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Vaccine Safety Publications

Recent CDC Vaccine Safety Publications by Year

2017 Publications

Moro P, Baumblatt J, Lewis P, Cragan J, Tepper N, Cano M. Surveillance of Adverse Events After Seasonal Influenza Vaccination in Pregnant Women and Their Infants in the Vaccine Adverse Event Reporting System, July 2010-May 2016. Drug Saf. (2017;40(2):145-152. doi: 10.1007/s40264-016-0482-1

Myers, T.R., McNeil, M.M., Ng, C.S. et al. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo) reported to the Vaccine Adverse Event Reporting System (VAERS), 2010-2015. Vaccine (2017). doi: 10.1016/j.vaccine.2017.02.030

2016 Publications

Moro PL, Cragan J, Lewis P, Sukumaran L. Major Birth Defects after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990 to 2014. Birth Defects Res (2017).doi: 10.1002/bdra.23622

Moro PL, Sukumaran L. Cholera vaccination: pregnant women excluded no more. Lancet Infect Dis (2017);17(5):469-470. doi: 10.1016/S1473-3099(17)30055-5.

Chen RT, Moro PL, Bauwens J, Bonhoeffer J. Obstetrical and neonatal case definitions for immunization safety data. Vaccine (2016);34(49):5991-5992. doi: 10.1016/j.vaccine.2016.08.026.

Moro PL, Woo EJ, Paul W, Lewis P, Petersen BW, Cano M. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015. PLoS Negl Trop Dis (2016);10(7):e0004846. doi: 10.1371/journal.pntd.0004846.

Moro PL, Li R, Haber P, Weintraub E, Cano M. Surveillance systems and methods  for monitoring the post-marketing safety of influenza vaccines at the Centers for Disease Control and Prevention. Expert Opin Drug Saf (2016);15(9):1175-83. doi: 10.1080/14740338.2016.1194823.

Moro PL, Cragan J, Tepper N, Zheteyeva Y, Museru O, Lewis P, Broder K. Enhanced surveillance of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011-2015. Vaccine (2016);34(20):2349-53. doi: 10.1016/j.vaccine.2016.03.049.

Lindsey NP, Rabe IB, Miller ER, Fischer M, Staples JE. Adverse event reports following yellow fever vaccination, 2007-13. J Travel Med. 2016 Jul 4;23(5). doi: 10.1093/jtm/taw045

Miller ER, Moro PL, Cano M, Lewis P, Bryant-Genevier M, Shimabukuro TT. Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990–2013. Vaccine 2016, 34 (25): 2841-2846. doi: 10.1016/j.vaccine.2016.04.021.

Su JR. Miller ER. Duffy J. Baer BM. Cano MV. Notes from the Field:Administration error involving a meningococcal conjugate vaccine-United States, March 1, 2010-Sept. 22, 2015. MMWR 2016 65(06);161-162. doi: 10.15585/mmwr.mm6506a4.

Moro, P., Baumblatt, J., Lewis, P. et al. Surveillance of Adverse Events After Seasonal Influenza Vaccination in Pregnant Women and Their Infants in the Vaccine Adverse Event Reporting System, July 2010–May 2016.  Drug Saf (2016). doi:10.1007/s40264-016-0482-1

2015 Publications

Abrams JY, Weintraub ES, Baggs JM, McCarthy NL, Schonberger LB, Lee GM, et al. Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006. Vaccine. 2015 Jan 3;33(2):382-7.
 

Baker MA, Kaelber DC, Bar-Shain DS, Moro PL, Zambarano B, Mazza M, et al. Advanced clinical decision support for vaccine adverse event detection and reporting. Clin Infect Dis. 2015 Sep 15;61(6):864-70. Epub 2015 Jun 9.
 

Chen RT, Shimabukuro TT, Martin DB, Zuber PL, Weibel DM, Sturkenboom M. Enhancing vaccine safety capacity globally: A lifecycle perspective. Vaccine. Epub 2015 Sep 30.
 

Datwani H, Moro PL, Harrington T, Broder K. Chorioamnionitis following vaccination in the Vaccine Adverse Event Reporting System. Vaccine. 2015 Jun 17;33(27):3110-3. Epub 2015 May 11.
 

Duffy J, Weintraub E, Vellozzi C, DeStefano F; Vaccine Safety Datalink. Narcolepsy and influenza A(H1N1) pandemic 2009 vaccination in the United States. Neurology. 2014 Nov 11;83(20):1823-30. Epub 2014 Oct 15.
 

Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and control of influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 influenza season. MMWR Morb Mortal Wkly Rep. 2015 Aug 7;64(30):818-25.
 

Haber P, Parashar UD, Haber M, DeStefano F. Intussusception after monovalent rotavirus vaccine—United States, Vaccine Adverse Event Reporting System (VAERS), 2008–2014. Vaccine. 2015 Sep 11;33(38):4873-7. Epub 2015 Aug 11.
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Hibbs BF, Moro PL, Lewis P, Miller ER, Shimabukuro T. Vaccination errors reported to the Vaccine Adverse Event Reporting System, United States, 2000–2013. Vaccine. 2015 Jun 22;33(28):3171-8. Epub 2015 May 14.
 

Iqbal S, Li R, Gargiullo P, Vellozzi C. Relationship between Guillain-Barré syndrome, influenza-related hospitalizations, and influenza vaccine coverage. Vaccine. 2015 Apr 21;33(17):2045-9. Epub 2015 Mar 4.
 

Iqbal S, Shi J, Seib K, Lewis P, Moro PL, Woo EJ, et al.  Preparation for global introduction of inactivated poliovirus vaccine: Safety evidence from the US Vaccine Adverse Event Reporting System, 2000-2012. Lancet Infect Dis. 2015 Oct;15(10):1175-82. Epub 2015 Aug 16.
 

Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway A, et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA. 2014 Nov 12;312(18):1897-904.
 

Klein NP, Lewis E, Fireman B, Hambidge SJ, Naleway A, Nelson JC, et al. Safety of measles-containing vaccines in 1-Year-old children. Pediatrics. 2015 Feb;135(2):e321-9. Epub 2015 Jan 5.
 

Lopalco PL, DeStefano F. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines. Vaccine. 2015 Mar 24;33(13):1541-8. Epub 2014 Nov 4.
 

McNamara LA, Shumate AM, Johnsen P, MacNeil JR, Patel M, Bhavsar T, et al. First use of a serogroup B meningococcal vaccine in the us in response to a university outbreak. Pediatrics. 2015 May;135(5):798-804.
 

McNeil MM, Weintraub E, Duffy J, Sukumaran L,  Jacobsen SJ, Klein NP, et al. Risk of anaphylaxis following vaccination in children and adults. J Allergy Clin Immunol. Epub 2015 Sep 28.
 

Miller ER, Moro PL, Cano M, Shimabukuro T. Deaths following vaccination: What does the evidence show? Vaccine. 2015 Jun 26;33(29):3288-92. Epub 2015 May 23.
 

Miller ER, Shimabukuro T, Hibbs B, Moro P, Broder K, Vellozzi C. Vaccine safety resources for nurses. Am J Nurs. 2015 Aug; 115(8):55-58.
 

Moro PL, Arana J, Cano M, Lewis P, Shimabukuro TT. Deaths reported to the Vaccine Adverse Event Reporting System, United States, 1997-2013. Clin Infect Dis. 2015 Sep 15;61(6):980-7. Epub 2015 May 28.
 

Moro PL, Jankosky C, Menschik D, Lewis P, Duffy J, Stewart B, et al. Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013. J Pediatr. 2015 Apr;166(4):992-7. Epub 2015 Jan 15.
 

Moro PL, McNeil MM, Sukumaran L, Broder KR. The Centers for Disease Control and Prevention’s public health response to monitoring Tdap safety in pregnant women in the United States. Hum Vaccin Immunother. Epub 2015 Sep 17.
 

Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, et al. Safety of quadrivalent human papillomavirus vaccine (Gardasil®) in pregnancy: Adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013. Vaccine. 2015 Jan; 33(4): 519-22.
 

Payne DC, Baggs J, Klein NP, Parashar UD. Does preventing rotavirus infections through vaccination also protect against naturally occurring intussusception over time? Clin Infect Dis. 2015 Jan 1;60(1):163-4.
 

Petrosky E, Bocchini JA Jr, Hariri S, Chesson H, Curtis CR, Saraiya M, et al; Centers for Disease Control and Prevention (CDC). Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep. 2015 Mar 27;64(11):300-4.
 

Rabe IB, Miller ER., Fischer M, Hills SL. Adverse events following vaccination with an inactivated, Vero cell culture-derived Japanese encephalitis vaccine in the United States, 2009-2012. Vaccine. 2015 Jan 29;33(5):708-12.
 

Rha B, Tate JE, Weintraub E, Haber P, Yen C, Patel M, Cortese MM. Intussusception following rotavirus vaccination: An updated review of the available evidence. Expert Rev Vaccines. 2014 Nov;13(11):1339-48. Epub 2014 Jul 26.
 

Stratton KG, Cook AJ, Jackson LA, Nelson JC. Simulation study comparing exposure matching with regression adjustment in an observational safety setting with group sequential monitoring. Stat Med. 2015 Mar 30;34(7):1117-33.
 

Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015 Aug 26;33(36):4398-405. Epub 2015 Jul 22.
 

Sukumaran L, McCarthy NL, Kharbanda EO, McNeil MM, Naleway AL, Klein NP, et al. Association of Tdap vaccination with acute events and adverse birth outcomes among pregnant women with prior tetanus-containing immunizations. JAMA. 2015 Oct 20;314(15):1581-1587.
 

Sukumaran L, McCarthy NL, Kharbanda EO, Weintraub ES, Vasquez-Benitez G, McNeil MM, et al. Safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis and influenza vaccinations in pregnancy. Obstet Gynecol. 2015 Nov;126(5):1069-74.
 

Sukumaran L, McCarthy NL, Li R, Weintraub ES, Jacobsen SJ, Hambidge SJ, et al. Demographic characteristics of members of the Vaccine Safety Datalink (VSD): A comparison with the United States population. Vaccine. 2015 Aug 26;33(36):4446-50. Epub 2015 Jul 23.
 

Sukumaran L, McNeil MM, Moro PL, Lewis PW, Winiecki SK, Shimabukuro TT. Adverse events following measles, mumps, and rubella vaccine in adults reported to the Vaccine Adverse Event Reporting System (VAERS), 2003-2013. Clin Infect Dis. 2015 May 15;60(10):e58-65.

