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Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine.

Donahue JG, Kieke BA, Lewis EM, Weintraub ES, Hanson KE, McClure DL, Vickers ER, Gee J, Daley MF, DeStefano F, Hechter RC, Jackson LA, Klein NP, Naleway AL, Nelson JC, Belongia EA.

Pediatrics. 2019 Dec;144(6). pii: e20191808. doi: 10.1542/peds.2019-1808. Epub 2019 Nov 18.


Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15.

Donahue JG, Kieke BA, King JP, Mascola MA, Shimabukuro TT, DeStefano F, Hanson KE, McClure DL, Olaiya O, Glanz JM, Hechter RC, Irving SA, Jackson LA, Klein NP, Naleway AL, Weintraub ES, Belongia EA.

Vaccine. 2019 Oct 16;37(44):6673-6681. doi: 10.1016/j.vaccine.2019.09.035. Epub 2019 Sep 17.


Applying sequential surveillance methods that use regression adjustment or weighting to control confounding in a multisite, rare-event, distributed setting: Part 2 in-depth example of a reanalysis of the measles-mumps-rubella-varicella combination vaccine and seizure risk.

Cook AJ, Wellman RD, Marsh T, Shoaibi A, Tiwari R, Nguyen M, Boudreau D, Weintraub ES, Jackson L, Nelson JC.

J Clin Epidemiol. 2019 Sep;113:114-122. doi: 10.1016/j.jclinepi.2019.04.019. Epub 2019 May 2.


Similar relative risks of seizures following measles containing vaccination in children born preterm compared to full-term without previous seizures or seizure-related disorders.

McClure DL, Jacobsen SJ, Klein NP, Naleway AL, Kharbanda EO, Glanz JM, Jackson LA, Weintraub ES, McLean HQ.

Vaccine. 2019 Jan 3;37(1):76-79. doi: 10.1016/j.vaccine.2018.11.038. Epub 2018 Nov 23.


Assessing Potential Confounding and Misclassification Bias When Studying the Safety of the Childhood Immunization Schedule.

Daley MF, Shoup JA, Newcomer SR, Jackson ML, Groom HC, Jacobsen SJ, McLean HQ, Klein NP, Weintraub ES, McNeil MM, Glanz JM.

Acad Pediatr. 2018 Sep - Oct;18(7):754-762. doi: 10.1016/j.acap.2018.03.007. Epub 2018 Mar 28.


Infant Hospitalizations and Mortality After Maternal Vaccination.

Sukumaran L, McCarthy NL, Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Jackson L, Klein NP, Naleway AL, McClure DL, Hechter RC, Kawai AT, Glanz JM, Weintraub ES.

Pediatrics. 2018 Mar;141(3). pii: e20173310. doi: 10.1542/peds.2017-3310. Epub 2018 Feb 20.


Methods for addressing "innocent bystanders" when evaluating safety of concomitant vaccines.

Wang SV, Abdurrob A, Spoendlin J, Lewis E, Newcomer SR, Fireman B, Daley MF, Glanz JM, Duffy J, Weintraub ES, Kulldorff M.

Pharmacoepidemiol Drug Saf. 2018 Apr;27(4):405-412. doi: 10.1002/pds.4399. Epub 2018 Feb 13.


Rates and risk factors associated with hospitalization for pneumonia with ICU admission among adults.

Storms AD, Chen J, Jackson LA, Nordin JD, Naleway AL, Glanz JM, Jacobsen SJ, Weintraub ES, Klein NP, Gargiullo PM, Fry AM.

BMC Pulm Med. 2017 Dec 16;17(1):208. doi: 10.1186/s12890-017-0552-x.


Risk of venous thromboembolism following influenza vaccination in adults aged 50years and older in the Vaccine Safety Datalink.

Vickers ER, McClure DL, Naleway AL, Jacobsen SJ, Klein NP, Glanz JM, Weintraub ES, Belongia EA.

