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Vaccine Safety Datalink Publications


Kharbanda EO, Vazquez-Benitez G, Romitti PA et al. Identifying birth defects in automated data sources in the Vaccine Safety Datalink. Pharmacoepidemiol Drug Saf 2017.Ref ID: 340

Hambidge SJ, Ross C, Shoup JA et al. Integration of data from a safety net health care system into the Vaccine Safety Datalink. Vaccine 2017.Ref ID: 341

Klein NP, Lewis E, McDonald J et al. Risk factors and familial clustering for fever 7-10days after the first dose of measles vaccines. Vaccine 2017;35:1615-1621.Ref ID: 342

Daley MF, Glanz JM, Newcomer SR et al. Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule. Vaccine 2017;35:1873-1878. Ref ID: 343

Duffy J, Lewis M, Harrington T et al. Live attenuated influenza vaccine use and safety in children and adults with asthma. Ann Allergy Asthma Immunol 2017;118:439-444. Ref ID: 344

Ray GT, Lewis N, Goddard K et al. Asthma exacerbations among asthmatic children receiving live attenuated versus inactivated influenza vaccines. Vaccine 2017 Ref ID: 345


Sukumaran L, Omer SB. Repeat Tdap Vaccination and Adverse Birth Outcomes–Reply. JAMA 2016;315:1286. Ref ID: SUKUMARAN2016

Duffy J, Weintraub E, Hambidge SJ et al. Febrile Seizure Risk After Vaccination in Children 6 to 23 Months. Pediatrics 2016. Ref ID: DUFFY2016

Vazquez-Benitez G, Kharbanda EO, Naleway AL et al. Risk of Preterm or Small-for-Gestational-Age Birth After Influenza Vaccination During Pregnancy: Caveats When Conducting Retrospective Observational Studies. Am J Epidemiol 2016;184:176-186. Ref ID: VAZQUEZBENITEZ2016

Baxter R, Lewis E, Goddard K et al. Acute demyelinating events following vaccines – a case centered analysis. Clin Infect Dis 2016. Ref ID: BAXTER2016A

DeSilva M, Vazquez-Benitez G, Nordin JD et al. Tdap Vaccination During Pregnancy and Microcephaly and Other Structural Birth Defects in Offspring. JAMA 2016;316:1823-1825. Ref ID: DESILVA2016

Glanz JM, Newcomer SR, Jackson ML, Omer SB, Bednarczyk RA, Shoup JA, Daley MF: Vaccine Safety Datalink. White Paper on Studying the Safety of the Childhood Immunization Schedule [PDF – 896K]

Kharbanda EO, Vazquez-Benitez G, Lipkind HS et al. Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013. Vaccine 2016.

McCarthy NL, Gee J, Sukumaran L et al. Vaccination and 30-Day Mortality Risk in Children, Adolescents, and Young Adults. Pediatrics 2016;137:1-8.

Tartof SY, Qian L, Rieg GK et al. Safety of Seasonal Influenza Vaccination in Hospitalized Surgical Patients: A Cohort Study. Ann Intern Med 2016.

Li R, Stewart B, McNeil MM et al. Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons. Pharmacoepidemiol Drug Saf 2016.

Gee J, Weinbaum C, Sukumaran L, Markowitz LE. Quadrivalent HPV vaccine safety review and US safety monitoring plans for nine-valent HPV vaccine. Hum Vaccin Immunother 2016;0.

Baxter R, Lewis E, Fireman B, DeStefano F, Gee J, Klein NP. Case-centered analysis of Optic Neuritis following vaccines. Clin Infect Dis 2016.


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.

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.

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.

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.

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.

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.

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.


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.

Hambidge SJ, Newcomer SR, Narwaney KJ, Glanz JM, Daley MF, Xu S, et al. Timely versus delayed early childhood vaccination and seizuresPediatrics. 2014;133(6):e1492-e1499.

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 OutcomesJAMA. 2014;312(18):1897-1904.

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.

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.

