This boy was born on June 30, 1998 and received the varicella vaccination on June 29, 2000. 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. Vaccine. 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. 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. According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. Ophthalmology. VAERS accepts all reports of suspected adverse events, in all age groups. of underreporting varies widely. As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. And the CDCs role in the dissemination of vaccine misinformation, unwilling though it may be, is attracting increasing scrutiny as it jeopardises what President Biden calls his administrations most important battle: the global coronavirus vaccine rollout. Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. 2006 the published KD incidence for U.S. children under 5 rose from 11.0 Epub 2021 Feb 23. %PDF-1.6 % 1. Many physicians consider vaccination extremely safe and parents or patients are not provided with information regarding potential adverse outcomes. Conclusions: 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. This, of course, is intended to increase reporting of adverse events to VAERS. VAERS, Report an Adverse Event, accessed April 9, 2021. (1986) 8(1):78-80. Conclusion to During No, seriously, look at the stupidity on display here: For over three weeks, the website of the US government Vaccination Adverse Reporting System (VAERS) has been inaccessible to most users. Basically, VAERS is a passive reporting system, in which anyone can report suspected adverse events after any vaccination to be recorded in the database. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. Symptoms represent the medical condition (s) in the adverse event description and lab data from the VAERS Report Form. It is a statement of fact that there are over 3,000 reports of deaths in VAERS among people who received a Covid vaccine. Read more at NPR. Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. Her pre-study laboratory values were completely normal. Mercolas reference #7 is superfluous, because it also references #6. 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]. Sensitivity was reported as either a single value, or a range if data were available from >1 study. 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. 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. 300 0 obj <>stream 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. During the same Both thought that she could have Guillian-barre syndrome. If confirmed by a larger trial, the KD !F+% H30Dif>$cBT1n0 "|G 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. Her joint pains became episodic but more intense during the attacks and she experienced some muscle weakness on and off. She remains disabled and out of work and the event has been reported to VAERS. Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? Im. The https:// ensures that you are connecting to the 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. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. 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. This prevents researchers from determining "hot lots" since calculation of the number of adverse reactions per lot is not possible. vaccinedeathreport - Read online for free. It simply contains whatever people have voluntarily reported. Her physician recommended prompt vaccination and she received a first dose of varicella vaccine on May 18, 1998. Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. between Harvard and Constella. risk 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. event underreporting. Epub 2020 Jun 27. It just states it as fact. Clipboard, Search History, and several other advanced features are temporarily unavailable. Bethesda, MD 20894, Web Policies 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. She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. apply On any given 12-hour shift, I am seeing patients be admitted to the ICU within days or weeks of receiving the vaccines after suffering . J. Epidem. What about the US and VAERS? 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.. Links to VAERS are included. The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. But definitely its being underreported.. This 3.5-year-old boy from Georgia who had no pre-existing conditions, received a dose of varicella vaccine on May 12, 1995. the voluntary system used in the U.S. to signal vaccine side effects. It is the Vaccine Adverse Event. 112:495, 2003. 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. 7. 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. She worked as a research coordinator in the infectious disease unit of a Medical School. 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. VAERS is a national vaccine safety surveillance program that helps to detect unusual or unexpected reporting patterns of adverse events for vaccines. VAERS accepts all reports without judging whether the event was caused by the vaccine. Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. 57, No. RAVKINA LI, MATSEVICH GR: Morphological changes in the central nervous system in post-vaccinal encephalomyelitis developing after chickenpox vaccination in children. annually This is the study everyone cites when stating that VAERS captures only 1% of vaccine-related injuries. (1993) 35(4):345-347. Im referring, of course, to antivaxxers resurrecting old antivaccine tropes, dusting them off, and updating them for the age of COVID. and Nobel Prize winner turned homeopathy believer, antivaxxer, autism quack, and now COVID-19 crank, Luc Montagnier. 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. 9. So, OK whatever the number is, its not 6,000. Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. The Centers for Disease Control and Prevention released new data showing that a total of 965,843 adverse event reports following COVID vaccines were submitted between December 14, 2020, and December 10, 2021, to the Vaccine Adverse Event Reporting System (VAERS). 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. (1999) 127(6):733-734. The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. 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. So where is that information in this study? FOIA 290 0 obj <>/Filter/FlateDecode/ID[<2DFFE8CD87B0A54688B7A1A0039905EB>]/Index[284 17]/Info 283 0 R/Length 53/Prev 85940/Root 285 0 R/Size 301/Type/XRef/W[1 2 1]>>stream However, the CDC and FDA have never required the vaccine manufacturers to publicly divulge the number of vaccines contained in a given lot. The patient's nausea decreased and her fever subsided. 