Feel free to jump to the heading "Safety Net #5" below, everything stated until then is a repeat of what was written on the first post.
When it comes to products that are available for purchase, there are many safety nets that are established, to protect consumers from dangerous products, and to ensure that products are designed, manufactured, and distributed in such a way that potential harms can be more easily minimized, and/or identified more quickly once in distribution. Unfortunately, there are shortcomings in many of these consumer safety nets, or industry has found a way to bypass some of those protective measures. As a result, unsafe products continue to be made and distributed widely. What’s more unique to vaccines though, is that every single safety net that was established to protect people and ensure product safety, all those protective measures have actually all been neutralized by the pharmaceutical industry. This neutralization has happened either by direct financial funding from pharma, or indirectly through Governmental conflicts of interest that affect internal policy, bureaucracy, and legislation. But before explaining how the consumer protective safety nets have been neutralized when it comes to vaccines, I’ll first list what those protective measures were, or should be. (Bolding in the list below denotes which topic point will be discussed in this article).
The consumer safety nets for vaccine products are:
Government and our political leaders who represent the people
Federal agencies that oversee vaccine regulation, research, safety, and distribution: These agencies include: The Food and Drug Administration (FDA), The Centers for Disease Control (CDC), The Department of Health and Human Services (DHHS), The Institute of Medicine (IOM). Yes, these agencies are all based in the United States, however their policy are often adopted on a global scale.
Scientific research and medical journals
Our doctors and the institutions where they are educated and employed
Vaccine Adverse Event Reporting System (VAERS)
The legal system
Safety Net #5: VAERS
In this article, we will be discussing how the VAERS database is supposed to play a role in protecting the public, and how the VAERS database has been compromised by the regulatory agencies, HHS, CDC and FDA. (More information about the financial leverage and conflicts of interest affecting these agencies is provided in the previous articles Safety & Efficacy Part 23-2 and Safety & Efficacy 23-3.
The Vaccine Adverse Event Reporting System (VAERS) is an American surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
The National Childhood Vaccine Injury Act (NCVIA) of 1986 requires through law, (Link Here and Here) that health professionals and vaccine manufacturers report medical events occurring temporally after vaccination (causation does not need to be established), to the U.S. Department of Health and Human Services (HHS). In response to NCVIA, the CDC and FDA established the VAERS database where such medical events are reported and tracked.
The Canadian version of VAERS is called CAEFISS. And Health Canada has the following to say about a doctors responsibility in reporting events to the Canadian CAEFISS database:
Report events which have a temporal association with a vaccine and which cannot be clearly attributed to other causes. A causal relationship does not need to be proven, and submitting a report does not imply causality.
Vaccine reactions DO NOT necessarily happen instantaneously after receiving a vaccine. In fact, many reactions can take days, weeks, or months, before displaying their symptoms. I imagine you might find it hard to believe that reactions can take weeks or months to appear, and if so, then take a look at the US Government Injury Table for yourself here. It explains the timing by which symptoms for specific conditions must occur, following a vaccination, to receive immediate financial compensation with no questions asked.
In a video I linked to two articles previous, Dr. David Davis speaks about VAERS. He says that he has been an emergency room physician for 35 years now, and although the VAERS database was created 27 years ago, he was unaware of its existence, and he didn’t know he was required by law to report medical events to it, until recently. In the video, he states that he asked his colleagues if they had been reporting medical events to VAERS, and not a single doctor he spoke with had reported a single event at the time of his asking. This is the reality for nearly 100% of doctors.
Recognizing that the VAERS database has been in existence for 27 years now, there is absolutely no excuse as to why its existence, or the types of events that are required to be reported to it, are not common knowledge.
I find it very interesting that medical institutions DO NOT forget to teach our doctors how necessary it is to vaccinate children according to the vaccination schedule. And as parents, we hear about the importance of vaccinations all the time, not only at each and every health appointment, but also regularly through media. So how could it be that the Health Authority has forgotten to provide an education to our doctors about the types of medical events to watch for after vaccination, and the obligation they have to report such events to an established federal database. The public is also allowed to file these reports for themselves, or on behalf of their children. So again, why has the Health Authority forgotten to inform the public of the existence, by explaining it at each and every vaccination appointment?
In fact, in Merck's MMR vaccine package insert (Link Here) which is provided to health professionals, it states (emphasis mine):
Patients, parents, or guardians should be instructed to report any serious adverse reactions to their health-care provider who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967."