Vaccine. 2017 Oct 13;35(43):5872-5877. doi: 10.1016/j.vaccine.2017.08.086. Epub 2017 Sep 6.


Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule.

Daley MF, Glanz JM, Newcomer SR, Jackson ML, Groom HC, Lugg MM, McLean HQ, Klein NP, Weintraub ES, McNeil MM.

Vaccine. 2017 Apr 4;35(15):1873-1878. doi: 10.1016/j.vaccine.2017.02.058. Epub 2017 Mar 9.


Vaccine adverse events in a safety net healthcare system and a managed care organization.

Narwaney KJ, Breslin K, Ross CA, Shoup JA, Wain KF, Weintraub ES, McNeil MM, Hambidge SJ.

Vaccine. 2017 Mar 1;35(9):1335-1340. doi: 10.1016/j.vaccine.2017.01.017. Epub 2017 Feb 6.


Integration of data from a safety net health care system into the Vaccine Safety Datalink.

Hambidge SJ, Ross C, Shoup JA, Wain K, Narwaney K, Breslin K, Weintraub ES, McNeil MM.

Vaccine. 2017 Mar 1;35(9):1329-1334. doi: 10.1016/j.vaccine.2017.01.027. Epub 2017 Feb 1.


Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008-2011.

Naleway AL, Crane B, Smith N, Daley MF, Donahue J, Gee J, Greene SK, Harrington T, Jackson LA, Klein NP, Tseng HF, Vellozzi C, Weintraub ES; Vaccine Safety Datalink.

Vaccine. 2016 Jan 2;34(1):167-71. doi: 10.1016/j.vaccine.2015.10.006. Epub 2015 Nov 6.


Influenza Vaccination During Pregnancy: Influenza Seasons 2002-2012, Vaccine Safety Datalink.

Groom HC, Henninger ML, Smith N, Koppolu P, Cheetham TC, Glanz JM, Hambidge SJ, Jackson LA, Kharbanda EO, Klein NP, McCarthy NL, Nordin JD, Weintraub ES, Naleway AL.

Am J Prev Med. 2016 Apr;50(4):480-488. doi: 10.1016/j.amepre.2015.08.017. Epub 2015 Oct 31.


Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations.

Sukumaran L, McCarthy NL, Kharbanda EO, McNeil MM, Naleway AL, Klein NP, Jackson ML, Hambidge SJ, Lugg MM, Li R, Weintraub ES, Bednarczyk RA, King JP, DeStefano F, Orenstein WA, Omer SB.

JAMA. 2015 Oct 20;314(15):1581-7. doi: 10.1001/jama.2015.12790.


Risk of anaphylaxis after vaccination in children and adults.

McNeil MM, Weintraub ES, Duffy J, Sukumaran L, Jacobsen SJ, Klein NP, Hambidge SJ, Lee GM, Jackson LA, Irving SA, King JP, Kharbanda EO, Bednarczyk RA, DeStefano F.

J Allergy Clin Immunol. 2016 Mar;137(3):868-78. doi: 10.1016/j.jaci.2015.07.048. Epub 2015 Oct 6.


Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis and Influenza Vaccinations in Pregnancy.

Sukumaran L, McCarthy NL, Kharbanda EO, Weintraub ES, Vazquez-Benitez G, McNeil MM, Li R, Klein NP, Hambidge SJ, Naleway AL, Lugg MM, Jackson ML, King JP, DeStefano F, Omer SB, Orenstein WA.

Obstet Gynecol. 2015 Nov;126(5):1069-74. doi: 10.1097/AOG.0000000000001066.


Demographic characteristics of members of the Vaccine Safety Datalink (VSD): A comparison with the United States population.

Sukumaran L, McCarthy NL, Li R, Weintraub ES, Jacobsen SJ, Hambidge SJ, Jackson LA, Naleway AL, Chan B, Tao B, Gee J.

Vaccine. 2015 Aug 26;33(36):4446-50. doi: 10.1016/j.vaccine.2015.07.037. Epub 2015 Jul 23.


Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006.

Abrams JY, Weintraub ES, Baggs JM, McCarthy NL, Schonberger LB, Lee GM, Klein NP, Belongia EA, Jackson ML, Naleway AL, Nordin JD, Hambidge SJ, Belay ED.

Vaccine. 2015 Jan 3;33(2):382-7. doi: 10.1016/j.vaccine.2014.10.044. Epub 2014 Nov 4.


The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety.

McNeil MM, Gee J, Weintraub ES, Belongia EA, Lee GM, Glanz JM, Nordin JD, Klein NP, Baxter R, Naleway AL, Jackson LA, Omer SB, Jacobsen SJ, DeStefano F.

Vaccine. 2014 Sep 22;32(42):5390-8. doi: 10.1016/j.vaccine.2014.07.073. Epub 2014 Aug 6. Review.


Risk of intussusception after monovalent rotavirus vaccination.

Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, Klein NP, Glanz JM, Jacobsen SJ, Naleway A, Jackson LA, DeStefano F.

N Engl J Med. 2014 Feb 6;370(6):513-9. doi: 10.1056/NEJMoa1311738. Epub 2014 Jan 14.


Identification of seizures among adults and children following influenza vaccination using health insurance claims data.

Thyagarajan V, Su S, Gee J, Duffy J, McCarthy NL, Chan KA, Weintraub ES, Lin ND.

Vaccine. 2013 Dec 5;31(50):5997-6002. doi: 10.1016/j.vaccine.2013.10.026. Epub 2013 Oct 19.


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.

Glanz JM, Narwaney KJ, Newcomer SR, Daley MF, Hambidge SJ, Rowhani-Rahbar A, Lee GM, Nelson JC, Naleway AL, Nordin JD, Lugg MM, Weintraub ES.

JAMA Pediatr. 2013 Nov;167(11):1060-4. doi: 10.1001/jamapediatrics.2013.2353.


Reply: To PMID 23545349.

Price CS, Destefano F, Weintraub ES.

J Pediatr. 2013 Oct;163(4):1231-2. doi: 10.1016/j.jpeds.2013.06.002. Epub 2013 Jul 13. No abstract available.


Guillain-Barré Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009-2011.

Greene SK, Rett MD, Vellozzi C, Li L, Kulldorff M, Marcy SM, Daley MF, Belongia EA, Baxter R, Fireman BH, Jackson ML, Omer SB, Nordin JD, Jin R, Weintraub ES, Vijayadeva V, Lee GM.

PLoS One. 2013 Jun 26;8(6):e67185. doi: 10.1371/journal.pone.0067185. Print 2013.


Increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines is not associated with risk of autism.

DeStefano F, Price CS, Weintraub ES.

J Pediatr. 2013 Aug;163(2):561-7. doi: 10.1016/j.jpeds.2013.02.001. Epub 2013 Mar 30.


A population-based cohort study of undervaccination in 8 managed care organizations across the United States.

Glanz JM, Newcomer SR, Narwaney KJ, Hambidge SJ, Daley MF, Wagner NM, McClure DL, Xu S, Rowhani-Rahbar A, Lee GM, Nelson JC, Donahue JG, Naleway AL, Nordin JD, Lugg MM, Weintraub ES.

JAMA Pediatr. 2013 Mar 1;167(3):274-81. doi: 10.1001/jamapediatrics.2013.502.


Adapting group sequential methods to observational postlicensure vaccine safety surveillance: results of a pentavalent combination DTaP-IPV-Hib vaccine safety study.

Nelson JC, Yu O, Dominguez-Islas CP, Cook AJ, Peterson D, Greene SK, Yih WK, Daley MF, Jacobsen SJ, Klein NP, Weintraub ES, Broder KR, Jackson LA.

Am J Epidemiol. 2013 Jan 15;177(2):131-41. doi: 10.1093/aje/kws317. Epub 2013 Jan 4.


Secular trends in diagnostic code density in electronic healthcare data from health care systems in the Vaccine Safety Datalink project.

