How Do We Monitor Vaccines for Safety?

The Vaccine Adverse Event Reporting System (VAERS) is one of the national vaccine safety programs that monitor approved vaccinations

Are vaccines monitored for safety after they are approved?

Yes. All vaccines approved in the United States are continually monitored for side effects and adverse events reported after vaccination.

Although several agencies are involved in this effort, the primary system for receiving and reviewing vaccine reports is the Vaccine Adverse Event Reporting System (VAERS).

What is the work of VAERS?

VAERS monitors the safety of vaccines after they are authorized or licensed for use by the U.S. Food and Drug Administration (FDA). The system is co-managed by CDC and FDA.

The VAERS scientists collect and analyze information from reports of side effects and adverse events after the administration of U.S. licensed vaccines.

What side effects and adverse events are commonly reported?

Most reports following vaccinations involve relatively mild side effects, and no medical intervention is required. These include pain or swelling at the injection site, headache, chills, or fever.

It’s important to note that these reactions are not only common, but they are also typical signs that your body is building protection.

However, reported events could also include allergic reactions, severe illnesses, hospitalizations, and death. This information may assist in identifying whether a pattern of adverse events is emerging for a specific vaccine.

What does VAERS do with the reports they receive?

These reports provide the data necessary to help scientists determine where patterns and problems may exist in administering a vaccine to the U.S. population.

For example, a report to VAERS does not mean that a vaccine caused an adverse event. However, if it looks as though a vaccine might be causing a problem, appropriate agencies will investigate further and act to address the concern and inform the public.

Reports to VAERS enable scientists to:

1. Assess the safety of newly licensed vaccines
2. Detect new, unusual, or rare adverse events that happen after vaccination
3. Monitor increases in known side effects, like arm soreness where a shot was given
4. Identify potential patient risk factors for specific types of health problems related to vaccines
5. Identify and address possible reporting clusters
6. Recognize persistent safe-use problems and administration errors
7. Watch for unexpected or unusual patterns in adverse event reports
8. Serve as a monitoring system in public health emergencies

What else do we need to know about VAERS?

Although VAERS data and findings are reported to the CDC and FDA, they are also available to the public (without identifiable patient information). Instructions for accessing the information through the VAERS WONDER system are available online.

Here are five things you need to know about VAERS:

1. VAERS is a national vaccine safety monitoring program that uses reports submitted from across the U.S. to identify patterns of adverse events after vaccination.
2. VAERS accepts reports from anyone, which includes patients, family members, healthcare providers, and vaccine manufacturers.
3. VAERS is a passive monitoring system, meaning it relies on people sending in reports of their experiences after vaccination.
4. Healthcare providers and vaccine manufacturers are required by law to report adverse events after vaccination.
5. If VAERS detects a pattern of adverse events following vaccination, other vaccine safety monitoring systems conduct follow-up studies.

Does VAERS monitor COVID-19 vaccinations?

Yes. In fact, one of the best examples of VAERS vaccine monitoring has involved the COVID-19 vaccinations.
Following hundreds of millions of doses, reports of serious adverse events after a COVID-19 vaccination have been rare.

Regardless, the CDC and FDA continue to closely monitor several reporting systems, like the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), and V-safe.

How does our local health department participate in the VAERS program?

As with all vaccine providers, the Moultrie County Health Department (MCHD) is required by law to submit information to VAERS when an individual reports an adverse event following vaccination.

We will continue to make such reports as appropriate to ensure that potential vaccine-related incidents are accurately recorded in the VAERS system and available to support effective vaccine monitoring.

The MCHD encourages all individuals to consult with their vaccine provider before receiving immunizations to ensure the chosen vaccines are appropriate and beneficial to the person receiving them.

Additionally, all individuals are encouraged to report unexpected reactions after vaccination to their vaccine provider or to the VAERS system.

For further information on the VAERS system or vaccine safety and availability, contact your vaccine provider or the MCHD at 217-728-4114. To make a vaccine appointment, please see our clinic dates.