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VAERS: What is it?
The document summarizes the Vaccine Adverse Event Reporting System (VAERS), which monitors safety issues with vaccines in the United States. VAERS was established in 1990 to collect reports of adverse events following vaccination. Health care providers are required to report any adverse event listed on the vaccine package insert or in the VAERS Table of Reportable Events. Anyone can submit a report to VAERS of any unwanted side effect following vaccination. While VAERS reports alone cannot prove that a vaccine caused an adverse event, the system serves as an early warning to detect potential safety issues with vaccines.
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VAERS: What is it?
- 1. Reporting Vaccine Injury: VAERS,What is it? Jennifer Stella, B.S. Microbiology
- 2. Vaccine Adverse EventReporting System “VAERS” • Established in 1990 to fulfill a requirement of the National Childhood Vaccine Injury Act of 1986 • The national vaccine safety monitoring system used for collecting and analyzing reports • Run by Centers for Disease Control & Prevention (CDC) and Food & Drug Administration (FDA) • Serves as an early warning system that may detect possible safety problems with U.S. vaccines • Operated separately from FAERS (which monitors safety signals for all other drugs and biologics) https://vaers.hhs.gov/about.html
- 3. What Should GetReported? • Health care providers are required to report: – any adverse event listed by the vaccine manufacturer as a contraindication (in the “package insert”) – any adverse event listed in the “Table of Reportable Events Following Vaccination” • Anyone can file a report, to include any adverse experience (unwanted or unexpected side effect) post- vaccine. • You may hear that “correlation does not equal causation.” – You know your child best – Document, get it into the medical records – File a VAERS report, even if it is not clear whether the vaccine was the actual cause
- 4. “VAERS Table ofReportable Events Following Vaccination” https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf
- 5. https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf “VAERS Table ofReportable Events Following Vaccination”
- 6. “VAERS Table ofReportable Events Following Vaccination” https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf
- 7. VAERS – Disclaimer •CDC and FDA warn about misinterpretation of VAERS reports and data: “When evaluating data from VAERS, it is important to note that for any reported event, no cause and effect relationship has been established. VAERS is interested in all potential associations between vaccines and adverse events. Therefore VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS in not documentation that a vaccine caused the event.” Source: https://vaers.hhs.gov/data/dataguide.html
- 8. VAERS: Critical sothe “experts” can take “post-market” actions • After VAERS received the first report that a baby had an intussusception and died after receiving the Rotashield (Rotavirus) vaccine, there was no immediate reaction. When many reports arrived in a short time, the use of the vaccine was halted and a short while later, the vaccine was appropriately withdrawn from the market. • When thousands of reactions following DTP (Diphtheria, Tetanus and Pertussis) vaccination were reported to VAERS, the decision was made to switch to the DTaP, which contained an acellular pertussis component instead of the problematic whole cell vaccine that had been used for decades in the United States. • Similarly, after multiple reports of paralysis were reported to VAERS following oral polio vaccination, the OPV was withdrawn from the US market and the inactivated polio vaccine (IPV) was reintroduced. - F. Edward Yazbak, MD
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- 12. Limitations of VAERS •Passive monitoring system • Few post-reaction follow-ups are available • Subject to under-reporting by a factor of 10 to as much as a factor of 100 • Subject to reporting bias www.medalerts.org
- 14. VAERS Reports fromVermont Number of “adverse reactions” reported after vaccination Year of vaccination 0 50 100 150 200 250 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2016 No. VT ER visits No. total VT reports
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- 16. Example Report (unofficial) VermontVAERS 2016 • Total Reactions Reported 2016: 81 • Reported: – Emergency room visits: 25 – Hospitalizations: 2 – Permanent disabilities: none reported – Deaths: none reported • Summary of Actions Taken by Health Dept to supporting filing of petitions to VCIP: none reported FLU4 / SANOFI PASTEUR / UI678AD 3 DTAPIPV / GLAXOSMITHKLINE BIOLOGICALS / 3N7Y7 2 HEPA / GLAXOSMITHKLINE BIOLOGICALS / 294X9 2 HPV9 / MERCK & CO. INC. / L019297 2 PPV / UNKNOWN MANUFACTURER 2 VARZOS / UNKNOWN MANUFACTURER 2 DTAP / GLAXOSMITHKLINE BIOLOGICALS / Z2M9L 2 DTAP / UNKNOWN MANUFACTURER 1 DTAPHEPBIP / GLAXOSMITHKLINE BIOLOGICALS / 33E9E 1 DTAPHEPBIP / GLAXOSMITHKLINE BIOLOGICALS / 4922C 1 DTAPIPV / GLAXOSMITHKLINE BIOLOGICALS / 43HB3 1 DTAPIPV / GLAXOSMITHKLINE BIOLOGICALS / H53CL 1 DTAPIPV / GLAXOSMITHKLINE BIOLOGICALS / T325H 1 FLU3 / CSL LIMITED / WT54006 1 FLU3 / CSL LIMITED / WT56908 1 Vaccines and lot number:
- 17. Deaths Reported fromVermont Data source: US Department of Health and Human Services. https://vaers.hhs.gov 1989 - 1 2005 - 1 1994 - 1 2007 - 1 1997 - 1 2011 - 3 1998 - 1 2014 - 2
Editor's Notes
- #2 Before I get started I just wanted to thank all of you for being here today. Some of you have travelled from far away to join us. A quick reminder that we will be showing the film Vaxxed after my talk, at noon today, for free. Before I get started, how many of you know what VAERS is (can you raise your hands)? How many of you have a report filed in the VAERS system? How many of you have never heard of VAERS? Ok, thanks. Also before I get started I wanted to be sure to tell you that I am not a medical professional and nothing I say here today should be construed as medical advice. I am sharing with you today information about VAERS, our nation’s Vaccine Adverse Event Reporting System, as I have learned about it through person experience and research. I have compiled information for you so that you have a starting point upon which you may come to know how and where to file a report as well as the limitations and potential usefulness of the data. This presentation is by no means complete given the short time frame. Ok here we go.
