Dale R Burwen

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi 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
  2. ncbi 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
  3. ncbi 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
  4. ncbi 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
  5. ncbi 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
  6. ncbi Blood use in the ambulatory setting among elderly in the United States
    Mikhail Menis
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Transfusion 49:1186-94. 2009
  7. ncbi Blood use by inpatient elderly population in the United States
    Steven A Anderson
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852 1448, USA
    Transfusion 47:582-92. 2007
  8. ncbi 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
  9. ncbi Babesiosis among elderly Medicare beneficiaries, United States, 2006-2008
    Mikhail Menis
    Food and Drug Administration, Rockville, MD 20852, USA
    Emerg Infect Dis 18:128-31. 2012
  10. ncbi 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

Detail Information

Publications14

  1. ncbi 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...
  2. ncbi 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
    ....
  3. ncbi 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...
  4. ncbi 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...
  5. ncbi 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...
  6. ncbi Blood use in the ambulatory setting among elderly in the United States
    Mikhail Menis
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Transfusion 49:1186-94. 2009
    ..There is currently a lack of broad population-based studies detailing ambulatory blood utilization patterns among the US elderly...
  7. ncbi Blood use by inpatient elderly population in the United States
    Steven A Anderson
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852 1448, USA
    Transfusion 47:582-92. 2007
    ..As the US population ages the demand for blood is expected to grow. There have been no comprehensive studies, however, detailing blood use by the elderly in the United States...
  8. ncbi 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...
  9. ncbi Babesiosis among elderly Medicare beneficiaries, United States, 2006-2008
    Mikhail Menis
    Food and Drug Administration, Rockville, MD 20852, USA
    Emerg Infect Dis 18:128-31. 2012
    ..The highest babesiosis rates were in Connecticut, Rhode Island, New York, and Massachusetts, and findings suggested babesiosis expansion to other states...
  10. ncbi 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
    ..Evaluating the properties of these data mining methods will help determine the value of such methods in vaccine safety surveillance...
  11. ncbi 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...
  12. ncbi 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...
  13. ncbi 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
    ..However, confirmation of a vaccine association could modify the management of infants who develop TBF after immunizations...
  14. ncbi National and state trends in quality of care for acute myocardial infarction between 1994-1995 and 1998-1999: the medicare health care quality improvement program
    Dale R Burwen
    Centers for Medicare and Medicaid Services, Baltimore, MD, USA
    Arch Intern Med 163:1430-9. 2003
    ..While meaningful population-based improvement has been achieved, ample opportunities for improvement exist. Further work is required to elucidate the strategies associated with improvements in quality of care...