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2014 Publications

Briere EC, Rubin L, Moro PL, Cohn A, Clark T, Messonnier N. Prevention and control of haemophilus influenzae type b disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2014 Feb 28;63(RR-01):1-14
Daley MF, Yih WK, Glanz JM, Hambidge SJ, Narwaney KJ, Yin R, et al. Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccineVaccine. 2014;32(25):3019-3024.
Duffy J, Weintraub, E, Vellozzi, C, DeStefano F. Narcolepsy and influenza A(H1N1) pandemic 2009 vaccination in the United StatesNeurology. 2014;83(20):1823-30.
Grohskopf LA, Olsen SJ, Sokolow LZ, Bresee JS, Cox NJ, et al. Prevention and control of seasonal influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) — United States, 2014–15 influenza seasonMMWR. 2014 Aug 15;63(32):691-697.
Haber P, Moro PL, McNeil MM, Lewis P, Woo EJ, Hughes H, Shimabukuro TT. Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013. Vaccine. 2014 Nov;32(48):6499-504.
Haber P, Moro PL, McNeil MM, Lewis P, Woo EJ, Hughes H, et al. Post-licensure surveillance of trivalent live attenuated influenza vaccine in children aged 2-18 years, Vaccine Adverse Event Reporting System (VAERS), United States, July 2005-June 2012. J Ped Infect Dis. Epub 2014 May 7.
Hambidge SJ, Newcomer SR, Narwaney KJ, Glanz JM, Daley MF, Xu S, et al. Timely versus delayed early childhood vaccination and seizures. Pediatrics. 2014 Jun;133(6):e1492-9.
Hibbs BF, Miller ER, Shimabukuro T; Centers for Disease Control and Prevention (CDC). Notes from the field: Rotavirus vaccine administration errors–United States, 2006-2013. MMWR. 2014 Jan;63(4):81.
Hofstetter AM, Jakob K, Klein NP, Dekker CL, Edwards KM, et al. Live vaccine use and safety in DiGeorge syndrome. Pediatrics. 2014 Apr;133(4):e946-54.
Jackson ML, Peterson D, Nelson JC, Greene SK, Jacobsen SJ, Belongia EA, et al. Using winter 2009-2010 to assess the accuracy of methods which estimate influenza-related morbidity and mortality. Epidemiol Infect. 2014 Dec 12:1-9.
Kawai AT, Li L, Kulldorff M, Vellozzi C, Weintraub E, Baxter R, et al. Absence of associations between influenza vaccines and increased risks of seizures, Guillain-Barre syndrome, encephalitis, or anaphylaxis in the 2012-2013 season. Pharmacoepidemiol Drug Saf. 2014;23(5):548-553.
Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway A, et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA. 2014 Nov;312(18):1897-904.
Kharbanda EO, Vazquez-Benitez G, Lipkind H, Naleway AL, Klein NP, Cheetham TC, et al. Receipt of pertussis vaccine during pregnancy across 7 Vaccine Safety Datalink sitesPrev Med. 2014 Oct;67:316-9.
Li R, Stewart B, Weintraub E, McNeil MM. Continuous sequential boundaries for vaccine safety surveillance. Stat Med. 2014 Aug 30;33(19):3387-3397.
Lopalco PL, DeStefano F. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines. Vaccine. 2015 Mar 24;33(13):1541-8.
McNeil MM, Cano M, Miller ER, Petersen BW, Engler RJ, Bryant-Genevier MG. Ischemic cardiac events and other adverse events following ACAM2000® smallpox vaccine in the Vaccine Adverse Event Reporting System. Vaccine. 2014 Aug 20;32(37):4758-65.
McNeil MM, Gee J, Weintraub ES, Belongia EA, Lee GM, Glanz JM, et al. The Vaccine Safety Datalink: Successes and challenges monitoring vaccine safetyVaccine. 2014 Sep 22;32(42):5390-5398.
Moro PL, Museru OI, Niu M, Lewis P, Broder K. Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women. Am J Obstet Gynecol. 2014 Jun;210(6):561.e1-6
Naleway AL, Irving SA, Henninger ML, Li DK, Shifflett P, Ball S, et al. Safety of influenza vaccination during pregnancy: A review of subsequent maternal obstetric events and findings from two recent cohort studiesVaccine. 2014;32(26):3122-3127.
Naleway AL, Kurosky S, Henninger ML, Gold R, Nordin JD, Kharbanda EO, et al. Vaccinations given during pregnancy, 2002-2009: a descriptive studyAm J Prev Med. 2014;46(2):150-157.
Nelson JC, Shortreed SM, Yu O, Peterson D, Baxter R, Fireman B, et al. Integrating database knowledge and epidemiological design to improve the implementation of data mining methods to evaluate vaccine safety in large healthcare databasesStat Anal Data Min. 2014 Oct;7(5):337–351.
Nordin JD, Kharbanda EO, Vazquez-Benitez G, Lipkind H, Lee GM, Naleway AL. Monovalent H1N1 influenza vaccine safety in pregnant women, risks for acute adverse events. Vaccine. 2014 Sep 3;32(39):4985-4992.
Nordin JD, Kharbanda EO, Vazquez Benitez G, Lipkind H, Vellozzi C, Destefano F; Vaccine Safety Datalink. Maternal influenza vaccine and risks for preterm or small for gestational age birth. J Pediatr. 2014 May;164(5):1051-1057.e2.
Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, Sharma D, et al. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine. JAMA Pediatr. 2014 Mar;168(3):211-9.
Tartof SY, Tseng HF, Liu IL, Qian L, Sy LS, Hechter RC, et al. Inpatient admission for febrile seizure and subsequent outcomes do not differ in children with vaccine-associated versus non-vaccine associated febrile seizures. Vaccine. 2014;32(48):6408-14.
Tartof SY, Tseng HF, Liu AL, Qian L, Sy LS, Hechter RC, et al. Exploring the risk factors for vaccine-associated and non-vaccine associated febrile seizures in a large pediatric cohortVaccine. 2014;32(22):2574-2581
Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med. 2014 Feb; 370:513-519.
Xu S, Newcomer S, Nelson J, Qian L, McClure D, Pan Y, et al. Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design. Biom J. 2014 May;56(3):513-25.

2013 Publications

Baxter R, Bakshi N, Fireman B, Lewis E, Ray P, Vellozzi C, et al. Lack of association of Guillain-Barre syndrome with vaccinations. Clin Infect Dis. 2013 Jul;57(2):197-204.
 

DeStefano F, Price CS, Weintraub ES. Increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines Is not associated with risk of autism. J Pediatr. 2013 Aug;163(2):561-7.
 

Dodd CN, Romio SA, Black S, Vellozzi C, Andrews N, Sturkenboom M, et al. International collaboration to assess the risk of Guillain Barré Syndrome following influenza A (H1N1) 2009 monovalent vaccines. Vaccine. 2013 Sep;31(40):4448-58.
 

Glanz JM, Narwaney KJ, Newcomer SR, Daley MF, Hambidge SJ, Rowhani-Rahbar A, et al. Association between undervaccination with Diphtheria. Tetanus Toxoids, and Acellular Pertussis (DTaP) vaccine and risk of pertussis infection in children 3 to 36 months of age. JAMA Pediatr. 2013 Nov;167(11):1060-4.
 

Glanz JM, Newcomer SR, Narwaney KJ, Hambidge SJ, Daley MF, Wagner NM, et al. A population-based cohort study of undervaccination in 8 managed care organizations across the United StatesJAMA Pediatr. 2013;167(3):274-281.
 

Gold R, Naleway A, Riedlinger K. Factors predicting completion of the human papillomavirus vaccine seriesJ Adolesc Health. 2013;52(4):427-432.
 

Greene SK, Li L, Shay DK, Fry AM, Lee GM, Jacobsen SJ, et al. Risk of adverse events following oseltamivir treatment in influenza outpatients, Vaccine Safety Datalink Project, 2007-2010Pharmacoepidemiol Drug Saf. 2013;22(4):335-344.
 

Greene SK, Rett MD, Vellozzi C, Li L, Kulldorff M, Marcy SM, et al. Guillain-Barré syndrome, influenza vaccination, and antecedent respiratory and gastrointestinal infections: A case-centered analysis in the Vaccine Safety Datalink, 2009-2011. PLoS One. 2013 Jun;8(6):e67185.
 

Haber P, Patel M, Pan Y, Baggs J, Haber M, Museru O, et al. Intussusception after Rotavirus Vaccines—United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2012. Pediatrics. 2013 Jun;131(6):1042-9.
 

Halsey NA, Griffioen M, Dreskin SC, Dekker CL, Wood R, Sharma D, et al. Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS. Vaccine. 2013 Dec;31(51):6107-12.
 

Hechter RC, Qian L, Sy LS, Greene SK, Weintraub ES, Naleway AL, et al. Secular trends in diagnostic code density in electronic healthcare data from health care systems in the Vaccine Safety Datalink Project. Vaccine. 2013 Feb;31(7):1080-85.
 

Henninger M, Crane B, Naleway A. Trends in influenza vaccine coverage in pregnant women, 2008 to 2012Perm J. 2013;17(2):31-36.
 

Henninger M, Naleway A, Crane B, Donahue J, Irving S. Predictors of seasonal influenza vaccination during pregnancyObstet Gynecol. 2013;121(4):741-749.
 

Iqbal S, Barile JP, Thompson WW, DeStefano F. Number of antigens in early childhood vaccines and neuropsychological outcomes at age 7-10 yearsPharmacoepidemiol Drug Saf. 2013;22(12):1263-1270.
 

Irving SA, Kieke BA, Donahue JG, Mascola MA, Baggs J, DeStefano F, et al. Trivalent inactivated influenza vaccine and spontaneous abortionObstet Gynecol. 2013;121(1):159-165.
 

Jackson ML, Yu O, Nelson JC, Naleway A, Belongia EA, Baxter R, et al. Further evidence for bias in observational studies of influenza vaccine effectiveness: the 2009 influenza A(H1N1) pandemicAm J Epidemiol. 2013;178(8):1327-1336.
 

Jackson LA, Peterson D, Nelson JC, Marcy SM, Naleway AL, Nordin JD, et al. Vaccination site and risk of local reactions in children 1 through 6 years of age. Pediatrics. 2013 Feb;131(2):283-9.
 

Kharbanda EO, Vazquez-Benitez G, Lipkind H, Naleway A, Lee G, Nordin JD; Vaccine Safety Datalink. Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events. Obstet Gynecol. 2013 Sep;122(3):659-67.
 

Kharbanda EO, Vazquez-Benitez G, Shi WX, Lipkind H, Naleway A, Molitor B, et al. Assessing the safety of influenza immunization during pregnancy: the Vaccine Safety DatalinkAm J Obstet Gynecol. 2012;207(3 Suppl):S47-S51.
 

McCarthy NL, Gee J, Lin ND, Thyagarajan V, Pan Y, Su S, et al. Evaluating the safety of influenza vaccine using a claims-based health system. Vaccine. 2013 Dec;31(50):5975-82.
 

McCarthy NL, Weintraub E, Vellozzi C, Duffy J, Gee J, Donahue JG, et al. Mortality rates and cause-of-death patterns in a vaccinated population. Am J Prev Med. 2013 Jul;45(1):91-7.
 

McCarthy NL, Irving S, Donahue JG, Weintraub E, Gee J, Belongia E, et al. Vaccination coverage levels among children enrolled in the Vaccine Safety Datalink. Vaccine. 2013 Dec;31(49):5822.
 

McNeil MM, Li R, Pickering S, Real TM, Smith PJ, Pemberton MR, et al. Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)? Vaccine. 2013 May;31(24):2673-9. 2013 Apr.
 

Moro PL, Harrington T, Shimabukuro T, Cano M, Museru OI, Menschik D, et al. Adverse events after Fluzone® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011-2013. Vaccine. 2013 Oct;31(43):4984-7.
 

Moro PL, Museru OI, Broder K, Cragan J, Zheteyeva Y, Tepper N, et al. Safety of influenza A (H1N1) 2009 live attenuated monovalent vaccine in pregnant women. Obstet Gynecol. 2013 Dec;122(6):1271-8.
 

Naleway AL, Gold R, Kurosky S, Riedlinger K, Henninger ML, Nordin JD, et al. Identifying pregnancy episodes, outcomes, and mother-infant pairs in the Vaccine Safety DatalinkVaccine. 2013;31(27):2898-2903.
 

Nelson JC, Yu O, Dominguez-Islas CP, Cook AJ, Peterson D, Greene SK, et al. Adapting group sequential methods to observational postlicensure vaccine safety surveillance: Results of a pentavalent combination DTaP-IPV-Hib vaccine safety study. Am J Epidemiol. 2013 Jan;177(2):131-41.
 

Nelson JC, Marsh T, Lumley T, Larson EB, Jackson LA, Jackson M, et al. Validation sampling can reduce bias in health care database studies: an illustration using influenza vaccination effectivenessJ Clin Epidemiol. 2013;66(8 Suppl):S110-S121.
 

Newcomer SR, Hambidge SJ, McClure DL, Daley MF, Klein NP, Glanz JM. Factors that may explain observed associations between trivalent influenza vaccination and gastrointestinal illness in young childrenVaccine. 2013;31(37):3894-3898.
 

Nordin JD, Parker ED, Vazquez-Benitez G, Kharbanda EO, Naleway A, Marcy SM, et al. Safety of the yellow fever vaccine: a retrospective studyJ Travel Med. 2013;20(6):368-373.
 

Nordin JD, Kharbanda EO, Benitez GV, Nichol K, Lipkind H, Naleway A, et al. Maternal safety of trivalent inactivated influenza vaccine in pregnant women. Obstet Gynecol. 2013 Mar;121(3):519-25.
 

Pahud BA, Williams SE, Dekker CL, Halsey N, LaRussa P, et al. Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccinationPediatr Infect Dis J. 2013 Feb;32(2):163-168.
 

Pan Y, Rose CE, Haber M, Ma Y, Carrasco JL, Stewart B, et al. Assessing agreement of repeated binary measurements with an application to the CDC’s anthrax vaccine clinical trial. Int J Biostat. 2013 Jul;9(1). 14.
 

Poli F, Overeem S, Lammers GJ, Plazzi G, Lecendreux M, Bassetti CL, et al. Narcolepsy as an adverse event following immunization: Case definition and guidelines for data collection, analysis and presentation. Vaccine. 2013 Jan;31(6):994-1007.
 

Qian L, Tseng HF, Sy LS, Jacobsen SJ. Confounder adjustment in vaccine safety studies: Comparing three offset terms for case-centered approach. Vaccine. 2013 Jan;31(2):431-5.
 

Rowhani-Rahbar A, Fireman B, Lewis E, Nordin J, Naleway A, Jacobsen SJ, et al. Effect of age on the risk of fever and seizures following immunization with measles-containing vaccines in children. JAMA Pediatr. 2013 Dec;167(12):1111-7.
 

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-analysisLancet. 2013;381(9876):1461-1468.
 

Schmidt MA, Gold R, Kurosky SK, Daley MF, Irving SA, Gee J, et al. Uptake, coverage, and completion of quadrivalent human papillomavirus vaccine in the Vaccine Safety Datalink, July 2006-June 2011. J Adolesc Health. 2013 Nov;53(5):637-41.
 

Thyagarajan V, Su S, Gee J, Duffy J, McCarthy NL, Chan KA, et al. Identification of seizures among adults and children following influenza vaccination using health insurance claims data. Vaccine. 2013 Dec;31(50):5997-6002.
 

Tseng HF, Sy LS, Qian L, Marcy SM, Jackson LA, Glanz J, et al; Vaccine Safety Datalink. Safety of a tetanus-diphtheria-acellular pertussis vaccine when used off-label in an elderly population. Clin Infect Dis. 2013 Feb;56(3):315-21.
 

