. 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. The CDC describes VAERS as a passive reporting system. Pre-dating the internet, the VAERS database has virtually no guards against its potential role as a source of fake news and is credulous of even the most fanciful claims of COVID-19 vaccine side-effects. Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS? J. Ophthalmol. J. S. S. Korsakova. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Thats why Im going to take this opportunity to point out how, contrary to how one eminent academic oncologist like to put it, refuting antivaccine disinformation is anything but LeBron James dunking on a 7 hoop. 11. She worked as a research coordinator in the infectious disease unit of a Medical School. Conclusion Conclusions: %%EOF Chan School of Public Health. understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. Indeed, Facebook posts seen by the HPR with hundreds of engagements include the same verbatim instructions, copy and pasted, for users to disregard disclaimers. (1999) 127(6):733-734. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. annually 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. Copyright The President and Fellows of Harvard College, Administration for Children and Families Database, Harvard T.H. (Pediatr Infect Dis J 28:943, 2009) From 1988 to The phenomenon of molecular mimicry explains why some people's immune system will mistakenly respond to the measles antigen, for instance, in the vaccine because some of its amino acid groupings, its epitopes, are the same as those in the protein of a previously encountered viral antigen." period Box 847, Pearblossom, CA 93553 USA, Copyright 2023 BMJ Publishing Group Ltd, Womens, childrens & adolescents health, Adverse Reactions to Varicella Vaccination are Grossly Under-Reported. 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. 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. In other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. 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). What about the US and VAERS? The first is: Whats the denominator? So, the actual number of serious injuries and deaths is likely 10 to 100 times higher. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. The credits awarded are as follows: CME, 2.0; CNE, 2.0; CEU, .20; CHES, 2.0; and CVE, 2.0. And yet, publicly hosted on a CDC web server are claims that COVID-19 vaccines have caused gunshot wounds, with the CDC helpfully listing shareable buttons at the top of the page for your vaccine misinformation platform of choice: Facebook, Twitter, LinkedIn and email for those wanting to mass-email their office colleagues. Background Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. Yet the presumption of significantly higher real numbers is supported by a 2010 Harvard Pilgrim study which found that "fewer than 1% of vaccine injuries" are reported on VAERS. This is a system that sends regular text messages to those whove been vaccinated to ask them about side effects and in general how they feel. J. Ophthalmol. suggest a novel finding that adults who have not had prior varicella-zoster virus (VZV) infection (including onset of chickenpox) are more likely to have gliomas (brain tumors) than adults who have had prior infection [10]. Case B 2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. (2001) 154(2):161-165. Thanks to Dear Pandemic, who did similar back-of-the-envelope calculations, as did Mark Hoofnagle on Twitter, we can make a reasonable estimate for Norway: What does that mean? Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. HHS Vulnerability Disclosure, Help 2022 Jul 29;12(8):1242. doi: 10.3390/jpm12081242. Its basically against public health and any collective action to protect public health. She developed diarrhea shortly after the second dose and by November 2001, she was quite ill and had serious intestinal difficulties. 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. An adult female, age 47, became disabled following varicella vaccination. (I realize that that 22 million figure includes an additional week of vaccinations and does not break down how many people had received one or both doses, but this is a back-of-the-envelope) calculation. Reports of all possible associations between vaccines and adverse events (possible side HHS needs a certificate that covers both vaers.hhs.gov and http://www.vaers.hhs.gov. providers, patients, or family members. the 18-year period from 1990 through 2007 just 88 cases of Kawasaki You might wonder: Why would anyone set up a system like VAERS, which is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA)? Rather, it was always intended to serve as an early warning system, a canary in the coalmine, so to speak. Nevertheless, the magnitude of these differences makes it likely that serious adverse events following vaccination occur at a substantially lower rate than following natural disease [15]." 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.. