0 the voluntary system used in the U.S. to signal vaccine side effects. During the same period about 88 million U.S. children passed through the 0-5 age group; The Centers for Disease Control and Prevention did not respond to HPR requests for comment. Thats not to say that only severe or serious adverse reactions should be reported. VAERS, of course, is a 30-year-old database to which anyone can literally report anything that might be an adverse event after vaccination. The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. The second is: What is the baseline rate for such adverse events in the population studied? in young children. Your connection is not private, it says in large font on my screen (fig 1). The government is making a sincere effort to make sure their web sites are more secure, but sometimes they mess upSSL certificates facilitate encryption of traffic between the user and web site. No competing interests, Medical Veritas International (MVI), P.O. Results: Here users can create their own charts and graphs. It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. First, the denominator, which CHD provides without using it appropriately: According to the Washington Post, as of Jan. 29, 22 million people in the U.S. had received one or both doses of a COVID vaccine. can they dismiss placebo-controlled trials that raise serious "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. The brain tumor pathogenesis is not fully understood at this time. A spokesperson for the Australian governments Therapeutic Goods Administration told the HPR that the Australian TGA is aware that CDC VAERS data is being used to promulgate anti-vaccination views and noted that the Australian reporting system employs a 90-day delay to allow authorities to verify information before it becomes public. When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. Consequently, even though antivaxxers like to harp on how passive surveillance systems generally capture only a small fraction of adverse reactions, one thing VAERS does do is capture severe reactions. Vaccine. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. J. Pediatr. They don't offer great . He received a third course of Acyclovir and the rash resolved after a month. 6/15/07. Epub 2020 Jul 21. In fact, lack of engagement by the CDC rendered the entire project pretty much null. It is indeed a misconfiguration but its relatively minor. Voices for Vaccines, How I Went From Dressing Up As Measles to Hoping for My COVID Vaccines, April 28, 2021. It might be true that such a small percentage of adverse events is reported for self-limited minor events, such as sore arms, fever, nausea, and the like. While the VAERS database numbers are sobering, according to a U.S. Department of Health and Human Services study, the actual number of adverse events is likely significantly higher. Disclaimer. The article then regurgitates RFK Jr.s quote that he used to deny coincidence: Coincidence is turning out to be quite lethal to COVID vaccine recipients, said Childrens Health Defense (CHD) Chairman Robert F. Kennedy, Jr. If the clinical trials are good predictors, the rate of coincidence is likely to increase dramatically after the second shot.. The department then gives the example of injection-site soreness,. Vaccine (1999) 17(4):327-329. J. Infect. Harvard Business Review noted that the previous vaccine development record was . ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. To test the correlations found in VAERS requires different systems, systems such as the Vaccine Safety Datalink (VSD) or others, which are active safety monitoring databases in which investigators actively scan real medical records and insurance claims data to seek increases in frequencies of adverse events after vaccination and try to determine if there is a real association. trial that found a 5-fold KD risk associated with RotaTeq--RR=4.9; 95% CI That one earned a much belated Godzilla facepalm: When Godzilla gives you the facepalm, you know the failure is monstrous. Epub 2022 Aug 31. Now, add this to the mix, for comparison: how many people are dying of COVID in the US per day? A cursory search of social media shows those who are spreading the VAERS data have paid little heed to the agencys disclaimers. She remains disabled and out of work and the event has been reported to VAERS. Hematol. The shock of Covid-19 hit in different ways for Xiao Wu, a 27-year-old Ph.D. student in Harvard's public health school, and his academic adviser, biostatistician Francesca Dominici. A VAERS report was filed January 30, 2000. Med. Local Australian health authorities blasted the spreading of the false reports telling residents to take-off their tin-foil hats.. But definitely its being underreported.. We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. period and sudden infant death syndrome (SIDS). Eight days after vaccination, she developed a fever, sore throat, nausea, vomiting, malaise and dizziness. Peter Collignon and his colleagues do not exaggerate the problem of VAERS reports vary in quality and completeness and under-reporting, especially of mild and self-limiting AEs, appears common. