Research Topics
| R BallSummaryAffiliation: Food and Drug Administration Country: USA Publications
| Collaborators
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Detail Information
Publications
Comparing data mining methods on the VAERS databaseDavid Banks
The Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
Pharmacoepidemiol Drug Saf 14:601-9. 2005..Evaluating the properties of these data mining methods will help determine the value of such methods in vaccine safety surveillance...- Passive surveillance for generalized vaccinia in the United States using the Vaccine Adverse Event Reporting System (VAERS)Marthe Bryant-Genevier
CBER OBE DE Vaccine Safety Branch, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, USA
Vaccine 24:3632-5. 2006..We assessed the utility of passive reporting for GV surveillance by reviewing all Vaccine Adverse Event Reporting System (VAERS) reports of any post-smallpox vaccination rash in civilians and military personnel... - Predicting risk of decompression sickness in humans from outcomes in sheepR Ball
Naval Medical Research Institute, Bethesda, Maryland 20889 5607, USA
J Appl Physiol 86:1920-9. 1999..This model supports the hypothesis that species of similar body mass have similar DCS risk... - Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the vaccine: Adverse Event Reporting SystemRobert Ball
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
J Clin Epidemiol 55:819-24. 2002..Development and application of case definitions for other adverse events reported after vaccination should enhance the value of vaccine safety databases. Published by Elsevier Science Inc... - Kinetic and dynamic models of diving gases in decompression sickness preventionRobert Ball
Decompression Program, Diving and Environmental Physiology Department, Naval Medical Research Institute, Bethesda, Maryland, USA
Clin Pharmacokinet 41:389-402. 2002.... - Methods of ensuring vaccine safetyRobert Ball
Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
Expert Rev Vaccines 1:161-8. 2002..This will require investment in resources to identify true adverse effects, understand their pathophysiology, and design and manufacture safer vaccines... - Safety data on meningococcal polysaccharide vaccine from the Vaccine Adverse Event Reporting SystemR Ball
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852, USA
Clin Infect Dis 32:1273-80. 2001..That there were few reports of serious adverse events, with >6 million doses having been distributed, and no clear signal of a previously unrecognized serious reaction is reassuring with regard to the safety of meningococcal vaccine... - Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: reports to the vaccine adverse event reporting systemR Ball
The Vaers Working Group Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
Pediatr Infect Dis J 20:219-23. 2001..We identified six cases of SJS or TEN after vaccination without other obvious triggers, suggesting that SJS and TEN might very rarely be caused by vaccination. Confirmation of this hypothesis will likely require controlled studies... - An assessment of thimerosal use in childhood vaccinesL K Ball
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Foodand Drug Administration, Rockville, Maryland 20852, USA
Pediatrics 107:1147-54. 2001..This action was prompted in part by a risk assessment from the Food and Drug Administration that is presented here... - 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 vaccineA W McMahon
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, USA
Vaccine 26:427-9. 2008.... 
Can network analysis improve pattern recognition among adverse events following immunization reported to VAERS?R Ball
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
Clin Pharmacol Ther 90:271-8. 2011..NA offers a complementary approach to current statistical data-mining techniques for visualizing multidimensional patterns, providing a structural framework for evaluating AE data...- Comparison of military and civilian reporting rates for smallpox vaccine adverse eventsA W McMahon
Office of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, MD, USA
Pharmacoepidemiol Drug Saf 16:597-604. 2007.... - Extensive limb swelling after immunization: reports to the Vaccine Adverse Event Reporting SystemEmily Jane Woo
Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852, USA
Clin Infect Dis 37:351-8. 2003..Postvaccination ELS can involve both the proximal and distal segments of the extremity, affects all age groups, and occurs after vaccination with a broad range of vaccines... - Developmental regression and autism reported to the Vaccine Adverse Event Reporting SystemEmily Jane Woo
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
Autism 11:301-10. 2007..Further research might determine whether the pathogenesis of autism with developmental regression differs from that of autism without regression... - Perinatal hepatitis B transmission and vaccination timing in a managed care cohort: assessment of the temporary delay in newborn hepatitis B vaccination due to thimerosal contentSoju Chang
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, Rockville, MD 20852, USA
Pediatr Infect Dis J 26:329-33. 2007..S. childhood immunization schedule, of vaccinations during the first 2 years of life... - Neurologic disease associated with 17D-204 yellow fever vaccination: a report of 15 casesAnn W McMahon
1401 Rockville Pike, HFM 220, Rockville, MD 20852, USA
Vaccine 25:1727-34. 2007..Laboratory and epidemiological evidence suggests that YEL caused encephalitis. Additional studies will be required to confirm whether YEL can rarely result in GBS and/or ADEM... - Adverse events after hepatitis A B combination vaccineEmily Jane Woo
Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852, USA
Vaccine 24:2685-91. 2006.... - Transient bulging fontanelle after vaccination: case report and review of the vaccine adverse event reporting systemStephen B Freedman
Division of Pediatric Emergency Medicine, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
J Pediatr 147:640-4. 2005..However, confirmation of a vaccine association could modify the management of infants who develop TBF after immunizations... - Fatal syncope-related fall after immunizationEmily Jane Woo
Arch Pediatr Adolesc Med 159:1083. 2005 - Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001Weigong Zhou
Epidemic Intelligence Service Program, Epidemiology Program Office, CDC, USA
MMWR Surveill Summ 52:1-24. 2003..This knowledge facilitates improvement in the safety of vaccines and the vaccination process... - Understanding vaccine safety information from the Vaccine Adverse Event Reporting SystemFrederick Varricchio
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration/NIH/DHHS, Rockville MD, USA
Pediatr Infect Dis J 23:287-94. 2004..Confirmation in a controlled study is usually required. An understanding of the system's defined objectives and inherent drawbacks is vital to the effective use of VAERS data in vaccine safety investigations... - Perspectives on the use of data mining in pharmaco-vigilanceJune Almenoff
GlaxoSmithKline, Research Triangle Park, North Carolina, USA
Drug Saf 28:981-1007. 2005..The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues... 
