The Vaccine Adverse Event Reporting System (VAERS) has gotten a lot of attention on social media and in the news this year. This database, which includes hundreds of thousands of reports of health events that occurred minutes, hours, or days after vaccination, is a go to spot for many people looking for information about COVID-19 vaccine safety.
While VAERS is an extremely helpful tool used by experts to track adverse reactions and safety concerns associated with vaccinations (not just COVID-19, but all vaccines!), it is important to know a few things about the system before digging in too deeply.
Scientists and health experts consider VARES to be a starting point in the search for rare but potentially serious vaccine side effects. It is by no means the only system in place to track this data.
So, when reading about VAERS reports in the news or when talking with friends and loved ones about specific reports, be sure to have the following 6 things in mind:
1. VAERS is a national vaccine safety surveillance program that helps to detect unusual or unexpected reporting patterns of adverse events for vaccines.
Established in 1990, VAERS is the nation’s early warning system that monitors the safety of vaccines after they are authorized or licensed for use by the FDA. VAERS is part of the larger vaccine safety system in the United States that helps make sure all vaccines are safe. The system is co-managed by CDC and FDA.
Other pieces of this safety system include the CDC’s Vaccine Safety Datalink (VSD) and the Clinical Immunization Safety Assessment (CISA) project. These reporting systems are much better at assessing overall health risks and possible connections between adverse events and a vaccine.
2. VAERS accepts reports from anyone, including patients, family members, healthcare providers and vaccine manufacturers.
Anyone can submit a report to VAERS — healthcare professionals, vaccine manufacturers, and the general public. VAERS welcomes all reports, regardless of seriousness, and regardless of how likely the vaccine may have been to have caused the adverse event. Reports can be submitted successfully even if they are incomplete or are missing key details.
3. VAERS is not designed to determine if a vaccine caused or contributed to an adverse event. A report to VAERS does not mean the vaccine caused the event.
This fact has caused much confusion, specifically regarding the number of reported deaths associated with COVID-19 vaccines. In the past, there have been instances where people misinterpreted reports of death following vaccination as death caused by the vaccines; that is a mistake.
VAERS accepts all reports of adverse events following vaccination without judging whether the vaccine caused the adverse health event. Some reports to VAERS might represent true vaccine reactions, and others might be coincidental adverse health events not related to vaccination at all. Generally, a causal relationship cannot be established using information from VAERS reports alone.
Reports can also be made days, weeks, and months following a vaccination. That means that if a vaccinated person dies in a car accident, drowns, or dies from any other “natural” or “unnatural” cause, their death must be reported to VAERS as an adverse event. Since we’ve now vaccinated over 334 million people in the United States, it is to be expected that many deaths will occur coincidentally after vaccination.
4. VAERS is a passive surveillance system, meaning it relies on people sending in reports of their experiences after vaccination.
As a passive reporting system, VAERS relies on individuals to send in reports of adverse health events following vaccination.
The information collected by VAERS can quickly provide an early warning of a potential safety problem with a vaccine. Patterns of adverse events, or an unusually high number of adverse events reported after a particular vaccine, are called “signals.” If a signal is identified through VAERS, experts may conduct further studies to find out if the signal represents an actual risk.
5. Healthcare providers and vaccine manufacturers are required by law to report certain events after vaccination.
Healthcare providers are required to report to VAERS the following adverse events after COVID-19 vaccination under Emergency Use Authorization, and other adverse events if later revised by FDA.
Some things that healthcare providers are required to report on include:
- Vaccine administration errors, whether or not associated with an adverse event.
- Serious adverse events regardless of death. This could include:
- Death
- A life-threatening adverse event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
- An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
- Cases of Multisystem Inflammatory Syndrome (MIS).
- Cases of COVID-19 that result in hospitalization or death.
Further, healthcare providers are encouraged to report to VAERS any additional clinically significant adverse effects following vaccination, even if they are not sure if vaccination caused the event.
6. If VAERS detects a pattern of adverse events following vaccination, other vaccine safety monitoring systems conduct follow up studies.
The information that the VAERS system provides to the FDA and CDC is vitally important. If it looks as though a vaccine might be causing a wide-spread problem, the FDA and the CDC will investigate further and take action if needed.
We saw this system in action just recently when the CDC paused the Johnson & Johnson vaccine due to reports of cerebral venous sinus thrombosis (CVST). This pause allowed time for the FDA and CDC to investigate these reports and examine any possible linkages. A similar review process was followed when reports of myocarditis in the United States began to circulate. The J&J pause and investigation into cases of myocarditis are all signs that the VAERS reporting system is working extremely well! If at any point the CDC and FDA saw evidence showing a direct linkage between a vaccine and permanent disability and/or death, proper steps would be taken to ensure safety.
Note: For public awareness and in the interest of transparency, CDC is providing timely updates on the following serious adverse events of interest: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html