Hechter RC, Qian L, Sy LS, Greene SK, Weintraub ES, Naleway AL, Rowhani-Rahbar A, Donahue JG, Daley MF, Vazquez-Benitez G, Lugg MM, Jacobsen SJ.

Vaccine. 2013 Feb 4;31(7):1080-5. doi: 10.1016/j.vaccine.2012.12.030. Epub 2012 Dec 23.


Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010.

Greene SK, Rett M, Weintraub ES, Li L, Yin R, Amato AA, Ho DT, Sheikh SI, Fireman BH, Daley MF, Belongia EA, Jacobsen SJ, Baxter R, Lieu TA, Kulldorff M, Vellozzi C, Lee GM.

Am J Epidemiol. 2012 Jun 1;175(11):1100-9. doi: 10.1093/aje/kws195. Epub 2012 May 11.


Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data.

Nelson JC, Cook AJ, Yu O, Dominguez C, Zhao S, Greene SK, Fireman BH, Jacobsen SJ, Weintraub ES, Jackson LA.

Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:62-71. doi: 10.1002/pds.2324.


Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink.

Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, Kulldorff M, Lewis E, Fireman B, Daley MF, Klein NP, Weintraub ES.

Vaccine. 2011 Oct 26;29(46):8279-84. doi: 10.1016/j.vaccine.2011.08.106. Epub 2011 Sep 9.


Safety of trivalent inactivated influenza vaccine in children aged 24 to 59 months in the vaccine safety datalink.

Glanz JM, Newcomer SR, Hambidge SJ, Daley MF, Narwaney KJ, Xu S, Lee GM, Baggs J, Klein NP, Nordin JD, Naleway AL, Belongia EA, Weintraub ES.

Arch Pediatr Adolesc Med. 2011 Aug;165(8):749-55. doi: 10.1001/archpediatrics.2011.112.


Thimerosal exposure in early life and neuropsychological outcomes 7-10 years later.

Barile JP, Kuperminc GP, Weintraub ES, Mink JW, Thompson WW.

J Pediatr Psychol. 2012 Jan-Feb;37(1):106-18. doi: 10.1093/jpepsy/jsr048. Epub 2011 Jul 23.


H1N1 and seasonal influenza vaccine safety in the vaccine safety datalink project.

Lee GM, Greene SK, Weintraub ES, Baggs J, Kulldorff M, Fireman BH, Baxter R, Jacobsen SJ, Irving S, Daley MF, Yin R, Naleway A, Nordin JD, Li L, McCarthy N, Vellozzi C, Destefano F, Lieu TA; Vaccine Safety Datalink Project.

Am J Prev Med. 2011 Aug;41(2):121-8. doi: 10.1016/j.amepre.2011.04.004.


Near real-time vaccine safety surveillance with partially accrued data.

Greene SK, Kulldorff M, Yin R, Yih WK, Lieu TA, Weintraub ES, Lee GM.

Pharmacoepidemiol Drug Saf. 2011 Jun;20(6):583-90. doi: 10.1002/pds.2133.


Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project.

Yih WK, Kulldorff M, Fireman BH, Shui IM, Lewis EM, Klein NP, Baggs J, Weintraub ES, Belongia EA, Naleway A, Gee J, Platt R, Lieu TA.

Pediatrics. 2011 May;127 Suppl 1:S54-64. doi: 10.1542/peds.2010-1722I. Epub 2011 Apr 18.


Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism.

Price CS, Thompson WW, Goodson B, Weintraub ES, Croen LA, Hinrichsen VL, Marcy M, Robertson A, Eriksen E, Lewis E, Bernal P, Shay D, Davis RL, DeStefano F.

Pediatrics. 2010 Oct;126(4):656-64. doi: 10.1542/peds.2010-0309. Epub 2010 Sep 13.


Lack of association between acellular pertussis vaccine and seizures in early childhood.

