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VAERS and Vaccine Safety: What You Need to Know

Medically Reviewed by Michael W. Smith, MD on September 16, 2021

What Is VAERS?

VAERS stands for the Vaccine Adverse Event Reporting System. It’s a nationwide early warning system that helps the CDC and FDA spot possible safety problems with vaccines licensed in the U.S. The government created VAERS in 1990.

Anyone can report a possible vaccine side effect (also called an “adverse event”) to the VAERS database, including:

  • Patients
  • Parents or caregivers of patients
  • Doctors and other health care providers

In some cases, the law requires health care workers to send reports to VAERS. Vaccine makers must report all side effects they find out about.

What's the Purpose of VAERS?

VAERS doesn’t determine whether a vaccine caused or played a role in a particular health issue. Rather, it helps experts at the CDC and FDA spot patterns that might be early clues of a problem. This gives them a heads-up that they may need to do more research on a vaccine’s safety.

The main goals of VAERS are to:

  • Help spot new, unusual, or rare vaccine side effects.
  • Track rises in known side effects.
  • Spot things that might make people more likely to have certain side effects.
  • Check on the safety of newly licensed vaccines.
  • Determine whether possible side effects are showing up in clusters, like in a certain area or in a specific batch of vaccines
  • Spot mistakes made by health care workers when they’re vaccinating people.
  • Provide a safety monitoring system for the country in response to public health emergencies.

What Are Its Limits?

Some of the system’s drawbacks are:

  • In general, VAERS can’t tell us whether a vaccine caused a particular problem.
  • People file reports to VAERS that are often short on details and sometimes have mistakes.
  • People are more likely to report serious possible side effects than minor ones.
  • Reports on certain adverse events may rise due to media coverage.
  • VAERS data can’t be used to figure out rates of side effects.

Does It Say Thousands Have Died from COVID Vaccines?

VAERS doesn't say thousands of people have died from COVID vaccines. This is a myth. VAERS reports alone don’t determine whether vaccines cause or play a role in health problems or deaths.

Here are the facts: More than 380 million doses of COVID-19 vaccines were given in the U.S. from Dec. 14, 2020, to Sept. 13, 2021. During that time, VAERS got 7,653 reports of death among people who got vaccinated.

But health care providers must report any death after a COVID-19 vaccination to VAERS. When someone dies after getting vaccinated, it doesn’t necessarily mean the vaccine had anything to do with their death. Based on research that looked at death certificates, autopsies, and medical records, scientists have found no link between the COVID-19 vaccine and a higher risk of death.

Overall, COVID-19 vaccines are safe and effective. They’re the best way to protect yourself from the coronavirus, which had killed more than 660,000 people in the U.S. as of September 2021.

What Side Effects Should You Report to VAERS?

The government encourages people to report any medical issue that happens after someone gets vaccinated. Some problems may be caused by the vaccination. Others might have no connection.

The form you use to file a report with VAERS collects information about:

  • The vaccine
  • The person who got vaccinated
  • The reaction that happened

Each report of a possible side effect goes into the VAERS database. The data is available publicly, but VAERS keeps the identity of all patients confidential.

What Do Health Providers Have to Report?

Health care professionals are required by law to report any adverse event listed on the VAERS Table of Reportable Events Following Vaccination. This is a list of vaccines along with possible side effects for each. It also includes time frames for when the side effect could happen after vaccination. Health care providers also must report certain reactions that the vaccine maker lists.

The government urges, but doesn’t require, health workers to report any other possible side effect, even if it’s not clear that the vaccination caused it. The government also encourages health providers to report cases where a vaccine is given to someone incorrectly.

Here are some examples of side effects that doctors and other health care providers must report to VAERS after giving certain vaccines.

After a measles, mumps, and rubella vaccination:

After a COVID-19 vaccination:

  • Any life-threatening side effect or death
  • A new hospitalization or a longer hospital stay
  • Health problems that get in the way of someone's daily life
  • Birth defects in babies whose mothers got the shot while pregnant
WebMD Medical Reference

Sources

SOURCES:

Vaccine Adverse Event Reporting System: “VAERS Data,” “About VAERS,” “Frequently Asked Questions (FAQs),” “VAERS Table of Reportable Events Following Vaccination.”

CDC: “Selected Adverse Events Reported after COVID-19 Vaccination,” “COVID Data Tracker.”

Mayo Clinic: “Encephalitis.”

National Institutes of Health: “Encephalopathy Information Page.”

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