Williams SE, Edwards KM, Baxter RP, Larussa PS, Halsey NA, et al. Comprehensive assessment of serious adverse events following immunization by health care providersJ Pediatr. 2013 Jun;162(6):1276-81, 1281.e1.
 

Xu S, Hambidge SJ, McClure DL, Daley MF, Glanz JM, et al. A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design. Stat Med. 2013;30;32(19):3290-9.
 

Zeng C, Newcomer SR, Glanz JM, Shoup JA, Daley MF, Hambidge SJ, et al. Bias correction of risk estimates in vaccine safety studies with rare adverse events using a self-controlled case series designAm J Epidemiol.2013;178(12):1750-1759.
 

Zheteyeva Y, Moro PL, Yue X, Broder K. Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: a review of the Vaccine Adverse Event Reporting System. Am J Obstet Gynecol. 2013 Aug;208(6):478.e1-6.
 

2012 Publications

Baxter R, Lewis N, Bakshi N, Vellozzi C, Klein NP; CISA Network. Recurrent Guillain-Barre syndrome following vaccinationClin Infect Dis. 2012 Mar;54(6):800-4.
 

Broder KR, Martin DB, Vellozzi C. In the heat of a signal: Responding to a vaccine safety signal for febrile seizures after 2010–11 influenza vaccine in young children, United States. Vaccine. 2012 Mar;30(11):2032-34.
 

Cano M, Lewis P, Ou AC, Sharma D, Vellozzi C, Broder KR. Bell’s palsy cases following administration of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System (VAERS) [PDF – 1.84 MB]. J Vaccines Vaccin. 2012;3(2)134.
 

Greene SK, Rett M, Weintraub ES, Li L, Yin R, Amato AA, 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, 2009-2010Am J Epidemiol. 2012;175(11):1100-1109.
 

Greene SK, Shay DK, Yin R, McCarthy NL, Baxter R, Jackson ML, et al. Patterns in influenza antiviral medication use before and during the 2009 H1N1 pandemic, Vaccine Safety Datalink Project, 2000-2010Influenza Other Respir Viruses.2012;6(6):e143-e151.
 

Halsey NA, Edwards KM, Dekker CL, Klein NP, Baxter R, et al. Algorithm to assess causality after individual adverse events following immunizations. Vaccine. 2012 Aug 24;30(39):5791-8.
 

Hambidge SJ, Ross C, Glanz J, McClure D, Daley MF, Xu S, et al. Trivalent inactivated influenza vaccine is not associated with sickle cell crises in childrenPediatrics. 2012;129(1):e54-e59.
 

Hechter RC, Qian L, Sy LS, Greene SK, Weintraub ES, Naleway AL, et al. Secular trends in diagnostic code density in electronic healthcare data from health care systems in the Vaccine Safety Datalink projectVaccine. 2012;31(7):1080-1085.
 

Klein NP, Lewis E, Baxter R, Weintraub E, Glanz J, Naleway A, et al. Measles-containing vaccines and febrile seizures in children age 4 to 6 yearsPediatrics. 2012;129(5):809-814.
 

Leroy Z, Broder K, Menschik D, Shimabukuro T, Martin D.  Febrile seizures after 2010–2011 influenza vaccine in young children, United States: A vaccine safety signal from the vaccine adverse event reporting system. Vaccine. 2012;30(11):2020-3.
 

Loughlin AM, Marchant CD, Adams W, Barnett E, Baxter R, et al. Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)Vaccine. 2012 Nov 26;30(50):7253-9.
 

McClure DL, Xu S, Weintraub E, Glanz JM. An efficient statistical algorithm for a temporal scan statistic applied to vaccine safety analysesVaccine. 2012;30(27):3986-3991.
 

Moro PL, Tepper NK, Grohskopf LA, Vellozzi C, Broder K. Safety of seasonal influenza and influenza A (H1N1) 2009 monovalent vaccines in pregnancy. Expert Rev Vaccines. 2012 Aug;11(8):911-21.
 

Moro PL, Arana J, Cano M, Menschik D, Yue Lewis P, Haber P, et al. Postlicensure safety surveillance for high-dose trivalent inactivated influenza vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010–31 December 2010. Clin Infect Dis. 2012;54(11):1608-14.
 

Naleway AL, Gold R, Drew L, Riedlinger K, Henninger ML, Gee J. Reported adverse events in young women following quadrivalent human papillomavirus vaccinationJ Womens Health (Larchmt.). 2012;21(4):425-432.
 

Pahud BA, Rowhani-Rahbar A, Glaser C, Gavali S, Salibay CJ, et al.  Lack of association between childhood immunizations and encephalitis in California, 1998-2008. Vaccine. 2012 Jan 5;30(2):247-53.
 

Rowhani-Rahbar A, Baxter R, Rasgon B, Ray P, Black S, Klein JO, et al. Epidemiologic and clinical features of Bell’s palsy among children in northern CaliforniaNeuroepidemiology. 2012;38(4):252-258.
 

Rowhani-Rahbar A, Fireman B, Lewis N, Ray P, Rasgon B, Klein JO, et al. Rowhani-Rahbar et al. respond to “Immunization and Bell’s palsy in children.” Am J Epidemiol. 2012;175(9):888-889.
 

Rowhani-Rahbar A, Klein NP, Dekker CL, Edwards KM, Marchant CD, et al. Biologically plausible and evidence-based risk intervals in immunization safety researchVaccine. 2012 Dec 17;31(1):271-7.
 

Rowhani-Rahbar A, Klein NP, Lewis N, Fireman B, Ray P, Rasgon B, et al. Immunization and Bell’s palsy in children: a case-centered analysisAm J Epidemiol. 2012;175(9):878-885.
 

Shui IM, Baggs J, Patel M, Parashar UD, Rett M, Belongia EA, et al. Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infantsJAMA. 2012;307(6):598-604.
 

Shui IM, Rett MD, Weintraub E, Marcy M, Amato AA, Sheikh SI, et al. Guillain-Barré syndrome incidence in a large United States cohort (2000-2009)Neuroepidemiology. 2012;39(2):109-115.
 

Stewart B, Rose CE, Tokars JI, Martin SW, Keitel WA, Keyserling HL, et al. Health-related quality of life in the CDC Anthrax Vaccine Adsorbed Human Clinical Trial. Vaccine. 2012 Aug;30(40):5875-9.
 

Tse A, Tseng HF, Greene SK, Vellozzi C, Lee GM, VSD Rapid Cycle Analysis Influenza Working Group. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011Vaccine. 2012;30(11):2024-2031.
 

Tseng HF, Sy LS, Qian L, Marcy SM, Jackson LA, Glanz J, et al; Vaccine Safety Datalink. Safety of a tetanus-diphtheria-acellular pertussis vaccine when used off-label in an elderly population. Clin Infect Dis. 2013 Feb;56(3):315-21.
 

Xu S, Zeng C, Newcomer S, Nelson J, Glanz J. Use of fixed effects models to analyze self-controlled case series data in vaccine safety studiesJ Biom Biostat. 2012;Suppl 7:006.
 

Yih WK, Weintraub E, Kulldorff M. No risk of Guillain-Barré syndrome found after meningococcal conjugate vaccination in two large cohort studiesPharmacoepidemiol Drug Saf. 2012;21(12):1359-1360.
 

Zheteyeva YA, Moro PL, Tepper NK, Rasmussen SA, Barash FE, Revzina NV, et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. Am J Obstet Gynecol. 2012 Jul; 207(1):59.e1-7.
 

2011 Publications

Baggs J, Gee J, Lewis E, Fowler G, Benson P, Lieu T, et al. The Vaccine Safety Datalink: A model for monitoring immunization safety. Pediatrics. 2011 May;127 Suppl 1:S45-53.
 

Barile JP, Kuperminc GP, Weintraub ES, Mink JW, Thompson WW, et al. Thimerosal exposure in early life and neuropsychological outcomes 7-10 years laterJ Pediatr Psychol. 2011;37(1):106-118.
 

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 Oct; 29(46):8279-84.
 

Gidudu J, Sack DA, Pina M, Hudson MJ, Kohl KS, Bishop P, et al. Diarrhea: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2011 Jan;29(5): 1053-71.
 

Glanz JM, Newcomer SR, Hambidge SJ, Daley MF, Narwaney KJ, Xu S, et al. Safety of trivalent inactivated influenza vaccine in children aged 24 to 59 months in the Vaccine Safety DatalinkArch Pediatr Adolesc Med.2011;165(8):749-755.
 

Greene SK, Kulldorff M, Yin R, Yih WK, Lieu TA, Weintraub ES, et al. Near real-time vaccine safety surveillance with partially accrued data. Pharmacoepidemiol Drug Saf. 2011 Jun;20(6):583-90
 

Haber P, Iskander J, Walton K, Campbell SR, Kohl KS., et al. Internet-based reporting to the vaccine adverse event reporting system: a more timely and complete way for providers to support vaccine safety. Pediatrics. 2011 May;127 Suppl 1: S39-44.
 

Hambidge SJ, Ross C, McClure D, Glanz J; VSD team. Trivalent inactivated influenza vaccine is not associated with sickle cell hospitalizations in adults from a large cohortVaccine. 2011;29(46):8179-8181.
 

Huang WT, Suh C, Campagna E, Broder KR, Daley MF, Crane LA, et al. Adherence to the advisory committee on immunization practices recommendation to prevent injuries from postvaccination syncope: A national physician survey. Am J Prev Med. 2011 Sep;41(3):317-21.
 

Jackson LA, Yu O, Nelson JC, Dominguez C, Peterson D, Baxter R, et al. Injection site and risk of medically attended local reactions to acellular pertussis vaccinePediatrics. 2011;127(3):e581-e587.
 

Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovichet P. A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infantsPLoS One. 2011;6(6):e20102.
 

Klein NP, Aukes L, Lee J, Fireman B, Shapira SK, Slade B, et al. Evaluation of immunization rates and safety among children with inborn errors of metabolism. Pediatrics. 2011 May;127(5):e1139-46.
 

Klein NP, Gidudu J, Qiang Y, Pahud B, Rowhani-Rahbar A, Baxter R, et al. Developing the next generation of vaccinologists. Vaccine. 2011 Nov;29(50):9296-97.
 

Kulldorff M, Davis RL, Kolczak M, Lewis E, Lieu T, Platt R. A maximized sequential probability ratio test for drug and vaccine safety surveillance. Seq Anal. 2011 Jan;30(1): 58-78.
 

LaRussa PS, Edwards KM, Dekker CL, Klein NP, Halsey NA, Marchant C, et al. Understanding the role of human variation in vaccine adverse events: The Clinical Immunization Safety Assessment Network. Pediatrics. 2011 May;127 Suppl 1:S65-73.
 

Lee GM, Greene SK, Weintraub ES, Baggs J, Kulldorff M, Fireman BH. H1N1 and seasonal influenza vaccine safety in the Vaccine Safety Datalink projectAm J Prev Med. 2011;41(2):121-128.
 

McCarthy NL, Gee J, Weintraub E, Donahue JG, Nordin JD, Daley MF, et al. Monitoring vaccine safety using the Vaccine Safety Datalink: Utilizing immunization registries for pandemic influenza. Vaccine. 2011 Jul; 29(31):4891-96.
 

Miller EK, Batten B, Hampton L, Campbell SR, Gao J, Iskander J. Tracking vaccine-safety inquiries to detect signals and monitor public concerns. Pediatrics. 2011 May;127 Suppl 1:S87-91.
 

Miller EK, Dumitrescu L, Cupp C, Dorris S, Taylor S, Sparks R. Atopy history and the genomics of wheezing after influenza vaccination in children 6-59 months of age. Vaccine. 2011 Apr;29(18):3431-37.
 

Morgan TM, Schlegel C, Edwards KM, Welch-Burke T, Zhu Y, Sparks R. Vaccines are not associated with metabolic events in children with urea cycle disorders. Pediatrics. 2011 May;127(5):e1147-53.
 

Moro PL, Broder K, Zheteyeva Y, Revzina N, Tepper N, Kissin D, et al. Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System. Am J Obstet Gynecol. 2011; 205(5):473.e1-9.
 

Moro PL, Yue X, Lewis P, Haber P, Broder K. Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine administered to adults 65 years of age and older reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010. Vaccine. 2011;29(50):9404-8.

 

Moro PL, Broder K, Zheteyeva Y, Walton K, Rohan P, Sutherland A, et al. Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009. Am J Obstet Gynecol. 2011 Feb; 204(2):146.e1-7.
 

Mullooly JP, Schuler R, Mesa J, Drew L, DeStefano F; VSD team. Wheezing lower respiratory disease and vaccination of premature infantsVaccine. 2011;29(44):7611-7617.
 

Navar-Boggan AM, Halsey NA, Escobar GJ, Golden WC, Klein NP. Underimmunization in the Neonatal Intensive Care Unit. J Perinatol. 2012 May;32(5):363-7.
 