Vaccine risk perception among reporters of autism after vaccination: vaccine adverse event reporting system 1990-2001Emily Jane Woo
Food and Drug Administration, HFM 222, 1401 Rockville Pike, Rockville, MD 20852, USA
Am J Public Health 94:990-5. 2004..We investigated vaccine risk perception among reporters of autism to the Vaccine Adverse Event Reporting System (VAERS)...- Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccineRobert P Wise
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
JAMA 292:1702-10. 2004..Clinical trials evaluate a vaccine's safety before approval, but some risks may escape detection or adequate characterization until larger population exposures occur after licensure... - Polyarteritis nodosa reports to the vaccine adverse event reporting system (VAERS): implications for assessment of suspected vaccine-provoked vasculitisElizabeth M Begier
Vaccine Safety Branch, Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852-1448, USA
J Rheumatol 31:2181-8. 2004.... - Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003Ann W McMahon
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, Maryland 20852, USA
Pediatrics 115:453-60. 2005..In April 2002, the Advisory Committee on Immunization Practices (ACIP) encouraged providers to vaccinate healthy 6- to 23-month-old infants and children with trivalent influenza vaccine (TIV)... - Adverse events reported following live, cold-adapted, intranasal influenza vaccineHector S Izurieta
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
JAMA 294:2720-5. 2005..Although prelicensure testing involved 20 228 vaccinees, clinical trials were not of sufficient size to detect rare adverse events reliably... - Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007Penina Haber
Centers for Disease Control and Prevention, National Center for Immunizations and Respiratory Diseases, 1600 Clifton Rd, MS A 47, Atlanta, GA 30333, USA
Pediatrics 121:1206-12. 2008..Although the new rotavirus vaccine (RotaTeq; Merck, West Point, PA) introduced in 2006 was not associated with intussusception in prelicensure trials, additional monitoring is important to ensure a complete safety profile... - Elective termination of pregnancy after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS): 1990-2006Soju Chang
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, 1401 Rockville Pike, HFM 222, Rockville, MD 20852 United States
Vaccine 26:2428-32. 2008..Good quality information may be obtained from controlled observational studies... - Effectiveness of influenza vaccinationM Miles Braun
N Engl J Med 357:2730; author reply 2730-1. 2007 - Adverse event reports following vaccination for Lyme disease: December 1998-July 2000Sarah L Lathrop
Centers for Disease Control and Prevention, Epidemic Intelligence Service, Atlanta, GA 30333, USA
Vaccine 20:1603-8. 2002.... - Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002Elizabeth M Begier
Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852-1448, USA
Clin Infect Dis 38:771-9. 2004..Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis... - Varicella-zoster vaccineEmily Jane Woo
N Engl J Med 357:88. 2007 - Evaluating adverse events after vaccination in the Medicare populationDale R Burwen
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
Pharmacoepidemiol Drug Saf 16:753-61. 2007.... - Using simulation to assess the sensitivity and specificity of a signal detection tool for multidimensional public health surveillance dataHenry Rolka
Centers for Disease Control and Prevention CDC, Epidemiology Program Office, Division of Public Health Surveillance and Informatics, Mailstop K74, 1600 Clifton Road, NE, Atlanta, GA 30333, USA
Stat Med 24:551-62. 2005..Knowing these rates is important for determining the degree of response to an MGPS signal detection event in 'live' data... - Zidovudine and perinatal human immunodeficiency virus type 1 transmission: a population-based approachNorma S Harris
Department of Epidemiology and Biostatistics, University of South Carolina, School of Public Health, Columbia, South Carolina, USA
Pediatrics 109:e60. 2002..This study examined the impact of the full 3-arm zidovudine regimen on the perinatal transmission of human immunodeficiency virus type 1 (HIV-1) using population-based data... - Correlates of public health workforce acceptance of smallpox immunization in VirginiaMarthe Bryant-Genevier
CBER OBE DE Vaccine Safety Branch, Food and Drug Administration, Rockville, Maryland 20852 1448, USA
Public Health Nurs 23:339-46. 2006..By October 24, 2003, 38,577 of 500,000 targeted civilians received smallpox vaccine in the Pre-Event Smallpox Vaccination Campaign, Phase I. We investigated reasons for the low vaccination uptake... - Safety review of the purified chick embryo cell rabies vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS), 1997-2005Azra Dobardzic
Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852, USA
Vaccine 25:4244-51. 2007..Most reported AEs are non-serious and consistent with pre-licensure safety data. The rabies risk must be carefully considered before vaccine discontinuation...