Research Topics
Species | Robert BallSummaryAffiliation: Food and Drug Administration Country: USA Publications
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Detail Information
Publications
HLA type and immune response to Borrelia burgdorferi outer surface protein a in people in whom arthritis developed after Lyme disease vaccinationRobert Ball
Center for Biologics Evaluation and Research, FDA, Rockville, Maryland, USA
Arthritis Rheum 60:1179-86. 2009....
Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug AdministrationRobert Ball
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, USA
Pediatrics 127:S31-8. 2011..In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety...- Thrombocytopenia after vaccination: case reports to the US Vaccine Adverse Event Reporting System, 1990-2008Emily Jane Woo
Food and Drug Administration, FDA CBER OBE, Rockville, MD 20852, USA
Vaccine 29:1319-23. 2011..TP was reported after inactivated and live viral vaccines. Platelet counts <10×10(9)/L were reported. Identified vaccines could be prioritized for hypothesis-testing studies... 
Preventable mix-ups of tuberculin and vaccines: reports to the US Vaccine and Drug Safety Reporting SystemsSoju Chang
Office of Biostatistics and Epidemiology, US Food and Drug Administration FDA, 1401 Rockville Pike, Rockville, MD 20852, USA
Drug Saf 31:1027-33. 2008..Errors involving the mix-up of tuberculin purified protein derivative (PPD) and vaccines leading to adverse reactions and unnecessary medical management have been reported previously...- Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS)Emily Jane Woo
US Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, Maryland 20852, USA
Drug Saf 31:667-74. 2008..Stratified empirical Bayesian (EB) methods have been compared with crude, but not stratified, proportional reporting ratios (PRRs) in their performance on adverse event data... - Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007Manette T Niu
Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Division of Epidemiology, Vaccine Safety Branch, 1401 Rockville Pike, HFM 220, Rockville, MD 20852, United States
Vaccine 27:290-7. 2009..Continued monitoring of VAERS and analysis of potential associations between AVA vaccination and rare, serious events is warranted... - Surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2009-2010Dale R Burwen
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
Am J Public Health 102:1921-7. 2012..We implemented active surveillance for Guillain-Barré syndrome (GBS) following seasonal or H1N1 influenza vaccination among the Medicare population during the 2009-2010 influenza season... - Kawasaki disease after vaccination: reports to the vaccine adverse event reporting system 1990-2007Wei Hua
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, Food and Drug Administration FDA, Rockville, MD 20852 1448, USA
Pediatr Infect Dis J 28:943-7. 2009..A review of RotaTeq (rotavirus vaccine live) clinical trial data revealed higher, though not statistically significantly, KD rates among RotaTeq vaccines than placebo recipients. In June 2007, the RotaTeq label was revised accordingly... - Evaluation of Guillain-Barré Syndrome among recipients of influenza vaccine in 2000 and 2001Dale R Burwen
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
Am J Prev Med 39:296-304. 2010..Studies published after the IOM report have been limited by passively reported data or lack of validation of coded diagnoses... - Network analysis of possible anaphylaxis cases reported to the US vaccine adverse event reporting system after H1N1 influenza vaccineTaxiarchis Botsis
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
Stud Health Technol Inform 169:564-8. 2011..Additional validation and development of this approach is needed to improve future pharmacovigilance efforts... - 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... - 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... - 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... - 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)... - 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.... - 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... - 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... - 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.... - 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)... - Text mining for the Vaccine Adverse Event Reporting System: medical text classification using informative feature selectionTaxiarchis Botsis
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
J Am Med Inform Assoc 18:631-8. 2011..Our objective was to demonstrate a multi-level text mining approach for automated text classification of VAERS reports that could potentially reduce human workload... - 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... - 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... - 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... - Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination programDaniel A Salmon
National Vaccine Program Office, Office of Public Health and Science, Department of Health and Human Services, 200 Independence Ave, Washington, DC 20201, USA
Pediatrics 127:S78-86. 2011..These efforts improved monitoring of 2009 H1N1 vaccine safety, hold promise for enhancing future national monitoring of vaccine safety, and may ultimately help improve public confidence in vaccines... - Vaccine adverse event text mining system for extracting features from vaccine safety reportsTaxiarchis Botsis
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA
J Am Med Inform Assoc 19:1011-8. 2012..To develop and evaluate a text mining system for extracting key clinical features from vaccine adverse event reporting system (VAERS) narratives to aid in the automated review of adverse event reports... - The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterpriseMichael Nguyen
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
Pharmacoepidemiol Drug Saf 21:291-7. 2012..FDA and PRISM will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise... - 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... - 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... - 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.... - 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... - 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... - Outpatient transfusions and occurrence of serious noninfectious transfusion-related complications among US elderly, 2007-2008: utility of large administrative databases in blood safety researchMikhail Menis
Analytic Epidemiology Branch, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
Transfusion 52:1968-76. 2012..Our study evaluated types and quantities of transfused components as well as occurrence of TRALI, ABO, and Rh incompatibilities among the US elderly in the institutional outpatient setting during 2007 to 2008... - Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010Gregory W Daniel
HealthCore, Inc, Alexandria, Virginia, USA
Transfusion 52:2113-21. 2012..Our study objective was to assess occurrence of recorded TEs after administration of different US-licensed IG products and investigate potential risk factors using a large administrative database... - 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... - 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...