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 Analysis Data Mining. 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, et al. Maternal influenza vaccine and risks for preterm or small for gestational age birthJ Pediatr. 2014;164(5):1051-1057.

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;370(6):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 designBiom J. 2014;56(3):513-525.


Baxter R, Bakshi N, Fireman B, Lewis E, Ray P, et al. Lack of association of Guillain-Barré syndrome with vaccinationsClin Infect Dis. 2013; 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 autismJ Pediatr. 2013;163(2):561-567.

Dodd CN, Romio SA, Black S, Vellozzi C, Andrews N, Sturkenboom M, et al. International collaboration to assess the risk of Guillain Barre Syndrome following Influenza A (H1N1) 2009 monovalent vaccinesVaccine. 2013;31(40):4448-4458.

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 ageJAMA Pediatr. 2013;167(11):1060-1064.

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-Barre syndrome, influenza vaccination, and antecedent respiratory and gastrointestinal infections: A case-centered analysis in the Vaccine Safety Datalink, 2009-2011PLoS One. 2013;8(6):e67185.

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 agePediatrics. 2013;131(2):283-289.

Kharbanda EO, Vazquez-Benitez G, Lipkind H, Naleway A, Lee G, Nordin JD, et al. Inactivated influenza vaccine during pregnancy and risks for adverse obstetric eventsObstet Gynecol. 2013;122(3):659-667.

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. Evaluating the safety of influenza vaccine using a claims-based health systemVaccine. 2013;31(50):5975-5982.

McCarthy NL, Irving S, Donahue JG, Weintraub E, Gee J, Belongia E. Vaccination coverage levels among children enrolled in the Vaccine Safety DatalinkVaccine. 2013;31(49):5822-5826.

McCarthy NL, Weintraub E, Vellozzi C, Duffy J, Gee J, Donahue JG. Mortality rates and cause-of-death patterns in a vaccinated populationAm J Prev Med. 2013;45(1):91-97.

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 studyAm J Epidemiol. 2013;177(2):131-141.

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 womenObstet Gynecol. 2013;121(3):519-525.

Qian L, Tseng HF, Sy LS, Jacobsen SJ. Confounder adjustment in vaccine safety studies: Comparing three offset terms for case-centered approachVaccine. 2013;31(2):431-435.

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 2011J Adolesc Health. 2013;53(5):637-641.

Tseng HF, Sy LS, Liu IL, Qian L, Marcy SM, Weintraub E, et al. Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in childrenVaccine. 2013;31(22):2578-2583.

Xu S, Hambidge SJ, McClure DL, Daley MF, Glanz JM. A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series designStat Med. 2013;32(19):3290-3299.

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.


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.

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.

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.

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.

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, 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.

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. Safety of a tetanus-diphtheria-acellular pertussis vaccine when used off-label in an elderly populationClin Infect Dis. 2012;56(3):315-321.

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.


Baggs J, Gee J, Lewis E, Fowler G, Benson P, Lieu T, et al. The Vaccine Safety Datalink: A model for monitoring immunization safetyPediatrics. 2011;127(Supp 1):S45-S53.

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 DatalinkVaccine. 2011;29(46):8279-8284.

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 dataPharmacoepidemiol Drug Saf. 2011;20(6):583-590.

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.

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.

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

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 influenzaVaccine. 2011;29(31):4891-4896.

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.

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

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.

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.

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 projectPediatrics. 2011;127(Suppl 1):S54-S64.


Belongia EA, Irving SA, Shui IM, Kulldorff M, Lewis E, et al. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccinePediatr Infect Dis J. 2010;29(1):1-5.

Donahue JG, Kieke BA, Gargiullo PM, Jumaan AO, Berger NR, McCauley JS, et al. Herpes zoster and exposure to the varicella zoster virus in an era of varicella vaccinationAm J Public Health. 2010;100(6):1116-1122.

Goodman MJ, Nordin JD, Belongia EA, Mullooly JP, Baggs J, et al. Henöch-Schonlein purpura and polysaccharide meningococcal vaccinePediatrics. 2010;126(2):e325-e329.