- #3 VAERS was the Established in 1990 to fulfill a requirement of the National Childhood Vaccine Injury Act of 1986 It is THE national vaccine safety monitoring system used for collecting and analyzing reports. Run by CDC and FDA, it’s primary objective is to serve as an early warning system that may detect possible safety problems with a vaccine. VAERS is operated separately from FAERS (which monitors safety signals for all other drugs and biologics and which must, by law, be reviewed and reported on regularly) and is a critically important database which, according to CDC, is used by CDC/FDA to assess the safety of newly licensed vaccines, detect new, unusual, or rare vaccine adverse events; to Detect new, unusual, or rare vaccine adverse events, and to assess the safety of newly licensed vaccines.
- #4 Vaccines are pharmaceutical products, biologic drugs, which are defined as products made from living organisms or contain components of living organisms. They come with inherent and unavoidable risks as evidenced in manufacturer warning labels such as those reviewed earlier by Dorian (the package inserts). There is simply no way of knowing how a given unique individual may react to any drug or vaccine. If you (or your child) are unlucky enough to experience an adverse event – you need to document as much as you can and also get healthcare providers to document too. And you should make sure that a VAERS report gets filed.
- #5 Here is just one small part of the Reportable Events Table, which is several pages long. The Reportable Events Table (RET) reflects what is reportable by law (42 USC 300aa-25). In addition, healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event) for any vaccine, whether or not it is listed on the RET. This includes ANY untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product ; any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical product (in this case a vaccine). One thing that I know I experienced, and many other parents too, was denial by the pediatrician who ordered the shots, that the vaccines could have anything to do with his immediate symptoms or those that came months later. You know your child best. You will need to advocate. Document, get the experience written into medical records, and likely file the report yourself.
- #6 Sometimes you will see these symptoms also listed in in the product warnings (package inserts)
- #7 VAERS reports need not be limited to things on this table, This is the list of what “must”, by law, be reported by health care providers. Currently, there is no penalty for health care providers who do not report. Good thing, then, that just like the FDA’s drug event reporting – anyone can file a report. And these reports that come in really are truly important. In fact, VAERS reports of symptoms and outcomes not listed on the table have played a critically important role in the past – leading to withdrawal of unsafe vaccines from the market.
- #8 So, the CDC and FDA warn about misinterpretation of data. And it is true that not all VAERS reports have been evaluated as to the correlation being the causation. So while this database is highly searchable, and available for you to read what other consumers have to say about their experiences with vaccines – you should take it with a grain of salt.
- #9 On the other hand, after a vaccine gets FDA approval (sometimes fast tracked approval), VAERS stands as the most important sentinel to help detect problems. VAERS data have triggered action by officials in the past… For example, after VAERS received the first report that a baby had an intussusception and died after receiving the Rotashield (Rotavirus) vaccine, there was no immediate reaction. But after many reports, the use of the vaccine was halted and later, withdrawn from the market. After thousands of reactions following DTP (Diphtheria, Tetanus and Pertussis) vaccination were reported to VAERS, the decision was made to switch to an acellular pertussis vaccine, which is presumed to be safer After multiple reports of paralysis were reported to VAERS following oral polio vaccination, the OPV was withdrawn from the US market and the inactivated polio vaccine (IPV) was reintroduced.
- #10 As a consumer, and parents are the lion’s share of today’s vaccine consumers until the adult mandates roll in, as consumer, if you are unlucky enough to experience an adverse experience after a vaccine – it is to VAERS that you will report. Try to get the person who gave the vaccine to give you a copy of the vaccine package insert so you can read it, and try to get them to evaluate your child. It is also optimal to direct your healthcare provider to document the event fully in the child’s medical file, and also to direct your doctor to report the reaction. Make sure everything is writing. But if he or she will not, you can file the report yourself. Your report need not be limited only to the doctor’s conclusions – you should put everything in there from tests and diagnoses to most especially what you witnessed and saw at home.
