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Gauging Vaccine Reactions Absent Reliable Reporting

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.


1 McNeil, MM, Weintraub ES, Duffy, Sukumaran L, Jacobsen SJ, Klein NP, Hambidge SJ, Lee GM, Jackson LA,  Irving SA, King JP, Kharbanda EO, Bednarczyk RA and DeStefano F. Risk of anaphylaxis after vaccination in children and adults. The Journal of Allergy and Clinical Immunology Oct. 6, 2015.
2 Dallas, ME. Vaccines Rarely Cause Serious Reactions. U.S. News & World Report Oct. 15, 2015.
3 U.S. Department of Health and Human Services. Adverse Effects of Vaccines: Evidence and Causality. Institute of Medicine Report Brief August 2011.
4 Centers for Disease Control and Prevention. Vaccinations and Immunizations, Possible Side-effects from Vaccines. CDC.
5 Centers for Disease Control and Prevention. Vaccine Safety Datalink (VSD). CDC.
6 Insert 2005 IOM report on VSD.
7 Marcella Piper-Terry: Shawn Siegel cohosts. ADHD/ASD recovery. 3-14-13. YouTube.com Mar. 16, 2014 (published).
8 National Vaccine Information Center. Report Vaccine Reactions. It’s the Law! NVIC.
9 National Vaccine Information Center. Proposed Changes Restrict Vaccine Reaction Reporting. NVIC.

15 Responses to Gauging Vaccine Reactions Absent Reliable Reporting

  1. Raymond Negron Reply

    November 5, 2015 at 10:31 pm

    Great Information.

    My Daughter has gone through hell since middle school after a Vaccination was given against my instructions, followed by rapid degradation of her health within 1 and 1/2 weeks.

    This is a continuing struggle for our entire family. The story is to long and complex to detail for the general public.

    • Diane Reply

      November 9, 2015 at 11:48 am

      Dear Raymond,

      I stopped vaccinating my now adult. Children in their twenties 17 years ago after not one but 3 had severe reactions to DPT, and MMR. Without getting too specific two suffered seizures one at 2 months , one at two years old and the other at 15 months after MMR.
      Everyone is very healthy all graduated from college my youngest is a college sophomore. I took a religious exemption. Best Heath decision I could have made reducing illnesses by 90% as we moved forward through childhood.
      My suggestion to you as I did this for all four of my children is too seek physicians who work with alternative medicine. A homeopath designed what remedies were necessary to clean my children’s immune systems out from the viruses injected and helped me to build up their immunity so their bodies could fight disease naturally as they were designed to do. Im not telling you not to see a physician when your child is sick, but to add alternative medicine to help your child recover and build their immune system up is something to consider.
      I am sorry for your daughters suffering. The sad part is the government could care less about the situation. I was threatened every year by schools and camps to vaccinate. Vaccination should be optional never mandatory like any other medical procedure. Stay strong your child health depends on it.

    • TeeJae Reply

      November 9, 2015 at 10:21 pm

      Raymond, what vaccine was given to your middle-schooler? I ask because my son will be entering middle school soon, and I want to know what to avoid! Thank you.

  2. Linda Reply

    November 9, 2015 at 10:36 am

    It’s time they stop these vaccines, but then they’d lose billions of dollars and it is all about the money not people’s lives. I’m so sorry about your daughter. We have to stop this.

  3. Dr. Love Reply

    November 9, 2015 at 11:16 am

    God’s guidelines for healthy eating, exercise, and the compounds God provided for our health in His natural creation are all signposts on the way to the fulfillment of His promises. As we walk on His pathway to healing diseases and illnesses, we must heed them in order to achieve their desired end – a long and satisfying, full life. (See Psalm 91:16; Proverbs 9:11 & John 10:10).

  4. James Reply

    November 9, 2015 at 11:23 am

    As a parent, I personally know at least 3 other parents who’s children had serious reactions immediately after vaccination. CDC numbers are definitely bogus. People need to do their own research and make decisions for themselves. If we push back, others will push back. Let’s push the issue into the light of day for all to see. Talk to other people about it, as I do. All you have to do is plant a seed – meaning get others to ask questions about vaccinations. CDC should be representing children and individuals, not the interests of corporations.

