Vaccine Safety

Recent Publications (2011-2012)

Specific outcomes in vaccine safety research

• 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; 30(11):2032-2034.
  http://www.ncbi.nlm.nih.gov/pubmed/22361305
• 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.
• Huang WT, Suh CA, Campagna E, Broder KR, Daley MF, Crane LA, Stokley S, Kempe A. Adherence to the Advisory Committee on Immunization Practices Recommendation to Prevent Injuries from Postvaccination Syncope: A National Physician Survey. American Journal of Preventive Medicine, 2011; 41(3):317-321.
  http://www.ncbi.nlm.nih.gov/pubmed/21855747
• 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.
• 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.
• 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; 127 Suppl 1:S87-91. Epub 2011 Apr 18.
  http://www.ncbi.nlm.nih.gov/pubmed/21502241
• 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.
• 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.
• 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.
• DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177-90.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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, 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

• 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.

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