Emily Jane Woo

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi 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
  2. ncbi Adverse Events After Recombinant Human BMP2 in Nonspinal Orthopaedic Procedures
    Emily Jane Woo
    US Food and Drug Administration, HFM 222, 1401 Rockville Pike, Rockville, MD, 20852, USA
    Clin Orthop Relat Res 471:1707-11. 2013
  3. ncbi Recombinant human bone morphogenetic protein-2: adverse events reported to the Manufacturer and User Facility Device Experience database
    Emily Jane Woo
    US Food and Drug Administration, HFM 222, 1401 Rockville Pike, Rockville, MD 20852, USA
    Spine J 12:894-9. 2012
  4. ncbi Adverse events reported after the use of recombinant human bone morphogenetic protein 2
    Emily Jane Woo
    US Food and Drug Administration, Rockville, MD, USA
    J Oral Maxillofac Surg 70:765-7. 2012
  5. ncbi 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
  6. ncbi 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
  7. 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
  8. 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
  9. 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
  10. ncbi 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

Detail Information

Publications15

  1. ncbi 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...
  2. ncbi Adverse Events After Recombinant Human BMP2 in Nonspinal Orthopaedic Procedures
    Emily Jane Woo
    US Food and Drug Administration, HFM 222, 1401 Rockville Pike, Rockville, MD, 20852, USA
    Clin Orthop Relat Res 471:1707-11. 2013
    ..Most events in this analysis occurred after off-label uses. Postmarketing review of adverse event reports remains an important approach for identifying potential safety concerns...
  3. ncbi Recombinant human bone morphogenetic protein-2: adverse events reported to the Manufacturer and User Facility Device Experience database
    Emily Jane Woo
    US Food and Drug Administration, HFM 222, 1401 Rockville Pike, Rockville, MD 20852, USA
    Spine J 12:894-9. 2012
    ..However, because of its size, scope, and nature, the US Food and Drug Administration's database of postmarketing reports is useful for detecting new and unexpected safety concerns...
  4. ncbi Adverse events reported after the use of recombinant human bone morphogenetic protein 2
    Emily Jane Woo
    US Food and Drug Administration, Rockville, MD, USA
    J Oral Maxillofac Surg 70:765-7. 2012
    ..The objective of this analysis was to characterize adverse events reported after the use of rhBMP-2 in oral and maxillofacial procedures...
  5. ncbi 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...
  6. ncbi 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...
  7. 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...
  8. 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...
  9. 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...
  10. ncbi 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...
  11. ncbi 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...
  12. ncbi 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)...
  13. ncbi 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...
  14. 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...
  15. ncbi 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
    ....