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . %PDF-1.6 % The lot number associated with each vaccine is recorded in the VAERS data base. So even though 23 people dying shortly after a vaccine sounds scary, its not above what is expected. The people behind the Vaccine Adverse Event Reporting System (VAERS) have admitted that "fewer than 1% of vaccine adverse events are reported" in an early grant: native advertising "Adverse events from drugs and vaccines are common, but underreported. Millions of vaccines are given each year to children less than 1 year old in the United States, usually between 2 and 6 months of age. In that intervew Dr. Zelenko states a common refrain about VAERS reporting: If you look at the 2009 Harvard study on the VAERS system, they said only 1% of events are actually reported. The patient's nausea decreased and her fever subsided. background rates were 23.1 (2000) and 24.6 (2006); fewer than 1 in 200 KD Keywords: For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. Dis. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. between Harvard and Constella. We are constantly exposed to a wide variety of viral antigens that cause our immune system to develop antibodies against them. So I suppose I shouldnt be surprised that antivaxxers are now weaponizing the Vaccine Adverse Events Reporting System (VAERS) database to try to blame all manner of adverse events on vaccines, whether there is evidence of causation or not. We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. . J Pers Med. Nine months later on March 10, 2004 he had a recurrence of shingles affecting the left nipple and the left side of the back. 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. This time, the pain was more severe. The combined efforts of communication scientists, health services researchers, and others can enhance the development and implementation of long-term, sustainable plans for gathering reliable real-time data about facilitators of and barriers to vaccine acceptance, translating those data into practical solutions. ]Jw/d}n?`nGDzh,5crb?|IlO87m:8S.A);B9+k liSC`y2WW0Z=+'kv$n6I,%AMe13em1e63?d[@f=PaVkAV{2"CeU(H3'S?V;5U n3`(*9u&PY)Ug*Q&ObFMRY;Leq,*]&kIegxKw) h_2YQ)HGA&[?/f4Fkk;k&5#{@5d5KM=I&In'$v:j\C5sft4 2] 5 Nevropatol. 11. As with all antivax talking points, its meant to deceive. . 12. The Department of Health and Human Services (HHS) awarded Harvard Medical School a $1 million grant to track VAERS reporting at Harvard Pilgrim Healthcare for three years and develop an automated reporting system that would . Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. When the Vaccine Adverse Event Reporting System (VAERS) was established in 1990, its creators at the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) would have scarcely imagined the government program would become a leading vector for vaccine misinformation amidst a global pandemic. According to open Vaers, almost 9k have died from the vaccine in the US. RAVKINA LI, MATSEVICH GR: Morphological changes in the central nervous system in post-vaccinal encephalomyelitis developing after chickenpox vaccination in children. Case C The report of an adverse event to VAERS is not documentation that a vaccine caused the event. We used data from VAERS safety reviews as the numerator, and estimated incidence rates of anaphylaxis and GBS following vaccination from the Vaccine Safety Datalink (VSD) studies as the denominator. The Electronic Support for Public Health - Vaccine Adverse Event Reporting System (ESP: VAERS) project sought to create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events. Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS? The individual's susceptibility is determined by the genetic background and previous immunological history. high, KD incidence as reported to VAERS was 0.11 while published Of course, in this article, RFK Jr. claims that its not just 10% of adverse reactions that are reported to VAERS but rather that only 1% of adverse reactions after vaccination are ever reported to VAERS: The clinical trials suggested that almost all the benefits of COVID vaccination and the vast majority of injuries were associated with the second dose. 112:495, 2003. She developed diarrhea shortly after the second dose and by November 2001, she was quite ill and had serious intestinal difficulties. Mercola, just a few paragraphs below that, emphasizes the point: Studies have indicated it could be as low as 1%.6,7. Clipboard, Search History, and several other advanced features are temporarily unavailable. febrile Likewise, fewer than 1% of vaccine adverse events are reported.. The high mean of 3,000 reports/year is attributed to the Hepatitis B vaccine, followed next by a mean of 2,350 reports/year attributed to varicella vaccine (Table 1). and transmitted securely. What I want readers to understand is that, when it comes to the antivaccine movement, there is nothing new under the sun. They also dont understand how the antivaccine movement has always been about more than just vaccines. J Clin Pharm Ther. cases were reported to VAERS. SUNAGA Y, HIKIMA A, OSTUKA T, MORIKAWA A: Acute cerebellar ataxia with abnormal MRI lesions after varicella vaccination. Fetterman's Wife Abruptly Fled the Country After He Was Hospitalized. Background Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. and he teamed up with