Huang WT, Gargiullo PM, Broder KR, Weintraub ES, Iskander JK, Klein NP, Baggs JM; Vaccine Safety Datalink Team.

Pediatrics. 2010 Aug;126(2):263-9. doi: 10.1542/peds.2009-1496. Epub 2010 Jul 19.


Accuracy of influenza vaccination status in a computer-based immunization tracking system of a managed care organization.

Sy LS, Liu IL, Solano Z, Cheetham TC, Lugg MM, Greene SK, Weintraub ES, Jacobsen SJ.

Vaccine. 2010 Jul 19;28(32):5254-9. doi: 10.1016/j.vaccine.2010.05.061. Epub 2010 Jun 8.


Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project.

Greene SK, Kulldorff M, Lewis EM, Li R, Yin R, Weintraub ES, Fireman BH, Lieu TA, Nordin JD, Glanz JM, Baxter R, Jacobsen SJ, Broder KR, Lee GM.

Am J Epidemiol. 2010 Jan 15;171(2):177-88. doi: 10.1093/aje/kwp345. Epub 2009 Dec 4.


Accuracy of data on influenza vaccination status at four Vaccine Safety Datalink sites.

Greene SK, Shi P, Dutta-Linn MM, Shoup JA, Hinrichsen VL, Ray P, Nordin JD, Kuckler L, Weintraub ES, Yih WK.

Am J Prev Med. 2009 Dec;37(6):552-5. doi: 10.1016/j.amepre.2009.08.022.


Predictive value of seizure ICD-9 codes for vaccine safety research.

Shui IM, Shi P, Dutta-Linn MM, Weintraub ES, Hambidge SJ, Nordin JD, Lieu TA; Vaccine Safety Datalink Research Team.

Vaccine. 2009 Aug 27;27(39):5307-12. doi: 10.1016/j.vaccine.2009.06.092. Epub 2009 Jul 17.


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.

Yih WK, Nordin JD, Kulldorff M, Lewis E, Lieu TA, Shi P, Weintraub ES.

Vaccine. 2009 Jul 9;27(32):4257-62. doi: 10.1016/j.vaccine.2009.05.036. Epub 2009 May 30.


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 vaccine.

Tate JE, Curns AT, Cortese MM, Weintraub ES, Hambidge S, Zangwill KM, Patel MM, Baggs JM, Parashar UD.

Pediatrics. 2009 Mar;123(3):744-9. doi: 10.1542/peds.2008-1200.


Incidence of neonatal herpes simplex virus infections in two managed care organizations: implications for surveillance.

Xu F, Gee JM, Naleway A, Zangwill KM, Ackerson B, Eriksen E, Weintraub ES, Hutchins K, Wei F, Berman SM, Markowitz LE.

Sex Transm Dis. 2008 Jun;35(6):592-8. doi: 10.1097/OLQ.0b013e3181666af5.


Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years.

Thompson WW, Price C, Goodson B, Shay DK, Benson P, Hinrichsen VL, Lewis E, Eriksen E, Ray P, Marcy SM, Dunn J, Jackson LA, Lieu TA, Black S, Stewart G, Weintraub ES, Davis RL, DeStefano F; Vaccine Safety Datalink Team.

N Engl J Med. 2007 Sep 27;357(13):1281-92.


Hepatitis B vaccine and risk of multiple sclerosis.

Destefano F, Weintraub ES, Chen RT.

Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):705-7, author reply 707-8. No abstract available.


Factors influencing laboratory workers' decisions to accept or decline anthrax vaccine adsorbed (AVA): results of a decision-making study in CDC's anthrax vaccination program.

Fowler GL, Baggs JM, Weintraub ES, Martin SW, McNeil MM, Gust DA.

Pharmacoepidemiol Drug Saf. 2006 Dec;15(12):880-8.


Parents concerned about vaccine safety: Differences in race/ethnicity and attitudes.

Shui IM, Weintraub ES, Gust DA.

Am J Prev Med. 2006 Sep;31(3):244-51. Epub 2006 Jul 13.


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