Nelson JC, Cook AJ, Yu O, et al. Methods for observational post-licensure medical product safety surveillanceStat Methods Med Res. Epub 2 Dec 2011.
 

Nordin JD, Yih WK, Kulldorff M, Weintraub E. Tdap and GBS letter. Vaccine. 2011 Feb;29(6):1122.
 

Pahud BA, Glaser CA, Dekker CL, Arvin AM, Schmid DS. Varicella zoster disease of the central nervous system: Epidemiological, clinical, and laboratory features 10 years after the introduction of the varicella vaccine. J Infect Dis. 2011 Feb;203(3):316-23.
 

Ray P, Black S, Shinefield H, et al. Risk of rheumatoid arthritis following vaccination with tetanus, influenza and hepatitis B vaccines among persons 15-59 years of ageVaccine. 2011;29(38):6592-6597.
 

Salmon DA, Akhtar A, Mergler MJ, Vannice KS, Izurieta H, Ball R, et al. Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program. Pediatrics. 2011 May;127 Suppl 1:S78-86.
 

Slade B, 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 Jan;29(5):865-66.
 

Tseng HF, Liu A, Sy L, Marcy SM, Fireman B, Weintraub E, et al. Safety of zoster vaccine in adults from a large managed care cohort: a Vaccine Safety Datalink studyJ Intern Med. 2011;271(5):510-520.
 

Williams SE, Pahud BA, Vellozzi C, Donofrio PD, Dekker CL, et al. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination.Vaccine. 2011 Oct 26;29(46):8302-8.
 

Williams SE, Klein NP, Halsey N, Dekker CL, Baxter RP, et al. Overview of the clinical consult case review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) Network 2004-2009Vaccine. 2011 Sep 16;29(40):6920.
 

Woo EJ, Wise RP, Menschik D, Shadomy SV, Iskander J, Beeler J, et al. Thrombocytopenia after vaccination: Case reports to the US Vaccine Adverse Event Reporting System, 1990-2008. Vaccine. 2011 Feb;29(6):1319-23.
 

Xu S, Zhang L, Nelson JC, Zeng C, Mullooly J, McClure D, et al. Identifying optimal risk windows for self-controlled case series studies of vaccine safety. Stat Med. 2011 Mar;30(7):742-52.
 

Yen C, Jakob K, Esona MD, Peckham X, Rausch J, Hull JJ, et al. Detection of fecal shedding of rotavirus vaccine in infants following their first dose of pentavalent rotavirus vaccine. Vaccine. 2011 May;29(24):4151-55.
 

Yih WK, Kulldorff M, Fireman BH, Shui IM, Lewis EM, Klein NP, et al. Active surveillance for adverse events: The experience of the Vaccine Safety Datalink project. Pediatrics. 2011 May;127 Suppl 1: S54-S64.
 

Older Vaccine Safety Publications

2010 Publications

Bakare N, Menschik D, Tiernan R, Hua W, Martin D. Severe combined immunodeficiency (SCID) and rotavirus vaccination: Reports to the Vaccine Adverse Events Reporting System (VAERS). Vaccine. 2010 Sep;28(40):6609-12.
 

Belongia EA, Irving SA, Shui IM, Kulldorf M, Lewis E, Yin R, et al; Vaccine Safety Datalink Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. Pedatr Infect Dis J. 2010 Jan;29(1):1-5.
 

Fiore AE, Uyeki TM, Broder K, Finelli L, Euler GL, Singleton JA, et al. Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR. 2010 Aug;59(RR-8):1-62.
 

Goodman MJ, Nordin JD, Belongia EA, Mullooly JP, Baggs J. Henoch-Schonlein purpura and polysaccharide meningococcal vaccine. Pediatrics. 2010 Aug;126(2):e325-29.
 

Greene SK, Kulldorff M, Lewis EM, Li R, Yin R, Weintraub ES, et al. Near real-time surveillance for influenza vaccine safety: Proof of concept in the Vaccine Safety Datalink Project. Am J Epidemiol. 2010 Jan;171(2):177-88. 2009 Dec.
 

Huang WT, Chang S, Miller ER, Woo EJ, Hoffmaster AR, Gee JE, et al. Safety assessment of recalled Haemophilus influenzae type b (Hib) conjugate vaccines–United States, 2007-2008. Pharmacoepidemiol Drug Saf. 2010 Mar;19(3):306-310.
 

Huang WT, Gargiullo PM, Broder KR, Weintraub ES, Iskander JK, Klein NP, et al; Vaccine Safety Datalink. Lack of association between acellular pertussis vaccine and seizures in early childhood. Pediatrics. 2010 Aug;126(2):263-9.
 

Klein NP, Fireman B, Yih WK, Lewis E, Kulldorff M, Ray P, et al; Vaccine Safety Datalink. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics. 2010;126(1):e1-e8.
 

Klein NP, Gans HA, Sung P, Yasukawa LL, Johnson J, Sarafanov A, et al. Preterm infants’ T cell responses to inactivated poliovirus vaccine. J Infect Dis. 2010 Jan;201(2):214-22.
 

Li L, Kulldorff M. A conditional maximized sequential probability ratio test for pharmacovigilance. Stat Med. 2010 Jan;29: 284-95, 2010.
 

Lin ND, Kleinman K, Chan KA, Soumerai S, Mehta J, Mullooly JP, et al; Vaccine Safety Datalink. Multiple vaccinations and the risk of medically attended fever. Vaccine. 2010 Jun;28(25): 4169-74.
 

Lindsey NP, Staples JE, Jones JF, Sejvar JJ, Griggs A, Iskander J, et al. Adverse event reports following Japanese encephalitis vaccination in the United States, 1999-2009. Vaccine. 2010 Dec;29(1):58-64.
 

Marin M, Broder KR, Temte JL, Snider DE, Seward JF; Centers for Disease Control and Prevention (CDC). Use of combination measles, mumps, rubella, and varicella vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2010 May;59(RR-3):1-12.
 

McNeil MM, Broder KR, Vellozzi C, DeStefano F. Risk of fatal adverse events after H1N1 influenza vaccine: Limitations of passive surveillance data. Clin Infect Dis. 2010;51(7):871–72; author reply 872-3.
 

Muhammad RD, Haber P, Broder KR, Leroy Z, Ball R, Braun MM, et al. Adverse events following trivalent inactivated influenza vaccination in children: Analysis of the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2010 Jan;30(1):e1-e8.
 

Navar-Boggan AM, Halsey NA, Golden WC, Escobar GJ, Massolo M, Klein NP. Risk of fever and sepsis evaluations following routine immunizations in the neonatal intensive care unit. J Perinatol. 2010 Sep;30(9):604-9.
 

Price CS, Thompson WW, Goodson B, Weintraub ES, Croen LA, Hinrichsen VL, et al. Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism. Pediatrics. 2010 Oct;126(4):656-64.
 

Schmidt MA, Crane B, Mullooly JP, Naleway AL. Frequency of medically attended events following rapid revaccination with trivalent inactivated influenza vaccine. Vaccine. 2010 Nov;28(49):7713-5.
 

Smith MJ, Woods CR. On-time vaccine receipt in the first year does not adversely affect neuropsychological outcomes. Pediatrics. 2010 Jun;125(6):1134-41.
 

Sy LS, Liu IL, Solano Z, Cheetham TC, Lugg MM, Greene SK, et al. Accuracy of influenza vaccination status in a computer-based immunization tracking system of a managed care organization. Vaccine. 2010 Jul;28(32):5254-59.
 

Talbot EA, Brown KH, Kirkland KB, Baughman AL, Halperin SA, Broder KR. The safety of immunizing with tetanus-diphtheria-acellular pertussis vaccine (Tdap) less than 2 years following previous tetanus vaccination: Experience during a mass vaccination campaign of healthcare personnel during a respiratory illness outbreak. Vaccine. 2010 Nov;28(50):8001-7.

Vellozzi C, Broder KR, Haber P, Guh A, Nguyen M, Cano M, et al.  Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009-January 31, 2010. Vaccine. 2010 Oct; (45):7248-55.
 

Wong C, Krashin J, Rue-Cover A, Saraiya M, Unger E, Calugar A, et al. Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS). J Womens Health (Larchmt). 2010 Mar; 19(3):365-370.
 

Xu S, Gargiullo P, Mullooly J, McClure , Hambidge SJ, Glanz J. Fitting parametric and semi-parametric conditional Poisson regression models with cox’s partial likelihood in self-controlled case series and matched cohort studies. J Data Sci. 2010 Apr;8(2):349-60.
 

Zangwill KM, Yeh SH, Wong EJ, Marcy SM, Eriksen E, Huff KR, et al. Paralytic syndromes in children: Epidemiology and relationship to vaccination. Pediatr Neurol. 2010 Mar;42(3):206-12.
 

2009 Publications

Batra J, Eriksen E, Zangwill K, Lee M, Marcy S, Ward J; Vaccine Safety Datalink. Evaluation of vaccine coverage for low birth weight infants during the first year of life in a large managed care population. Pediatrics. 2009 Mar;123(3):951-958.
 

Bonhoeffer J, Bentsi-Echnill, Chen R, Fisher M, Gold M, Hartman K, et al; Brighton Collaboration Methods Working Group. Guidelines for collection, analysis, and presentation of vaccine safety data in pre- and post-licensure clinical studies. Vaccine. 2009 Apr;27(16):2282-8.
 

CDC. Safety of influenza A (H1N1) 2009 monovalent vaccines—United States, October 1–November 24, 2009. MMWR. 2009 Dec; 58(48):1351-1356.
 

Donahue JG, Kieke BA, Yih WK, Berger NR, McCauley JS, Baggs J, et al; Vaccine Safety Datalink. Varicella vaccination and ischemic stroke in children: Is there an association? Pediatrics. 2009 Feb;123(2)e228–34.
 

Durbin AP, Setse R, Omer SB, Palmer JG, Spaeder JA, Baker J, et al. Monitoring adverse events following yellow fever vaccination using an integrated telephone and internet-based system. Vaccine. 2009 Oct; 27(44):6143-47.
 

Fiore AE, Shay DK, Broder K, Iskander J, Uyeki TM, Mootrey G, et al. Prevention and control of seasonal influenza. MMWR. 2009 Jul;58(RR-8):1-52.
 

Greene SK, Shi P, Dutta-Linn MM, Shoup JA, Hinrichsen VL, Ray P, et al. Accuracy of data on influenza vaccination status at four Vaccine Safety Datalink sites. Am J Prev Med. 2009 Dec;37(6):552-5.
 

Haber P, Sejvar J, Mikaeloff Y, DeStefano F. Vaccines and Guillain-Barré syndrome. Drug Saf. 2009;32(4):309-23.
 

Hazlehurst B, Naleway A, Mullooly J. Detecting possible vaccine adverse events in clinical notes of the electronic medical record. Vaccine. 2009 Mar;27(14):2077-83.
 

Hua W, Izurieta HS, Slade B, Belay ED, Haber P, Tiernan R, et al. Kawasaki disease after vaccination: reports to the vaccine adverse event reporting system 1990-2007Pediatr Infect Dis J. 2009;28(11):943-7.
 

Jackson LA, Yu Onchee, Nelson J, Belongia EA, Hambidge SJ, Baxter R, et al. Risk of medically-attended local reactions following diphtheria toxoid containing vaccines in adolescents and young adults: A Vaccine Safety Datalink Study. Vaccine. 2009 Aug;27(36):4912-6.
 

Jackson LA, Onchee Y, Belongia EA, Hambidge SJ, Nelson J, Baxter R, et al. Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: A Vaccine Safety Datalink study. BMC Infect Dis. 2009 Oct;9:165.
 

Jackson LA, Baxter R, Naleway AL, Belongia EA, Baggs J. Patterns of pneumococcal vaccination and revaccination in elderly and non-elderly adults: A Vaccine Safety Datalink study. BMC Infect Dis. 2009 Mar;9:37.
 

Klein NP, Edwards KM, Sparks R, Dekker CL; Clinical Immunization Safety Assessment (CISA) Network. Recurrent sterile abscesses following immunization: A possible association with aluminum adjuvant. BMJ Case Rep. 2009;2009.
 

Klein NP, Kissner J, Aguirre A, Sparks R, Campbell S, Edwards KM, et al. Differential maternal responses to a newly developed vaccine information pamphlet. Vaccine 2009; 28:323–8.
 

Naleway AL, Belongia EA, Donahue JG, Kieke BA, Glanz J; Vaccine Safety Datalink. Risk of immune hemolytic anemia in children following immunization. Vaccine. 2009 Dec;27(52):7394-7.
 

Nelson JC, Bittner RCL, Bounds L, Zhao S, Baggs J, Donahue JG, et al. Compliance with multiple-dose vaccine schedules among older children, adolescents, and adults: results from a Vaccine Safety Datalink Study. Am J Public Health. 2009 Oct;99 Suppl 2:S389-97.
 

Niu MT, Ball R, Woo EJ, Burwen DR, Knippen M, Braun MM; et al. Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007. Vaccine. 2009;27(2):290-7.
 