On the National Vaccine Information Centre (NVIC) website, (NVIC is a non-profit organization that worked with Congress in 1986 to create the legislation for the National Childhood Vaccine Act) they provide a list of symptoms that need to be reported to VAERS. The list is as follows:
Pronounced swelling, redness, heat or hardness at the site of the injection
Body rash or hives
High pitched screaming or persistent crying for hours
Extreme sleepiness or long periods of unresponsiveness
Twitching or jerking of the body, arm, leg or head
Crossing of eyes
Weakness or paralysis of any part of the body
Loss of ability to roll over, sit up or stand up
Loss of eye contact or awareness or social withdrawal
Head banging or onset of repetitive movements (flapping, rubbing, rocking, spinning)
High fever (over 103 F)
Vision or hearing loss
Restlessness, hyperactivity or inability to concentrate
Sleep disturbances that change wake/sleep pattern
Joint pain or muscle weakness
Loss of memory
Onset of chronic ear or respiratory infections
Violent or persistent diarrhea or chronic constipation
Breathing problems (asthma)
Excessive bleeding (thrombocytopenia) or anemia
Parents CAN'T report a serious adverse reaction to their health-care provider, if they aren't instructed what those potential vaccine reactions are. So WHY are doctors and nurses not following through with their appropriate due diligence? The MMR package insert goes on to state (emphasis mine):
Under the National Childhood Vaccine Injury Act of 1986, health-care providers and manufacturers are REQUIRED to record and report certain suspected adverse events occurring within specific time periods after vaccination. However, the U.S. Department of Health and Human Services (DHHS) has established a Vaccine Adverse Event Reporting System (VAERS) which will accept all reports of suspected events. A VAERS report form as well as information regarding reporting requirements can be obtained by calling VAERS 1-800-822-7967.
If doctors are unaware, as Dr. Davis explained is the case, then subsequently these reports are RARELY filed, despite law stating they must be. Recognizing that, it becomes obvious that the existing VAERS database is a completely useless tool as a consumer safety measure. The US Government acknowledges that the current VAERS system is woefully inadequate, because it is a passive voluntary system. As a result of VAERS inadequacy, in 2006, the Government looked into having an automated system developed.
So, how would an automated VAERS system work?
Medical visits and medical records are managed in electronic online databases. Because of this, it becomes possible to use those electronic health records to identify medical events which occurred temporally after receipt of a vaccine. With the advent of an automated VAERS system, any temporal medical events could be copied into the modernized VAERS database. To create such an automated program, HHS used $1 million of tax payer money, and contracted Harvard Pilgrim Health Care Institute (Harvard) to develop the necessary software system, and to test the programming performance between 2006 and 2009.
Ross Lazarus, the Principle Investigator for the project, prepared his final report for HHS in 2010 (Here). Within that report, he explains exactly what I stated above, that very few adverse vaccine events are reported, because of doctors' lack of awareness. He says:
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.
When describing the performance of the software programming that his team created, he had the following to say:
Public and professional confidence in vaccination depends on reliable postmarketing surveillance systems to ensure that rare and unexpected adverse effects are rapidly identified. The goal of this project is to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS).
...Every patient receiving a vaccine was automatically identified, and for the next 30 days, their health care diagnostic codes, laboratory tests, and medication prescriptions are evaluated for values suggestive of an adverse vaccine event. When a possible adverse event was detected, it was recorded, and the appropriate clinician was to be notified electronically.
...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. This is an average of 890 possible events, an average of 1.3 events per clinician, per month. These data were presented at the 2009 AMIA conference.
When discussing the status and success of each of the goals identified for the project, (these goals were called "Aims" 1 through 4), Lazarus had the following to say about Aim 2 and 3:
...The goal of Aim 2 was the Development of [health data exchange] for [VAERS] to ensure secure transmission to CDC...Synthetic and real test data ... was generated and transmitted between Harvard and Constella. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the CDC had yet to respond to multiple requests to partner for this activity.
...[Regarding Aim 3] We had initially planned to evaluate the system by comparing adverse event findings to those in the Vaccine Safety Datalink project—a collaborative effort between CDC’s Immunization Safety Office and eight large managed care organizations. Through a randomized trial, we would also test the hypothesis that the combination of secure, computer-assisted, clinician-approved, adverse event detection, and automated electronic reporting will substantially increase the number, completeness, validity, and timeliness of physician-approved case reports to VAERS compared to the existing spontaneous reporting system; however, due to restructuring at CDC and consequent delays in terms of decision making, it became impossible to move forward with discussions regarding the evaluation of VAERS performance in a randomized trial, and compare VAERS performance to existing VAERS and Vaccine Safety Datalink data. Therefore, the components under this particular Aim were not achieved.
Regarding the final status of the project, Lazarus had the following to say:
Proactive, spontaneous, automated adverse event reporting imbedded within [electronic health records] 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.
Of course identifying any potential increase in medical events following immunization would help improve vaccine safety by:
ensuring unsafe and harmful vaccines are promptly removed from market, and
identifying vaccines brands that cause fewer reactions, which could allow for promotion of those less reactive vaccines
Using the study data, let's broaden our discussion of adverse vaccine reactions beyond the Harvard study group. In Lazaurs' final report summary, specific details were not provided about the study patients' ages, nor was information provided for the number of doses administered of each vaccine brand. Because of that, one can only use the general numbers provided, to calculate a rough average, concluding that each vaccinated person within the study received an average of 3.72 doses of vaccine, over the course of three years of testing.
