Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

It is a common anti-vaccine argument that fewer than 1% of vaccine injuries are reported to VAERS.

I've found that fewer than 1% of anti-vaccine signs are true...
I’ve found that fewer than 1% of anti-vaccine signs are true…

They even think that they have evidence from Harvard to support their claim!

Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

Do they?

Are fewer than 1% of vaccine injuries reported to VAERS?

It has long been suspected that reports to VAERS are under-reported, as it is a passive reporting system.

The original claims for under-reporting to VAERS were based on an old study about drug reactions and were not specific to vaccines though.

Is that the Harvard study?

Nope.

“Restructuring at CDC and consequent delays in terms of decision making have made it challenging despite best efforts to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. However, Preliminary data were collected and analyzed and this initiative has been presented at a number of national symposia.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

They are talking about a report, Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS), that was conducted at Harvard Pilgrim Health Care, Inc.

“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

It is very important to note that all the study found is that all possible reactions, including minor reactions, like pain and fever, are not common.

They didn’t actually finish the report to see how commonly those reactions were reported to VAERS.

But we already know that more serious reactions are reported to VAERS much more routinely.

“Sensitivities ranged from 72% for poliomyelitis after the oral poliovirus vaccine to less than 1% for rash and thrombocytopenia after the MMR vaccine.”

Rosenthal et al on The reporting sensitivities of two passive surveillance systems for vaccine adverse events

And there has even been a more recent report, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, which also used an ESP-VAERS system, that found great improvements in reporting of adverse events to VAERS.

Even more importantly, even with it’s limitations, VAERS works!

“Despite its limitations, VAERS effectively detected a possible problem soon after introduction of RRV-TV in the United States.”

Lynn R. Zanardi, et al on Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System

Although it would be ideal to have even more reports sent to VAERS, time and again, we have seen that VAERS works.

“On November 23, 2010, the combination of the coding term “febrile convulsion” and the Fluzone(®) TIV product exceeded a predetermined threshold in the VAERS database. By December 10, we confirmed 43 reports of febrile seizure following TIV in children aged 6-23 months. Clinical features of most reports were consistent with typical uncomplicated febrile seizures, and all children recovered. Further epidemiologic assessment of a possible association between TIV and febrile seizures was undertaken in a separate, population-based vaccine safety monitoring system.”

Leroy et al on Febrile seizures after 2010-2011 influenza vaccine in young children, United States: a vaccine safety signal from the vaccine adverse event reporting system.

As we have seen, for VAERS to work, we don’t need all side effects and reactions to be reported.

“VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination.”

Shimabukuro et al on Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

Also, VAERS is not the only safety system that we have to make sure that our vaccines are safe.

The other thing that folks should understand? Most reports to VAERS are not actually vaccine injuries

More on the Percentage of Reports to VAERS

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3 thoughts on “Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

  1. A quote from the in-question Harvard Pilgrim Health Care, Inc. study:

    “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.
    Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation”

    They were awarded two $499,405 grants to do that study. Why would the dept. of Health and Human Services award $998,810 in grants for a study, and then simply be non-responsive or “no longer available”? Is it possible – stick with me here, this is a complicated postulation – that someone (CDC, HHS) decided they didn’t like the outcome of the study, and instructed the right people to simply stop communicating with the researchers?

  2. Technically speaking, the Pilgrim-Health thing isn’t even a study. It’s a progress report on the ESP:VAERS system implementation.

    There was no study. There was no analysis of data.

    The 1% thing was just a unattributed and uncited figure in the “results” paragraph.

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