Patel MM, Haber P, Baggs J, Zuber P, Bines JE, Parashar UD. Intussusception and rotavirus vaccination: a review of the available evidence. Expert Rev Vaccines. 2009;8(11):1555-64.
 

Rosenberg M, Sparks R, McMahon A, Iskander J, Campbell JD, Edwards KM. Serious adverse events rarely reported after trivalent inactivated influenza vaccine (TIV) in children 6–23 months of age. Vaccine. 2009 Jul;27(32):4278-83.
 

Rue-Cover A, Iskander J, Lyn S, Burwen DR, Gargiullo P, Shadomy S, et al. Death and serious illness following influenza vaccination: A multidisciplinary investigation. Pharmacoepidemiol Drug Saf. 2009 Jun;18(6):504-11.
 

Shui IM, Shi P, Dutta-Linn MM, Weintraub ES, Hambidge SJ, Nordin JD, et al; Vaccine Safety Datalink. Predictive value of seizure ICD-9 codes for vaccine safety research. Vaccine. 2009 Aug;27(39):5307-12.
 

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 Aug;302(7):750-7.
 

Tate J, Curns A, Cortese M, Weintraub E, Hambidge S, Zangwill K, et al. Burden of acute gastroenteritis hospitalizations and emergency department visits in U.S. children that is totally preventable by rotavirus vaccination: a probe study using the now-withdrawn RotaShield vaccine. Pediatrics. 2009 Mar;123(3):744-9.
 

Tozzi AE, Bisiacchi P, Tarantino V, De Mei B, D’Elia L, Chariotti F, Salmaso S. Neuropsychological performance 10 years after immunization in infancy with thimerosal-containing vaccines. Pediatrics. 2009 Feb;123(2):475-82.
 

Vellozzi C, Burwen DR, Dobardzic A, Ball R, Walton K, Haber P. Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring. Vaccine. 2009 Mar;27(15):2114-20.
 

Wei F, Mullooly JP, Goodman M, McCarty MC, Hanson AM, Crane B, et al. Identification and characteristics of vaccine refusers. BMC Pediatr. 2009 Mar;9:18.
 

Yih WK, Nordin JD, Kulldorff M, Lewis E, Lieu TA, Shi P, et al. An assessment of the safety of adolescent and adult tetanus–diphtheria–acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink. Vaccine. 2009 Jul;27(32):4257-62.
 

2008 Publications

Asatryan A, Pool V, Chen RT, Kohl KS, Davis RL, Iskander JK; VAERS team. Live attenuated measles and mumps viral strain-containing vaccines and hearing loss: Vaccine Adverse Event Reporting System (VAERS), United States, 1990–2003. Vaccine. 2008 Feb 26;26(9):1166-72.
 

Benson PJ, Jackson LA, Rees TG, Dunn JB. Changes in DT vaccine frequency and indications for use following introduction of DTaP vaccine. Hum Vaccin. 2008 May-Jun;4(3):234-7.
 

Broder KR, Cohn AC, Schwartz B, Klein JD, Fisher MM, Fishbein DB, et al; Working Group on Adolescent Prevention Priorities. Adolescent immunizations and other clinical preventive services: A needle and a hook? Pediatrics. 2008 Jan;121 Suppl 1:S25-34.
 

Chapman LE, Iskander JK, Chen RT, Neff J, Birkhead GS, Poland G, et al. A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003–2004. Clin Infect Dis. 2008 Mar;46 Suppl 3:S271-93.
 

Chaves SS, Haber P, Walton K, Wise RP, Izurieta HS, Schmid DS, et al. Safety of varicella vaccine after licensure in the United States: experience from reports to the Vaccine Adverse Event Reporting System, 1995–2005. J Infect Dis. 2008 Mar 1;197 Suppl 2:S170-7.
 

Clayton HA, Cortese MM, Payne DC, Bartlett DL, Zimmerman LA, Williams WG, Wang M, Stockman LJ, Parashar U, Baggs J. Rotavirus vaccination coverage and adherence to the Advisory Committee on Immunization Practices (ACIP)-recommended vaccination schedule—United States, February 2006–May 2007. MMWR. 2008 Apr;57(15):398-401.
 

Fishbein DB, Broder KR, Markowitz L, Messonnier N. New, and some not-so-new, vaccines for adolescents and diseases they prevent. Pediatrics. 2008 Jan;121 Suppl 1:S5-14.
 

France EK, Glanz JM, Xu S, Hambidge S, Yamasaki K, Black SB, et al; Vaccine Safety Datalink. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics. 2008 Mar;121(3):e687-92.
 

Gidudu J, Kohl KS, Halperin S, Hammer SJ, Heath PT, Hennig R, et al; The Brighton Collaboration Local Reactions Working Group for A Local Reaction at or near Injection Site. A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2008 Dec;26(52):6800-13.
 

Glanz JM, France EK, Xu S, Hayes T, Hambidge S. A population-based, multisite cohort study of the predictors of chronic idiopathic thrombocytopenic purpura in children. Pediatrics. 2008 Mar;121(3):e506-12.
 

Haber P, Patel M, Izurieta HS, Baggs J, Gargiullo P, Weintraub E, et al. Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics. 2008 Jun;121(6):1206-12.
 

Halsey NA. The Human Papillomavirus Vaccine and Risk of Anaphylaxis. [Commentary]. CMAJ. 2008 Sep 9;179(6):509-10. Erratum in: CMAJ. 2008 Sep 23; 179(7):678.
 

Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008 Jun;57(RR-5):1-30; quiz CE2-4.
 

Iskander J, Broder K. Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience. Expert Rev Vaccines. 2008 Feb;7(1):75-82.
 

Iskander J, Gidudu J, Arboleda N, Huang WT. Selected major issues in vaccine safety. Ann Nestlé. 2008;66:93-102.
 

Klein NP, Massolo ML, Greene J, Dekker CL, Black S, Escobar GJ; Vaccine Safety Datalink. Risk factors for developing apnea after immunization in the neonatal intensive care unit. Pediatrics. 2008 Mar;121(3):463-9.
 

Kohl K, Magnus M, Ball R, Halsey N, Shadomy S, et al. Applicability, Reliability, Sensitivity, and Specificity of Six Brighton Collaboration Standardized Case Definitions for Adverse Events Following ImmunizationVaccine. 2008 Nov 25; 26(50):6349–60.
 

Leung J, Rue A, Lopez A, Ortega-Sanchez IR, Harpaz R, Guris D, et al. Varicella outbreak reporting, response, management, and national surveillance. J Infect Dis. 2008 Mar 1;197 Suppl 2:S108-13.
 

Lindsey NP, Schroeder BA, Miller ER, Braun MM, Hinckley AF, Marano N, et al. Adverse event reports following yellow fever vaccinationVaccine. 2008;26(48):6077-82.
 

McClure DL, Glanz JM, Xu S, Hambidge SJ, Mullooly JP, Baggs J. Comparison of epidemiologic methods for active surveillance of vaccine safety. Vaccine. 2008 Jun;26(26):3341-5.
 

McMahon AW, Iskander JK, Haber P, Braun MM, Ball R. Inactivated influenza vaccine (IIV) in children < 2 years of age: Examination of selected adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) after thimerosal-free or thimerosal-containing vaccine. Vaccine. 2008 Jan;26(3):427-9.
 

Morgan J, Roper MH, Sperling L, Schieber RA, Heffelfinger JD, Casey CG, et al. Myocarditis, pericarditis, and dilated cardiomyopathy after smallpox vaccination among civilians in the United States, January–October 2003. Clin Infect Dis. 2008 Mar 15;46 Suppl 3:S242-50.
 

Nachamkin I, Shadomy SV, Moran AP, Cox N, Fitzgerald C, Ung H, et al. Anti-ganglioside antibody induction by swine (A/NJ/1976/H1N1) and other influenza vaccines: Insights into vaccine-associated Guillain-Barre syndrome. J Infect Dis. 2008 Jul 15;198(2):226-33.
 

Rennels M, Black S, Woo E, Campbell S, Edwards KM. Safety of a fifth dose of diphtheria and tetanus toxoid and acellular pertussis vaccine in children experiencing extensive, local reactions to the fourth dosePediatr Infect Dis J. 2008 May;27(5):464-5.
 

Sutherland A, Izurieta H, Ball R, Braun MM, Miller ER, Broder KR, et al; Centers for Disease Control and Prevention.  Syncope after vaccination—United States, January 2005–July 2007. MMWR. 2008 May;57(17):457-60.
 

Swerdlow DL, Roper MH, Morgan J, Schieber RA, Sperling LS, Sniadack MM, et al; Smallpox Vaccine Cardiac Adverse Events Working Group. Ischemic cardiac events during the Department of Health and Human Services Smallpox Vaccination Program, 2003. Clin Infect Dis. 2008 Mar 15;46 Suppl 3:S234-41.
 

Tatti KM, Slade BA, Patel M, Messonier NR, Jackson T, Kirkland K, et al. Real-time polymerase chain reaction detection of Bordetella pertussis DNA in acellular pertussis vaccines. Pediatr Infect Dis J. 2008 Jan;27(1):73-4.
 

Thomas TN, Reef S, Neff L, Sniadack MM, Mootrey GT. A review of the smallpox vaccine adverse events active surveillance system. Clin Infect Dis. 2008 Mar 15;46 Suppl 3:S212-20.
 

Wood RA, Berger M, Dreskin SC, Setse R, Engler RJM, Dekker CL, et al; Hypersensitivity Working Group of the Clinical Immunization Safety Assessment (CISA) Network. An algorithm for treatment of patients with hypersensitivity reactions after vaccines. Pediatrics. 2008 Sep;122(3):e771-7.
 

2007 Publications

Beigel J, Kohl KS, Brinley F, Graham PL, Khuri-Bulos N, LaRussa PS, et al. Generalized vaccinia as an adverse event following exposure to vaccinia virus: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5745–5753.
 

Beigel J, Kohl KS, Khuri-Bulos N, Bravo L, Nell P, Marcy SM, et al. Rash including mucosal involvement: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5697–5706.
 

Belongia E, Izurieta H, Braun MM, Ball R, Haber P, Baggs J, et al. Postmarketing monitoring of intussusception after RotaTeq vaccination – United States, February 1, 2006-February 15, 2007. MMWR. 2007 Mar 16;56(10):218-22.
 

Buettcher M, Baer G, Bonhoeffer J, Schaad UB, Heininger U. Three-year surveillance of intussusception in children in Switzerland. Pediatrics. 2007;120(3):473–480.
 

Buettcher M, Heininger U, Braun M, Bonhoeffer J, Halperin S, Heijbel H, et al. Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: Case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2007;25(31):5875–5881.
 

DeStefano F, Weintraub ES, Chen RT. Hepatitis B vaccine and risk of multiple sclerosis [letter]. Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):705-7, author reply 707-8.
 

Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, et al. Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007 Jul 13; 56(RR-6):1-54.
 

Graham PL, LaRussa PS, Kohl KS; Brighton Collaboration Vaccinia Virus Adverse Event Working Group for Robust Take. Robust take following exposure to vaccinia virus: Case definition and guidelines of data collection, analysis, and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5763-70.
 

Haber MJ, Shay DK, Davis XM, Patel R, Jin X, Weintraub E, et al. Effectiveness of interventions to reduce contact rates during a simulated influenza pandemic. Emerg Infect Dis. 2007 Apr;13(4):581-9.
 

Haber P, Slade B, Iskander J. Guillain-Barré Syndrome (GBS) after vaccination reported to the United States Vaccine Adverse Event Reporting System (VAERS) in 2004 [Letter]. Vaccine. 2007;25(48):8101.
 

Halperin S, Kohl KS, Gidudu J, Ball L, Hammer SJ, Heath P, et al. Cellulitis at injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5803–5820.
 

Hirichsen V, Kruskal B, O’Brien MA, Lieu TA, Platt R; Vaccine Safety Datalink Team. Using electronic medical records to enhance detection and reporting of vaccine adverse events. J Am Med Inform Assoc. 2007 Nov-Dec;14(6):731-5.
 

Jackson LA, Neuzil KM, Nahm MH, Whitney CG, Yu O, Nelson JC, et al. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2007;25(20):4029–4037.
 

Jackson ML, Nelson JC, Chen RT, Davis RL, Jackson LA; Vaccine Safety Datalink team. Vaccines and changes in coagulation parameters in adults on chronic warfarin therapy: a cohort study. Pharmacoepidemiol Drug Saf. 2007 Jul;16(7):790-6.
 

Jones JF, Kohl KS, Ahmadipour N, Bleijenberg G, Buchwald D, Evengard B, et al. Fatigue: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5685–5696.
 

Jorch G, Tapiainen T, Bonhoeffer J, Fischer TK, Heininger U, Hoet B, et al. Unexplained sudden death, including sudden infant death syndrome (SIDS), in the first and second years of life: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5707–5716.
 

Klein NP, Fireman B, Enright A, Ray P, Black S, Dekker CL; Clinical Immunization Safety Assessment Network. A role for genetics in the immune response to the varicella vaccine. Pediatr Infect Dis J. 2007 Apr;26(4):300-5.
 

Kohl KS, Ball L, Gidudu J, Hammer SJ, Halperin S, Heath P, et al. Abscess at injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5821–5838.
 

