Vaccine Safety

Resource Library

Recent Publications (2009-2011)

Specific outcomes in vaccine safety research

Belongia EA, Irving SA, Shui IM, Kulldorff M, Lewis E, Yin R, Lieu TA, Weintraub E, Yih WK, Li R, Baggs J. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. Pediatr Infect Dis J 29: 1-5, 2010.
Gidudu J, Sack DA, Pina M, et al; The Brighton Collaboration Diarrhea Working Group. Diarrhea: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2011 Jan 29:29(5): 1053-71.
Goodman MJ, Nordin JD, Belongia EA, Mullooly JP, Baggs J. Henoch-Schonlein Purpura and Polysaccharide Meningococcal Vaccine. Pediatrics. 2010 Aug;126(2):e325-9.
Huang WT, Gargiullo PM, Broder KR, Weintraub ES, Iskander JK, Klein NP, Baggs JM. Lack of Association Between Acellular Pertussis Vaccine and Seizures in Early Childhood. Pediatrics. 2010 Aug;126(2):263-9.
Huang WT, Suh CA, Daley MF, Crane LA, Babbel C, Barrow J, Broder KR, Stokley S, Marin M, Beaty B, Kempe A. Physicians' knowledge, adherence, and practices about current recommendations on postvaccination syncope and injury prevention. American Journal of Preventive Medicine (in press 2011).
Jackson LA, Yu O, Nelson JC, Dominguez C, Peterson D, Baxter R, Hambidge SJ, Naleway AL, Belongia EA, Nordin JD, Baggs J. Injection Site and Risk of Medically Attended Local Reactions to Acellular Pertussis Vaccine. Pediatrics 127: e581-e587, 2011.
Jackson LA, Yu Onchee, Nelson J, Belongia EA, Hambidge SJ, Baxter R, Naleway A, Nordin J, Baggs J, Iskander J. Risk of medically-attended local reactions following diphtheria toxoid containing vaccines in adolescents and young adults: A Vaccine Safety Datalink Study. Vaccine. 2009:27:4912-4916.
Klein NP, Edwards KM, Sparks R and Dekker CL; on behalf of the Clinical Immunization Safety Assessment (CISA) Network. Recurrent Sterile Abscesses Following Immunization: A Possible Association with Aluminum Adjuvant. BMJ Case Reports. 2009.
Lin ND, Kleinman K, Chan KA, Soumerai S, Mehta J, Mullooly JP, Shay DK, Kolczak M, Lieu TA. Multiple vaccinations and the risk of medically attended fever. Vaccine 28: 4169-74, 2010 combination vaccine and the risk of febrile seizures. Pediatrics 126: e1-e8, 2010.
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 Oct 1;51(7):871-2; author reply 872-3.
Miller EK, Dumitrescu L, Cupp C, Dorris S, Taylor S, Sparks R, Fawkes D, Frontiero V, Rezendes AM, Marchant C, Edwards KM, Crawford DC. Atopy history and the genomics of wheezing after influenza vaccination in children 6-59 months of age. Vaccine. 2011 Apr 18;29(18):3431-7.
Naleway AL, Belongia EA, Donahue JG, Kieke BA, Glanz JM: Vaccine Safety Datalink. Risk of immune hemolytic anemia in children following immunization. Vaccine. 2009 Dec 9;27(52):7394-7.
Nordin James D., Michael J. Goodman, Edward A. Belongia, John P. Mullooly, James Baggs, Henoch-Schönlein Purpura and Polysaccharide Meningococcal Vaccine PEDIATRICS Vol. 126 No. 2 August 2010, pp. e325-e329.
Nordin JD, Yih WK, Kulldorff M, Weintraub E. Tdap and GBS letter. Vaccine. 2011 Feb 1;29(6):1122. Epub 2010 Dec 2.
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 1;203(3):316-23.
Payne DC, Rose Jr CE, Kerrison J, Aranas A, Duderstadt S and McNeil MM. Anthrax Vaccination and Risk of Optic Neuritis in the United States Military, 1998-2003. Arch. Neurology 2006;63:871-875.
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. Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism. Pediatrics. 2010 Oct;126(4):656-64. Epub 2010 Sep 13.
Slade B, Gee J, Broder K, Vellozzi C. Comment on the contribution by Souayah et al., Guillain-Barré syndrome after Gardasil vaccination: Data from Vaccine Adverse Event Reporting System 2006-2009. Vaccine 2011;29(5):685-686.
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.
Wong C, Krashin J, Rue-Cover A, Saraiya M, Unger E, Calugar A, Markowitz L. Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS). Journal of Women's Health 2010 Mar 19(3):365-370.
Woo EJ, Wise RP, Menschik D, Shadomy SV, Iskander J, Beeler J, Varricchio F, Ball R. Thrombocytopenia after vaccination: case reports to the US Vaccine Adverse Event Reporting System, 1990-2008. Vaccine. 2011 Feb 1;29(6):1319-23.
Yen C, Jakob K, Esona MD, Peckham X, Rausch J, Hull JJ, Whittier S, Gentsch JR, Larussa P. Detection of fecal shedding of rotavirus vaccine in infants following their first dose of pentavalent rotavirus vaccine. Vaccine. 2011 May 31;29(24):4151-5.