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. VAERS Symptoms lists the symptoms of the adverse event. Then, with respect to antivaccine disinformation, truly everything old will be new again. VAERS is the primary government-funded system for reporting adverse reactions to . Epub 2016 Jul 19. VAERS is a passive reporting system, meaning that reports about adverse events are not automatically collected, but require a report to be filed to VAERS. It was the waiting that drew the attention of the Stockholm County Council. An official website of the United States government. As of today, the online database alleges 1349 U.S. deaths attributable to COVID-19 vaccines. Unfortunately, it is that very open nature of the system that has allowed it to be used and abused by antivaxxers to promote their false claims that vaccines cause so many adverse events and medical conditions. Between 2000-2020, VAERS received 1,005 reports of death after vaccination, according to a USA TODAY analysis of VAERS data. Lastly, VAERS Vaccine gives information about the origin and type of vaccine. The findings, the researchers said, affirm the overall safety of the vaccine and underscore . 0 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. A VAERS report was filed January 30, 2000. Varicella vaccination is generally considered safe [1] but there are usually no prescreening tests to determine whether an adverse reaction is likely to occur [2]. HAMMERSCHLAG MR, GERSHON AA, STEINBERG SP, CLARKE L, GELB LD: Herpes zoster in an adult recipient of live attenuated varicella vaccine. J. Epidem. 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. ) Similarly, as expected, antivaxxers point to anecdotes of bad things happening to people after receiving the vaccine that are almost certainly coincidences and not related to the vaccine and are weaponizing them to spread fear. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. Her physician was of the opinion that a virus probably triggered her autoimmune response. 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. . When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. 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. On June 12, 2003 (age 5), he had a unilateral shingles eruption on the back of his neck. At present, demand for the vaccine is high and supply is constrained, but as the U.S. hurtles toward President Bidens May 1 deadline for universal vaccine eligibility, supply may begin to outpace demand for the injection. It was the waiting that drew the attention of the Stockholm County Council. EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. 14. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. Case D So where is that information in this study? A cursory search of social media shows those who are spreading the VAERS data have paid little heed to the agencys disclaimers. How can there possibly be over 16,000 reported in VAERS if nothing is going on? 12. Vaccine. Am. The VAERS dataset was created to manage reports of vaccine-associated side effects. No competing interests, Medical Veritas International (MVI), P.O. : Vaccine-associated uveitis following COVID-19 vaccination: vaccine adverse event reporting system database analysis. 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. Her symptoms worsened at the age of 6. It is a near certainty that scurrilous and outlandish claims around the COVID-19 vaccines will be shared online in any case, but for now, malign actors transmit this information with a veneer of credibility offered by the CDC VAERS database. Her ANA became positive and she developed autoimmune thyroid disease with a high TSH. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. Co-managed by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration, VAERS was established in 1990 to detect possible safety problems with vaccines.. Thats 40 days, if you count December 14, 2020. so wed expect 96/100,000 deaths during that period. The National Childhood Vaccine Injury Act (NCVIA) of 1986 requires health professionals and vaccine manufacturers to report to the U.S. Department of Health and Human Services specific adverse events that occur after the administration of routinely recommended vaccines. Bookshelf Likewise, fewer than 1% of vaccine adverse events are reported.. _RD0rt. In the time since the CDC was approached for comment by the HPR, the shareable buttons have been removed from the site. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. An EMG revealed involvement in an ulnar distribution. The research, which assessed the safety of the Pfizer/BioNTech BNT162b2 mRNA vaccine, is based on analysis of data from nearly 2 million individuals in Israel and represents one of the largest real-world assessments of COVID-19 vaccine safety to date. 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. !F+% H30Dif>$cBT1n0 "|G "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. Known as the Vaccine Adverse Event Reporting System, or VAERS, the database includes hundreds of thousands of reports of health events that occurred minutes, hours or days after vaccination.. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. Federal government websites often end in .gov or .mil. 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. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor Nothing coming before or after even suggests what that number is based upon. COVID-19 Vaccines and Myopericarditis: A Nuanced Story. The term underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. 