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 projectAm J Epidemiol. 2010;171(2):177-188.

Huang WT, Gargiullo PM, Broder KR, Weintraub ES, Iskander JK, Klein NP, et al. Lack of association between acellular pertussis vaccine and seizures in early childhoodPediatrics. 2010;126(2):263-269.

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

Li L, Kulldorff M. A conditional maximized sequential probability ratio test for pharmacovigilanceStat Med. 2010;29(2):284-295.
Lin ND, Kleinman K, Chan KA, Soumerai S, Mehta J, Mullooly JP, et al. Multiple vaccinations and the risk of medically attended fever. Vaccine. 2010;28(25):4169-4174.

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 autismPediatrics. 2010;126(4):656-664.

Schmidt MA, Crane B, Mullooly JP, Naleway AL. Frequency of medically attended events following rapid revaccination with trivalent inactivated influenza vaccineVaccine. 2010;28(49):7713-7715.

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 organizationVaccine. 2010 Jul 19;28(32):5254-9.

Xu S, Gargiullo P, Mullooly J, McClure D, 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. [PDF – 95 KB] J Data Sci. 2010;8:349-360.

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 safetyStat Med. 2010;30(7):742-752.

Zangwill KM, Yeh SH, Wong EJ, Marcy SM, Eriksen E, Huff KR, et al. Paralytic syndromes in children: epidemiology and relationship to vaccinationPediatr Neurol. 2010;42(3):206-212.


Batra JS, Eriksen EM, Zangwill KM, Lee M, Marcy SM, Ward JI, et al. Evaluation of vaccine coverage for low birth weight infants during the first year of life in a large managed care populationPediatrics. 2009;123(3):951-958.

Donahue JG, Kieke BA, Yih WK, Berger NR, McCauley JS, Baggs J, et al. Varicella vaccination and ischemic stroke in children: Is there an association? Pediatrics. 2009;123(2):e228-e234.

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 sitesAm J Prev Med. 2009;37(6):552-555.

Harris K, Baggs J, Davis RL, Black S, Jackson LA, Mullooly JP, et al. Influenza vaccination coverage among adult solid organ transplant recipients at three health maintenance organizations, 1995-2005Vaccine. 2009;27(17):2335-2341.

Hazlehurst B, Naleway A, Mullooly J. Detecting possible vaccine adverse events in clinical notes of the electronic medical recordVaccine. 2009;27(14):2077-2083.

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 studyBMC Infect Dis. 2009;9:37.

Jackson LA, Yu O, Belongia EA, Hambidge SJ, Nelson J, Baxter R. Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: A Vaccine Safety Datalink studyBMC Infect Dis. 2009;9:165.

Jackson LA, Yu O, Nelson J, Belongia EA, Hambidge SJ, Baxter R. Risk of medically attended local reactions following diphtheria toxoid containing vaccines in adolescents and young adults: A Vaccine Safety Datalink studyVaccine. 2009;27(36):4912-4916.

Lorick SA, Fishbein D, Weintraub E, Wortley PM, Lee GM, Zhou F, et al. Uptake of meningococcal conjugate vaccine among adolescents in large managed care organizations, United States, 2005: Demand, supply and seasonalityBMC Infect Dis. 2009;9:175.

Naleway AL, Belongia EA, Donahue JG, Kieke BA, Glanz JM; Vaccine Safety Datalink team. Risk of immune hemolytic anemia in children following immunizationVaccine. 2009;27(52):7394-7397.

Nelson JC, Bittner RC, 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 studyAm J Public Health. 2009;99(Suppl 2):S389-S397.

Patel MM, Haber P, Baggs J, Zuber P, Bines JE, Parashar UD. Intussusception and rotavirus vaccination: A review of the available evidenceExpert Rev Vaccines. 2009;8(11):1555-1564.

Shui IM, Shi P, Dutta-Linn MM, Weintraub ES, Hambidge SJ, Nordin JD, et al. Predictive value of seizure ICD-9 codes for vaccine safety researchVaccine. 2009;27(39):5307-5312.

