![]() healthcare providers with complex vaccine safety questions about their patients, provide technical assistance for vaccine safety issues, and conduct clinical research studies about vaccine safety. CDC’s Clinical Immunization Safety Assessment (CISA) Project - The CISA Project is a collaboration between CDC and medical research centers that serve as a vaccine safety resource for U.S.Through VSD, CDC monitors in-season weekly counts and rates of COVID-19 vaccination in pregnant people. The system is also used to help determine whether possible side effects identified using VAERS are related to vaccination. The Vaccine Safety Datalink (VSD) - VSD is a network of thirteen integrated healthcare organizations across the United States that monitor and evaluate the safety of vaccines.CDC clinicians review all pregnancy reports related to COVID-19 vaccinations. The VAERS reporting form has a question to identify pregnant people (question 8). Scientists investigate reports of events that are unexpected, appear to happen more often than expected, or have unusual patterns. CDC and FDA’s Vaccine Adverse Event Reporting System (VAERS) - VAERS is a national system to which healthcare professionals, vaccine manufacturers, and the public can report possible side effects or health problems that happen after vaccination.FDA’s Biologics Effectiveness and Safety (BEST) System - A system of claims-based data used for active surveillance and research.ĬDC and FDA have multiple safety monitoring systems in place to capture information about COVID-19 vaccination during pregnancy.FDA then shares this information with CDC. This system looks for any vaccine-related claims among Medicare participants aged 65 years and older. Food and Drug Administration (FDA) actively monitors vaccine safety through the CMS Medicare Claims database. The Centers for Medicare and Medicaid Services (CMS) - The U.S.healthcare providers with complex vaccine safety questions about their patients, provides technical assistance for vaccine safety issues, and conducts clinical research studies about vaccine safety. CDC’s Clinical Immunization Safety Assessment (CISA) Project - A collaboration between CDC and medical research centers that serves as a vaccine safety resource for U.S.The Vaccine Safety Datalink (VSD) - A network of 13 integrated healthcare organizations and networks across the United States that conducts active surveillance and research using electronic health records.Watch video: VAERS and Vaccine Safety: How It Works.Learn more: How VAERS helps to monitor vaccine safety.CDC also encourages reporting of any medically important adverse event even if it isn’t clear that the vaccine caused the health problem. For healthcare providers: Under Emergency Use Authorization, FDA requires healthcare professionals to report to VAERS certain adverse events that occur after COVID-19 vaccination. ![]() ![]() If you need further assistance reporting to VAERS, please call 1-80. There are two ways to report an adverse event to VAERS: report online or report using a writable pdf form.The majority of reports to VAERS after COVID-19 vaccination have been non-serious adverse events.Reports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are further assessed. CDC and FDA’s Vaccine Adverse Event Reporting System (VAERS) - A national system that accepts reports from healthcare professionals, vaccine manufacturers, and the public about adverse events that happen after vaccination.
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