What Is VAERS? Why the CDC Database Is Crucial to Vaccine Safety—And How to Use It Responsibly
There's a lot of information out there about the COVID-19 vaccines. You could spend an entire day reading clinical trial data, catching up on info from the Centers for Disease Control and Prevention on potential side effects, and cruising social media to learn about your friends' personal experiences.
But there's one resource that's been getting a lot of attention lately. It's the CDC's Vaccine Adverse Event Reporting System (VAERS), a national early warning system to detect possible safety problems in vaccines licensed in the US. VAERS didn't start with COVID-19—it's actually been around for decades. Still, since the COVID-19 vaccines are new, plenty of people in the general public have suddenly started caring about the reporting system.
So what's the deal with VAERS and why is everyone suddenly interested in it? Here's what you need to know.
OK, what is VAERS?
VAERS was established by the CDC and the US Food and Drug Administration in 1990 to help detect possible safety issues with vaccines once they moved from clinical trial stages to being used by the general public.
"It's meant to be very inclusive of any type of signal that may or may not relate to the vaccine," infectious disease expert Amesh A. Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security, tells Health. "It's a surveillance system used to understand what's going on with real-world usage of the vaccine."
VAERS accepts and analyzes reports of possible side effects after a person has received a vaccine, the Department of Health and Human Services (HHS) explains. Anyone can report an issue to VAERS, although healthcare professionals are required to report certain side effects and vaccine manufacturers are required to report all side effects that they're alerted about.
A big thing to keep in mind: VAERS relies on people to send in reports of their side effects. It's not actually designed to determine if a vaccine actually caused a health problem, but it can help pick up patterns of side effects that could potentially suggest a problem with a vaccine.
How to use VAERS
Anyone can submit to VAERS, whether they're patient, or parents of a patient, or siblings of a patient—you get it. You have two options with this—you can submit a report online, or download a writable PDF and complete it offline before submitting it.
Here's what you'll need to provide to fill out the form:
- Your age
- Date of birth
- The brand of vaccine you got and dosage
- The date, time, and location you got the vaccine
- The date and time when your side effects started
- Your symptoms
- What happened with your side effects
- Medical tests and lab results, if you had them
- Your doctor's contact info, if it's relevant
Another way you can use VAERs is by checking out what other people have submitted. You can search the data online or download the raw data to put into a spreadsheet.
While VAERS can be viewed by the public, information identifying you to your report is not.
If you choose to use VAERS, do so with caution
Here's the thing: Anyone can report anything to VAERS, whether it's related to the vaccine or not. So, if you happen to develop a stomachache after you get your COVID-19 vaccine, you can report it to VAERS, even though your pain is more likely due to the fact that you ate too much celebratory cake post-vaccination than the vaccine itself. Still, it can go into the system and then "stomachache" might be linked to the vaccine.
This is all part of the system, though, and it's actually encouraged that you report everything. The VAERS website even says this: "Please report clinically important adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event." Meaning, if you're not sure if what you're experiencing after the vaccine is relevant or not, you should report it anyway.
That said, there's a disclaimer on VAERS that specifically warns that these aren't proven side effects caused by the vaccine. Instead, there may be an association. "While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness," the disclaimer says. "The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable."
"VAERS is meant to pick up lots of signals, most of which are going to be noise," Dr. Adalja says. "But not everything that happens after a vaccine is caused by the vaccine."
Case in point: Tucker Carlson recently claiming that many people are dying from the COVID-19 vaccine, citing VAERS data, while failing to point out that there's no evidence that the vaccine caused those deaths. "People forget to say that everybody is reporting everything right now because of COVID-19 and the vaccines," Dr. Adalja says. "We're also giving the vaccines to people who are high risk, and they could die of other causes." You could also get the vaccine and die in a car crash the next day, and it would end up in VAERS.
While VAERS data has been abused and misread recently, Dr. Adalja says that's not fault of the surveillance process—it's a user interpretation issue.
Overall, he says, "VAERS is an important part of our safety system."
The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.
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