General vaccine safety, vaccines and vaccination practices, methodology and systems for vaccine safety monitoring

Baggs J, Gee J, Lewis E, Fowler G, Benson P, Lieu T, Naleway A, Klein NP, Baxter R, Belongia E, Glanz J, Hambidge SJ, Jacobsen SJ, Jackson L, Nordin J, Weintraub E. The Vaccine Safety Datalink: a model for monitoring immunization safety. Pediatrics 127 Suppl 1: S45-S53, 2011.
CDC. Prevention and Control of Influenza with Vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR 2010 Aug 6; 59(RR08):1-62.
CDC. Use of Combination Measles, Mumps, Rubella, and Varicella Vaccine: Recommendations of the Advisory Committee on Immunization Practices. MMWR 2010 May 7; 59(RR03):1-12.
DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177-90.
Durbin AP, Setse R, Omer SB, Palmer JG, Spaeder JA, Baker J, Lessans F, and Halsey NA. Monitoring Adverse Events Following Yellow Fever Vaccination Using an Integrated Telephone and Internet-based System. Vaccine 2009 Oct 19; 27(44):6143-47.
Fowler GL, Baggs JM, Weintraub ES, Martin SW, McNeil MM, and Gust DA. 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. Pharmacoepidemiol. & Drug Saf. 2006 15:880-8.
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. Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project. Am J Epidemiol 171: 177-88, 2010.
Greene SK, Kulldorff M, Yin R, Yih WK, Lieu TA, Weintraub ES, Lee GM. Near real-time vaccine safety surveillance with partially accrued data. Pharmacoepidemiol Drug Saf 2011.
Greene SK, Shi P, Dutta-Linn MM, Shoup JA, Hinrichsen VL, Ray P, Nordin JD, Kuckler L, Weintraub ES, Yih WK. 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, Iskander J, Walton K, Campbell SR, and Kohl KS. Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety. Pediatrics 2011;127 Suppl 1: S39-44.
Hazlehurst B, Naleway A, Mullooly J. Detecting possible vaccine adverse events in clinical notes of the electronic medical record. Vaccine 27 (2009) 2077–2083.
Huang WT, Chang S, Miller ER, Woo EJ, Hoffmaster AR, Gee JE, Paddock CD, Clark T, Iskander J, Ball, Broder K. Safety assessment after recall of Haemophilus influenzae type b conjugate vaccine — United States, 2007–2008. Pharmacoepidemiology and Drug Safety 2010;19(3):306-310.
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 Mar25;9(1):37.May;127(5):e1139-46.
Jackson LA, Onchee Y, Belongia EA, Hambidge SJ, Nelson J, Baxter R, Naleway A, Gay C, Nordin J, Baggs J, and Iskander J. 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; 9: 165.
Klein NP, Gidudu J, Qiang Y, Pahud B, Rowhani-Rahbar A, Baxter R, Dekker CL, Edwards KM, Halsey NA, Larussa P, Marchant C, Tokars JI, Destefano F. Developing the next generation of vaccinologists. Vaccine. 2011 Apr 19.
Klein NP, Kissner J, Aguirre A, Sparks R, Campbell S, Edwards KM, Dekker CL, Shui I, Gust DA. Differential Maternal Responses to a Newly Developed Vaccine Information Pamphlet. Vaccine 2009; 28:323–8.
Kulldorff M, Davis RL, Kolczak M, Lewis E, Lieu T, Platt R. A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance. Sequential Analysis. 2011:30: 1, 58-78.
LaRussa PS, Edwards KM, Dekker CL, Klein NP, Halsey NA, Marchant C, Baxter R, Engler RJ, Kissner J, Slade BA. Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network. Pediatrics. 2011 May;127 Suppl 1:S65-73.
Li L, Kulldorff M. A conditional maximized sequential probability ratio test for pharmacovigilance. Stat Med 29: 284-95, 2010.
Lindsey NP, Staples JE, Jones JF, Sejvar JJ, Griggs A, Iskander J, Miller ER, Fischer M. Adverse Event Reports Following Japanese Encephalitis Vaccination in the United States, 1999-2009. Vaccine 2010 Dec 10;29(1):58-64.
Martin SW, Tierney BC, Aranas A, Rosenstein NE, Franzke LH, Apicella L, Marano N, and McNeil MM.An Overview of Adverse Events Reported by Participants in CDC’s Anthrax Vaccine and Antibiotics Availability Program. Pharmacoepidemiol. & Drug Saf. 2005;14:393-401. (with a complimentary editorial by E.A. Bresnitz).
McCarthy NL, Gee J, Weintraub E, Donahue JG, Nordin JD, Daley MF, Naleway A, Henninger M, Baxter R, Crane B, Aukes L, Wagner N, Fisher S, Jacobsen SJ, Sy L, Baggs J. Monitoring vaccine safety using the Vaccine Safety Datalink: Utilizing immunization registries for pandemic influenza. Vaccine. 2011 May 17.
