R Ball

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. 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
  2. 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
  3. ncbi request reprint Predicting risk of decompression sickness in humans from outcomes in sheep
    R Ball
    Naval Medical Research Institute, Bethesda, Maryland 20889 5607, USA
    J Appl Physiol (1985) 86:1920-9. 1999
  4. 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
  5. ncbi request reprint Kinetic and dynamic models of diving gases in decompression sickness prevention
    Robert Ball
    Decompression Program, Diving and Environmental Physiology Department, Naval Medical Research Institute, Bethesda, Maryland, USA
    Clin Pharmacokinet 41:389-402. 2002
  6. 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
  7. ncbi request reprint Safety data on meningococcal polysaccharide vaccine from the Vaccine Adverse Event Reporting System
    R 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
  8. ncbi request reprint Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: reports to the vaccine adverse event reporting system
    R 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
  9. ncbi request reprint An assessment of thimerosal use in childhood vaccines
    L 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
  10. ncbi request reprint 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 vaccine
    A W McMahon
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, USA
    Vaccine 26:427-9. 2008

Collaborators

Detail Information

Publications40

  1. 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...
  2. 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...
  3. ncbi request reprint Predicting risk of decompression sickness in humans from outcomes in sheep
    R Ball
    Naval Medical Research Institute, Bethesda, Maryland 20889 5607, USA
    J Appl Physiol (1985) 86:1920-9. 1999
    ..This model supports the hypothesis that species of similar body mass have similar DCS risk...
  4. 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...
  5. ncbi request reprint Kinetic and dynamic models of diving gases in decompression sickness prevention
    Robert Ball
    Decompression Program, Diving and Environmental Physiology Department, Naval Medical Research Institute, Bethesda, Maryland, USA
    Clin Pharmacokinet 41:389-402. 2002
    ....
  6. 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...
  7. ncbi request reprint Safety data on meningococcal polysaccharide vaccine from the Vaccine Adverse Event Reporting System
    R 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...
  8. ncbi request reprint Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: reports to the vaccine adverse event reporting system
    R 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...
  9. ncbi request reprint An assessment of thimerosal use in childhood vaccines
    L 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...
  10. ncbi request reprint 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 vaccine
    A W McMahon
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, USA
    Vaccine 26:427-9. 2008
    ....
  11. doi request reprint 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...
  12. ncbi request reprint Comparison of military and civilian reporting rates for smallpox vaccine adverse events
    A W McMahon
    Office of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, MD, USA
    Pharmacoepidemiol Drug Saf 16:597-604. 2007
    ....
  13. pmc Simulating adverse event spontaneous reporting systems as preferential attachment networks: application to the vaccine adverse event reporting system
    J Scott
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration
    Appl Clin Inform 5:206-18. 2014
    ..Assessing the performance of such signal detection procedures requires simulated SRS databases, but simulation strategies proposed to date each have limitations...
  14. pmc Automating case definitions using literature-based reasoning
    T Botsis
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, Food and Drug Administration FDA, Rockville, MD
    Appl Clin Inform 4:515-27. 2013
    ..The application of CDefs still relies on manual steps and this is a major source of inefficiency in surveillance and research...
  15. ncbi request reprint Fatal syncope-related fall after immunization
    Emily Jane Woo
    Arch Pediatr Adolesc Med 159:1083. 2005
  16. 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...
  17. 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...
  18. ncbi request reprint Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001
    Weigong Zhou
    Epidemic Intelligence Service Program, Epidemiology Program Office, CDC, USA
    MMWR Surveill Summ 52:1-24. 2003
    ..Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events...
  19. 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
    ....
  20. ncbi request reprint Transient bulging fontanelle after vaccination: case report and review of the vaccine adverse event reporting system
    Stephen 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
    ..To describe the features of transient bulging fontanelle (TBF) after vaccination...
  21. 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...
  22. ncbi request reprint Perspectives on the use of data mining in pharmaco-vigilance
    June 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...
  23. 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...
  24. 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)...
  25. 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...
  26. 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...
  27. 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)...
  28. 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...
  29. doi request reprint Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007
    Penina 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...
  30. ncbi request reprint Adverse event reports following vaccination for Lyme disease: December 1998-July 2000
    Sarah L Lathrop
    Centers for Disease Control and Prevention, Epidemic Intelligence Service, Atlanta, GA 30333, USA
    Vaccine 20:1603-8. 2002
    ..Although events reported to VAERS are not necessarily causally associated with vaccination, VAERS reports can be used to identify possible safety concerns that occur at too low a rate to have been identified prior to licensure...
  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. ncbi request reprint Effectiveness of influenza vaccination
    M Miles Braun
    N Engl J Med 357:2730; author reply 2730-1. 2007
  33. ncbi request reprint Zidovudine and perinatal human immunodeficiency virus type 1 transmission: a population-based approach
    Norma 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...
  34. ncbi request reprint Varicella-zoster vaccine
    Emily Jane Woo
    N Engl J Med 357:88. 2007
  35. 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
    ....
  36. 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...
  37. 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...
  38. 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...
  39. ncbi request reprint Using simulation to assess the sensitivity and specificity of a signal detection tool for multidimensional public health surveillance data
    Henry 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...
  40. 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...