Robert Ball

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration
    Robert 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
  2. pmc HLA type and immune response to Borrelia burgdorferi outer surface protein a in people in whom arthritis developed after Lyme disease vaccination
    Robert Ball
    Center for Biologics Evaluation and Research, FDA, Rockville, Maryland, USA
    Arthritis Rheum 60:1179-86. 2009
  3. doi request reprint Thrombocytopenia after vaccination: case reports to the US Vaccine Adverse Event Reporting System, 1990-2008
    Emily Jane Woo
    Food and Drug Administration, FDA CBER OBE, Rockville, MD 20852, USA
    Vaccine 29:1319-23. 2011
  4. ncbi request reprint Preventable mix-ups of tuberculin and vaccines: reports to the US Vaccine and Drug Safety Reporting Systems
    Soju 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
  5. ncbi request reprint 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
  6. doi request reprint Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007
    Manette 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
  7. pmc Surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2009-2010
    Dale 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
  8. doi request reprint Kawasaki disease after vaccination: reports to the vaccine adverse event reporting system 1990-2007
    Wei 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
  9. ncbi request reprint Comparing data mining methods on the VAERS database
    David 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
  10. ncbi request reprint Network analysis of possible anaphylaxis cases reported to the US vaccine adverse event reporting system after H1N1 influenza vaccine
    Taxiarchis 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

Detail Information

Publications38

  1. doi request reprint Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration
    Robert 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...
  2. pmc HLA type and immune response to Borrelia burgdorferi outer surface protein a in people in whom arthritis developed after Lyme disease vaccination
    Robert Ball
    Center for Biologics Evaluation and Research, FDA, Rockville, Maryland, USA
    Arthritis Rheum 60:1179-86. 2009
    ....
  3. doi request reprint Thrombocytopenia after vaccination: case reports to the US Vaccine Adverse Event Reporting System, 1990-2008
    Emily 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...
  4. ncbi request reprint Preventable mix-ups of tuberculin and vaccines: reports to the US Vaccine and Drug Safety Reporting Systems
    Soju 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...
  5. ncbi request reprint 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...
  6. doi request reprint Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007
    Manette 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...
  7. pmc Surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2009-2010
    Dale 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...
  8. doi request reprint Kawasaki disease after vaccination: reports to the vaccine adverse event reporting system 1990-2007
    Wei 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...
  9. ncbi request reprint Comparing data mining methods on the VAERS database
    David 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
    ..The Vaccine Adverse Event Reporting System (VAERS) contains approximately 150 000 reports of adverse events that are possibly associated with vaccine administration...
  10. ncbi request reprint Network analysis of possible anaphylaxis cases reported to the US vaccine adverse event reporting system after H1N1 influenza vaccine
    Taxiarchis 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...
  11. ncbi request reprint Adverse events reported following live, cold-adapted, intranasal influenza vaccine
    Hector 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...
  12. ncbi request reprint Developmental regression and autism reported to the Vaccine Adverse Event Reporting System
    Emily 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...
  13. ncbi request reprint 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 content
    Soju 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...
  14. doi request reprint Evaluation of Guillain-Barré Syndrome among recipients of influenza vaccine in 2000 and 2001
    Dale 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...
  15. pmc Vaccine adverse event text mining system for extracting features from vaccine safety reports
    Taxiarchis 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...
  16. ncbi request reprint Safety review of the purified chick embryo cell rabies vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS), 1997-2005
    Azra 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...
  17. ncbi request reprint Evaluating adverse events after vaccination in the Medicare population
    Dale 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
    ....
  18. ncbi request reprint Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003
    Ann 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)...
  19. ncbi request reprint Polyarteritis nodosa reports to the vaccine adverse event reporting system (VAERS): implications for assessment of suspected vaccine-provoked vasculitis
    Elizabeth 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
    ..To examine polyarteritis nodosa (PAN) reports to the Vaccine Adverse Event Reporting System (VAERS) as the initial stage in investigating the hypothesis that vaccination can very rarely cause PAN...
  20. ncbi request reprint Understanding vaccine safety information from the Vaccine Adverse Event Reporting System
    Frederick 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...
  21. ncbi request reprint Neurologic disease associated with 17D-204 yellow fever vaccination: a report of 15 cases
    Ann 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...
  22. pmc Text mining for the Vaccine Adverse Event Reporting System: medical text classification using informative feature selection
    Taxiarchis 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...
  23. pmc Vaccine risk perception among reporters of autism after vaccination: vaccine adverse event reporting system 1990-2001
    Emily 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)...
  24. ncbi request reprint Correlates of public health workforce acceptance of smallpox immunization in Virginia
    Marthe 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...
  25. ncbi request reprint 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...
  26. doi request reprint Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program
    Daniel 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...
  27. doi request reprint The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise
    Michael 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...
  28. ncbi request reprint Adverse events after hepatitis A B combination vaccine
    Emily Jane Woo
    Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852, USA
    Vaccine 24:2685-91. 2006
    ....
  29. ncbi request reprint Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine
    Robert 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...
  30. ncbi request reprint Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002
    Elizabeth 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...
  31. doi request reprint Elective termination of pregnancy after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS): 1990-2006
    Soju 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...
  32. doi request reprint Data mining for prospective early detection of safety signals in the Vaccine Adverse Event Reporting System (VAERS): a case study of febrile seizures after a 2010-2011 seasonal influenza virus vaccine
    David Martin
    Office of Biostatistics and Epidemiology, FDA Center for Biologics Evaluation and Research, WOC1 Building, Room 455S, 1401 Rockville Pike, Rockville, MD, 20852, USA
    Drug Saf 36:547-56. 2013
    ..In order to refine Northern Hemisphere influenza vaccine safety surveillance, VAERS data mining analyses based on vaccine brand name were initiated during the 2010-2011 influenza season...
  33. doi request reprint Application of information retrieval approaches to case classification in the vaccine adverse event reporting system
    Taxiarchis Botsis
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, US FDA, Woodmont Office Complex 1, Rm 306N, 1401 Rockville Pike, Rockville, MD 20852, USA
    Drug Saf 36:573-82. 2013
    ..Previously we showed it was possible to classify reports using features extracted from the text of the reports...
  34. ncbi request reprint Extensive limb swelling after immunization: reports to the Vaccine Adverse Event Reporting System
    Emily 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...
  35. doi request reprint Outpatient transfusions and occurrence of serious noninfectious transfusion-related complications among US elderly, 2007-2008: utility of large administrative databases in blood safety research
    Mikhail 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...
  36. doi request reprint Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010
    Gregory 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...
  37. ncbi request reprint Methods of ensuring vaccine safety
    Robert 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...
  38. ncbi request reprint Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the vaccine: Adverse Event Reporting System
    Robert 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...