  5. Beth Reply

    November 9, 2015 at 11:43 am

    Fair is Fair. If CDC feels it is important for schools to report % vaccinated, I think it is only fair that any known side effects of vaccines be reported by all doctors & hospitals. All doctors & hospitals should have to ask vaccine questions when patients show up with any side effect fainting, brain injury, GB, seizures, SIDs, ect. Let’s post those results for all to see.

    • momoftwo Reply

      January 11, 2016 at 4:31 pm

      Absolutely, Beth. It is up to us, the general public, to push our legislators for laws that will bring down the hammer on all doctors who neglect to report serious medical events within proximity to vaccination because it “can’t be the vaccine” as they have been taught that vaccines are “safe and effective”. It is unacceptable, especially in the current climate of all kinds of laws mandating vaccines for everything under the sun, to not punish and/or fine those who do not report.

      I’m the mother of a child who started seizures within 24 hours of vaccination and whose child stopped breathing and almost died, yet his pediatrician said it was a “coincidence” and declined to report it. Despite the fact that seizures are a known possible side effect with the pertussis vaccine (well, known to anybody who actually looks at the manufacturer insert, apparently that is not my child’s pediatrician).

  6. Vaccine Information Reply

    November 9, 2015 at 12:34 pm

    Prior to 2012 Public Health Canada clearly disclosed a 1/100K SAE risk to routine vaccination.
    Vaccine safety Advocates began to link to the PHC website and calculate that a 1/100k SAE rate applied to the 500 million or so administrations in just the US every year means there are 1000’s of injured people the PHC suddenly severed all the links, and then later scrubbed the site entirely of any quantified injury rates.
    It would be interesting for a Canadian individual or group to do a FOIA request to determine the chain of events that led to the removal of this injury risk disclosure that was once a boilerplate section of all vaccine surveillance communications.

  7. Cindy Griffin Reply

    November 9, 2015 at 2:30 pm

    Mark Twain got it right: “There are lies, damned lies and statistics.”

  8. Jesse Reply

    November 9, 2015 at 3:02 pm

    There is no way to completely provide 100 percent safety. We need safety, for our children. Take the consent back, it is not there right to offer safety to everyone and not to anyone.

  9. Harris Glasser Reply

    November 9, 2015 at 5:42 pm

    300 million Americans have to stand up and start shouting at the politicians pushing their corporate lobbyist’sm products onto our children. They have nbo right to take away our rights.
    This IS NOT a dictatorship by the corporations

  10. Harris Glasser Reply

    November 9, 2015 at 5:43 pm

    This is not a dictatorship run by the corporations. Get these politicians OUT OF OFFICE NOW that are befriended by the corporate lobbyists

  11. mark brody Reply

    November 10, 2015 at 6:55 pm

    Adverse reactions to vaccinations can be obvious because of their sudden appearance in proximity to the vaccination event. However, more insidious subtle changes to health from the cumulative effects of multiple vaccinations may appear without any clear connection to vaccinations. Asthma, ADHD, autism, and various immunologic disorders may never be reported as a vaccination injury because the injury is slow subtle and difficult to prove (except by long term epidemiologic studies, which no one wants to pay for, for obvious reasons). When we speak of vaccine injury rates, these subtle types of injuries are surely never included, but they should be.

  12. Sandy Kanervisto Reply

    November 13, 2015 at 8:30 am

    When our son passed away after receiving the 2009 H1N1 Flumist vaccine I contacted numerous doctors and nurses to have them report the death to VAERS and everyone of them said they could not help, one nurse said if she was caught she could lose her job. I finally ended up going back to the health department where he received the vaccine. They reported but left out most of the information I gave them. I called several times for over a year to have them correct it. Thy would say they would have someone call back to get the information. I still have not heard from them,

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