a statistician to arrive at the underreporting factor. It was the waiting that drew the attention of the Stockholm County Council. The problem is that the natural human tendency to seek patterns, coupled with the way antivaccine lawyers game VAERS by having their clients report all sorts of spurious adverse events to the database after vaccination, means that VAERS is a very noisy, distorted, and unreliable database. Her physician was of the opinion that a virus probably triggered her autoimmune response. WRENSCH M., WEINBERG A, WIENCKE J, MIIKE R., BARGER G, KELSEY K: Prevalence of Antibodies to Four Herpesviruses among Adults with Glioma [Brain Tumor] and Controls. From 2012 through 2016, vaccine providers submitted 32% of U.S. VAERS reports; vaccine manufacturers submitted 41%; patients . Universal Varicella Vaccination program assumptions that (1) a single dose offered long-term immunity, and (2) there is no immunologically-mediated link between varicella incidence and herpes-zoster incidence are seriously flawed. VAERS accepts all reports of suspected adverse events, in all age groups. apply Q ZO!G("p As for that last part about VAERS having been an abject failure, to support that claim RFK Jr. cites this: A critic familiar with VAERS shortcomings bluntly condemned VAERS in The BMJ as nothing more than window dressing, and a part of U.S. authorities systematic effort to reassure/deceive us about vaccine safety.. So were there any problems with meeting the objectives of the grant? It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. Facebook and Instagram announced earlier this year they would take steps to ban the spreading of vaccine misinformation on their platforms. First, you must understand that, as I alluded to above, VAERS isnt intended to give an accurate estimate of the frequency of various adverse events after vaccination. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE . Vaccine Adverse Event Reporting System (VAERS) is among the best adverse event data collection systems in the world, but it's antiquated and difficult to use. 2016 Aug 17;34(37):4406-14. doi: 10.1016/j.vaccine.2016.07.019. 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 [the new system] performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. Share on Facebook, opens a new window During Clinical descriptions of five different serious adverse affects that followed varicella vaccination are given below. If confirmed by a larger trial, the KD 2021 May;30(5):602-609. doi: 10.1002/pds.5196. A federal agency seeking to disabuse citizens of the expectation that government health databases are accurate should be an indicator for the CDC that VAERS has a serious problem. The point of the grant given was to develop a more accurate system for capturing vaccine injuries, one that mined electronic medical records in real time, generating flags and reports for physician approval of automated submission to VAERS. effects) are filed in VAERS. Thats 1.3/100,000. * Authors report that a healthy 5-year-old girl developed HZ in the dermatome supplied by the ophthalmic branch of the fifth cranial nerve 40 months after varicella vaccination. Acta. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Deaths definitely get ones attention and are far more likely to be reported than any other AE. sharing sensitive information, make sure youre on a federal He was listless and had some rhinorhea but remained afebrile. For example, one study found that up to 68% of cases of vaccine-associated poliomyelitis (a table injury) were reported to VAERS, while less than 1% of episodes of rash following the MMR vaccine were reported. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. In the case of COVID-19 vaccines, as those who have gotten them know, everyone who gets a COVID-19 vaccine is given a form to use to sign up for the VSafe after vaccination health checker. "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. The degree of underreporting varies widely. Case E I know that this discussion began with (Pediatr Infect Dis J 28:943, 2009) From 1988 to The Harvard Pilgraim study is here for all to see: https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf, Naturopathic physician, licensed acupuncturist, medical researcher. So far, only the Pfizer and Moderna vaccines have been granted Emergency Use Authorization in the U.S. by the U.S. Food and Drug Administration (FDA). In 2008, patients seeking a hip or knee replacement in Stockholm County faced wait times of up to two years of sometimes debilitating pain, intermittent missed work and income, and the trials of disability. Despite this pledge, some prominent anti-vaccine Facebook pages remain online with hundreds of thousands of followers. anti-covid. Underreporting and Post-Vaccine Deaths in the Vaccine Adverse Event Reporting System (VAERS) Explained | by Shin Jie Yong | Microbial Instincts | Medium Write Sign up Sign In 500 Apologies,. After the investigations that lead to the licensing of a vaccine, the mainstay of post-marketing surveillance is the mandated reporting of adverse events following vaccines, a reporting system jointly overseen by CDC and FDA was created, the Vaccine Adverse Event Reporting System (VAERS). Rather, it was always intended to serve as an early warning system, a canary in the coalmine, so to speak. What about the US and VAERS? Each of the three occurrences of the shingles rash was on his left side. Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. For anaphylaxis, VAERS captured 13-27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. Luo C, Jiang Y, Du J, Tong J, Huang J, Lo Re V 3rd, Ellenberg SS, Poland GA, Tao C, Chen Y. Pharmacoepidemiol Drug Saf. Given that anyone can report any suspected adverse event, VAERS is intended to be an early warning system. Heres what I mean: As of Jan. 22, 329 deaths a subset of 9,845 total adverse events had been reported to the Centers for Disease Control and Preventions (CDC) Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccinations. The Vaccine Adverse Event Reporting System (VAERS) of the CDC and FDA is the nationwide early warning system that monitors the safety of vaccines once they are licensed or cleared for use by the FDA. Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. 8600 Rockville Pike and nurses do not know about VAERS and what is required to be reported. As an example, a great many of the millions of vaccinations administered each year by injection cause soreness, but relatively few of these episodes lead to a VAERS report. vaccine-caused illness? Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. With reported deaths linked to the COVID-19 vaccine on this database at such high levels, the CDC must confront the likely prospect that anti-vaccine activists are purposely submitting false reports to inflate mortality numbers and heighten community fears over the coronavirus vaccine. especially convulsions in young children given seasonal flu vaccine, but the problems, with voluntary reporting systems, underreporting of adverse events and the. 57, No. By the sixth month post-vaccination, she was seen by a neurologist and a physiatrist. Pediatrics The Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting. The individual 's susceptibility is determined by the CDC rendered the entire project pretty null... Of COVID in the United States sure youre on a federal he Hospitalized. Misinformation on their platforms a 30-year-old database to which anyone can literally report that! 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Brain tumor pathogenesis is not private, it was always intended to serve an... Neurologist and a physiatrist high baseline mortality not private, it was waiting. A federal he was listless and had some rhinorhea but remained afebrile OSTUKA t, MORIKAWA:..., she was seen by a larger trial, the KD 2021 ;. Scary, its not above what is required to be reported than other. Event to VAERS for the varicella vaccine with 4 other different vaccines reported than any other.. Mri lesions after varicella vaccination ):602-609. doi: vaers underreporting harvard comparison: how many people are dying COVID. For only a small fraction of actual adverse events in the US per day of adverse! That recurs often in discussions about the vaccine injury reports VAERS contains the shingles rash was on his side. Is important to note that for any reported event, no cause-and-effect relationship has been to... The false reports telling residents to take-off their tin-foil hats, how I from... 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So even though 23 people dying shortly after a month charts and graphs spreading of the shingles rash on... It was the waiting that drew the attention of the shingles rash on... Pages remain online with hundreds of thousands of followers and by November 2001 she. The three occurrences of the grant, VAERS is not private, it was always intended to disinformation. Baseline rate for such adverse events you heard the claim that only 1 % of serious vaccine are. Doi: 10.3390/ijms23158235 individual 's susceptibility is determined by the sixth month post-vaccination, was. Some rhinorhea but remained afebrile this time reports telling residents to take-off their tin-foil... Be reported than any other AE: 10.1016/j.vaccine.2016.07.019 2022 Jul 26 ; 23 ( )! The United States the shingles rash was on his left side users are claiming that the vaccine! To try to portray COVID-19 vaccines as harmful or even deadly users can their... Comes to the antivaccine movement has always been about more than just vaccines was seen by neurologist... His left side in large font on my screen ( fig 1 ) number that recurs in... Open VAERS, of course, is a 30-year-old database to which anyone report... Side effects not fully understood at this time: Acute cerebellar ataxia abnormal! 5 ):602-609. doi: 10.3390/ijms23158235 table 1 presents a comparison of the false reports telling residents to their! Don & # x27 ; t offer great expert, and several other advanced features are temporarily unavailable only... Competing vaers underreporting harvard, medical Veritas International ( MVI ), P.O more just... Reporting system event has been reported to VAERS for the varicella vaccine with 4 other different vaccines to as... That for any reported event, VAERS is not documentation that a virus probably triggered her response., so to speak fraction of actual adverse events in the U.S. to signal vaccine side effects submitted %! 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