- #12 As consumers, we can also search VAERS data, just as we can search the safety record of other prescription medications. Again – the CDC and FDA warn about misinterpretation of data. And it is true that not all VAERS reports have been evaluated as to the correlation being the causation. So while this database is highly searchable, and available for you to read what other consumers have to say about their experiences with vaccines – you should take it with a grain of salt. But why not take a look and see what other consumers have to say as part of your overall decision? We scour consumer reports for all things baby – the car seat, the crib, the stroller,,,, why not the vaccine?
- #13 Before doing so, remember that VAERS is a passive reporting system which comes with limitations – such the fact it is a passive montoring system, that does not track a patient’s entire history -- nor are the reports managed by a health-care provider. Also, few post-reaction follow-ups are available. Passive systems can also be affected by under-reporting – there are estimates of under-reporting by a factor of 10 to as much as a factor of 100 (meaning that the true number of vaccine reactions is between 10 and 100 times higher than what is reported to VAERS). The system can also be subject to reporting bias; For example, there might be more reports from new vaccines because people are worried about them. News articles might excite the public to submit more VAERS reports. It is possible that the kind of people who report reactions may be different than those who don’t recognize a reaction or ignore it, causing more bias.
- #14 One thing is clear: since the liability shield came into effect in 1988, the childhood vaccination schedule has exploded. Without “exemptions”, parents of babies born today would be expected to agree to 49 doses of 14 vaccines before the age of 6 in order to send baby to daycare or school, and 56 injections of 74 doses by age 18 – including even vaccines for pregnant women! Today’s “pediatric schedule” is seven times the number of injections recommended in 1983, before industry was freed from liability for product harm. You will hear more later today about the liability shield from Mary Holland. In many ways, the liability shield is the elephant in the room. So - when a teen drowns after a vaccine, or an elder shoots himself after getting very sick after a mercury-laden flu , or when teen has a car accident after HPV vaccine – it was not the vaccine, it was coincidence. Right? It was not, could not be, could not possible be, a vaccine. As the schedule continues to grow, more and more people report adverse reactions due to vaccination. Perhaps there needs to be more attention given to those report. Perhaps we need more active monitoring.
- #15 So, back to the search function on VAERS. As the schedule continues to grow, it is clear that more and more people are reporting adverse reactions due to vaccination. And as the schedule continues to grow, and as there is no liability, more and more concerned people are speaking out. VAERS is THE vaccine reporting system to which consumers are directed to report their adverse vaccine experiences. It is worth examining closely what consumers are experiencing. I personally think the data – even when taken with a grain of salt – can be useful information to consider as part of the overall vaccination equation. And I think there needs to be close, local scrutiny of the data so we can help those who are truly injured by a vaccine or multiple vaccines.
- #16 Which is why we are asking the health department to compile Vermont’s VAERS annually and trying to pass H.247, a bill to require this information to be posted publicly.
- #17 Vermont is a small state. Decision makers, rather than blindly following the AAP white coats advising them, need to wrap their arms around the human, and economic costs associated with mandatory vaccination policies. H247 would require more visibility and transparency and hopefully lead to more accountability. Now, not all reports can be construed as caused by vaccines. But again, this is the sentinel system to which we are told to report. At the very least, the reports should be taken seriously. Here are the stats from 2016. This took all of 5 minutes to compile. The bill is an easy lift for any claiming to be in charge of immunization as safety should be of the utmost priority.
- #18 In conclusion, close monitoring of “adverse event reports” filed to the reporting system VAERS shows that each year, Vermonters report being injured by vaccines. Vermont is a small state. So when a baby has a vaccine reaction, and the doctor refuses to acknowledge it, or refuses to file a VAERS report, or refuses to consider the inherent risk in continuing to vaccinate that child or siblings of that child – word gets around fast. When a child dies after a vaccine, word gets around fast. Now normally, there would be market forces at play here. Parents search for a more compassionate and responsible doctor. Parents choose to say no to the same product that harmed their neighbor’s child. Under normal circumstances a doctor boycott, or a product boycott, might be all that is needed to enact change. However, with mandatory vaccination on the march, it becomes more difficult. These are not normal circumstances. Parent’s rights to free medical choice when it comes to risk taking, is being restricted in unprecedented ways. We need to turn the tide. What are the costs, both economic and human, associated with policies which mandate vaccination even when the risk to benefit ratio does not make sense? If lawmakers had known that these adverse events and death reports existed in a database, and had they read the reports and perhaps met the affected persons - would they have voted differently? Would they have fought harder to preserve our philosophical exemption, the means by which we give – or withhold informed consent? the right to choose? Would they have not questioned more the assumption behind moving from voluntary to mandatory vaccinations? While much more needs to be done to protect consumers from vaccine injury, the VAERS bill H247 could be a first step so as to put important data in front of decision makers so they can see for themselves that their policies – currently aimed only at “raising rates” can and do have unintended and sometime horrendous consequences. And where there is risk, (and no liability!) there must be choice. VAERS is not perfect but it could it be used much more efficiently by local health department employees so that they can act responsibly in the face of vaccine tragedies. It is our hope that by improving transparency and providing our decision makers with more data than simply, “the vaccination rates” there will be a better understanding, moving forward.