Vaccine Adverse Event Reporting System (VAERS)
Vaccines are developed in accordance with the highest standards of safety. However, as with any medical procedure, vaccination has some risks. Individuals react differently to vaccines, and there is no way to predict the reaction of a specific individual to a particular vaccine.
The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report adverse events (possible side effects) that occur following vaccination, so the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) established the Vaccine Adverse Event Reporting System (VAERS) in 1990. VAERS is a national passive reporting system that accepts reports from the public on adverse events associated with vaccines licensed in the United States. VAERS data are monitored to—
- Detect new, unusual, or rare vaccine adverse events
- Monitor increases in known adverse events
- Identify potential patient risk factors for particular types of adverse events
- Identify vaccine lots with increased numbers or types of reported adverse events
- Assess the safety of newly licensed vaccines
Approximately 30,000 VAERS reports are filed annually, with 10–15% classified as serious (causing disability, hospitalization, life-threatening illness or death). Anyone can file a VAERS report, including health care providers, manufacturers, and vaccine recipients or their parents or guardians. The VAERS form requests the following information: the type of vaccine received, the timing of vaccination, the onset of the adverse event, current illnesses or medication, past history of adverse events following vaccination, and demographic information about the recipient. VAERS forms can be completed online, or you can complete a paper form and mail or fax it to VAERS. To request a paper VAERS form to be faxed to you, or if you need assistance in filling it out, call (800) 822-7967.
A contractor, under the supervision of FDA and CDC, enters the information from VAERS forms into a database. Those reporting an adverse event to VAERS receive a confirmation letter containing a VAERS identification number. Additional information may be submitted to VAERS using the assigned identification number. Selected cases of serious adverse reactions are followed up at 60 days and one year post-vaccination to check the recovery status of the patient. The FDA and CDC use VAERS data to monitor vaccine safety and conduct research studies. VAERS data (without identifying personal information) are also available to the public.
While VAERS provides useful information on vaccine safety, the data are somewhat limited. Specifically, judgments about causality (whether the vaccine was truly responsible for an adverse event) cannot be made from VAERS reports because of incomplete information. As a result, researchers have turned more recently to large-linked databases (LLDB) to study vaccine safety. LLDB provide scientists with access to the complete medical records of millions of individuals receiving vaccines (all identifying information is deleted to protect the confidentiality of the patient). One example of a LLDB is the Vaccine Safety Datalink (VSD) Project.
Reporting Vaccine Adverse Events
Everyone is encouraged to report any clinically significant or unexpected event (even if uncertain that the vaccine caused the event) for any vaccine. The Reportable Events Table (RET) lists and explains injuries and conditions that are presumed to be caused by vaccines, and time periods in which the first symptom must occur after receiving the vaccine. It is used by the Vaccine Injury Compensation Program, which is operated by the U.S. Health Resources and Services Administration. Health care providers are required by law to report to VAERS any conditions on the RET, vaccine adverse events that are listed in the manufacturer's insert, and clinically significant or unexpected events following vaccination.
National Surveillance Data for Vaccine Adverse Events
VAERS Data: When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. VAERS receives reports on all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.
In 2006, FDA licensed RotaTeq, a new rotavirus vaccine. The same year, CDC implemented a post-licensure vaccine safety study of the RotaTeq vaccine.
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