McNeil MM, Ma GW, Aranas A, Payne DC, and Rose, Jr CE. A Comparative Assessment of Immunization Records in the Defense Medical Surveillance System and the Vaccine Adverse Event Reporting System. Vaccine. 2007;25; 3428-3436.
Miller E, Batten B, Hampton L, Campbell SR, Gao J, and Iskander J. Tracking Vaccine-Safety Inquiries to Detect Signals and Monitor Public Concerns. Pediatrics. 2011 May;127 Suppl 1:S87-91.
Muhammad R, Haber P, Broder KR, Ball R, Braun MM, Davis RL, McMahon AW. Adverse events following inactivated influenza vaccination in children 2 through 17 years of age: analysis of the Vaccine Adverse Event Reporting System:1990-2006. Journal of Pediatric Infectious Diseases. 2010 (Jan);30(1):e1-e8.
Navar-Boggan AM, Halsey NA, Golden WC, Escobar GJ, Massolo M, and Klein NP. Risk of Fever and Sepsis Evaluations Following Routine Immunizations in the Neonatal Intensive Care Unit. J Perinatol. 2010 Feb 25; 2010: 1-6.
Nelson JC, Bittner RCL, Bounds L, Zhao S, Baggs J, Donahue JG, Hambidge SJ, Jacobsen SJ, Klein NP, Naleway AL, Zangwill KM, Jackson LA. 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.
Payne DC, Aranas A, McNeil MM, Duderstadt S, and Rose Jr. CE. Concurrent Vaccinations and U.S. Military Hospitalizations. Ann. Epidemiol. 2007;17:697-703.
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;16:46-54.
Payne DC, Rose Jr. CE, Aranas A, Zhang Y, Tolentino H, Weston E, McNeil MM, and Ruscio B. Assessment of Anthrax Vaccination Data in the Defense Medical Surveillance System, 1998-2004. Pharmacoepidemiol. & Drug Saf. 2007;16:605-611.
Rosenberg M, Sparks R, McMahon A, Iskander J, Campbell JD, and Edwards KM. Serious Adverse Events Rarely Reported After Trivalent Inactivated Influenza Vaccine (TIV) in Children 6–23 Months of Age. Vaccine. 2009 Jul 9; 27(32):4278-83.
Salmon DA, Akhtar A, Mergler MJ, Vannice KS, Izurieta H, Ball R, Lee GM, Vellozzi C, Garman P, Cunningham F, Gellin B, Koh H, Lurie N, and the H1N1 Working Group of the Federal Immunization Safety Task Force. Immunization- Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program. Pediatrics. 2011 May;127 Suppl 1:S78-86.
Schmidt MA, Crane B, Mullooly JP, Naleway AL. Frequency of medically attended events following rapid revaccination with trivalent inactivated influenza vaccine. Vaccine. 2010 Nov 16;28(49):7713-5.
Shui I, Ping Shia, M. Maya Dutta-Linn, Eric S.Weintraub, Simon J. Hambidge, James D. Nordin, Tracy A. Lieu, for the Vaccine Safety Datalink Research Team. Predictive value of seizure ICD-9 codes for vaccine safety research. Vaccine 27 (2009) 5307–5312.
Sy LS, Liu IL, Solano Z, Cheetham TC, Lugg MM, Greene SK, Weintraub ES, Jacobsen SJ. Accuracy of influenza vaccination status in a computer-based immunization tracking system of a managed care organization. Vaccine. 2010 Jul 19;28(32):5254-9.
Tierney BC, Martin SW, Franzke LH, Marano N, Reissman DB, Louchart RD, Goff JA, Rosenstein NE, Sever JL, and McNeil MM. 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.
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. BMC Med Inform Decis Mak 2007; 7: 3.
Vellozzi C, Broder KR, Haber P, Guh A, Nguyen M, Cano M, Lewis P, McNeil MM, Bryant M, Singleton J, Martin D, DeStefano F. 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 21;28(45):7248-55.
Wei F, Mullooly JP, Goodman M, McCarty MC, Hanson AM, Crane B, Nordin JD. Identification and characteristics of vaccine refusers. BMC Pediatr. 2009 Mar 5;9:18
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. Journal of Data Science 8: 349-60, 2010.
Xu S, Zhang L, Nelson JC, Zeng C, Mullooly J, McClure D, Glanz J. Identifying optimal risk windows for self-controlled case series studies of vaccine safety. Stat Med. 2011 Mar 30;30(7):742-52. doi: 10.1002/sim.4125.
Yih WK, Nordin JD, Kulldorff M, Lewis E, Lieu TA, Shi P, Weintraub ES. 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 27 (2009) 4257–4262.
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. Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project. Pediatrics 127 Suppl 1: S54-S64, 2011.

