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. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. During the 18-year period from 1990 through 2007 just 88 cases of Kawasaki Disease in children under 5 were reported to VAERS. of underreporting varies widely. 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. Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. 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. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. One observation that Ive made about how antivaxxers have joined the COVID-19 cranks and conspiracy theorists and started casting doubt on COVID-19 vaccines is that everything old is new again. 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.. It relies on people to submit reports of adverse reactions to vaccines; it doesnt actively look for them, as active surveillance systems do. A federal agency seeking to disabuse citizens of the expectation that government health databases are accurate should be an indicator for the CDC that VAERS has a serious problem. What has been reported to VAERS is less than the expected baseline death rate in the US for any given day pre-pandemic (the death figures used were for the year 2019). Two months later on May 13, 2004 he had still another recurrence with moderate pain, in the same location as previously mentioned. 2016 Aug 17;34(37):4406-14. doi: 10.1016/j.vaccine.2016.07.019. Paediatr. 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). (27.2.23) Die dunklen Seiten von grnen Technologien - Seit 2020 sind die Preise fr kritische Rohstoffe rapide angestiegen und halten sich seit Ende 2022 auf hohem Niveau. Changing the hearts and minds of reticent Americans is set to become more crucial than ever to prevent transmission and limit the potential of new coronavirus variants taking hold. (1999) 127(6):733-734. 284 0 obj <> endobj COVID-19 Vaccines and Myopericarditis: A Nuanced Story. official website and that any information you provide is encrypted Image by Mat Napo is licensed under the Unsplash License. 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. 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? Her skin sensitivity also became more intense. NASERI A, GOOD WV, CUNNINGHAM ET JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the CDC had yet to respond to multiple requests to partner for this activity. 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. Mercolas reference #7 is superfluous, because it also references #6. Am. 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. So far, only the Pfizer and Moderna vaccines have been granted Emergency Use Authorization in the U.S. by the U.S. Food and Drug Administration (FDA). Reference to the Harvard study regarding the 1% figure adds legitimacy it doesnt deserve. and nurses do not know about VAERS and what is required to be reported. 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." Vaers records 321 cases of myocarditis within five days of receiving a vaccination, falling to almost zero by 10 days. These statistics are, of course, patently false. The estimated underreporting factor for COVID jab . Case C months old, when suspicion for vaccine adverse effects should be It is the Vaccine Adverse Event. The coding of VAERS reports requires careful interpretation. The US Vaccine Adverse Event Reporting System (VAERS) is "overwhelmed" with reports of vaccine adverse effects in the wake of the COVID-19 vaccination campaign, cardiologist Dr. Peter. . 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. What about the US and VAERS? 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. An official website of the United States government. Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. Spoiler alert: Excess mortality during the pandemic has been VERY high. If anyone can find one or several citations that actually seek to quantify VAERS underreporting, please send me a note. (1993) 35(4):345-347. VAERS reports can be submitted voluntarily by anyone, including healthcare This provides a useful policy contrast to the unfettered publication of unverified claims by the U.S. CDC and FDA. Copyright The President and Fellows of Harvard College, Administration for Children and Families Database, Harvard T.H. 9. He had moderate pain and the lesions were tender and sensitive to clothing. consequently the incidence rate reported to VAERS was 0.10 KD cases per health to other vaccines and other serious clinical problems. The Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting. No competing interests, Copyright 2023 BMJ Publishing Group Ltd, Womens, childrens & adolescents health. VAERS is a government database managed by the Centers for Disease. Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. in young children. 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. Im. . 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. Then, with respect to antivaccine disinformation, truly everything old will be new again. The average age of those who died was 76.5. Her physician reassured her by saying: Do you think I would give the vaccination to my own children if I thought it wasn't safe? Her physician also informed her that state law mandates chickenpox vaccination but never told her that she could withhold her consent. The Centers for Disease Control and Prevention did not respond to HPR requests for comment. A quote from the in-question Harvard Pilgrim Health Care, Inc. study: "Adverse events from drugs and vaccines are common, but underreported. way the data are used by public health officials and the vaccine industry 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. First, lets get back to the question of the denominator. Facebook and Instagram announced earlier this year they would take steps to ban the spreading of vaccine misinformation on their platforms. 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. J. Ophthalmol. Data are updated on a monthly basis. And of course my favorite example is the VAERS excess deaths. The second is: What is the baseline rate for such adverse events in the population studied? 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. 2006 the published KD incidence for U.S. children under 5 rose from 11.0 It was the waiting that drew the attention of the Stockholm County Council. sharing sensitive information, make sure youre on a federal During the same period about 88 million U.S. children passed through the 0-5 age group; 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. 4. associated with RotaTeq would translate to an extra 4000 U.S. cases Each of the three occurrences of the shingles rash was on his left side. VAERS accepts all reports without judging whether the event was caused by the vaccine. 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. 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. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. 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. From your lips to QAnon's ears.. providers, patients, or family members. Her pre-study laboratory values were completely normal. Case E Additionally, the senators said the COVID-19 tests used by . There is another story being missed regarding that Harvard Pilgrim study, though. 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*. Links to VAERS are included. Overview of the ESP:VAERS project . VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirmation can be made that an adverse event was linked to a vaccine. 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. annually He remains permanently disabled. Am. Paediatr. VAERS accepts all reports without judging whether the event was caused by the vaccine. 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. 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. Re: Singh etal. 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. hbbd``b`$Oo@UHYWY 0 I Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. Would you like email updates of new search results? Thats 1.3/100,000. Children's deaths of any kind are rare, researchers noted. Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation. (2001) 154(2):161-165. The .gov means its official. 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. Eight days after vaccination, she developed a fever, sore throat, nausea, vomiting, malaise and dizziness. J Pers Med. She worked as a research coordinator in the infectious disease unit of a Medical School. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). J. Pediatr. So how are antivaxxers weaponizing 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. 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. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. trial that found a 5-fold KD risk associated with RotaTeq--RR=4.9; 95% CI 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 . 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. 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. They also allow users to verify that they are connected to the real web site, rather than a hackers web site. He received a third course of Acyclovir and the rash resolved after a month. The VAERS dataset also appears to be immune from Facebooks anti-misinformation protocols and remains a prominent feature of the anti-vaccine campaigning repertoire. 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. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. Reports of all possible associations between vaccines and adverse events (possible side Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . The VAERS dataset was created to manage reports of vaccine-associated side effects. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. 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. As with all antivax talking points, its meant to deceive. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. It simply contains whatever people have voluntarily reported. She received a first dose of the vaccine in March and the second in May 2001. Both thought that she could have Guillian-barre syndrome. A certain number of 80+ year olds die every day. 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 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). Universal Varicella Vaccination program assumptions that (1) a single dose offered long-term immunity, and (2) there is no immunologically-mediated link between varicella incidence and herpes-zoster incidence are seriously flawed. This, of course, is intended to increase reporting of adverse events to VAERS. The U.S. Epub 2022 Sep 11. 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. Pediatrics POSER CM: Neurological Complications of Vaccinations. At this age, infants are at greatest risk for certain medical adverse events, including high fevers, seizures, it varies but in the past 4 weeks, about 0.9-1 per 100k *per day* pic.twitter.com/NVz2MXmFIx. Control and Prevention did not respond to HPR requests for comment to antivaccine disinformation, truly everything old be... 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