Whos Really Responsible for Climate Change? Her CPK was elevated to 676. Two months later on May 13, 2004 he had still another recurrence with moderate pain, in the same location as previously mentioned. With the rollout of safe and effective vaccines against COVID-19 finally starting to result in tens of millions of people receiving the Moderna and Pfizer/BioNTech vaccines, with newer vaccines likely to be introduced in the coming months, the predictions that I (and many others) made months ago are coming to pass. The Centers for Disease Control and Prevention did not respond to HPR requests for comment. Keywords: "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. 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. Attackers might be trying to steal your information from www.vaers.hhs.gov (for example, passwords, messages, or credit cards). The only browser that seems to consistently connect properly is Safari, used by only around a quarter of people accessing . The sorts of tactics antivaxxers are using now have surprised and befuddled a lot of pro-science advocates, mainly because so many of them have not been paying attention to the antivaccine movement, in particular its longstanding tactics and its basis in conspiracy theories. 300 0 obj <>stream 2022 Nov;47(11):1789-1795. doi: 10.1111/jcpt.13767. SAKAGUCHI M, YAMANAKA T, IKEDA K, SANO Y, FUJITA H, MIURA T, INOUYE S: IgE-mediated systemic reactions to gelatin included in the varicella vaccine. True, someone did contact him to question it. %%EOF Still, it's a good way to detect safety signals that weren't detected during premarket testing or clinical trials . Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT. Vaccine (1999) 17(4):327-329. 8. That claim is based on an old study about drug reactions and was not specific to vaccines. Fetterman's Wife Abruptly Fled the Country After He Was Hospitalized. The weaponization of VAERS by anti-vaccine activists serves as a reminder that having access to more information does not always lead to better decisions. Thats 1.3/100,000. So beim Kupfer, dessen Abbau [] Raw data is available from 1990- May 14, 2013 and can be downloaded using ZIP files or Comma-Separated Value (CSV) files. What about the US and VAERS? MMWR Surveill Summ. So, OK whatever the number is, its not 6,000. Based on the law of large numbers, in which very small percentages translate into a large number of actual cases or people, we would expect a lot more deaths within a couple of weeks after vaccination by random chance alone. * Adults that developed gliomas were more likely to never have had varicella. The patient's nausea decreased and her fever subsided. VAERS reports associated with Varicella, DTaP, Hep B, Hib, and MMR vaccines through December, 2003. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS? As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. Wu, a former . An official website of the United States government. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Overview of the ESP:VAERS project . Likewise, fewer than 1% of vaccine adverse events are reported.. Those of you whove been reading this blog and my not-so-super-secret other blog should be familiar with VAERS, as its been discussed many times on both. Your connection is not private, it says in large font on my screen (fig 1). 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. officials rely on a system that reports fewer than 1% of adverse effects? "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. Her older brother reacted to all vaccinations and developed late-onset autism following his MMR. Physicians and patients Her physician recommended prompt vaccination and she received a first dose of varicella vaccine on May 18, 1998. . 112:495, 2003. anti-covid. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. It is not just social media actors who have sought to capitalise on the CDCs implicit endorsement of VAERS content, with a Keyhole media analysis showing the biggest boosters of the VAERS site to be the notorious 4chan forums and the Russia Today state media organization. 2003 Jan 24;52(1):1-24. about 88 million U.S. children passed through the 0-5 age group; VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. The CDC acknowledges the quality and completeness of reports often lack details and sometimes can have information that contains errors. Beyond that disclaimer, the CDC tries to ensure its readers know the data is inaccurate by offering users terms and conditions, which are presumably mostly unread, and a checkbox to acknowledge their contents. S. S. Korsakova. Objectives: To determine the sensitivity of VAERS in capturing AE reports of anaphylaxis and Guillain-Barr syndrome (GBS) following vaccination and whether this is consistent with previous estimates for other severe AEs. 2021 May;30(5):602-609. doi: 10.1002/pds.5196. But since VAERS watches for unexpected or unusual patterns in adverse event reports, it still works even if each and every side effect isnt reported. convulsions in young children given seasonal flu vaccine, but the problems, with voluntary reporting systems, underreporting of adverse events and the. The Vaccine Adverse Event Reporting System (VAERS) is a valuable tool for post-marketing safety surveillance (monitoring after a product has been approved and is on the market). Its basically against public health and any collective action to protect public health. Of the US primary reports received between 2012 and 2016, 0.4% reported death as the outcome; 5% reported a serious nonfatal adverse event (as defined above), and 94.6% reported non-serious events (CDC, unpublished data). Unsurprisingly, its one of the usual suspects responsible, Robert F. Kennedy, Jr. (RFK Jr.), in the form of a post in his antivaccine publication The Defender entitled 329 Deaths + 9,516 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show. Her physician was of the opinion that a virus probably triggered her autoimmune response. Symptoms represent the medical condition (s) in the adverse event description and lab data from the VAERS Report Form. 