Results 321 to 330 of about 1,261,156 (366)

A real-world pharmacovigilance study of axitinib: data mining of the public version of FDA adverse event reporting system

Expert Opinion on Drug Safety, 2021
Background Axitinib was approved for treatment of advanced renal cell carcinoma (RCC). The current study was to assess axitinib-related adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Yamin Shu, Yufeng Ding, Bing Dai, Qilin Zhang   +3 more
semanticscholar   +1 more source

A review of the Vaccine Adverse Event Reporting System database

Expert Opinion on Pharmacotherapy, 2004
The Vaccine Adverse Event Reporting System (VAERS) is an epidemiological database that has been maintained by the FDA and Centers for Disease Control and Prevention (CDC) since 1990. Authors from the National Immunization Programme of the CDC have previously described an epidemiological technique to make qualitative and quantitative measurement in the ...
David A. Geier, Mark R. Geier
openaire   +3 more sources

An evaluation of the FDA adverse event reporting system and the potential for reporting bias

Journal of Cosmetic Dermatology, 2021
AbstractBackgroundThe FDA maintains the Adverse Event Reporting System (CAERS) database, which contains product complaint reports for foods, dietary supplements, and cosmetics. Product line perception and subsequent adverse event reporting may be impacted by negative media attention.MethodsThe purpose of this analysis was to use the CAERS database to ...
Andrew D. Monnot, Ernest S. Fung, Goli S. Compoginis, Kevin M. Towle   +3 more
openaire   +3 more sources

Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)?

Vaccine, 2013
Healthcare provider (HCP) reporting to the Vaccine Adverse Event Reporting System (VAERS) is important to assuring the safety of U.S. licensed vaccines. HCP awareness of and practices regarding reporting of adverse events following immunization (AEFI) is understudied.A large, nationally representative sample of U.S.
Theresa M. Real, Rongxia Li, Michael M. McNeil, Susanne Pickering, Michael R. Pemberton, Philip J. Smith   +5 more
openaire   +2 more sources

Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

Psychotherapy and Psychosomatics, 2020
Introduction: Esketamine nasal spray received approval for treatment-resistant depression in March 2019. Objective: Using the FDA Adverse Event Reporting System (FAERS) database (March 2019–March 2020), we analysed esketamine-related adverse events (AEs)
C. Gastaldon, E. Raschi, J. Kane, C. Barbui, G. Schoretsanitis   +4 more
semanticscholar   +1 more source

Misinformation and the Vaccine Adverse Event Reporting System

JAMA
This Viewpoint posits that to improve public understanding of the system, the Vaccine Adverse Event Reporting System (VAERS) could use a more accurate name, well-defined guidance about the reporting system’s nature and use, and comprehensible information about an event’s verification status.
Kathleen Hall, Jamieson, Kevin B, Johnson, Anne R, Cappola   +2 more
openaire   +2 more sources

Reported Adverse Events with Painkillers: Data Mining of the US Food and Drug Administration Adverse Events Reporting System

Drug Safety, 2017
One-third of adults in the USA experience chronic pain and use a variety of painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. However, some serious adverse events (AEs), such as cardiovascular incidents, overdose, and death, have been found to be related to painkillers.We used 2015 and 2016 AE reports from ...
Allison Kowalski, Vicki Osborne, Jae Min, Mattia Prosperi   +3 more
openaire   +3 more sources

Developmental regression and autism reported to the Vaccine Adverse Event Reporting System [PDF]

Autism, 2007
We report demographic and clinical characteristics of children reported to the US Vaccine Adverse Event Reporting System (VAERS) as having autism or another developmental disorder after vaccination. We completed 124 interviews with parents and reviewed medical records for 31 children whose records contained sufficient information to evaluate the child'
Robert Ball, Rebecca Landa, Andrew W. Zimmerman, M. Miles Braun, Emily Jane Woo   +4 more
openaire   +2 more sources

Suboptimal reporting of adverse medical events to the FDA Adverse Events Reporting System by nurse practitioners and physician assistants

Expert Opinion on Drug Safety, 2012
The Adverse Events Reporting System (AERS) of the FDA is used to identify toxicities of drugs that are on the market. Nurse practitioners (NP) and physician assistants (PA), having an increasing role in the delivery of medical care, are also needed to participate in post-marketing pharmacovigilance.
Humberto Sifuentes, Mike L Marshall, Jamie Ehrenpreis, Zachary L. Smith, Eli D. Ehrenpreis   +4 more
openaire   +3 more sources

Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990–2007

Vaccine, 2009
During the period March 1, 1998 to January 14, 2007, approximately 6 million doses of Anthrax vaccine adsorbed (AVA) vaccine were administered. As of January 16, 2007, 4753 reports of adverse events following receipt of AVA vaccination had been submitted to the Vaccine Adverse Event Reporting System (VAERS).
M. Miles Braun, Manette T. Niu, Robert Ball, Dale R. Burwen, Maureen Knippen, Emily Jane Woo   +5 more
openaire   +3 more sources