Tate JE, Curns AT, Cortese MM, Weintraub ES, Hambidge S, Zangwill KM, et al. Burden of acute gastroenteritis hospitalizations and emergency department visits in US children that is potentially preventable by rotavirus vaccination: A probe study using the now-withdrawn rotashield vaccinePediatrics. 2009;123(3):744-749.

Wei F, Mullooly JP, Goodman M, McCarty MC, Hanson AM, Crane B, et al. Identification and characteristics of vaccine refusersBMC Pediatr. 2009;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 DatalinkVaccine. 2009;27(32):4257-4262.


Benson PJ, Jackson LA, Rees TG, Dunn JB. Changes in DT vaccine frequency and indications for use following introduction of DTaP vaccineHum Vaccin. 2008;4(3):234-237.

Clayton HA, Cortes MM, Payne DC, Bartlett DL, Zimmerman LA, Williams WG, et al. Rotavirus vaccination coverage and adherence to the Advisory Committee on Immunization Practices (ACIP)-recommended vaccination schedule–United States, February 2006-May 2007MMWR. 2008;57(15):398-401.

France EK, Glanz J, Xu S, Hambidge S, Yamasaki K, Black SB, et al. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in childrenPediatrics. 2008;121(3):e687-e692.

Glanz J, France E, Xu S, Hayes T, Hambidge S, et al. A population-based, multisite cohort study of the predictors of chronic idiopathic thrombocytopenic purpura in childrenPediatrics. 2008;121(3):e506-e512.

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, 2007Pediatrics. 2008;121(6):1206-1212.

Klein NP, Massolo ML, Greene J, Dekker CL, Black S, Escobar GJ, et al. Risk factors for developing apnea after immunization in the neonatal intensive care unitPediatrics. 2008;121(3):463-469.

McClure DL, Glanz JM, Xu S, Hambidge SJ, Mullooly JP, Baggs J, et al. Comparison of epidemiologic methods for active surveillance of vaccine safetyVaccine. 2008;26(26):3341-3345.

Mullooly JP, Donahue JG, DeStefano F, Baggs J, Eriksen E; VSD Data Quality Working Group. Predictive value of ICD-9-CM codes used in vaccine safety researchMethods Inf Med. 2008;47(4):328-335.

Weinmann S, Chun C, Mullooly JP, Riedlinger K, Houston H, Loparev VN, et al. Laboratory diagnosis and characteristics of breakthrough varicella in childrenJ Infect Dis. 2008;197(Suppl 2):S132-S138.

Young HA, Geier DA, Geier MR. Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety DatalinkJ Neurol Sci. 2008; 271(1-2):110-118.


Hinrichsen VL, 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 eventsJ Am Med Inform Assoc. 2007;14(6):731-735.

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 studyPharmacoepidemiol.Drug Saf. 2007;16(7):790-796.

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

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 eventsMed Care. 2007;45(10 Suppl 2):S89-S95.

Mullooly JP, Bridges CB, Thompson WW, Chen J, Weintraub E, Jackson LA, et al. Influenza- and RSV-associated hospitalizations among adultsVaccine. 2007;25(5):846-855.

Mullooly JP, Schuler R, Barrett M, Maher JE. Vaccines, antibiotics, and atopyPharmacoepidemiol Drug Saf. 2007;16(3):275-288.

Thompson WW, Price C, Goodson B, Shay DK, Benson P, Hinrichsen VL, et al. Early thimerosal exposure and neuropsychological outcomes at 7 to 10 yearsN Engl J Med. 2007;357(13):1281-1292.

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 studyPharmacoepidemiol Drug Saf. 2007;16(7):736-745.


Averhoff F, Zucker J, Vellozzi C, Redd S, Woodfill C, Waterman S, et al. Adequacy of surveillance to detect endemic rubella transmission in the United StatesClin Infect Dis. 2006;43(Suppl 3):S151-S157.