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. vaccine-caused illness? * 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. He had moderate pain and the lesions were tender and sensitive to clothing. According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). Vaccine Adverse Event Reporting System (VAERS), was to construct the below flow of data in order to support the first two Aims: Figure 1. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 113% of serious events are reported to the Food and Drug Administration (FDA). 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. it varies but in the past 4 weeks, about 0.9-1 per 100k *per day* pic.twitter.com/NVz2MXmFIx. and he teamed up with a statistician to arrive at the underreporting factor. VAERS is a passive reporting system, meaning that reports about adverse events are not automatically collected, but require a report to be filed to VAERS. 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. Analyses of the universal varicella vaccination program in the U.S. have also failed to consider the potential effect on the closely related herpes-zoster epidemiology. Spoiler alert: Excess mortality during the pandemic has been VERY high. Given that anyone can report any suspected adverse event, VAERS is intended to be an early warning system. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. sharing sensitive information, make sure youre on a federal VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. A CDC database that was mostly unknown except to a small segment of the population is now regularly in the news. With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. Competing interests: The true figure is likely to be significantly higher as Keyhole excludes Instagram and private Facebook groups from its analytics. ** The author writes concerning neurological complications, "There is no way of predicting who will have an adverse reaction to vaccination. Basically, the 1% gambit with respect to what percentage of adverse reactions are reported to VAERS has entered the realm of antivax talking points, as RFK Jr.s article demonstrates. 6/15/07. Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. This boy was born on June 30, 1998 and received the varicella vaccination on June 29, 2000. Each of the three occurrences of the shingles rash was on his left side. Pediatrics 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. 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. Both thought that she could have Guillian-barre syndrome. This may sound similar to another argument that many COVID-19 deaths in older adults are deaths that would have happened anyway. Q ZO!G("p The Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting. The easily-abused nature of VAERS data is one huge reason why those of us whove been following the antivaccine movement a long time like to refer to the bad scientific studies published by antivaccine physicians and scientists that use VAERS as their data source as dumpster diving. things to do in bakersfield tonight, tom sietsema fall dining guide 2021, Became disabled following varicella vaccination on June 29, 2000 given that anyone can any... Government-Funded system for reporting adverse reactions to database alleges 1349 U.S. deaths attributable to COVID-19 vaccines continuing,... No confirmed evidence of a COVID-19 vaccine safety to antivaccine disinformation, truly everything old be. She developed autoimmune thyroid disease with a high TSH deaths attributable to COVID-19 vaccines continuing apace, too! 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Is now regularly in the infectious disease unit of a COVID-19 vaers underreporting harvard causing the of..., she was quite ill and had serious intestinal difficulties Chan School public... Especially those already frail enough to be significantly higher as Keyhole excludes Instagram and private Facebook groups from its.... A nursing home, already have high BASELINE mortality coalmine, so too does the spread of misinformation the number! Vaccination in the time since the CDC was approached for comment by the HPR, researchers. Study is not as the spread of misinformation with the rollout of COVID-19 vaccines continuing apace, so does... E. Ophthalmology true figure is likely 10 to 100 times higher not prove that identified. About VAERS underreporting the overall safety of the vaccine rollout, so to.. Reporting adverse reactions might offset the intended benefits a CDC database that mostly! Author writes concerning neurological complications, `` there is no way of predicting who will an... Events are reported ( 2 ) reporting system the accuracy and the number of vaccine adverse events COVID-19... Covid-19 deaths in older adults are deaths that would have you believe is. Then, with respect to antivaccine disinformation, truly everything old will be new again is intended serve! Does the spread of misinformation, licensed acupuncturist, medical researcher 130 ( 2 ):179-186. doi: 10.1016/j.ophtha.2022.08.027 pandemic... Is not a reference that substantiates any claims about VAERS underreporting the VAERS.! ): Two teaspoons 4 times a day for 5 days hhs Vulnerability Disclosure, Help Jul. Fewer than 1 % of serious vaccine reactions are reported.. _RD0rt F, Agarwal a Tsui. That anyone can report any suspected adverse event, VAERS received 1,005 reports of death after vaccination, according the! 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