Kohl KS, Gidudu J, Bonhoeffer J, Braun MM, Buettcher M, Chen RT, et al. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine. 2007;25(31):5671–5674.
 

Kohl KS, Walop W, Gidudu J, Ball L, Halperin S, Hammer SJ, et al. Induration at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5839–5857.
 

Kohl KS, Walop W, Gidudu J, Ball L, Halperin S, Hammer SJ, et al. Swelling at or near injection site: Case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine. 2007;25(31):5858–5874.
 

Lieu TA, Kulldorff M, Davis RL, Lewis EM, Weintraub E, Yih K, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care. 2007 Oct;45(10 Supl 2):S89-95.
 

McNeil MM, Ma GW, Aranas A, Payne DC, Rose CE Jr. A comparative assessment of immunization records in the Defense Medical Surveillance System and the Vaccine Adverse Event Reporting System. Vaccine. 2007 Apr 30;25(17):3428-36.
 

Miller ER, Iskander J, Pickering S, Varricchio F. How can you promote vaccine safety? Nursing. 2007;37(4):58–63.
 

Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96.
 

Mullooly JP, Bridges CB, Thompson WW, Chen J, Weintraub E, Jackson LA, et al. Influenza- and RSV-associated hospitalizations among adults. Vaccine. 2007 Jan 15;25(5):846-55.
 

Mullooly JP, Schuler R, Barrett M, Maher JE. Vaccines, antibiotics, and atopy. Pharmacoepidemiol Drug Saf. 2007 Mar;16(3):275-88.
 

Nell P, Kohl KS, Graham PL, LaRussa PS, Marcy SM, Fulginiti VA, et al. Progressive vaccinia as an adverse event following exposure to vaccinia virus: Case definition and guidelines of data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5735–5744.
 

Nell P, Kohl KS, Graham PL, LaRussa PS, Marcy SM, Fulginiti VA, et al. Eczema vaccinatum as an adverse event following exposure to vaccinia virus: case definition & guidelines of data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5725–5734.
 

Payne DC, Aranas A, McNeil MM, Duderstadt S, and Rose Jr. CE. Concurrent vaccinations and U.S. military hospitalizations. Ann. Epidemiol. 2007 Sep;17(9):697-703.
 

Payne DC, Franzke LH, Stehr-Green PA, Schwartz B, and McNeil MM. Development of the Vaccine Analytic Unit’s research agenda for investigating potential adverse events associated with anthrax vaccine adsorbed. Pharmacoepidemiol Drug Saf. 2007 Jan;16(1):46-54.
 

Payne DC, Rose Jr. CE, Aranas A, Zhang Y, Tolentino H, Weston E, et al. Assessment of anthrax vaccination data in the Defense Medical Surveillance System, 1998-2004. Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):605-11.
 

Rüggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, et al. Anaphylaxis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675–5684.
 

Sejvar JJ, Kohl KS, Bilynsky R, Blumberg D, Cvetkovich T, Galama J, et al. Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): Case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5771-92
 

Tapiainen T, Prevots R, Izurieta HS, Abramson J, Bilynsky R, Bonhoeffer J, et al. Aseptic meningitis: Case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5793-802.
 

Thompson WW, Price C, Goodson B, Shay DK, Benson P, Hinrichsen VL, et al. Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years. N Engl J Med. 2007 Sep 27;357(13):1281-92.
 

Tolentino HD, Matters MD, Walop W, Law B, Tong W, Liu F, Fontelo P, Kohl K, and Payne DC. A UMLS-based spell checker for natural language processing in vaccine safety 2007; 7: 3.
 

Wenger P, Oleske JM, Kohl KS, Fisher MC, Brien JH, Graham PL, et al. Inadvertent inoculation as an adverse event following exposure to vaccinia virus: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5754–5762.
 

Wise RP, Bonhoeffer J, Beeler J, Donato H, Downie P, Matthews D, et al. Thrombocytopenia: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5717-24.
 

Woo EJ, Ball R, Landa R, Zimmerman AW, Braun MM; VAERS Working Group. Developmental regression and autism reported to the Vaccine Adverse Event Reporting System. Autism. 2007; 11(4):301-10.
 

Wood R, Setse R, Halsey NA; Clinical Immunization Safety Assessment Network Hypersensitivity Working Group. Irritant skin test reactions to common vaccines. J Allergy Clin Immunol. 2007 Aug;120(2):478-81.
 

Yu O, Bohlke K, Hanson CA, Delaney K, Rees TG, Zavitkovsky A, et al. Hepatitis B vaccine and risk of autoimmune thyroid disease: A Vaccine Safety Datalink study. Pharmacoepidemiol Drug Saf. 2007 Jul;16(7):736-45.
 

2006 Publications

Bines JE, Liem NT, Justice F, Son TN, Carlin JB, de Campo M, et al. Validation of a clinical case definition for acute intussusception in infants in Vietnam and Australia. Bull World Health Organ. 2006 Jul;84(7):569-75.
 

Broder KR, Cortese MM, Iskander JK, Kretsinger K, Slade BA, Brown KH, et al. Preventing tetanus, diphtheria, and pertussis among adolescents: Use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006 Mar 24; 55(RR-3):1-34.
 

CDC. Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine—United States, October 2005–February 2006. MMWR. 2006;55(13):364–366.
 

DiMiceli L, Pool V, Kelso JM, Shadomy SV, Iskander J; VAERS Team. Vaccination of yeast sensitive individuals: Review of safety data in the US vaccine adverse event reporting system (VAERS). Vaccine. 2006;24(6):703–707.
 

Fowler GL, Baggs JM, Weintraub ES, Martin SW, McNeil MM, Gust DA. Factors influencing laboratory workers’ decisions to accept or decline anthrax vaccine adsorbed (AVA): Results of a Ddcision-making study in CDC’s anthrax vaccination programPharmacoepidemiol Drug Saf. 2006 Dec;15(12):880-8.
 

France EK, Smith-Ray R, McClure D, Hambidge S, Xu S, Yamasaki K, et al. Impact of maternal influenza vaccination during pregnancy on the incidence of acute respiratory illness visits among infants. Arch Pediatr Adolesc Med. 2006 Dec;160(12):1277-83.
 

Glanz JM, McClure DL, Xu S, Hambidge SJ, Lee M, Kolczak MS, et al. Four different study designs to evaluate vaccine safety were equally validated with contrasting limitations. J Clin Epidemiol. 2006 Aug;59(8):808-18.
 

Hambidge SJ, Glanz JM, France EK, McClure D, Xu S, Yamasaki K, et al. Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. JAMA. 2006 Oct 25;296(16):1990-7.
 

Iskander J, Pool V, Zhou W, English-Bullard R; VAERS Team. Data mining in the US using the Vaccine Adverse Event Reporting System. Drug Saf. 2006;29(5):375-84.
 

Jackson LA, Nelson JC, Whitney CG, Neuzil KM, Benson P, Malais D, et al. Assessment of the safety of a third dose of pneumococcal polysaccharide vaccine in the Vaccine Safety Datalink population. Vaccine. 2006;24(2):151–156.
 

Jackson LA, Neuzil KM, Baggs J, Davis RL, Black S, Yamasaki KM, et al. Compliance with the recommendations for 2 doses of trivalent inactivated influenza vaccine in children less than 9 years of age receiving influenza vaccine for the first time: A Vaccine Safety Datalink study. Pediatrics. 2006;118(5):2032–2037.
 

Lin ND, Kleinman K, Chan KA, Yu XJ, France EK, Wei F, et al. Variation in hepatitis B immunization coverage rates associated with provider practices after the temporary suspension of the birth dose. BMC Pediatr. 2006 Nov 13;6:31.
 

Miller ER, Woo EJ. Time to prevent injuries from postimmunization syncope. Nursing. 2006; 36(12 Pt.1):20.
 

Muralles AA, Ray P, Black S, Shinefield H, Casey CG, Campbell S, et al. Active telephone surveillance to evaluate adverse events among civilian smallpox vaccine recipients. Vaccine. 2006;24(4):476–484.
 

Payne DC, Rose CE Jr, Kerrison J, Aranas A, Duderstadt S, McNeil MM. Anthrax vaccination and risk of optic neuritis in the United States military, 1998-2003Arch. Neurology 2006;63:871-875.
 

Prosser LA, Bridges CB, Uyeki TM, Hinrichsen VL, Meltzer MI, Noelle-Angelique MM, et al. Health benefits, risks, and cost-effectiveness of influenza vaccination of children. Emerg Infect Dis. 2006 Oct;12(10):1548-58.
 

Ray P, Hayward J, Michelson D, Lewis E, Schwalbe J, Black S, et al. Encephalopathy after whole-cell pertussis or measles vaccination: Lack of evidence for a causal association in a retrospective case-control study. Pediatr Infect Dis J. 2006 Sep;25(9):768-73.
 

Sekaran N, Edwards, K. Extensive swelling reaction associated with diphtheria and tetanus toxoids and acellular pertussis vaccinePediatr Infect Dis J. 2006 Apr; 25(4):374-5.
 

Tapiainen T, Bär G, Bonhoeffer J, Heininger U. Evaluation of The Brighton Collaboration case definition of acute intussusception during active surveillance. Vaccine. 2006 Feb 27;24(9):1483-7.
 

Varricchio F, Reed J; VAERS Working Group. Follow-up study of medication errors reported to the Vaccine Adverse Event Reporting System (VAERS). South Med J. 2006 May;99(5):486-9.
 

Vellozzi C, Mitchell T, Miller E, Casey CG, Eidex RB, Hayes EB. Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) and corticosteroid therapy: Eleven United States cases, 1996-2004. Am J Trop Med Hyg. 2006 Aug;75(2):333-6.
 

Vermeer-de Bondt PE, Dzaferagić A, David S, van der Maas NA. Performance of The Brighton Collaboration case definition for hypotonic–hyporesponsive episode (HHE) on reported collapse reactions following infant vaccinations in the Netherlands. Vaccine. 2006 Nov 30;24(49-50):7066-70.
 

Woo EJ, Ball R, Braun M, Clark T, Rosenstein Messonnier N, Wharton M, et al. Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine—United States, June 2005–September 2006. MMWR. 2006 Oct 20;55(41):1120-4.
 

Woo EJ, Ball R, Landa R, Zimmerman AW, Braun MM; VAERS Working Group. Developmental regression and autism reported to the Vaccine Adverse Event Reporting System. Autism. 2007 Jul;11(4):301-10.
 

Woo EJ, Miller NB, Ball R; VAERS Working Group. Adverse events after hepatitis A B combination vaccine. Vaccine. 2006;24(14):2685–2691.
 

2005 Publications

Baggs J, Chen R, Damon I, Rotz L, Allen C, Fullerton K, et al. Safety profile of smallpox vaccine: Insights from the pre-event smallpox vaccination programClin Infect Dis. 2005;40(8):1133-40.
 

Belongia EA, Naleway A, Kieke B, Qutaishat S, Casey C, Shay DK, et al. Validation of a screening instrument to identify persons for exclusion from smallpox vaccination. Clin Infect Dis. 2005 Feb 15;40(4):620-3.
 

Bloom S, Rguig A, Berraho A, Zniber L, Bouazzaoui N, Zaghloul Z, et al. Congenital rubella syndrome burden in Morocco: a rapid retrospective assessmentLancet. 2005 Jan 8;365(9454):135-41.
 

Casey CG, Iskander JK, Roper MH, Mast EE, Wen XJ, Tӧrӧk TJ, et al. Adverse events associated with smallpox vaccination in the United States, January-October 2003. JAMA. 2005 Dec 7;294(21):2734-43.
 

CDC. Guillain-Barré syndrome among recipients of Menactra® meningococcal conjugate vaccine—United States, June–July 2005MMWR Dispatch. 2005;54:1-3.
 

Davis RL, Kolczak M, Lewis E, Nordin J, Goodman M, Shay DK, et al. Active surveillance of vaccine safety: a system to detect early signs of adverse eventsEpidemiology. 2005 May;16(3):336-41.
 

DeStefano F, Weintraub ES, Chen RT. Recombinant hepatitis B vaccine and the risk of multiple sclerosis: a prospective study [letter]Neurology. 2005 Apr 12;64(7):1317; author reply 1318.
 

Gust D, Brown C, Sheedy K, Hibbs B, Weaver D, Nowak G. Immunization attitudes and beliefs among parents: Beyond a dichotomous perspectiveAm J Health Behav. 2005 Jan-Feb;29(1):81-92.
 

Gust DA, Kennedy A, Shui I, Smith PJ, Nowak G, Pickering LK. Parent Attitudes Toward Immunizations and Healthcare Providers: The Role of InformationAm J Preventive Health. 2005 Aug;29(2):105-12.
 

Iskander J, Haber P, Herrera G. Monitoring vaccine safety during an influenza pandemicYale J Biol Med. 2005; 78(5):265-75.
 

Izurieta HS, Haber P, Wise RP, Iskander J, Pratt D, Mink C, et al. Adverse events reported following live, cold-adapted, intranasal influenza vaccine. JAMA. 2005 Dec 7;294(21):2720-5.
 