CDC. Update: Guillain-Barre syndrome among recipients of Menactra meningococcal conjugate vaccine–United States, June 2005-September 2006MMWR. 2006;55(41):1120-1124.

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

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 infantsArch Pediatr Adolesc Med.2006;160(12):1277-1283.

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 limitationsJ Clin Epidemiol. 2006;59(8):808-818.

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 oldJAMA. 2006;296(16):1990-1997.

Heffelfinger JD, Heckbert SR, Psaty BM, Weiss NS, Thompson WW, Bridges CB, et al. Influenza vaccination and risk of incident myocardial infarctionHum Vaccin. 2006;2(4):161-166.

Jackson LA, Nelson JC, Whitney CG, Neuzil KM, Benson P, Malais D. Assessment of the safety of a third dose of pneumococcal polysaccharide vaccine in the Vaccine Safety Datalink populationVaccine. 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 studyPediatrics. 2006;118(5):2032-2037.

Lieberman P, Camargo CA, Jr., Bohlke K, Jick H, Miller RL, Sheikh A, et al. Epidemiology of anaphylaxis: Findings of the American College of Allergy, Asthma and Immunology Epidemiology of Anaphylaxis Working GroupAnn Allergy Asthma Immunol. 2006;97(5):596-602.

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

Mullooly JP, Crane B, Chun C. Trivalent inactivated influenza vaccine safety in children: Assessing the contribution of telephone encountersVaccine. 2006;24(13):2256-2263.

Neuzil KM, Jackson LA, Nelson J, Klimov A, Cox N, Bridges CB, et al. Immunogenicity and reactogenicity of 1 versus 2 doses of trivalent inactivated influenza vaccine in vaccine-naive 5-8-year-old childrenJ Infect Dis.2006;194(8):1032-1039.

Prosser LA, Bridges CB, Uyeki TM, Hinrichsen VL, Meltzer MI, Molinari NM, et al. Health benefits, risks, and cost-effectiveness of influenza vaccination of childrenEmerg Infect Dis. 2006;12(10):1548-1558.

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 studyPediatr Infect Dis J. 2006;25(9):768-773.


Belongia EA, Naleway A, Kieke B, Qutaishat S, Casey C, et al. Validation of a screening instrument to identify persons for exclusion from smallpox vaccinationClin Infect Dis. 2005;40(4):620-623.

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;16(3):336-341.

DeStefano F, Weintraub ES, Chen RT. Recombinant hepatitis B vaccine and the risk of multiple sclerosis: A prospective studyNeurology. 2005;64(7):1317.

Hazlehurst B, Mullooly J, Naleway A, Crane B. Detecting possible vaccination reactions in clinical notes. AMIA Annu Symp Proc. 2005:306-310.

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):3697-3703.

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.

Lin ND, Kleinman K, Chan KA, Yu XJ, France EK, Xu S, et al. Impact of the introduction of pneumococcal conjugate vaccine on immunization coverage among infantsBMC Pediatr. 2005;5:43.

Mell LK, Ogren DS, Davis RL, Mullooly JP, Black SB, Shinefield HR, et al. Compliance with national immunization guidelines for children younger than 2 years, 1996-1999Pediatrics. 2005;115(2):461-467.

Mullooly JP, Riedlinger K, Chun C, Weinmann S, Houston H. Incidence of herpes zoster, 1997-2002 [PDF – 120 KB]Epidemiol Infect.2005;133(2):245-253.

Prosser LA, Bridges CB, Uyeki TM, Rêgo VH, Ray GT, Meltzer MI, et al. Values for preventing influenza-related morbidity and vaccine adverse events in childrenHealth Qual Life Outcomes. 2005;3:18.


Black SB, Shinefield HR, France EK, Fireman BH, Platt ST, et al. Effectiveness of influenza vaccine during pregnancy in preventing hospitalizations and outpatient visits for respiratory illness in pregnant women and their infantsAm J Perinatol. 2004;21(6):333-339.

Bohlke K, Davis RL, DeStefano F, Marcy SM, Braun MM, et al. Epidemiology of anaphylaxis among children and adolescents enrolled in a health maintenance organizationJ Allergy Clin Immunol. 2004;113(3):536-542.

