:519-23; PMID:15317031; http://dx.doi.org/10.1002/pds.1001
35. Poland GA, Jacobson RM. The clinician's guide to the anti- vaccinationists' galaxy. Hum Immunol 2012; 73:859-66; PMID:22504410; http://dx.doi.org/10.1016/j.humimm.2012.03.014
36. Jemal A, Simard EP, Dorell C, Noone AM, Markowitz LE, Kohler B, Eheman C, Saraiya M, Bandi P, Saslow D, et al. Annual Report to the Nation on the Status of Cancer, 1975-2009, featuring the burden and trends in human papillomavirus(HPV)-associated cancers and HPV vaccination coverage levels. J Natl Cancer Inst 2013; 105:175-201; PMID:23297039; http://dx.doi.org/10.1093/ jnci/djs491
37. Zimet GD, Rosberger Z, Fisher WA, Perez S, Stupiansky NW. Beliefs, behaviors and HPV vaccine: Correcting the myths and the misinformation. Prev Med 2013; (Forthcoming); PMID:23732252; http://dx.doi.org/10.1016/j.ypmed.2013.05. 013