Research Topics
| Robert P WiseSummaryAffiliation: Food and Drug Administration Country: USA Publications
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Detail Information
Publications
Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccineRobert 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...
Thrombocytopenia after vaccination: case reports to the US Vaccine Adverse Event Reporting System, 1990-2008Emily 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...- Anaphylactoid reactions to Dextran 40 and 70: reports to the United States Food and Drug Administration, 1969 to 2004Craig E Zinderman
Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, MD 20852, USA
J Vasc Surg 43:1004-9. 2006..To reduce the risk of anaphylactoid reactions, physicians should consider routine administration of dextran 1 before the infusion of a clinical dextran... - 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... - Pediatric deaths reported after vaccination: the utility of information obtained from parentsLinda E Silvers
U S Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, Maryland 20855, USA
Am J Prev Med 22:170-6. 2002..This investigation explored whether routinely interviewing parents for follow-up of VAERS pediatric deaths would provide additional information important to vaccine safety... - Pharmacoepidemiologic implications of erroneous varicella vaccinations in pregnancy through confusion with Varicella zoster immune globulinRobert P Wise
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, Food and Drug Administration FDA, 1401 Rockville Pike, Rockville, MD 20852 1448, USA
Pharmacoepidemiol Drug Saf 11:651-4. 2002..Periodic reassessments of selected preventable problems might strengthen efforts to minimize product risks... - Reported infections after human tissue transplantation before and after new Food and Drug Administration (FDA) regulations, United States, 2001 through June, 2010Tarun K Mallick
Office of Biostatistics and Epidemiology, FDA CBER, 1401 Rockville Pike, Suite 400 S, Rockville, MD 20852, USA
Cell Tissue Bank 13:259-67. 2012..However, these data do not confirm that the reported infections were caused by suspect tissues; most reports may represent routine post-surgical infections not actually due to allografts... - Thromboembolic adverse events after use of recombinant human coagulation factor VIIaKathryn A O'Connell
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
JAMA 295:293-8. 2006..Use in patients without hemophilia has been increasing since licensure... - Babesia infection through blood transfusions: reports received by the US Food and Drug Administration, 1997-2007Diane M Gubernot
Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852 1448, USA
Clin Infect Dis 48:25-30. 2009..Babesia infection is a transfusion-transmissable disease. An estimated 70 cases were reported during 1979-2007; most of these cases were reported during the past decade... - Thrombocytopenia: case definition and guidelines for collection, analysis, and presentation of immunization safety dataRobert P Wise
Food and Drug Administration, Rockville, MD, USA
Vaccine 25:5717-24. 2007 - Polyarteritis nodosa reports to the vaccine adverse event reporting system (VAERS): implications for assessment of suspected vaccine-provoked vasculitisElizabeth 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.... - Transient bulging fontanelle after vaccination: case report and review of the vaccine adverse event reporting systemStephen 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... - Unexplained sudden death, including sudden infant death syndrome (SIDS), in the first and second years of life: case definition and guidelines for collection, analysis, and presentation of immunization safety dataGerhard Jorch
University of Magdeburg, Magdeburg, Germany
Vaccine 25:5707-16. 2007 - 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... - Guidelines for good pharmacoepidemiology practices (GPP)Elizabeth B Andrews
Pharmacoepidemiol Drug Saf 17:200-8. 2008 - Guidelines for submitting adverse event reports for publicationWilliam N Kelly
William N Kelly Consulting, Inc, Oldsmar, Florida 34677, USA
Drug Saf 30:367-73. 2007..They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events... - Guidelines for submitting adverse event reports for publicationWilliam N Kelly
William N Kelly Consulting, Inc, Oldsmar, Florida 34677, USA
Pharmacoepidemiol Drug Saf 16:581-7. 2007..They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events... - Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001Weigong Zhou
Epidemic Intelligence Service Program, Epidemiology Program Office, CDC, USA
MMWR Surveill Summ 52:1-24. 2003..This knowledge facilitates improvement in the safety of vaccines and the vaccination process... - Epoetin and pure red-cell aplasiaM M Braun
N Engl J Med 352:511-2; author reply 511-2. 2005