Eriksen EM, Perlman JA, Miller A, Marcy SM, Lee H, Vadheim C, et al. Lack of association between hepatitis B birth immunization and neonatal death: A population-based study from the Vaccine Safety Datalink projectPediatr Infect Dis J. 2004;23(7):656-662.

France EK, Glanz JM, Xu S, Davis RL, Black SB, Shinefield HR, et al. Safety of the trivalent inactivated influenza vaccine among children: A population-based studyArch Pediatr Adolesc Med. 2004;158(11):1031-1036.

Maher JE, Mullooly JP, Drew L, DeStefano F. Infant vaccinations and childhood asthma among full-term infantsPharmacoepidemiol Drug Saf. 2004;13(1):1-9.

Mullooly J, Drew L, DeStefano F, Maher J, Bohlke K, Immanuel V, et al. Quality assessments of HMO diagnosis databases used to monitor childhood vaccine safetyMethods Inf Med. 2004;43(2):163-170.

Mullooly JP, Maher JE, Drew L, et al. Evaluation of the impact of an HMO’s varicella vaccination program on incidence of varicellaVaccine. 2004;22(11-12):1480-1485.

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 childrenPediatrics. 2004;113(3 Pt 1):585-593.

Spector L, Groves F, DeStefano F, Liff J, Klein M, Mullooly J, et al. Medically recorded allergies and the risk of childhood acute lymphoblastic leukaemiaEur J Cancer. 2004;40(4):579-584.


Bohlke K, Davis RL, Marcy SM, Braun MM, DeStefano F, et al. Risk of anaphylaxis after vaccination of children and adolescents. Pediatrics. 2003;112(4):815-820

DeStefano F, Verstraeten T, Jackson LA, Okoro CA, Benson P, Black SB, et al. Vaccinations and risk of central nervous system demyelinating diseases in adultsArch Neurol. 2003;60(4):504-509.

Jackson LA, Neuzil KM, Yu O, Benson P, Barlow WE, Adams AL, et al. Effectiveness of pneumococcal polysaccharide vaccine in older adultsN Engl J Med. 2003;348(18):1747-1755.

Mell LK, Davis RL, Mullooly JP, Black SB, Shinefield HR, Zangwill KM, et al. Polio extraimmunization in children younger than 2 years after changes in immunization recommendationsPediatrics. 2003;111(2):296-301.

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

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 databasesPediatrics. 2003;112(5):1039-1048.

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 vaccinationPediatrics. 2003;112(2):e98-103.

Verstraeten T, DeStefano F, Chen RT, Miller E. Vaccine safety surveillance using large linked databases: Opportunities, hazards and proposed guidelinesExpert Rev Vaccines. 2003;2(1):21-29.

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


Black SB, Lewis E, Shinefield HR, 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 cohortPediatr Infect Dis J. 2002;21(6):568-569.

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;21(2):97-102.

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

DeStefano F, Verstraeten T, Chen RT. Hepatitis B vaccine and risk of multiple sclerosisExpert Rev Vaccines. 2002;1(4):461-466.

Gonzalez IM, Averhoff FM, Massoudi MS, Yusuf H, DeStefano F, Kramarz P, et al. Hepatitis B vaccination among adolescents in 3 large health maintenance organizationsPediatrics. 2002;110(5):929-934.

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

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


Barlow WE, Davis RL, Glasser JW, Rhodes PH, Thompson RS, Mullooly JP, et al. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccineN Engl J Med. 2001;345(9):656-661.

Chen RT, DeStefano F, Pless R, Mootrey G, Kramarz P, Hibbs B. Challenges and controversies in immunization safetyInfect Dis Clin North Am. 2001;15(1):21-39, viii.

Davis RL, Lieu TA, Mell LK, Capra AM, Zavitkovsky A, Quesenberry CP Jr, et al. Impact of the change in polio vaccination schedule on immunization coverage rates: A study in two large health maintenance organizationsPediatrics. 2001;107(4):671-676.