Jackson LA, Neuzil KM, Whitney CG, Starkovich P, Dunstan M, Yu O, et al. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccineVaccine. 2005;23(28):3697-703.
 

Kennedy A, Brown C, Gust D. Vaccine beliefs of parents who oppose compulsory vaccinationPublic Health Rep. 2005 May-Jun; 120(3): 252–258.
 

Kennedy A, Gust D. Parental vaccine beliefs and child’s school typeJ Sch Health. 2005 Sep;75(7):276-80.
 

Khromava AY, Eidex RB, Weld LH, Kohl KS, Bradshaw RD, Chen RT, et al. Yellow fever vaccine: an updated assessment of advanced age as a risk factor for serious adverse eventsVaccine. 2005 May 9;23(25):3256-63.
 

Kohl KS, Bonhoeffer J, Braun MM, Chen RT, Duclos P, Heijbel H, et al. The Brighton Collaboration: Creating a global standard for case definitions (and guidelines) for adverse events following immunization. In Advances in Patient Safety: From Research to Implementation. Henriksen K, Battles JB, Marks ES, et al., eds. Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb.
 

Martin SW, Tierney BC, Aranas A, Rosenstein NE, Franzke LH, Apicella L, et al. An overview of adverse events reported by participants in CDC’s anthrax vaccine and antimicrobial availability program.. Pharmacoepidemiol Drug Saf. 2005 Jun;14(6):393-401.
 

McMahon AW, Iskander J, Haber P, Chang S, Woo EJ, Braun MM, etc. Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003. Pediatrics. 2005;115(2):453-60.
 

Lewis N, Black S, Weintraub E, Baggs J, Thompson W, DeStefano F, et al. Rapid assessment of influenza vaccination coverage among HMO members—Northern California influenza seasons, 2001–02 through 2004–05MMWR. 2005;54(27):676-678.
 

Mandell DS, Thompson WW, Weintraub ES, DeStefano F, Blank MB. Trends in diagnosis rates for autism and ADHD at hospital discharge in the context of other psychiatric diagnosesPsychiatr Serv. 2005 Jan;56(1):56-62.
 

McMahon AW, Iskander J, Haber P, Chang S, Woo EJ, Braun MM, et al. Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003Pediatrics. 2005;115(2):453-60.
 

Papania MJ, Strebel PM.  Measles surveillance: the importance of finding the tip of the iceberg [commentary]Lancet. 2005 Jan 8;365(9454):100-1.
 

Rollison D, Helzlsouer K, Halsey N, Shah K, and Viscidi R. Markers of past infection with simian virus 40 (SV40) and risk of incident non-Hodgkin lymphoma in a Maryland cohortCancer Epidemiol Biomarkers Prev. 2005 June; 14(6) 1448-1452.
 

Sejvar J, Boneva R, Lane JM, Iskander J. Severe headaches following smallpox vaccinationHeadache. 2005 Jan;45(1):87-8.
 

Sejvar JJ, Labutta RJ, Chapman LE, Grabenstein JD, Iskander J, Lane JM. Neurologic adverse events associated with smallpox vaccination in the United States, 2002-2004JAMA. 2005 Dec 7;294(21):2744-50.
 

Shui I, Kennedy A, Wooten K, Schwartz B, Gust D. Factors influencing African American mothers’ concerns about immunization safety: A summary of focus group findings in AtlantaJ Natl Med Assoc. 2005 May;97(5):657-66.
 

Vellozzi CJ, Lane MJ, Averhoff F, Mauer T, Norton S, Damon I, Casey C. Generalized vaccinia, progressive vaccinia andeczema vaccinatum are rare following smallpox vaccination: United States Surveillance, 2003. Clin Infect Dis. 2005 Sep 1;41(5):689-97. Epub 2005 Jul 26.
 

Verstraeten T, Davis R, Destefano F. Immunity to tetanus is protective against the development of multiple sclerosis. Med Hypotheses. 2005;65(5):966-9.
 

Yeung LF, Lurie P, Dayan G, Eduardo E, Britz PH, Redd SB, et al. A limited measles outbreak in a highly vaccinated US boarding school. Pediatrics. 2005 Dec;116(6):1287-91.
 

2004 Publications

Begier EM, Burwen DR, Haber P, Ball R; Vaccine Adverse Event Reporting System Working Group. Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002. Clin Infect Dis. 2004;38(6):771-9.
 

Begier EM, Langford CA, Sneller MC, Wise RP, Ball R; VAERS Working Group. Polyarteritis nodosa reports to the Vaccine Adverse Event Reporting System (VAERS): Implications for assessment of suspected vaccine-provoked vasculitis. J Rheumatol. 2004;31(11):2181-8.
 

Bines JE, Kohl KS, Forster J, Zanardi LR, Davis RL, Hansen J, et al. Acute intussusception in infants and children as an adverse event following immunization: Case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5-6):569-74.
 

Bonhoeffer J, Kohl KS, Chen RT, Duclos P, Heijbel H, Heininger U, et al. Standardized case definitions of adverse events following immunization (AEFI). Vaccine. 2004 Jan 26;22(5-6):547-50.
 

Bonhoeffer J, Vermeer P, Halperin S, Kempe A, Music S, Shindman J, et al. Persistent crying in infants and children as an adverse event following immunization: Case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5-6):586-91.
 

Bonhoeffer J, Gold MS, Heijbel H, Vermeer P, Blumberg D, Braun M, et al. Hypotonic-Hyporesponsive Episode (HHE) as an adverse event following immunization: Case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5-6):563-8.
 

Bonhoeffer J, Menkes J, Gold MS, de Souza-Brito G, Fisher MC, Halsey N, et al. Generalized convulsive seizure as an adverse event following immunization: Case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5-6):557-62.
 

Chen R. Evaluation of vaccine safety after the events of 11 September 2001: Role of cohort and case-control studies. Vaccine. 2004 May 7;22(15-16):2047-53.
 

Freed GL, Clark SJ, Hibbs BH, Santoli JM. Parental vaccine safety concerns. The experience of pediatricians and family physicians. Am J Prev Med. 2004 Jan;26(1):11-4.
 

Haber P, Zanardi LR, Chen RT, Mootrey GT, Pless R,  English R, et al. An analysis of rotavirus vaccine reports to the Vaccine Adverse Event Reporting System: More than intussusception alone?  Pediatrics. 2004 Apr;113(4):e353-9.
 

Haber P, DeStefano F, Angulo FJ, Iskander J, Shadomy SV, Weintraub E, et al. Guillain-Barré syndrome following influenza vaccination. JAMA. 2004 Nov 24;292(20):2478-81
 

Iskander JK, Miller ER, Chen RT. The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety. Pediatr Ann. 2004;33(9):599-606.
 

Kohl KS, Marcy SM, Blum M, Connell Jones M, Dagan R, et al. Fever After Immunization: Current concepts and improved future scientific understanding. Clin Infect Dis. 2004 Aug 1;39(3):389-94.
 

Marcy SM, Kohl KS, Dagan R, Nalin D, Blum M, Connell Jones M, et al. Fever as an adverse event following immunization: Case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5-6):551-6.
 

Muetsch M, Zhou W, Rhodes P, Bopp M, Chen RT, Linder T, et al. Inactivated intranasal influenza vaccine and the risk of Bell’s Palsy in Switzerland. N Engl J Med. 2004 Feb 26;350(9):896-903.
 

O’Brien MA, Uyeki TM, Shay DK, Thompson WW, Kleinman K, McAdam A, et al. Incidence of outpatient visits and hospitalizations related to influenza in infants and young children. Pediatrics. 2004 Mar;113(3 Pt 1):585-93.
 

Rothstein E, Kohl KS, Ball L, Halperin SA, Halsey N, Hammer SJ, et al. Nodule at injection site as an adverse event following immunization: Case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5-6):575-85.
 

Steinberg EB, Bishop R, Haber P, Dempsey AF, Hoekstra RM, Nelson JM, et al. Typhoid fever in travelers: Who should be targeted for prevention? Clin Infect Dis. 2004 Jul 15;39(2):186-91. Epub 2004 Jul 1.
 

Varricchio F, Iskander J, DeStefano F, Ball R, Pless R, Braun MM, et al. Understanding vaccine safety: Information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2004 Apr;23(4):287-94.
 

Wise RP, Iskander J, Pratt RD, Campbell S, Ball R, Pless RP, et al. Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA. 2004;292(14):1702-10.
 

Zhou WG, Pool V, Destefano F, Iskander JK, Haber P, Chen RT, and The VAERS Working Group.  A potential signal of Bell’s palsy after parenteral inactivated influenza vaccines: Reports to the Vaccine Adverse Event Reporting System (VAERS) – United States, 1991-2001. Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):505-10.
 

2003 Publications

Bohlke K, Davis RL, Marcy SM, Braun MM, DeStefano F, et al. The risk of anaphylaxis following vaccination of children and adolescents. Pediatrics. 2003;112:815-20.
 

CDC. Update: Multistate outbreak of monkeypox- Illinois, Indiana, Kansas, Missouri, Ohio, and Wisconsin, 2003. MMWR. 2003;52:642-646.
 

Chen RT, Lane JM. Myocarditis: The unexpected return of smallpox vaccine adverse events. Lancet. 2003 Oct 25;362(9393):1345-6.
 

Cono J, Casey CG, Bell DM. Smallpox vaccination and adverse reactions: Guidance for clinicians. MMWR. 2003;52(No. RR-4):1-28.
 

DeStefano F, VerstraetenT, Jackson LA, Okoro CA, Benson P, Black SB, et al. Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol. 2003;60:504-9.
 

DeStefano F, Verstraeten T, Chen RT. Hepatitis B vaccine and risk of multiple sclerosis. Expert Rev of Vaccines. 2003;2(1):21-29.
 

Gust DA, Woodruff R, Kennedy A, Brown C, Sheedy K, Hibbs B. Parental perceptions surrounding risks and benefits of immunizations. Semin Pediatr Infect Dis. 2003 Jul;14(3):207-12.
 

Haber P, DeStefano F. Influenza vaccination and Guillain Barré syndrome. Clin Immunol. 2003; 109(3):359; author reply 360-1.
 

Hutwagner L, Thompson WW, Seeman GM, Treadwell T. The bioterrorism preparedness and response Early Aberration Reporting System (EARS). J Urban Health. 2003 Jun;80(2 Suppl 1):i89-96.
 

Jackson LA, Neuzil KM, Onchee Y, Benson P, Barlow WE, Adams AL, et al. Effectiveness of pneumococcalpolysaccharide vaccine in older adults. N Engl J Med. 2003 May 1;348(18):1747-55.
 

Jacobson SH, Sewell EC, Allwine DA, Medina EA, Weniger BG. Designing pediatric vaccine formularies and pricing pediatric combination vaccines using operations research models and algorithmsExpert Rev Vaccines. 2003 Feb;2(1):15-9.
 

Kelly WN. The quality of published adverse drug event reports. Ann Pharmacother. 2003:37(12):1774-1778.
 

Kohl K, Bonhoeffer J, Chen R, Duclos P, Heijbel H, Heininger U, et al.  The Brighton Collaboration: Enhancing comparability of vaccine safety data. Pharmacoepidemiol Drug Saf. 2003 Jun;12(4):335-40.
 

Lloyd JC, Haber P, Mootrey GT, Braun MM, Chen RT, and VAERS Working Group. Adverse event reporting rates following tetanus-diphtheria and tetanus toxoid vaccinations: Data from the Vaccine Adverse Event Reporting System (VAERS), 1991-1997. Vaccine. 2003 Sep 8;21(25-26):3746-50.
 

Mell L, Davis RL, Mullooly JP, Black SB, Shinefield HR, Zangwill KM, et al. Polio extra-immunization in children less than two years old following changes in immunization recommendation [PDF – 650 KB]. Pediatrics. 2003;111:296–301.
 

Naleway AL, Belongia EA, Greenlee, RT, Kieke BA, Chen RT, Shay DK. Eczematous skin disease and recall of past diagnoses: Implications for smallpox vaccination. Ann Int Med. 2003 Jul 1;139(1):1-7.
 

Tierney BC, Martin SW, Franzke LH, Marano N, Reissman DB, Louchart RD, et al. Serious adverse events among participants in the Centers for Disease Control and Prevention’s Anthrax Vaccine and Antimicrobial Availability Program for persons at risk for bioterrorism-related inhalational anthrax. Clin Infect Dis. 2003;37:905-911.
 

Thompson WW, Shay D, Weintraub E, Brammer L, Cox N, Anderson L, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003;289:179-186.
 

Verstraeten T, Davis RL, DeStefano F, Lieu TA, Rhodes PH, Black SB, et al. Safety of thimerosal-containing vaccines: A two-phased study of computerized health maintenance organization databases. Pediatrics 2003;112:1039-48.
 

Verstraeten T, DeStefano F, Chen RT, Miller E. Vaccine safety surveillance using large linked databases: Opportunities, hazards and proposed guidelines. Expert Rev Vaccines. 2003 Feb;2(1):21-9.
 