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. I dont know. By the sixth month post-vaccination, she was seen by a neurologist and a physiatrist. Pediatr. Q ZO!G("p VAERS is a publicly available, searchable database of reports that have not been verified. A Progressive Facade: Comparing the U.S. and Canadas Treatment of Indigenous Peoples, Bringing Down the Worlds Largest Heist: Interview with Clare Rewcastle Brown, Australian PM Details Trump Relationship, Says Obama Called Him a Lunatic. (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. How can there possibly be over 16,000 reported in VAERS if nothing is going on? The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Vulnerability Disclosure Policy - HHS.gov, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. As is stated on the VAERS website: Underreporting is one of the main limitations of passive surveillance systems, including VAERS. As I like to say, the greatest strength of VAERS is that anyone can report anything to it, but simultaneously the greatest weakness of VAERS is that anyone can report anything to it. Signals and trends of Guillain-Barr syndrome after the introduction of live-attenuated vaccines for influenza in the US and South Korean adverse event reporting systems. 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. Your connection is not private, it says in large font on my screen (fig 1). * 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 defined reporting sensitivity as the VAERS reporting rate divided by the VSD incidence rate. 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. It is bewildering, therefore, 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. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. . 100,000 person-years. Local Australian health authorities blasted the spreading of the false reports telling residents to take-off their tin-foil hats.. 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: 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 . Allergy Clin. J. Ophthalmol. It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. 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. He developed convulsions the following day, was hospitalized, and reportedly recovered. consequently the incidence rate reported to VAERS was 0.10 KD cases per 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. 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. She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. Maintained/created by: Centers for Disease Control, Food and Drug AdministrationWebsite: http://vaers.hhs.gov/data/indexGeographic unit of data: U.S National, U.S. State, Keywords: adverse event, CDC, FDA, Reporting, side effects, vaccination, vaccine, Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. Then, with respect to antivaccine disinformation, truly everything old will be new again. it varies but in the past 4 weeks, about 0.9-1 per 100k *per day* pic.twitter.com/NVz2MXmFIx. %%EOF Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019. 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. 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. 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. 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. Quite the vaccine. VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain . Jpn. Psikhiatr. 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. The literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. Here is the statement, with a bit of context: Adverse events from drugs and vaccines are common, but underreported. Background: 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. 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]." (1989) 160(3):535-537. 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. An HPR Keyhole analysis of social media indicates that over a 24-hour period in March, an expected 350,000 people had viewed or interacted with anti-vaccine information originating from the VAERS database. 8600 Rockville Pike 2023;130: S0161-6420(22)00672-8. doi: 10.1016/j.ophtha.2022.08.027. 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. (2001) 154(2):161-165. 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. In a yearlong period from August 2021 to July 2022, 821 children ages 0 to 19 died from covid-19 at a rate of 1 per 100,000. Her skin sensitivity also became more intense. So even though 23 people dying shortly after a vaccine sounds scary, its not above what is expected. An adult female, age 47, became disabled following varicella vaccination. Indeed, Facebook posts seen by the HPR with hundreds of engagements include the same verbatim instructions, copy and pasted, for users to disregard disclaimers. 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,. Competing interests: These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination. Exogenous exposures to wild type varicella have previously contributed a significant immunologic boosting effect that helps suppress the reactivation of herpes-zoster. Immonol. 2021 May;30(5):602-609. doi: 10.1002/pds.5196. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. Thats 1.3/100,000. Copyright The President and Fellows of Harvard College, Administration for Children and Families Database, Harvard T.H. Dis. It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. Data are updated on a monthly basis. On June 12, 2003 (age 5), he had a unilateral shingles eruption on the back of his neck. It would be a dramatic improvement over the current health-care-worker-initiated reports. Disease in children under 5 were reported to VAERS. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. Would you like email updates of new search results? Dr. Gorski's full information can be found here, along with information for patients. All narrative text taken from original VAERS reports are classified with Medical Dictionary for Regulatory Activities (MedDRA) concepts. Unsurprisingly, RFK Jr. fails to mention that the BMJ article to which he refers is a BMJ Rapid Response, which is basically a comment section that is not peer-reviewed that cranks love to use to post their ramblings and then cite them as though they were legitimate articles in The BMJ. Published online ahead of print). So, the actual number of serious injuries and deaths is likely 10 to 100 times higher. The lot number associated with each vaccine is recorded in the VAERS data base.
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