Davis RL, Kramarz P, Bohlke K, Benson P, Thompson RS, Mullooly J, 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;155(3):354-359.

Davis RL, Bohlke K. Measles vaccination and inflammatory bowel disease: Controversy laid to rest? Drug Saf. 2001;24(13):939-946.

DeStefano F, Mullooly JP, Okoro CA, Chen RT, Marcy SM, Ward JI, et al. Childhood vaccinations, vaccination timing, and risk of type 1 diabetes mellitusPediatrics. 2001;108(6):E112.

DeStefano F. The Vaccine Safety Datalink projectPharmacoepidemiol Drug Saf. 2001;10(5):403-406.

Jackson LA, Austin G, Chen RT, Stout R, DeStefano F, Gorse GJ, et al. Safety and immunogenicity of varying dosages of trivalent inactivated influenza vaccine administered by needle-free jet injectorsVaccine. 2001;19(32):4703-4709.

Kramarz P, DeStefano F, Gargiullo PM, Chen RT, Lieu TA, Davis RL, et al. Does influenza vaccination prevent asthma exacerbations in children? J Pediatr. 2001;138(3):306-310.

Kramarz P, France EK, DeStefano F, Black SB, Shinefield H, Ward JI, et al. Population-based study of rotavirus vaccination and intussusceptionPediatr Infect Dis J. 2001;20(4):410-416.

Lewis E, Shinefield HR, Woodruff BA, Black SB, Destefano F, Chen RT. Safety of neonatal hepatitis B vaccine administration. Pediatr Infect Dis J. 2001;20(11):1049-1054.

Lieu TA, Davis RL, Capra AM, Mell LK, Quesenberry CP, Martin KE, et al. Variation in clinician recommendations for multiple injections during adoption of inactivated polio vaccinePediatrics. 2001;107(4):E49.


Belay ED, Holman RC, Clarke MJ, Destefano F, Shahriari, et al. The incidence of Kawasaki syndrome in West Coast health maintenance organizationsPediatr Infect Dis J. 2000;19(9):828-832.

Chen RT, DeStefano F, Davis RL. The Vaccine Safety Datalink: Immunization research in health maintenance organizations in the US [PDF – 313 KB]Bull World Health Organ. 2000;78(2):186-194.

Chen RT, Mootrey G, DeStefano F. Safety of routine childhood vaccinations: An epidemiological reviewPaediatr Drugs 2000; 2:273-290.

DeStefano F. Opportunities for population-based clinical research using data from managed care organizations. In: Davis JR, ed. Managed Care Systems and Emerging Infections. Washington, D.C.: National Academy Press, 2000: 16-18.

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

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

Kramarz P, DeStefano F, Gargiullo PM, Davis RL, Chen RT, Mullooly JP, et al. Influenza vaccination in children with asthma in health maintenance organizationsVaccine. 2000;18(21):2288-2294.

Kuppermann M, Nease RF, Jr., Ackerson LM, Black SB, Shinefield HR, Lieu TA. Parents’ preferences for outcomes associated with childhood vaccinationsPediatr Infect Dis J. 2000;19(2):129-133.

Lieu TA, Black SB, Ray GT, Martin KE, Shinefield HR, Weniger BG. The hidden costs of infant vaccinationVaccine. 2000;19(1):33-41.


Davis RL, Rubanowice D, Shinefield HR, Lewis N, Gu D, Black SB, et al. Immunization levels among premature and low-birth-weight infants and risk factors for delayed up-to-date immunization statusJAMA. 1999;282(6):547-553.

DeStefano F, Chen RT. Negative association between MMR and autismLancet. 1999;353(9169):1987-1988.

Gargiullo PM, Kramarz P, DeStefano F, Chen RT. Principles of epidemiological research on drug effects. [Letter] Lancet. 1999;353(9151):501.

Jackson LA, Benson P, Sneller VP, Butler JC, Thompson RS, Chen RT, et al. Safety of revaccination with pneumococcal polysaccharide vaccineJAMA. 1999;281(3):243-248.