Verstraeten T, Jumaan AO,  Mullooly JP, Seward JF, Izurieta HS, DeStefano F, et al. A retrospective cohort study of the association of varicella vaccine failure with asthma, steroid use, age at vaccination, and measles-mumps-rubella vaccination. Pediatrics. 2003 Aug;112(2):e98-103.
 

Wharton M, Strikas RA, Harpaz R, Rotz LD, Schwartz B, Casey CG, et al. Recommendations for using smallpox vaccine in a pre-event vaccination program: Supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR. 2003;52(No. RR-7):1-16.
 

Yih WK, Lieu TA, Rêgo VH, O’Brien MA, Shay DK, Yokoe DS, et al. Attitudes of healthcare workers in U.S. hospitals regarding smallpox vaccination. BMC Public Health. 2003, 3:20
 

Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)— United States, 1991–2001. MMWR. 2003;52:(SS-1):1-24.
 

2002 Publications

Atkinson WL, Pickering LK, Schwartz B, Weniger BG, Iskander JK. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP) [sections on jet injection and occupational safety regulations]. MMWR. 2002;51(RR-2):12-13,15.
 

Black S, Lewis E, Shinefield H, Fireman B, Ray P, et al. Lack of association between receipt of conjugate Haemophilus influenzae type b vaccine (HBOC) in infancy and risk of type 1 (juvenile onset) diabetes: Long term follow up of the HBOC efficacy trial cohort. Pediatr Infect Dis J. 2002 Jun;21(6):568-9.
 

Bonhoeffer J, Kohl K, Chen R, Duclos P, Heijbel H, et al.  The Brighton Collaboration: Addressing the need for standardized case definitions of adverse events following immunization (AEFI)Vaccine. 2002 Dec 13;21(3-4):298-302.
 

CDC. Adverse events associated with 17D-derived yellow fever vaccination—United States, 2001–2002MMWR 2002;51:989-993.
 

Cetron MS, Marfin AA, Julian KG, Gubler DJ, Sharp DJ, et al. Yellow fever vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2002;51(RR-17):1-10.
 

Chang EJ, Zangwill KM, Lee H, Ward JI. Lack of association between rotavirus infection and intussusception: Implications for use of attenuated rotavirus vaccinesPediatr Infect Dis J. 2002 Feb;21(2):97-102.
 

DeStefano F, Gu D, Kramarz P, Truman BI, Iademarco BF, et al. Childhood vaccinations and risk of asthma. Pediatr Infect Dis J. 2002 Jun;21(6):498-504.
 

Ekwueme DU, Weniger BG, Chen RT. Model-based estimates of the risks of disease transmission and economic costs of seven injection devices in sub-Saharan AfricaBull World Health Organ. 2002; 80(11): 859–870.
 

Gonzalez IM, Averhoff FM, Massoudi MS, et al. Hepatitis b vaccination among adolescents in 3 large health maintenance organizations. Pediatrics. 2002 Nov;110(5):929-34.
 

Halsey NA.  The science of evaluation of adverse effects associated with vaccination. Semin Pediatr Infect Dis. 2002 Jul;13(3):205-14.
 

Halsey NA. Anthrax vaccine and causality assessment from individual case reports. Pharmacoepidemiol Drug Saf. 2002 Apr-May;11(3):185-7; discussion 203-4.
 

Jackson LA, Yu O, Heckbert SR, Psaty BM, Malais D, Barlow WE, Thompson WW, and the Vaccine Safety Datalink Study Group.  Influenza vaccination is not associated with a reduction in the risk of recurrent coronary eventsAm J Epidemiol. 2002;156 (7): 634-640.
 

Kohl K, Bonhoeffer J, Chen R, Duclos P, Heijbel H, et al. The Brighton Collaboration: Enhancing comparability of vaccine safety data. Pharmacoepidemiol Drug Saf. 2003 Jun;12(4):335-40.
 

Lathrop S, Ball R, Haber P, Mootrey G, Braun M, et al. Adverse event reports following vaccination for Lyme disease: December 1998-July 2000Vaccine. 2002 Feb 22;20(11-12):1603-8.
 

Mullooly, J, Pearson J, Drew L, Schuler R, Maher J, et al. Wheezing lower respiratory disease and vaccination of full-term infants. Pharmacoepidemiol Drug Saf. 2002 Jan-Feb;11(1):21-30.
 

Pool V, Braun MM, Kelso JM, Mootrey G, Chen RT, et al. Prevalence of anti-gelatin IgE antibodies in persons with anaphylaxis following measles-mumps-rubella vaccine in the U.SPediatrics. 2002 Dec;110(6):e71.
 

Pless R. Hibbs B. Chiropractic students attitudes about vaccination: A cause for concern? CMAJ. 2002 Jun;166(12):1544-5.
 

Setia S, Mainzer H, Washington ML, Coil G, Snyder R, et al. Frequency and causes of vaccine wastageVaccine. 2002 Jan 15;20(7-8):1148-56.
 

2001 Publications

Barlow WE, Davis RL, Glasser JW, Rhodes PH, Thompson RS, et al. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccineN Engl J Med. 2001;345:656-61.
 

Chen RT, Pless R, Destefano F.  Epidemiology of autoimmune reactions induced by vaccinationJ Autoimmun 2001;16:309-18.
 

Chen RT, Pool V, Takahashi H, Weniger BG, Patel B. Combination vaccines: Postlicensure safety evaluationClin Infect Dis 2001;33 (Suppl 4):s327-s333.
 

Chen RT, DeStefano F, Pless R, Mootrey G, Kramarz P, Hibbs B. Challenges and Controversies in Immunization Safety. In: Peter G, Gardner P (eds). Vaccine recommendations: challenges and controversies. Infect Dis Clinics of North America 2001;15:21-39.
 

Davis RL, Kramarz P, Bohlke K, Benson P, Thompson RS, et al. Measles-mumps-rubella and other measles-containing vaccines do not increase the risk for inflammatory bowel disease: A case-control study from the Vaccine Safety Datalink projectArch Pediatr Adolesc Med. 2001 Mar;155(3):354-359.
 

Davis RL, Lieu TA, Mell LK et al. Impact of the change in polio vaccination schedule on immunization coverage rates: A study in two large health maintenance organizations. Pediatrics 2001;107:671-676
 

Destefano F, Davis RL, Chen RT.  Autism and MMR vaccination: Controversy laid to rest? CNS Drugs. 2001;15(11):831-7.
 

DeStefano F, Mullooly JP, Okoro CA, Chen RT, Marcy SM, et al. Childhood vaccinations, vaccination timing, and risk of type 1 diabetes mellitusPediatrics. 2001;108:e112-3.
 

Jackson LA, Austin G, Chen RT, Stout R, DeStefano F, et al. Safety and immunogenicity of varying doses of trivalent inactivated influenza vaccine administered by needle-free jet injectorsVaccine. 2001;19:4703-4709.
 

Kramarz P, France EK,  Black SB, Shinefield H, Ward JI, et al. Population based study of rotavirus vaccination and intussusceptionPed Infect Dis J. 2001 Apr;20(4):410-6.
 

Kramarz P, DeStefano F, Gargiullo P, Chen RT, Lieu TA, et al. Does influenza vaccination prevent asthma exacerbations in children? Journal of Pediatrics. 2001;138(3):306-10.
 

Lewis E, Shinefield HR, Woodruff BA, Black SB, DeStefano F, et al. Safety of neonatal hepatitis B vaccine administrationPediatr Infect Dis J. 2001; 20: 1049-1054.
 

Lieu TA, Davis RL, Capra AM, et al. Variation in clinician recommendations for multiple injections during adoptions of inactivated polio vaccinePediatrics. 2001; 107:e49.
 

Meyerhoff AS, Weniger BG, Jacobs RJ. The economic value to parents of reducing the pain and emotional distress of childhood vaccine injectionsPediatr Infect Dis J. 2001;20(11):s57-s62.
 

Rota JS, Salmon DA, Rodewald LE, Chen RT, Hibbs BF, Gangarosa EJ. Processes for obtaining nonmedical exemptions to State immunization lawsAJPH. 2001;91:645-48.
 

Sewell EC, Jacobson SH, Weniger BG. “Reverse engineering” a formulary selection algorithm to determine the economic value of pentavalent and hexavalent combination vaccines. Pediatr Infect Dis J. 2001;20(11):s45-s56.
 

Verstraeten T, Baughman AL, Cadwell B, Zanardi L, Haber P, Chen R and VAERS Team. Enhancing vaccine safety surveillance: A capture-recapture analysis of intussusception after rotavirus vaccination.  Am J Epidemiol 2001; 154:1006–12.
 

Wattigney WA, Mootrey GT, Braun MM, Chen RT. Surveillance for poliovirus vaccine adverse events, 1991-1998: Impact of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine. Pediatrics. 2001; 107(5):E83.
 

Zanardi LR, Haber P, Mootrey GT, Niu MT, Wharton M. Intussusception among recipients of rotavirus vaccine: Reports to the vaccine adverse event reporting system. Pediatrics. 2001;107(6):E97.
 

2000 Publications

Belay ED, Holman RC, Clarke MJ, DeStefano F, Shahriari A, et al. The incidence of Kawasaki syndrome in West Coast health maintenance organizationsPed Infect Dis J. 2000;19:828-32.
 

Braun MM, Mootrey GT, Salive ME, Chen RT, Ellenberg SS, VAERS Working Group. Infant immunization with acellular pertussis vaccines in the United States: Assessment of the first two years’ data from the Vaccine Adverse Event Reporting System (VAERS)Pediatrics. 2000;104(4):e51.
 

Chen RT, DeStefano F, Davis RL, Jackson LA, Thompson RS, et al. The Vaccine Safety Datalink: Immunization research in health maintenance organizations in the USA. Bull WHO. 2000;78:186-194.
 

Chen RT, Hardy IRB, Rhodes PH, Tyshchenko DK, Moiseeva AV, Marievsky VF. Ukraine, 1992: First assessment of diphtheria vaccine effectiveness during the recent resurgence of diphtheria in the former Soviet Union: IntroductionJ Infect Dis 2000;181(suppl 1):S178-S183.
 

Chen RT, Mootrey GT, DeStefano F. Safety of routine childhood vaccinations. An epidemiological reviewPediatric Drugs. 2000;2(4):273-290.
 

Collet JP. MacDonald N. Cashman N. Pless R. Monitoring signals for vaccine safety: The assessment of individual adverse event reports by an expert advisory committee. Advisory Committee on Causality AssessmentBull WHO. 2000;78(2):178-85.
 

DeStefano F. Opportunities for population-based clinical research using data from managed care organizations. In: Davis JR, editor. Managed care systems and emerging infections. Washington, DC: National Academy Press, 2000;16-8.
 

Feikin DR, Lezotte DC, Hamman RF, Salmon DA, Chen RT, Hoffman RE. Individual and community risks of measles and pertussis associated with personal exemptions to immunizationJAMA. 2000;284:3145-50.
 

Izurieta HS, Thompson WW, Kramarz P, Shay DK, Davis RL, et al. Influenza and the rates of hospitalization for respiratory disease among infants and young childrenN Engl J Med. 2000;342(4):232-239.
 

Izurieta HS, Thompson WW, Shay DK. Influenza and hospitalizations in children [Letter]. N Engl J Med. 2000;342:1753.
 

Kramarz P, DeStefano F, Gargiullo PM, Davis RL, Chen RT, et al. Influenza vaccination in children with asthma in health maintenance organizationsVaccine. 2000;18:2288-2294.
 

Kramarz P, DeStefano F, Gargiullo PM, Davis RL, Chen RT, et al. Does influenza vaccination exacerbate asthma? Analysis of a large cohort of children with asthmaArch Fam Med. 2000;9(7):617-623.
 

Kuppermann M, Nease RF, Ackerson LM, Black SB, Shinefield HR, Lieu TA. Parent preferences for outcomes associated with childhood vaccinationsPediatr Infect Dis. 2000;19:129-133.
 

Lieu TA, Black SB, Ray GT, Martin KE, Shinefield HR, Weniger BG. The hidden costs of infant vaccinationVaccine. 2000;19:33-41.
 

Pless R. Vaccination benefits, risks and safety: The need for a complete pictureBull WHO. 2000;78(2):219-221.
 

Pless R, Risher JF. Mercury, infant neurodevelopment, and vaccinationJ Pediatr. 2000;136(5):571-573.
 

Salmon, DA., Gangarosa EJ, Chen RT. Health consequences of exemptions from immunization laws [letter]JAMA. 2000; 283: 1141-2.
 

Takahashi H. Need for improved vaccine safety surveillanceVaccine. 2000;19(9-10):1004.
 

Takahashi H, Pool V, Tsai TF, Chen RT. Adverse events after Japanese Encephalitis vaccination: Review of post-marketing surveillance data from Japan and the United States. Vaccine. 2000: 18(26), 2963-2969.
 

Wise RP, Salive ME, Braun MM, Mootrey GT, Seward JF, Rider LG, Krause PR. Post licensure safety surveillance for varicella vaccineJAMA. 2000;284:1271-1279.
 

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