Hector S Izurieta
Affiliation: Food and Drug Administration
- 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...
- 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...
- 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...
- 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...
- 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...
- Babesiosis among elderly Medicare beneficiaries, United States, 2006-2008Mikhail 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...
- Application of the immunological disease continuum to study autoimmune and other inflammatory events after vaccinationHelen C Koenig
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
Vaccine 29:913-9. 2011..We show how this could have important implications to assess mechanisms of potential immune-mediated adverse events following vaccination...
- Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005Sandra S Chaves
Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA
J Infect Dis 197:S170-7. 2008..Ongoing safety surveillance and further studies may shed light on some of the hypothesized associations...
- Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007Penina 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...
- Effectiveness of influenza vaccinationM Miles Braun
N Engl J Med 357:2730; author reply 2730-1. 2007
- Aseptic meningitis: case definition and guidelines for collection, analysis and presentation of immunization safety dataTerhi Tapiainen
University Children's Hospital, Basel, Switzerland
Vaccine 25:5793-802. 2007