Mullooly J, Drew L, DeStefano F, Chen R, Okoro K, Swint E, et al. Quality of HMO vaccination databases used to monitor childhood vaccine safetyAm J Epidemiol. 1999;149(2):186-194.


Davis RL, Mell LK, Zavitkovsky A, Thompson RS, Lieu TA, Capra AM, et al. Impact of the sequential IPV/OPV schedule on vaccination coverage levels–United States, 1997MMWR. 1998;47(47):1017-1019.

Lieu TA, Black SB, Takahashi H, Ray P, Capra AM, Shinefield HR, et al. Varicella serology among school age children with a negative or uncertain history of chickenpoxPediatr Infect Dis J. 1998;17(2):120-125.

Lieu TA, Capra AM, Makol J, Black SB, Shinefield HR. Effectiveness and cost-effectiveness of letters, automated telephone messages, or both for underimmunized children in a health maintenance organization. Pediatrics. 1998;101(4):E3.

Niu MT, Rhodes P, Salive M, Lively T, Davis DM, Black S, et al. Comparative safety of two recombinant hepatitis B vaccines in children: Data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD)J Clin Epidemiol. 1998;51(6):503-510.

Parashar UD, Holman RC, Bresee JS, Clarke MJ, Rhodes PH, Davis RL, et al. Epidemiology of diarrheal disease among children enrolled in four West Coast health maintenance organizationsPediatr Infect Dis J. 1998;17(7):605-611.

Udovic SL, Lieu TA, Black SB, Ray PM, Ray GT, Shinefield HR. Parent reports on willingness to accept childhood immunizations during urgent care visitsPediatrics. 1998;102(4):E47.


Barlow WE. Global measures of local influence for proportional hazards regression models. Biometrics. 1997;53(3):1157-1162.

Black S, Shinefield H, Ray P, Lewis E, Chen R, et al. Risk of hospitalization because of aseptic meningitis after measles-mumps-rubella vaccination in one- to two-year-old children: An analysis of the Vaccine Safety Datalink (VSD) ProjectPediatr Infect Dis J. 1997;16(5):500-503.

Chen RT, Glasser JW, Rhodes PH, Davis RL, Barlow WE, Thompson RS. Vaccine Safety Datalink project: A new tool for improving vaccine safety monitoring in the United StatesPediatrics. 1997;99(6):765-773.

Davis RL, Marcuse E, Black S, Shinefield H, Givens B, Schwalbe J, et al. MMR2 immunization at 4 to 5 years and 10 to 12 years of age: A comparison of adverse clinical events after immunization in the Vaccine Safety Datalink project. Pediatrics. 1997;100(5):767-771.

Davis RL, Black S, Vadheim C, Shinefield H, Baker B, Pearson D, et al. Immunization tracking systems: Experience of the CDC Vaccine Safety Datalink sitesHMO Pract. 1997;11(1):13-17.

Lieu TA, Black SB, Ray P, Schwalbe JA, Lewis EM, Lavetter A, et al. Computer-generated recall letters for underimmunized children: How cost-effective? Pediatr Infect Dis J. 1997;16(1):28-33.

Ray P, Black S, Shinefield H, Dillon A, Schwalbe J, Holmes S, et al. Risk of chronic arthropathy among women after rubella vaccinationJAMA. 1997;278(7):551-556.



Wassilak SG, Glasser JW, Chen RT, Hadler SC. Utility of large-linked databases in vaccine safety, particularly in distinguishing independent and synergistic effectsAnn NY Acad Sci. 1995;754:377-382.


Lieu TA, Black SB, Ray P, Chellino M, Shinefield HR, Adleret NE. Risk factors for delayed immunization among children in an HMOAm J Public Health. 1994;84(10):1621-1625.

Pearson DC, Thompson RS. Evaluation of Group Health Cooperative of Puget Sound’s Senior Influenza Immunization ProgramPublic Health Rep. 1994;109(4):571-578.