What is the Vaccine Adverse Event Reporting System (VAERS)?

Vaccines are a vital tool for preserving both personal and community health, however, vaccines do have the potential to cause adverse reactions. To help ensure that these reactions are identified and investigated, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) established the Vaccine Adverse Event Reporting System (VAERS).

What is VAERS?

VAERS is a national program used to help scientists and doctors identify potentially harmful patterns in vaccines. The program was created in 1990 as a way for anyone to report post-vaccine health problems. This includes allergic reactions, intestinal conditions, neurological conditions, blood clots, illnesses, or other problems that may or may be related to a vaccination. From the reports, doctors and scientists can monitor increases in common adverse reactions, identify new side effects, assess the overall safety of particular vaccines, and with much more.

VAERS is a passive surveillance system. As a passive system, VAERS relies on people to recognize an adverse reaction and then report it themselves. This does put some limitations on VAERS. Since reports are not automatically collected, many adverse reactions can go under-reported. Increasing awareness about VAERS can help counter this.

Who Can Make a VAERS Report

Anyone can make a VAERS report. Whether it's the person who received the vaccine, a parent or guardian, a healthcare provider, a vaccine manufacturer, or anyone from the general public - they are free to make a report as they see fit. You don't have to be the one that experienced the adverse reaction to report it.

Certain groups are required to make VAERS reports. Healthcare providers must report any adverse event listed in the VAERS Table of reportable events. Healthcare providers are not required, but are highly encouraged to, report any other adverse reactions and/or vaccine administration errors that occur. Administration errors refer to the way the vaccine was administered rather than the contents of the vaccine itself. Vaccine manufacturers are also required to report any adverse reactions that come to their attention.

Whether or not all mandatory reports are made is unknown due to the passive nature of the reporting system.

How to Make a VAERS Report

There are two ways to make a VAERS report. The first is through a writable PDF form and the second is directly through the VAERS website. Making a report does require a bit of information including:

  • Patient information (age, date of birth, and sex/gender)
  • Information on the vaccine administered (name, brand, dosage, lot number if available)
  • Date, time, and location of where the vaccine was administered
  • Date and time of when the adverse reaction began
  • Symptoms of the adverse reaction
  • Medical test or lab results of the adverse reaction (if available)
  • Physician's Contact information (if available)

This may seem like an overwhelming amount of information. We want to help make this process easier by offering to assist you with the VAERS report at no cost to you.

Why Make a VAERS Report

While adverse reactions are rare it is incredibly important that you make a VAERS report if you experience one. By making a report you are helping to improve vaccine safety for everyone. The more reports that are made, the easier it is for doctors and scientists to identify potential problems with vaccines.

VAERS has helped doctors and scientists identify adverse reactions that were not present during clinical trials. In 1997, doctors adjusted the polio vaccine schedule due to cases of paralysis that were reported to VAERS. That change greatly reduced the rare instances of severe side effects after polio vaccinations. More recently, in January 2021, 1266 reports of adverse reactions due to the COVID-19 Moderna vaccine were made. The CDC and FDA flagged 108 of those cases for further review and discovered that allergic reactions are one of the more common adverse reactions seen from that particular vaccine. If it weren't for the reports made to VAERS, this information may not have been discovered as quickly.

Making a VAERS report is one of the best things you can do to help improve vaccine safety for everyone. We encourage you to make a report or contact our office at (614) 389-9711 and tell us about any vaccine adverse reactions you’ve observed. We will make a VAERS report for you for free.