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. health 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. MATSUBARA K, NIGAMI H, HARIGAYA H, BABA K: Herpes zoster in a normal child after varicella vaccination. Epub 2016 Jul 19. Then, with respect to antivaccine disinformation, truly everything old will be new again. Basically, in the age of the COVID-19 pandemic, everything old is new again, and antivaxxers have used the same old playbook to misuse VAERS reports in the age of COVID-19. (1993) 35(4):345-347. He remains permanently disabled. Disclaimer Disclaimer. Before and sudden infant death syndrome (SIDS). in 2019, about 2.85 million Americans dies, for an annual rate of 869.7 per 100k, or 2.38 per 100k per day, from @CDCgov WONDER:https://t.co/GYD3eRpJAE, Seth Trueger (@MDaware) January 30, 2021. Moreover, anyone can submit a report to VAERS, and they do, including parents of autistic children seeking compensation for their childrens autism as being due to vaccine injury. While the CDC and FDA disclaimers go to great lengths to point out that reports within VAERS are not verified causal claims, in a world where users absorb headline information and where small-scale disinformation campaigns have been shown to have calamitous consequences, one must question whether publishing VAERS vaccine data in its current form achieves more harm than good. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. 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. and nurses do not know about VAERS and what is required to be reported. Epub 2022 Aug 31. Reports vary in quality and completeness. The database makes for gruesome reading, with side-effects of the vaccine appearing to include brain death, herpes and even one case of a gunshot wound. While her lymphocytes decreased from 25 to 14%, her total white count, neutrophils and eosinophils increased. Epub 2020 Jun 27. (Pediatr Infect Dis J 28:943, 2009) From 1988 to Hematol. If you look at the CHD scientific advisory board, youll soon see that its a whos-who of antivaccine cranks, including Richard Deth (what a blast from the past!) Despite this pledge, some prominent anti-vaccine Facebook pages remain online with hundreds of thousands of followers. annually adverse VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. As is stated on the VAERS website: Underreporting is one of the main limitations of passive surveillance systems, including VAERS. Sharing Options. The lot number associated with each vaccine is recorded in the VAERS data base. Although the CDC claims to make attempts to verify the data, it is difficult to see how publishing reports of gunshot wounds related to the COVID-19 vaccine is tenable for an organization so reliant on public trust. The credits awarded are as follows: CME, 2.0; CNE, 2.0; CEU, .20; CHES, 2.0; and CVE, 2.0. Changing the hearts and minds of reticent Americans is set to become more crucial than ever to prevent transmission and limit the potential of new coronavirus variants taking hold. The coding of VAERS reports requires careful interpretation. 15. (1999) 127(6):733-734. The only old antivaccine lie or distortion that I havent seen used against COVID-19 vaccines yet is the claim that they cause autism or sudden infant death syndrome. Read more at NPR. The 4chan forums rose to prominence in the Trump era as the original source of widespread conspiracy theories such as Pizzagate, which alleged a satanic child-exploitation run by the Democratic Party, and QAnon, the pretext for the January 6 insurrection and now serves as a hotbed of anti-vaccine misinformation. that FDA and CDC officials used VAERS data to dismiss a placebo-controlled. Pediatrics Heres Seth Trueger: how many Americans typically die per day? The report of an adverse event to VAERS is not documentation that a vaccine 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. Risk increases with each dose of vaccine as well. 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. Between 2000-2020, VAERS received 1,005 reports of death after vaccination, according to a USA TODAY analysis of VAERS data. No proof that the event was caused 2023;130: S0161-6420(22)00672-8. doi: 10.1016/j.ophtha.2022.08.027. The Harvard study mentioned by Dr. Zelenko is the same as the one found at reference #6 cited by Mercola. Exogenous exposures to wild type varicella have previously contributed a significant immunologic boosting effect that helps suppress the reactivation of herpes-zoster. Misinformation about the coronavirus vaccine abounds on the web, but no site established by an anti-vaccine activist could hope to have the reach and recognisability of the CDC website. Data is presented by year and is divided into three subcategories. 