Why the Vaccine Adverse Event Reporting System (VAERS) is Critical During the COVID-19 Vaccine Rollout

January 25, 2021 Inge Garrison, Chief Clinical Officer, RLDatix

Vaccines to prevent the coronavirus disease 2019 (COVID-19) are perhaps the best hope for ending the pandemic that has spread across the world and impacted countless lives. As we have seen, COVID-19 can cause severe medical complications and lead to death. Over the last year, experts have continued to gather and aggregate data about the virus, but there are still aspects of COVID-19 that present more questions than answers. Namely, there is no way to know how COVID-19 will affect you, as symptoms can vary. If an individual is infected with COVID-19, they risk spreading the disease to family, friends and others who might be at increased risk of severe illness from the virus 

In recent months, COVID-19 vaccine rollouts have begun, including the Pfizer-BioNtech COVID-19 vaccine (administered in two shots, 21 days apart) and Moderna’s COVID-19 vaccine (administered in two shots, 28 days apart). These COVID-19 vaccines help protect you by creating an antibody response in your body without you having to become extremely sick with the virusThe intended result is that the vaccine prevents you from contracting COVID-19becoming seriously ill from the virus or developing serious complications if you were to become infected 

Vaccine Standards and Adverse Event Reporting 

All COVID-19 vaccines have gone through the same clinical trial processes that are required of other vaccines. Before rolling out, safety reviews are conducted on the vaccines and the U.S. Food and Drug Administration (FDA) assigns proper authorizations. Each of these steps ensure the vaccine is safe and effective and were completed in record time due to innovations in technology, world-wide focus and clear communication. After a vaccine is approved for use, many vaccine safety monitoring systems watch for adverse events or side effects. This continued monitoring can detect adverse events that may not have been detected in even the most extensive clinical trials. If an unexpected adverse event is detectedit is quickly studied it to further assess whether it is a true safety concern. Experts then decide whether changes need to be applied to the U.S. vaccine recommendations. This monitoring is critical to help ensure that the vaccine’s benefits continue to outweigh the risks for individuals on the receiving end.  

Established in 1990, The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system that was instituted to detect any possible safety issues in U.S.-licensed vaccines. VAERS is a passive reporting system which means that it is dependent on individuals reporting any adverse events they experience from a vaccine. Healthcare providers are required by law to report vaccine adverse events to VAERS that take place within the specified time period after a vaccination is administered. You can find vaccine adverse events detailed in the VAERS Table of Reportable Events Following Vaccination 

Supporting Your Safety Journey: Submit a VAERS Report with RLDatix 

To help you in your efforts to standardize your collection of VAERS data, we have created a form template that aligns with the necessary VAERS reporting fields. This form can be built into a healthcare organization’s RLDatix system to simplify the reporting process and compile all enterprise and organizational data in a central repository. To access the COVID-19 resource library and locate the appropriate form for the RLDatix product you use, please click here. As the COVID-19 vaccine continues to be rolled out and new vaccines are introduced, each of us has a civil responsibility to report vaccine related events. Reporting any adverse events associated with the COVID-19 vaccine and others can help the CDC use this information to improve future iterations and rollouts.   

Prioritizing Safety Every Step of the Way 

The release of the COVID-19 vaccines signal a new chapter in the pandemic -- one of hope and path toward normalcy. As the vaccine rollout continues, it is critical that both healthcare organizations and citizens do their part to get vaccinated and report any adverse events associated with the vaccine and its doses. This intentional focus will help enable a learning culture and support the safety of those who receive it in the future.  As we learn how COVID-19 vaccines work in real-world conditions, it's important to continue using all available tools and strategies to help mitigate this pandemicWear a maskpractice social distancing and wash your hands often and properly. One of the most effective ways to ward off germs and viruses is to remain diligent with hand hygiene – it will always be a vital defense that all of us can practice to reduce the spread of infection 

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