Vaccine safety in special populations

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 14;28(40):6609-12.
Klein NP, Aukes L, Lee J, Fireman B, Shapira SK, Slade B, Baxter R, Summar M. Evaluation of immunization rates and safety among children with inborn errors of metabolism. Pediatrics. 2011 May;127(5):e1139-46.
Klein NP, Gans H, Sung P, Yasukawa LL, Johnson J, Sarafanov A, Chumakov K, Hansen J, Black S, and Dekker CL. Preterm Infants T Cell Responses to Inactivated Poliovirus Vaccine. Journal of Infectious Diseases. 2010 Jan 15; 201(2): 214-22.
Morgan TM, Schlegel C, Edwards KM, Welch-Burke T, Zhu Y, Sparks R, Summar M; the Urea Cycle Disorders Consortium. Vaccines Are Not Associated With Metabolic Events in Children With Urea Cycle Disorders. Pediatrics. 2011 May;127(5):e1147-e1153.
Moro P, Broder KR et al. Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine (TIV) and live attenuated influenza vaccine (LAIV) in the Vaccine Adverse Event Reporting System. American Journal of Obstetrics and Gynecology 2011;204(2):146.e1-e7.
Zangwill KM, Yeh SH, Wong EJ, Marcy SM, Eriksen E, Huff KR, Lee M, Lewis EM, Black SB, Ward JI. Paralytic syndromes in children: epidemiology and relationship to vaccination. Pediatr Neurol 42: 206-12, 2010.