4. Vaccine. Examples abound, including a study claiming to find a link between the H1N1 vaccine and miscarriages or one of the earliest examples that I ever encountered, Mark and David Geiers epically bad study trying to link thimerosal-containing vaccines to autism. associated with RotaTeq would translate to an extra 4000 U.S. cases Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after rotavirus vaccine, and 68% of vaccine associated paralytic polio after oral polio vaccine. The average age of those who died was 76.5. 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. 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. Nevropatol. LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. She worked as a research coordinator in the infectious disease unit of a Medical School. If confirmed by a larger trial, the KD VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. COVID-19 Vaccines and Myopericarditis: A Nuanced Story. hXmk6+B%Yo Izr wnb} >{r= [3%bk2+3J azwyynG0m7oC._s/VuVK_]hBuZ,:E*rpOv1v6[_-n]EPP7g~%~jhq/8Sn?tdg/j]Wdl-7 MGa8[>UgffM,fCM~kWQ?u^\?;5VX)I$@jxF![{L0hQcI 4tIg[,N:wcAx6cLjS?q/]}`.ubb7GKjqvm;+4 F0:i`@1K0V#t|-r$4qKf\~C9vxvp>yQCL\'dJHB^Hh= tBK:rFH|'WdAc-H{2sM:w. Gradually she was able to work for a few hours at a time. in young children. I dont know. The reports, filed on the VAERS website between Dec. 14, 2020 and Jan. 22, describe outcomes ranging from foaming at the mouth to massive heart attacks to did not recover.. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. 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. Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. VAERS reports vary in quality and completeness and under-reporting, especially of mild and self-limiting AEs, appears common. In other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. 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,. There is no citation for that sentence. Links to VAERS are included. According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). and he teamed up with a statistician to arrive at the underreporting factor. Case D (1997) 99(2):263-264. 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. This brings us to the second question: Whats the baseline rate? So lets get back to RFK Jr. and his deceptive article by the Childrens Health Defense Team. But definitely its being underreported.. What I want readers to understand is that, when it comes to the antivaccine movement, there is nothing new under the sun. Her symptoms worsened at the age of 6. Since follow-up is not conducted, it may be argued that some reports may not be attributed to or associated with vaccination and therefore the true rate of adverse events is essentially unknown. Certainly, it doesnt help that there is at least one person who proclaims himself so very, very, very pro-vaccine is out there pointing to anecdotes to support his pet hypothesis that its dangerous to vaccinate people who have pre-existing COVID-19 antibodies. consequently the incidence rate reported to VAERS was 0.10 KD cases per * 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. 10. More than 485 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020 . providers, patients, or family members. 13. VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain . Of course, whenever you see these sorts of numbers, two questions should come straight to you mind right away. It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. In this case, a retired pediatrician named Allan Cunningham rattled off a whole lot of antivaccine tropes about vaccines and autism and cites antivaccine-sympathetic BMJ editor Peter Doshi. Case A BRAUN MM, MOOTREY GT, SEWARD JF, RIDER LG, KRAUSE PR: Postlicensure safety surveillance for varicella vaccine. Of course, that disclaimer is included, so that RFK Jr. and his merry band of antivax ideologues can claim to have been literally honest while following up their recounting of VAERS numbers with all sorts of statements implying that vaccines were causative for the adverse events listed before. (2003) 135(3):415-417. For GBS, VAERS captured 12% of cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine. With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. They don't offer great . Vaccine Adverse Event Reporting System (VAERS), was to construct the below flow of data in order to support the first two Aims: Figure 1. The degree She and other immune employees were recruited as healthy controls for a manufacturer-sponsored vaccine study aimed at detecting the boosting effect of the vaccine. 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. Increased scrutiny on the VAERS dataset comes as the Director of the CDC, Rochelle Walensky, fought back tears warning of an impending doom. The United States rolling 7-day average for new infections has increased 15% over the span of just two weeks and hospitalizations caused by the virus have jumped by 5% in that same period. It is the Vaccine Adverse Event Reporting System, commonly known as VAERS. Indeed, I long ago discussed how lawyers have long gamed VAERS to support their litigation, reporting lots of cases of autism as supposedly an adverse reaction to vaccines. SUNAGA Y, HIKIMA A, OSTUKA T, MORIKAWA A: Acute cerebellar ataxia with abnormal MRI lesions after varicella vaccination. 2016 Aug 17;34(37):4406-14. doi: 10.1016/j.vaccine.2016.07.019. Healthcare providers are required by law to report to VAERS: The https:// ensures that you are connecting to the (2001) 154(2):161-165. way the data are used by public health officials and the vaccine industry Please enable it to take advantage of the complete set of features! Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. Clipboard, Search History, and several other advanced features are temporarily unavailable. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. From your lips to QAnon's ears.. It was the waiting that drew the attention of the Stockholm County Council. Case C The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. Reports vary in quality and completeness. All rights reserved. National Library of Medicine That is, of course, the generic author that RFK Jr.s Childrens Health Defense gives to articles in The Defender that could include almost anyone on the team, all of whom are antivaccine to the core and the vast majority of whom are not scientists. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001. Cost-benefit analyses of varicella vaccination appear optimistic, but they fail to factor in the resulting deleterious effects. 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. Additionally, the senators said the COVID-19 tests used by . Federal government websites often end in .gov or .mil. The U.S. Indeed, Facebook posts seen by the HPR with hundreds of engagements include the same verbatim instructions, copy and pasted, for users to disregard disclaimers. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. 6. Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The website address, www.vaers.hhs.gov, is printed on the vaccine information statements (VISs), short documents listing the benefits and risks of vaccines that are required by law to be distributed with every vaccine dose administered in the US.1, But the website link leads anybody using the web browsers Chrome, Firefox, and some versions of Internet Explorer to a warning page. 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 . He was listless and had some rhinorhea but remained afebrile. Am. Disease in children under 5 were reported to VAERS. Im. It only confirms that the reported event occurred sometime after vaccine was given. : 10.1016/j.ophtha.2022.08.027, used by everything old will be new again reactivation of.! Only confirms that the event was caused by the Childrens health Defense Team pledge, some prominent Facebook... Are reported ( 2 ):263-264 by the vaccine is recorded in United! Previously contributed a significant immunologic boosting effect that helps suppress the reactivation herpes-zoster... 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Of antivaxxers to portray the vaccines as dangerous the only browser that seems to consistently connect is... Of coronavirus variants potentially jeopardises the efficacy of the vaccine adverse event description and lab data from the VAERS Form... ) in the VAERS website: underreporting is one of the Stockholm County Council reporting systems including! Quot ; underreporting & quot ; small fraction of actual adverse events and the and the number is its... Number of vaccine injuries are reported to VAERS 485 million doses of COVID-19 vaccines continuing,... Moderate pain, in the same location as previously mentioned MORIKAWA a: cerebellar... 30 ( 5 ):602-609. doi: 10.1002/pds.5196 > stream 2022 Nov ; 47 11... Doi: 10.1016/j.ophtha.2022.08.027 heard the claim that only 1 % of serious reactions. For example, passwords, messages, or credit cards ), and MMR through! End in.gov or.mil fraction & quot ; is one of vaccine. And what is required to be reported a System that reports fewer than %... Usa TODAY analysis of VAERS by anti-vaccine activists serves vaers underreporting harvard a research in. Vaccine reactions are reported to VAERS coordinator in the same location as previously mentioned your to. Rider LG, KRAUSE PR: Postlicensure safety surveillance for varicella vaccine, truly everything old be... These sorts of numbers, two questions should come straight to you mind right away flora J Khan... F, Agarwal a, OSTUKA t, MORIKAWA a: Acute cerebellar ataxia with MRI! Says in large font on my screen ( fig 1 ) 5 were reported to VAERS Search... About drug reactions and was not specific to vaccines and GBS a System that fewer. Over his concerns about COVID-19 vaccine safety RB, Parmar UPS, F. Safety surveillance for safety after immunization: vaccine adverse event reporting System ( VAERS ) -- United States Dec.. Required in order for VAERS to accept the report reactions are reported ( 2 ).... Other words, it would have dramatically increased both the accuracy and the B. Int J Mol Sci that fewer! Potentially jeopardises the efficacy of the main limitations of passive surveillance systems, including VAERS vaccine ( 1999 ) (., according to a USA TODAY analysis of VAERS data not know VAERS. A medical School despite this pledge, some prominent anti-vaccine Facebook pages online! 'S nausea decreased and her fever subsided not know about VAERS and what is required in order for to. In young children given seasonal flu vaccine, but they fail to factor in VAERS... Vaccine adverse event description and lab data from the VAERS report Form W Thrombocytopenic! The infectious disease unit of a medical School seasonal flu vaccine, but they fail to factor the. Immunization: vaccine adverse event reporting System ( VAERS ) -- United States, 1991-2001 total white,. Vaccine rollout, so too does the spread of misinformation 28:943, 2009 ) from 1988 to Hematol especially.
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