A 35-year old female who had never had varicella, was exposed to infected children. The time period for the VAERS report runs from December 14, 2020 (the first day COVID-19 vaccines were generally available) to January 22, 2021. The patient's nausea decreased and her fever subsided. 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. MeSH Would you like email updates of new search results? I assume the claim from Kirsch is based on a 10 year old report from Harvard-Pilgrim insurance showing that only ~1% of drug related adverse effects are reported. The patient later developed a cough, marked fatigue, sensitivity to light and sound, disturbed sleep and more serious loss of appetite. The bottom line is that 285 deaths after COVID-19 vaccination reported to VAERS in a timeframe of 40 days is actually a very small number. Q ZO!G("p of underreporting varies widely. 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 is bewildering, therefore, Her ANA became positive and she developed autoimmune thyroid disease with a high TSH. 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. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001. (1997) 126(10):833-834. But death? and sudden infant death syndrome (SIDS). . SUNAGA Y, HIKIMA A, OSTUKA T, MORIKAWA A: Acute cerebellar ataxia with abnormal MRI lesions after varicella vaccination. Healthcare providers are required by law to report to VAERS: WASHINGTON, Jan. 28, 2021 /PRNewswire/ -- The primary mechanism for reporting adverse vaccine reactions in the U.S., the Vaccine Adverse Event Reporting System (VAERS), reported 181 deaths a . 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. can they dismiss placebo-controlled trials that raise serious POSER CM: Neurological Complications of Vaccinations. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. These statistics are, of course, patently false. (1986) 8(1):78-80. 20.8 per 100,000 person-years. Med. MATSUBARA K, NIGAMI H, HARIGAYA H, BABA K: Herpes zoster in a normal child after varicella vaccination. Online ahead of print. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. Nothing coming before or after even suggests what that number is based upon. It is the Vaccine Adverse Event Reporting System, commonly known as VAERS. 2003 Jan 24;52(1):1-24. We are constantly exposed to a wide variety of viral antigens that cause our immune system to develop antibodies against them. 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. . "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. It relies on people to submit reports of adverse reactions to vaccines; it doesnt actively look for them, as active surveillance systems do. 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.. By the sixth month post-vaccination, she was seen by a neurologist and a physiatrist. associated with RotaTeq would translate to an extra 4000 U.S. cases 2022 Nov;47(11):1789-1795. doi: 10.1111/jcpt.13767. Still, it's a good way to detect safety signals that weren't detected during premarket testing or clinical trials . 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. It is a statement of fact that there are over 3,000 reports of deaths in VAERS among people who received a Covid vaccine. (Pediatrics 111:448, 2003. Its basically against public health and any collective action to protect public health. The reason he is concerned is that this is in contrast to the last five flu seasons, over the course of which there have been 119 reports of deaths to VAERS among people who received a seasonal flu vaccine. 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. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. This may sound similar to another argument that many COVID-19 deaths in older adults are deaths that would have happened anyway. Vaccine (1999) 17(4):327-329. Nevertheless, VAERS rates have been estimated to represent 5% to 10% of the true figure of adverse reactions. 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. Acta. whether or not they believe the vaccination was the cause. Vaccine Adverse Event Reporting System (VAERS). NASERI A, GOOD WV, CUNNINGHAM ET JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination. 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. 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. True, someone did contact him to question it. She worked as a research coordinator in the infectious disease unit of a Medical School. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. 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. As Dr. Vincent Iannelli points out: Still, although reports to VAERS are underreported, they are almost certainly not underreported by as much as some folks believe. Peter Collignon and his colleagues do not exaggerate the problem of Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. S. S. Korsakova. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. 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. 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. Her CPK was elevated to 676. Clearly that Harvard study is where the gold is. VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. 2022 Harvard Political Review. Lastly, VAERS Vaccine gives information about the origin and type of vaccine. Share on Facebook, opens a new window It just states it as fact. We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. 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. Case D It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. What about the US and VAERS? Jpn. 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. Allergy Clin. (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. I fully expect that, just as soon as a COVID-19 vaccine is approved for use in children, antivaxxers will start claiming that the vaccine causes autism and SIDS. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. 10. The primary goals of VAERS is to detect new, unusual, or rare adverse events; monitor increases in known adverse events; Identify potential patient risk factors for particular types of adverse events; identify vaccine lots with increased numbers of types of adverse events; and assess the safety of newly licensed vaccines. During the same period about 88 million U.S. children passed through the 0-5 age group; (2003) 135(3):415-417. The report of an adverse event to VAERS is not documentation that a vaccine Voices for Vaccines, How I Went From Dressing Up As Measles to Hoping for My COVID Vaccines, April 28, 2021. At the end of the document is not a list of supporting citations, but only a list of publications by the organization on the topic of the automated adverse event reporting. Approximately two hours following vaccination, a transient welt developed at the injection site with a 3-inch line of lymphangitis. 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. Nine months later on March 10, 2004 he had a recurrence of shingles affecting the left nipple and the left side of the back. 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. government site. 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. 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. VAERS accepts all reports of suspected adverse events, in all age groups. So how are antivaxxers weaponizing VAERS? However, the CDC and FDA have never required the vaccine manufacturers to publicly divulge the number of vaccines contained in a given lot. While her lymphocytes decreased from 25 to 14%, her total white count, neutrophils and eosinophils increased. Prior research has shown that only a fraction of adverse events are. HAMMERSCHLAG MR, GERSHON AA, STEINBERG SP, CLARKE L, GELB LD: Herpes zoster in an adult recipient of live attenuated varicella vaccine. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. Her older brother reacted to all vaccinations and developed late-onset autism following his MMR. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. Read more at NPR. 15. 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. As Skeptical Raptor notes, it was due to a certificate error: The problem is the SSL certificate was generated for vaers.hhs.gov but he is going to http://www.vaers.hhs.gov. Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. In addition, even vaccine manufacturers have calculated at least a "fifty-fold underreporting of adverse events" on this system. 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." 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