History of the Vaccine Adverse Event Reporting System

In the early 1980’s, a handful of law firms (including Schlichtmann, Conway & Crowley) pursued vaccine injury lawsuits directly against vaccine manufacturers in civil court. Because of the number of claims filed in relation to the diphtheria, pertussis, and tetanus (DPT) vaccine, the United States Congress passed legislation to increase the safety and efficacy of vaccines.

As part of the National Childhood Vaccine Injury Act of 1986 (NCVIA), health professionals and vaccine manufacturers are able to report adverse events that occur following a routine vaccine injection. In response, the Center for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) created the Vaccine Adverse Event Reporting System (VAERS) in 1990 as a means for tracking this information.

How does the VAERS program work to make vaccines safer?

The VAERS program identifies potential risks of vaccination by monitoring and tracking the frequency of reported adverse events associated with each vaccine. This aids in signaling emerging safety concerns, working to ensure that the benefits of vaccines continue to outweigh the risks.

Between 1990 and 2014, over 123,000 reports were filed in the VAERS program. The reports documented injuries ranging from mild side effects, like fever, to more serious events involving permanent disability. These reports are reviewed by both the CDC and the FDA to assess product labeling and monitor trends for individual vaccines.

What type of events should be reported in the VAERS program?

VAERS is a passive reporting system. VAERS reports collect information about the type of vaccine received, timing of vaccination, onset of the adverse event, any preexisting conditions, prescribed medications, and past vaccination history. Anyone can submit a report to VAERS, although typically health care providers, vaccine manufacturers, and vaccine recipients are among those filing reports. Patients are encouraged to seek assistance from a healthcare professional when filing a report.

Although there is an established Reportable Events Table (RET), detailing conditions associated with the National Vaccine Injury Compensation Program (NVICP), the CDC and FDA encourage reporting of any significant health problem occurring after vaccination.

Because there are no established requirements for the severity of events, as many as 85% of reports are considered mild, like fever. Not all reported events are considered to be strictly caused by vaccines. Further investigation into the event, however, may determine if there is a more significant correlation between the event and the vaccine than the timing of the reaction alone

What happens after a VAERS report has been filed?

Once a report is filed, it is assigned a VAERS identification number, to provide additional information if necessary. Scientists from the CDC and/or FDA then work to identify the more serious events, occasionally requesting medical records to inform their understanding of the event. One year after the event, follow up letters are sent to check the recovery status of patients who had not recovered at the time of the initial report.

Reporting to the VAERS program has successfully removed high risk vaccines from the US market, like RotaShield in 1999. After increased reports of intussusception following vaccination, the CDC’s validation studies recommended suspending use and eventually discontinuing production of the vaccine.

For patients in pursuit of compensation for their vaccine injury, the National Vaccine Injury Compensation Program was created.

National Vaccine Injury Compensation Program

Vaccines are an important part of public health, working to save lives by preventing disease. Most of the time, vaccines are administered without any serious problems. Like with any medication, however, there is a risk of side effects, ranging from mild to serious.

For this reason, the US government created the National Vaccine Injury Compensation Program (NVICP), a “no-fault” alternative to the traditional legal system. Petitions can be filed by any individual, at any age, after developing an injury believed to be a result of a covered vaccine, if jurisdictional requirements are met.

Conway Homer, P.C. is the most experienced vaccine injury law firm in the United States. We represent clients from all 50 states and have advocated for landmark cases that have shaped the Vaccine Program and made it friendlier and more generous to those individuals who suffer from vaccine injuries. To get in touch with our dedicated team, click here for a free consultation.