The U.S. Vaccine Adverse Event Reporting System ( VAERS) Disregarded US Regulations on Counting Serious Cases for Years, Resulting in a Grossly Inaccurate Safety Assessment

A recently published study in the peer-reviewed journal Science, Public Health Policy and The Law, exposes a shocking finding of an illegal practice employed by the Center for Disease Control (CDC) for decades with regard to tracking serious adverse events (SAEs) following vaccination. Researchers found that the CDC has been failing to acknowledge and record as serious reports of citizens who experienced post vaccination “persistent or significant disability/incapacity”even though that is one of the criterion defining a serious adverse event (SAE) in the Code of Federal Regulations (CFR) since 1998. The article calls into question the integrity of the U.S. surveillance system known as the Vaccine Adverse Event Reporting System (VAERS).

The study details how the VAERS appears to have left out thousands of disability and incapacity reports from teenagers and young adults after Gardasil vaccination

In a 2009 study on Merck’s HPV vaccine Gardasil, the Food and Drug Administration (FDA) and CDC determined the rate of SAEs to be 6.2%, which they concluded did not signal a safety problem. However, the FDA and CDC officials excluded “a persistent or significant disability/incapacity” as “serious” despite federal regulations to the contrary. An independent assessment of SAEs based on the correct regulatory definition found that the rate reported by the VAERS was off significantly by almost 400%. The article explores the implications of this grossly inadequate reporting.

The mis-categorization of SAEs by the CDC appears to have hidden major safety concerns with Gardasil and possibly with other vaccines. Additional problems with the surveillance system may well be obscuring similar safety concerns with COVID vaccines today.

The article is linked below:

Significant Under-Reporting of Quadravalent Human Papillomavirus Vaccine-Associated Serious Adverse Events in the United States: Time for Change?” by Tomljenovic L, Tarsell E, Garrett J, Shaw CA & Holland MS