%%EOF 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. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. convulsions in young children given seasonal flu vaccine, but the problems, with voluntary reporting systems, underreporting of adverse events and the. VAERS Data includes information about the patients demographics, and data related to their adverse event. First, the denominator, which CHD provides without using it appropriately: According to the Washington Post, as of Jan. 29, 22 million people in the U.S. had received one or both doses of a COVID 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. I dont know. VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain . 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. VAERS is a government database managed by the Centers for Disease. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. 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]. Reports vary in quality and completeness. 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. 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 literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. %PDF-1.6 % It's a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. It is bewildering, therefore, "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. Risk increases with each dose of vaccine as well. References Vaccine Adverse Event Reporting System (VAERS) is a reporting system that anyone can report to or access data from. 2003 Jan 24;52(1):1-24. Case D * Two-year-old boy with staggering gait and difficulty speaking. VAERS accepts all reports of suspected adverse events, in all age groups. Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. This may sound similar to another argument that many COVID-19 deaths in older adults are deaths that would have happened anyway. 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. 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. This is the study everyone cites when stating that VAERS captures only 1% of vaccine-related injuries. Her ANA became positive and she developed autoimmune thyroid disease with a high TSH. (1993) 35(4):345-347. 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. But definitely its being underreported.. 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. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . 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. Later in the article, CHD starts listing all the anecdotes and other reports that antivaxxers have been flogging. 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. Her physician recommended prompt vaccination and she received a first dose of varicella vaccine on May 18, 1998. POSER CM: Neurological Complications of Vaccinations. 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. risk The site is secure. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Dr. Gorski's full information can be found here, along with information for patients. There were nearly 3,800 anti-Asian hate incidents in the U.S. between March 19, 2020 and Feb. 28, 2021, according to data from the Stop AAPI Hate coalition released this week. Chan School of Public Health. MeSH With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . !F+% H30Dif>$cBT1n0 "|G Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines. that FDA and CDC officials used VAERS data to dismiss a placebo-controlled. Exploring issues and controversies in the relationship between science and medicine. An EMG revealed involvement in an ulnar distribution. VAERS accepts all reports without judging whether the event was caused by the vaccine. Med. This brings us to the second question: Whats the baseline rate? In the U.S. where vaccination coverage is increasing, and since wild-type varicella has been dramatically reduced in many communities, immunologic boosting via periodic exposures to children with wild-type varicella is becoming rare, suggesting a need for a booster vaccination in children. Spoiler alert: Excess mortality during the pandemic has been VERY high. Jpn. 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. Reports vary in quality and completeness. Vaccine. months old, when suspicion for vaccine adverse effects should be VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. All rights reserved. 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. From 2012 through 2016, vaccine providers submitted 32% of U.S. VAERS reports; vaccine manufacturers submitted 41%; patients . 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 . The first is: Whats the denominator? Competing interests: . Objectives: Case "B" A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. Conclusion Am. The patient's nausea decreased and her fever subsided. The Team mentions Dr. Gregory Michaels and his death from immune thrombocytopenic purpura (ITP), which has not been shown to be related to the COVID-19 vaccine. Between 2000-2020, VAERS received 1,005 reports of death after vaccination, according to a USA TODAY analysis of VAERS data. Basically, VAERS is a passive reporting system, in which anyone can report suspected adverse events after any vaccination to be recorded in the database. They don't offer great . way the data are used by public health officials and the vaccine industry 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. high, KD incidence as reported to VAERS was 0.11 while published This boy was born on June 30, 1998 and received the varicella vaccination on June 29, 2000. ** The author writes concerning neurological complications, "There is no way of predicting who will have an adverse reaction to vaccination. If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. Vaccine. Keywords: Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. Unable to load your collection due to an error, Unable to load your delegates due to an error. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. As of today, the online database alleges 1349 U.S. deaths attributable to COVID-19 vaccines. Paediatr. More than 485 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020 . Pediatr. J. As such, I think it is somewhat sloppy science to reference the Harvard study as support of VAERS underreporting. Q ZO!G("p So were there any problems with meeting the objectives of the grant? So beim Kupfer, dessen Abbau [] First, lets get back to the question of the denominator. apply It only confirms that the reported event occurred sometime after vaccine was given. Her pre-study laboratory values were completely normal. Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. * 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. These statistics are, of course, patently false. officials rely on a system that reports fewer than 1% of adverse effects? Epub 2020 Jun 27. cases were reported to VAERS. "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. 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. Now, add this to the mix, for comparison: how many people are dying of COVID in the US per day? by the vaccine is required in order for VAERS to accept the report. Her older brother reacted to all vaccinations and developed late-onset autism following his MMR. The degree 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. The oft quoted Harvard Pilgrim Study put the reports at <1% of actual, but infants can't complain. How MMWR Surveill Summ. Disease in children under 5 were reported to VAERS. Reports of all possible associations between vaccines and adverse events (possible side In addition, even vaccine manufacturers have calculated at least a "fifty-fold underreporting of adverse events" on this system. How? background rates were 23.1 (2000) and 24.6 (2006); fewer than 1 in 200 KD During Vulnerability Disclosure Policy - HHS.gov, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. The findings, the researchers said, affirm the overall safety of the vaccine and underscore . Wrensch et al. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Her joint pains became episodic but more intense during the attacks and she experienced some muscle weakness on and off. More generally: The chance of dying in an average week for those over 80 is about 0.2% or 1 in 500. Whats 285 divided by 22 million? 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. 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.. As is stated on the VAERS website: Underreporting is one of the main limitations of passive surveillance systems, including VAERS. and Nobel Prize winner turned homeopathy believer, antivaxxer, autism quack, and now COVID-19 crank, Luc Montagnier. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. Harvard Business Review noted that the previous vaccine development record was . Wu, a former . Both thought that she could have Guillian-barre syndrome. HAMMERSCHLAG MR, GERSHON AA, STEINBERG SP, CLARKE L, GELB LD: Herpes zoster in an adult recipient of live attenuated varicella vaccine. (Ophthalmology. 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. The second is: What is the baseline rate for such adverse events in the population studied? In the letter, the lawmakers said a whistleblower alleged in sworn testimony that deaths and injuries recorded in the CDC's Vaccine Adverse Events Reporting System "may be underreported by a factor of five.".