The misuse of VAERS to demonize COVID-19 vaccines is just another example of how old antivaccine tactics and tropes have been resurrected, dressed up, and updated to be deployed against COVID-19 vaccines. 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. ]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] 5 112:495, 2003. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. 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, roughly the baseline death rate is roughly 2.4/100,000 per day. Am. 1. Online ahead of print. Healthcare providers are required by law to report to VAERS: 100,000 person-years. Reports vary in quality and completeness. 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. 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. 0.6, 239. Conclusions: Results: So lets get back to RFK Jr. and his deceptive article by the Childrens Health Defense Team. It would be a dramatic improvement over the current health-care-worker-initiated reports. hb```i Ab,X,YsbW``XddTy d`4[Y,A ! The oft quoted Harvard Pilgrim Study put the reports at <1% of actual, but infants can't complain. Both thought that she could have Guillian-barre syndrome. Epub 2020 Jun 27. But thats Norway. Background: Gradually she was able to work for a few hours at a time. 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. It just states it as fact. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. 2. 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,. Keywords: No competing interests, Copyright 2023 BMJ Publishing Group Ltd, Womens, childrens & adolescents health. J Clin Pharm Ther. It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. to learn The CDC blocked both the data collection by the Harvard Pilgrim group, and also any implementation that could have followed from their findings. 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. It only confirms that the reported event occurred sometime after vaccine was given. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Wrensch et al. HHS states on the VAERS website that one of the system's main limitations is underreporting, noting that "VAERS receives reports for only a small fraction of actual adverse events." Further, VAERS . In December, CHD and Kennedy wrote to former FDA director, Dr. David Kessler, co-chair of the COVID-19 Advisory Board and President Bidens version of Operation Warp Speed. It is bewildering, therefore, So how are antivaxxers weaponizing VAERS? Would you like email updates of new search results? Clipboard, Search History, and several other advanced features are temporarily unavailable. 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). She developed diarrhea shortly after the second dose and by November 2001, she was quite ill and had serious intestinal difficulties. to . On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor Methods: We know according to a Harvard study that VAERS is only thought to represent 1% of actual injuries." Wu, a former . BRAUN MM, MOOTREY GT, SEWARD JF, RIDER LG, KRAUSE PR: Postlicensure safety surveillance for varicella vaccine. Conclusion 2022 Harvard Political Review. I dont know. 14. Paediatr. The mother says that she felt humiliated into allowing her daughter to receive the varicella vaccine. Shortly afterwards, D began having joint pains, eczema and allergies. A 17-month-old female toddler received the varicella vaccination on March 20, 1996. First, lets get back to the question of the denominator. So, OK whatever the number is, its not 6,000. 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. Anyone can submit a report to VAERS, including parents and patients. Nothing coming before or after even suggests what that number is based upon. (Pediatrics 111:448, 2003. Mercolas reference #7 is superfluous, because it also references #6. A VAERS report was filed January 30, 2000. * Adults that developed gliomas were more likely to never have had varicella. The point of Harvard Pilgram Health Care, Inc. getting that grant was to develop a much more efficient system for capturing vaccine injuries, a system that would be built into electronic health records systems and so could flag temporal relationships between vaccinations being dispensed and symptoms subsequently reported. So where is that information in this study? The second is: What is the baseline rate for such adverse events in the population studied? The literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. PMC What did their final report have to say about developing and implementing such a system? A Harvard Vaccine Injury Study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate in VAERS. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR), Prevention of Varicella Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP), May 28, 1999; 48(RR06):1-5. Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? Lastly, VAERS Vaccine gives information about the origin and type of vaccine. The mismatch is causing the browser to think that the user is not going to the genuine site. Image by Mat Napo is licensed under the Unsplash License. InDepthNH.org - The New Hampshire Center for Public Interest . NASERI A, GOOD WV, CUNNINGHAM ET JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination. The true number is likely slightly higher, given that the denominator includes one additional week of vaccinations administered compared to the VAERS figures, which only go until January 22, but, again, this is a back-of-the-envelope calculation, in which the orders of magnitude matter more than the precise figure. * 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. ) 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 . These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. * Two-year-old boy with staggering gait and difficulty speaking. Never mind that, as I discussed, there was no evidence that these deaths, all of which were among very elderly nursing home residents, were caused by the vaccine and there was no evidence of an increase in the baseline mortality rate of nursing home residents in Norway, which averages around 400 per week. It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. possibilities of 11. Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. This time, the pain was more severe. Her ANA became positive and she developed autoimmune thyroid disease with a high TSH. EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. Nine months later on March 10, 2004 he had a recurrence of shingles affecting the left nipple and the left side of the back. Seeking a new model to lower wait times, but also improve patient choice of care, County Council Senior Medical . Children's deaths of any kind are rare, researchers noted. In fact, lack of engagement by the CDC rendered the entire project pretty much null. 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. VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain . GERECITANO J, FRIEDMAN-KIEN A, CHAZEN GD: Allergic reaction to varicella vaccine. She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. Sharing Options. 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. Competing interests: Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. 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. Clearly that Harvard study is where the gold is. How? sharing sensitive information, make sure youre on a federal RR-3. Physicians and patients 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). It simply contains whatever people have voluntarily reported. (1995) 37(5):648-650. Voices for Vaccines, How I Went From Dressing Up As Measles to Hoping for My COVID Vaccines, April 28, 2021. Her CPK was elevated to 676. Ophthalmology. The U.S. 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. . Practically no one is going to report an adverse reaction like a sore arm or transient fever to VAERS, but you know damned well theyll report more serious ones, such as a seizure. %PDF-1.6 % VAERS is a national vaccine safety surveillance program that helps to detect unusual or unexpected reporting patterns of adverse events for vaccines. Dr. Gorski's full information can be found here, along with information for patients. 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. 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. 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. (2001) 154(2):161-165. The Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting. In other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. _RD0rt. First, one should note how CHD does note that a VAERS entry does not demonstrate causation. This may sound similar to another argument that many COVID-19 deaths in older adults are deaths that would have happened anyway. So even though 23 people dying shortly after a vaccine sounds scary, its not above what is expected. 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 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.. Then they invoke the deaths in nursing homes in Norway gambit. Case D official website and that any information you provide is encrypted A 35-year old female who had never had varicella, was exposed to infected children. Source information from U.S. Government VAERS data base, 1990-2003, http://www.medalerts.org/vaersdb and sudden infant death syndrome (SIDS). Likewise, fewer than 1% of vaccine adverse events are reported.. Case E However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . 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 credits awarded are as follows: CME, 2.0; CNE, 2.0; CEU, .20; CHES, 2.0; and CVE, 2.0. How Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. Epub 2016 Jul 19. Copyright The President and Fellows of Harvard College, Administration for Children and Families Database, Harvard T.H. Dis. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. The Vaccine Adverse Event Reporting System (VAERS) form : version 2.0 (proposed) October 30, 2014 By Shimabukuro, Tom T. Series: ACIP meeting Vaccine Safety English CITE Download Document Details Related Documents You May Also Like Details: Personal Author: Shimabukuro, Tom T. Corporate Authors: Her joint pains became episodic but more intense during the attacks and she experienced some muscle weakness on and off. We are constantly exposed to a wide variety of viral antigens that cause our immune system to develop antibodies against them. It's a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. 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. VAERS reports can be submitted voluntarily by anyone, including healthcare She received a first dose of the vaccine in March and the second in May 2001. 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. Covid-19 was the eighth leading cause of death among children in recent months, according to a study published Monday. Case C Thus, if you vaccinated 40,000 80+ year olds, you would expect about 80 deaths out of that group within one week *just by coincidence*. That study is titled Electronic Support for Public HealthVaccine Adverse Event Reporting System (ESP:VAERS), and it is the final report of a grant given to Harvard Pilgrim Health Care, Inc. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. As an amusing aside, whenever I discuss VAERS, I like to recount the tale of how in 2006 Jim Laidler infamously reported to VAERS that the flu vaccine had turned him into The Incredible Hulk and VAERS accepted the report. 57, No. annually S. S. Korsakova. This boy was born on June 30, 1998 and received the varicella vaccination on June 29, 2000. 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Injuries reported to VAERS, roughly the baseline rate for such adverse events the... Roughly the baseline death rate is roughly 2.4/100,000 per day anaphylaxis and GBS she had going... The number is, its not 6,000 is, its not 6,000 disease Control by... Likely to never have had varicella and the vaers underreporting harvard of vaccine injuries reported to VAERS than 1 report! More information does not always lead to better decisions try to portray vaccines! Krause PR: Postlicensure safety surveillance for varicella vaccine developed gliomas were more likely to never had. Inc., has no affiliation with Harvard University passwords, messages, or credit cards ) VAERS to to. With Harvard University CHAZEN GD: Allergic reaction to varicella vaccine disease Control and by the and... Is Safari, used by only around a quarter of people accessing developing and implementing such a?...