To compare, according to the HHS there are 4 million babies born in the US each year. The pediatric population is the most heavily vaccinated, receiving a significantly greater number of vaccines than the study participants received. In the Results section of the study, the patient profile described that only 25% of the patients studied, were under the age of 18. So the pediatric population was not the main source for data in this trial. In this software testing, the data showed that 2.6% of vaccine recipients experienced a potentially vaccine related event (or a combination of events), within the following 30 days post vaccination (events described below). The software programming looked for:
an Emergency Room visit
an allergic reaction
an "unwell" doctor's office appointment
an abnormal vital sign assessment
abnormal lab results
a need for prescription drug(s)
Recognizing that there are 4 million infants born annually, and using the study's 2.6% adverse event rate, that means it's possible that at least 104,000 infants, age 0-11 months, will require medical support annually, following the receipt of the vaccines they received to protect them from 9 illness (for each illness 2 & 3 doses of vaccine are given that first year, meaning a total of 26 doses of vaccine are administered by age 1, the US). The same can be said for the toddlers in the 1-2 years age bracket, as they are vaccinated with 1 dose of vaccine against 10 different illnesses (therefore 10 total doses). That adds an at least 104,000 more children who will require medical care for their vaccine adverse events, annually. In the the childhood population, age 4-6 years, that group receives 1 dose of vaccine against 9 different illnesses (9 total doses), so they too will account for at least 104,000 medical events requiring doctor support. Also in the childhood population, age 11-12, that group receives vaccination against 6 illness (1 & 3 doses are required, for a total of 8 doses given), meaning that group will also likely account for at least 104,000 medical events requiring doctor support. So annually, at minimum, the US is likely seeing 416,000 adverse vaccine events that require medical support. That estimation does not included any other age groups, despite those groups receiving annual flu vaccination, adult booster shots, or travel vaccinations. At present, according to the CDC, approximately 30,000 reports are filed annually to VAERS. That means that currently VAERS is capturing less than 7% of the medical events that doctors are required, by law, to report.
Please note, it is reasonable to assume that a person's risk of reaction increases, when the number of drugs received within a period of time is increased. The pediatric population receives 36 doses of vaccine against 13 illnesses, within their first two years of life. In comparison, the study group received an average of 3.7 doses of vaccine over three years time. Based on the significantly increased vaccine exposure rate experienced in the pediatric population, one can reasonably assume that more than 2.6% of the pediatric population, are requiring medical support following an adverse vaccine event, annually.
The final report prepared by HHS (Here), explains that Harvard successfully achieved 3 of the 4 goals required of them to automate the VAERS database, but the project failed and was not completed. HHS noted that the project's failure was due to restructuring within the CDC, as this restructuring prevented the necessary testing from occurring, testing which could have satisfied the final outstanding goal. The final reports prepared by HHS and Harvard were completed in 2010, which means that the CDC has since had nine years to complete their restructuring and resume communications with the Harvard team. It appears that to date, neither HHS nor CDC have made any efforts to resume this project.
Harvard created an automated system that could quickly identify more reactive and unsafe vaccines. With such information, the Health Authority could properly manage the vaccine supply, allowing only the safest vaccines to remain on the market. Such action, may have restored faith in the vaccine program, recognizing that hesitancy has crept in and continues to grow. Unfortunately, it appears that HHS and CDC have done nothing in the past nine years, to advance automating VAERS. As a result, the public has been left to continue relying on a passive voluntary system which the Government admits is woefully inadequate and ineffective. That means, for the time being, $1 million tax payer dollars has been "wasted" and our infants and children remain at risk .
Last updated November 8, 2017
Continue to the next article in this series: Here
The National Childhood Vaccine Injury Act of 1986 Here
Reporting medical events to VAERS is the law Here
Medical events that need to be reported to VAERS Here
Merck MMR-II package insert states that parents should be instructed about reactions that need to be reported to VAERS, and doctors are required to file these reports Here
US National Vaccine Injury Table Here)
Dr. David Davis explains that in his first 35 years practicing as an ER physican, he never knew of the VAERS database and his responsibility to report medical events to it Here
The VAERS Link Here
The link to the Canadian version of VAERS (also a passive system) Here
Health Canada explains the responsibility to report temporally related events Here
Details from the Health and Human Services website, about the contract with Harvard Pilgrim Health Care Institute and the "conclusion" of the study Here and Here
Collaboration between Harvard Pilgrim Health Care Institute and Harvard Medical School Here and Here
Harvard's Principle Investigator, Ross Lazurus, provides his final report on the "failed" automation of the VAERS database Here
HHS website - American Birth Rate Here
Current US Childhood Vaccination Schedule Here
Current Canadian Vaccination Schedule (Province of Alberta) Here
CDC explains that approximately 30,000 reports are filed in VAERS annually Here
You are currently on Part 12 of a 14 Part Series.
View a Post in the Series Using the Links Below:
Part 1: Consumer Safety Nets Here
Part 2: HHS
Part 3: The FDA Here
Part 4: The CDC Here
Part 5: The DHHS & IOM Here
Part 6: Scientific Research Here
Part 7: Scientific Research Corruption Here
Part 8: The Medical Journals Here
Part 9: Our Doctors Here
Part 10: Doctors Responsibility Here
Part 11: Medical Institutions Here
Part 12: VAERS (You are on this page)
Part 13: The Media Here
Part 14: The Legal System Here