V is for VAERS (and Viewpoint Diversity)

On the Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System, or VAERS, was established in 1990 in response to The National Childhood Vaccine Injury Act (NCVIA) of 1986. NCVIA requires health professionals and vaccine manufacturers to report to the U.S. Department of Health and Human Services (HHS) specific adverse events that occur after the administration of routinely recommended vaccines. This act created the National Vaccine Injury Compensation Program (VICP), which provides compensation to people found to be injured by certain vaccines. The VICP protects pharmaceutical companies from liability related to vaccines by preventing the vaccine injured from bringing lawsuits against manufacturers; instead they must make a claim to the government. This program was put in place to help ensure that manufacturers will continue to produce vaccines. Anyone is allowed to submit a report to VAERS, but VAERS reports are usually submitted by health care providers, vaccine manufacturers, vaccine recipients (or their parents/guardians) and state immunization programs. Reporting an incident to VAERS can be done electronically or through a downloadable PDF form.

According to the VAERS site:

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.

While knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment, there is the possibility of overreporting in VAERS due to a number of variables as described by the McGill Office for for Science and Society:

…if the background rate of the event being reported, meaning how common this event is in the population, goes up, it’s likely that its frequency in VAERS will also go up. If the diagnostic criteria for a condition are expanded, more people will receive the diagnosis, which will make it look like its incidence has suddenly increased. This is what happened with autism over the years, and since the diagnosis for autism is usually made around the time a child receives a number of vaccines, it’s easy to witness more reports of autism being filed following vaccination and to wrongly claim causation. VAERS can also be biased in an interesting way: mild events following a vaccine are less likely to get reported compared to more severe ones. Finally, there is also the fact that as an adverse event gets widely reported in the media, more people will pay attention to it, leading to an increase in reports to VAERS. This is known as stimulated reporting.

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A 2011 final report of a grant given to Harvard Pilgrim Health Care, Inc., on the other hand, stated that VAERS is vastly underreported:

Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative. Proactive, spontaneous, automated adverse event reporting imbedded within EHRs and other information systems has the potential to speed the identification of problems with new drugs and more careful quantification of the risks of older drugs.

This 1% figure is cited by such entities as the oft-disparaged website OpenVAERS, which was created to allow for browsing of VAERS data without the need for an advanced search. Blogger Greg Nigh notes, however, that the 1% figure is unsupported by the Harvard Pilgrim paper (I am unable determine if the study carried out by Harvard Pilgrim resulted in that percentage).

Since the Harvard Pilgrim grant-funded study was carried out to create a more accurate system of capturing vaccine injuries through mining electronic medical records in real time and the CDC did not respond to requests to partner on this activity, Nigh concludes that while “the Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting” it is “a reference to substantiate claims that the CDC has no interest in making reports of vaccine injury either more accurate or more comprehensive.”

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A 2020 study on the capture rates of VAERS on anaphylaxis and Guillain-Barré syndrome (GBS) following vaccination found higher percentages of capture:

VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%. For anaphylaxis, VAERS captured 13–27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. For GBS, VAERS captured 12% of cases after the 2012–13 inactivated seasonal influenza vaccine, 15–55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine.

According to Reuters, from 1990 to 2001 VAERS data was only accessible through a Freedom of Information Act, but in 2001 the data was made available on the VAERS website. The data was moved to CDC Wonder in 2006. You can search VAERS data with a menu driven tool to produce tables, maps, or charts or download raw data for import into a database, spreadsheet, or text editing program. The CDC has created an instructional video on how to search VAERS as well as written instructions. The drop down search menus are easy to use and allow for both granular searches and broad comparisons such as the number of adverse events reported for all vaccines.

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VAERS does not provide the ability to compare adverse events by percentages of total vaccine doses administered. The CDC routinely runs Proportional Reporting Ration (PRR) data mining on VAERS and the FDA runs Empirical Bayesian data mining; Children’s Health Defense is suing the FDA to obtain their reports on the COVID-19 vaccines, which have not been made public.

Factcheck.org provides several explanations as to why there are more adverse effects reported for the COVID-19 vaccines, including:

…the huge number of VAERS reports following COVID-19 vaccination and relative paucity for other vaccines is likely mostly due to a reporting bias. For one, because the COVID-19 vaccines are or were at first authorized under an emergency use authorization, there are much broader reporting requirements for health care providers.

For the COVID-19 vaccines, health care providers are required by law to report any vaccine administration error; any serious adverse event following vaccination, regardless of the suspected cause; any case of Multisystem Inflammatory Syndrome; and any COVID-19 case that results in hospitalization or death.

In contrast, with all other vaccines, providers are only required to report select adverse events, including the so-called reportable events for each vaccine that occur within a certain time period after vaccination, such as an allergic anaphylactic reaction.

As always, be aware of funding sources for various sources of information and potential conflicts of interest. McGill University, for example, has received a donation from Pfizer as well as partnered with Pfizer on dementia and Alzheimer’s research. OpenVAERS does not disclose ownership but states on its webpage that it is a non-monetized site. Children’s Health Defense is a nonprofit 501(C)3 that solicits donations; I was unable to find names of corporate donors, if any. The Revolving Door Project examines the influence of the pharmaceutical industry on various agencies and the revolving door between government officials and the pharmaceutical industry.

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Top photo: Closeup of girl in doctor's office receiving a vaccine from a healthcare professional (48586536306).jpg/ Wikimedia Commons