Using data from the Centers for Disease Control and Prevention’s (CDC) Vaccine Safety Datalink (VSD), Michael McNeil, MD and a team of researchers from the CDC conducted a study that identified only 33 “confirmed vaccine-triggered anaphylaxis cases” in 25,173,965 vaccine doses given to patients during January 2009 through December 2011.1 According to the study, published in The Journal of Allergy and Clinical Immunology, the rate of anaphylaxis—a potentially life-threatening allergic reaction—was 1.31 per million vaccine doses.1

The results of the study have led to the general conclusion, at least in media articles, that vaccines rarely cause serious reactions. In fact, that was the headline of a recent article in U.S. News & World Report… “Vaccines Rarely Cause Serious Reactions.”2

The problem with such headlines, however, is that they give a false impression, because there are many other serious reactions associated with vaccination besides anaphylaxis. The Institute of Medicine (IOM), for example, lists numerous serious adverse effects from vaccines, apart from anaphylaxis, including: deltoid bursitis (frozen shoulder, characterized by shoulder pain and loss of motion), encephalitis (inflammation of the brain), febrile seizures, hepatitis, meningitis, pneumonia, and syncope (fainting).3 The CDC notes there is also notes permanent brain damage, coma, and death as possible, although, rare, reactions to vaccination.4

A second problem with such headlines has to do with the VSD used to draw conclusions for the study. According to the CDC:

The Vaccine Safety Datalink (VSD) is a collaborative project between CDC’s Immunization Safety Office and nine health care organizations. The VSD started in 1990 and continues today in order to monitor safety of vaccines and conduct studies about rare and serious adverse events following immunization.5

These nine health care organizations contracted by CDC to participate in the VSD include: Group Health Cooperative of Seattle, WA; Harvard Pilgrim of Boston, MA; Health Partners of Minneapolis, MN; Kaiser Permanente Colorado of Denver, CO: Kaiser Permanente Georgia of Atlanta, GA; Kaiser Permanente Northwest of Portland, OR; Marshfield Clinic of Marshfield, WI; Northern Carlifornia Kaiser Permanente of Oakland, CA; and Southern California Kaiser Permanente of Los Angeles, CA.5

According to the CDC:

The VSD uses electronic health data from each participating site. This includes information on vaccines—the kind of vaccine that is given to each patient, date of vaccination, and other vaccinations given on the same day. The VSD also uses information on medical illnesses that have been diagnosed at doctors’ offices, urgent care visits, emergency department visits and hospital stays.5

The underlying assumption is that the CDC’s nine health care partners share their patients’ electronic medical records with the VSD, and that this information is accurate and complete. But what if it isn’t? What if the doctors, nurses, and other health care workers employed by Kaiser Permanente, Group Health Cooperative, Harvard Pilgrim, Health Partners, and Marshfield Clinic inconsistently or inaccurately include vaccine-related information?  Or what if the data is selectively identified and cherry-picked by CDC officials for the purpose of performing and publishing studies that will come up with conclusions about reactions to vaccines that minimize or even deny vaccine safety issues?

If the information in the VSD were made easily available to independent researchers, who want to conduct their own studies to determine if they can replicate the CDC’s findings, then studies such as the McNeil team’s anaphylaxis study would be more credible. Without replication, however, such a study would simply be… interesting.

But the VSD is a medical records database that is not easily accessible to independent researchers.  It is a database that is closed to just about everyone, except the CDC and its partners.6 So the CDC is asking the public to trust the CDC’s research methodology and intent, as well as the quality of the medical records information contained in the VSD.

That’s a lot of trust, particularly in light of the history and poor quality of the Vaccine Adverse Event Reporting System (VAERS), operated jointly by the CDC and the U.S. Food and Drug Administration (FDA). Take the case of Marcella Piper-Terry as an example. Marcella’s teenage daughter suffered a grand mal seizure after having received the Tdap (tetanus, diphtheria, and pertussis) vaccine. Marcella recounted the experience…

The last vaccine injury for [my daughter] was within three hours of receiving a Tdap vaccine, and she had a grand mal seizure, she fell off the bed and hit her head. She stopped breathing while I held her head in my hands. Thankfully, she was resuscitated, and we went to the hospital in an ambulance. And while we were in the ambulance, I called our family doctor who had given her the vaccine, and I called his office and said, I want this reported to VAERS.7

We went to the hospital, they knew it was a vaccine injury, I told them what had happened. It was months later that I realized that it had not been reported. When I called my doctor’s office, I said, why didn’t you report this, and they said, well, you didn’t bring her back here. They said, we didn’t have to report it because you didn’t bring her back here. I said, I didn’t bring her back there because she stopped breathing, we went to the hospital in an ambulance. And so they said, well, it was the hospital that should’ve reported it. So I called the hospital, and I said, well why didn’t you report it? And they said, well, we didn’t administer the vaccine, the administering physician should’ve reported it. 7

You can begin to see the problem taking shape here. Nobody can figure out who should take the initiative to report, and so what often happens is that… no one does. It’s a bureaucratic problem, but it’s also one in which there is no incentive for anyone to take the initiative. And that’s because, even though the 1986 law mandates that providers report vaccine adverse reactions to VAERS, most vaccine providers do not appear to understand they are required under federal law to do it. Furthermore, as Marcella notes, the law does not specify legal consequences for those who fail to comply…

So I called VAERS, I called Health and Human Services and the VAERS office, and I asked the woman who answered the phone, I said, so who’s responsibility is it to report vaccine injuries… and she said, well, either one. … And I told her the situation, she said either one should’ve reported. And I said, isn’t that mandatory, according to the law? And she said, yes. And I said, so what are the consequences when physicians fail to report? And she said, well, there are no consequences. I said, that’s not a law. If there are no consequences, that’s a suggestion, that’s not a law.7

Although the National Childhood Vaccine Injury Act of 1986 requires doctors and other health care providers who administer vaccines to make a report to VAERS for “hospitalizations, injuries, deaths and serious health problems” following vaccination, it is estimated that this happens in only between 1-10% of the cases.8 9 VAERS receives about 30,000 reports annually.

Given the extreme under-reporting to the system, it is likely that the true number of vaccine adverse reactions in the United States is closer to at least 300,000 per year, and perhaps as high as 3 million. One can only guess how many of those would be serious reactions. Suddenly, the argument that vaccines are safe because adverse reactions are “rare” becomes a bogus one.

So when you read studies conducted by the CDC, or read on the CDC’s website, that the chances of an adverse reaction (serious or otherwise) to a vaccine are 1 in 1 million or 1 in 100,000,4 it is important to understand where these figures originate—in part from a thoroughly incomplete, and thus unreliable, VSD closed database and by an extremely flawed vaccine adverse event reporting system.

Under these circumstances and, together with acknowledged deficits in vaccine safety basic science research, it is impossible for CDC officials to conduct reasonable benefit-risk-cost analyses of the pros and cons of mandatory vaccination policies, because the true risks of vaccination are unknown. Consequently, there is no way for people being compelled to get vaccinated to do their own benefit-risk analysis and exercise their informed consent rights when it comes to vaccination.

Ultimately, no one, including the CDC, really knows what vaccine risks are for individuals or the population at large.. It appears to be more of a guessing game than anything else, with the CDC opting to severely low-ball its guess.

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