The Vaccine Adverse Events Reporting System (VAERS) 2021 dataset is more than 15 times larger than that of 2020, accounting for 35% of all data in the VAERS system. Despite continued assurances of vaccine safety from regulatory and public health agencies, the dataset in the Centers for Disease Control and Prevention (CDC) VAERS database represents a material difference from any previous year in reported serious adverse events. CDC acknowledges serious adverse events (SAE) associated with the COVID-19 vaccines authorized and approved in the United States yet reminds all they are a rare occurrence. The CDC goes on the record that the serious adverse event reports in VAERS are not necessarily associated with COVID-19. Moreover, for a truly accurate comparison to previous years the total number of vaccines administered doses must be compared to previous year. For example, starting in 2021 the COVID-19 vaccination program represented the largest such mass vaccination in U.S. history with an unprecedented 547 million doses administered to date. Undoubtedly SAEs would increase with such a vast endeavor. But what’s an acceptable amount of SAEs — given risk-benefit analyses associated with the dangers of SARS-CoV-2—from over 900,000 deaths to anywhere from 10% to 30% experience long COVID?
TrialSite has followed the alarming cases of adverse events including deaths after the rollout of the COVID-19 vaccines. The CDC confirmed increasing reports of deaths in VAERS from COVID-19 vaccine recipients, though causality was not indicated. Of course, TrialSite reminds the reader of a catastrophic COVID-19 death count with over 5.8 deaths worldwide and over 943,000 in America alone. With growing problems with long COVID (representing anywhere from 10% to 30% of COVID-19 cases) the government’s risk-benefit calculus weighs far heavier on the benefit side of the equation—across the board even when applied to children.
Now both mRNA-based vaccines (Pfizer-BioNTech and Moderna) are formally approved by the U.S. Food and Drug Administration (FDA), yet the companies enjoy liability shields due to the PREP Act emergency declaration. Although POTUS mandates were mostly rejected by the U.S. Supreme Court, the one associated with Health and Human Services Centers for Medicare and Medicaid Services stands, as do many vaccination rules at the local level such as school district in Los Angeles.
The Data: High Level Observations
The VAERS system contains data submitted from 1990 to the present. With the release of COVID-19 vaccines in 2020, the VAERS database expanded at an unprecedented rate. Again, this correlates with the unprecedented number of COVID-19 vaccinations totaling 547 million doses and climbing.
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By the end of 2021, the new COVID-19 vaccines rose to the top with the highest number of adverse reports. The number of reported adverse reactions to COVID-19 vaccines exceeded the combined number of reactions to the next 12 vaccines.
TrialSite reviews VAERS data for the years 2020 and 2021 below.
Events reported in the VAERS 2020 and 2021 database
VAERS 2020VAERS 202120 vaccine manufacturers in VAERS database42 vaccine manufacturers in VAERS database60,224 adverse events reported1,884,520 adverse events reportedCOVID-19 vaccines were 2nd in position of reported adverse events and 6th position in reported deaths.COVID-19 vaccines were 1st in position of all reported adverse events and deaths. They had more reported events than the next seven vaccines combined.
There were 1,884,520 reported events in total across the 95 vaccine products in the 2021 database. Of these, the seven highest-ranking vaccine products accounted for 1,225,371 (65%) events reported. Data for these seven vaccines is displayed below.
Table 1: Vaccine products with highest number of adverse events reported in 2021
Vaccine Products 2021No. of events reported (Total: 1,884,520) Percentage COVID19 VACCINE (COVID-19)754,97151.23%ZOSTER VACCINE (VARZOS)98,6926.70%INFLUENZA VIRUS VACCINE, TRIVALENT (INJECTED) (FLU3(SEASONAL))93,3526.33%VARIVAX-VARICELLA VIRUS LIVE (VARCEL)80,1655.44%MEASLES, MUMPS AND RUBELLA VIRUS VACCINE, LIVE (MMR)77,4825.26%PNEUMOCOCCAL VACCINE, POLYVALENT (PPV)60,9784.14%HEPATITIS B VACCINE (HEP)59,7314.05%
Graph 1: Vaccine Products versus number of events reported 2021 database
The table and graph below show the 2020 VAERS reports of vaccine products and events.
Table 2: Vaccine products and number of events reported in 2020 VAERS database
Vaccine ProductNo. of events reported (Total 60,224)PercentageZOSTER VACCINE (VARZOS)12,77325.44%COVID19 VACCINE (COVID19)*10,90821.73%INFLUENZA VIRUS VACCINE, QUADRIVALENT (INJECTED) (FLU4(SEASONAL))6,56013.07%PNEUMOCOCCAL VACCINE, POLYVALENT (PPV)2,9555.89%INFLUENZA VIRUS VACCINE, NO BRAND NAME (FLUX(SEASONAL))2,3444.67%UNKNOWN VACCINES (UNK)1,8183.62%VARIVAX-VARICELLA VIRUS LIVE (VARCEL)1,6983.38%
The first COVID-19 vaccine authorized for emergency use in the United States, UK and Europe by the end of 2020.
Graph 2: Vaccine products versus number of events in the 2020 VAERS
Manufacturers and Number of Events
The number of vaccine manufacturers reported in the database more than doubled in one year between 2020 and 2021, from 20 to 42. The three manufacturers with the highest numbers of adverse events in 2021 were Merck, Moderna, and Pfizer-BioNTech.
Table 3: Vaccine manufacturers in 2021 with reported events
Vaccine ManufacturerNo. of events reportedPercentageMERCK & CO. INC.397,28126.96%MODERNA345,58823.45%PFIZER-BIONTECH343,23923.29%SANOFI PASTEUR203,50113.81%GLAXOSMITHKLINE BIOLOGICALS157,48710.69%PFIZER-WYETH116,8467.93%UNKNOWN MANUFACTURER88,9886.04%JANSSEN64,5064.38%NOVARTIS VACCINES AND DIAGNOSTICS33,5582.28%CONNAUGHT LABORATORIES32,8542.23%
Graph 3: Vaccine manufacturers and reported events 2021
The manufacturers with the highest number of events reported in 2020 were GlaxoSmithKline, Merck, and Pfizer-BioNTech. Moderna ranked sixth.
Table 4: Vaccine manufacturers with reported events 2020
Vaccine ManufacturersNo. of events reported 2020PercentageGLAXOSMITHKLINE BIOLOGICALS16,27732.42%MERCK & CO. INC.12,28424.47%PFIZER\BIONTECH7,74315.42%SANOFI PASTEUR7,65315.24%UNKNOWN MANUFACTURER4,9359.83%MODERNA3,1426.26%SEQIRUS, INC.2,8235.62%PFIZER\WYETH2,0434.07%NOVARTIS VACCINES AND DIAGNOSTICS1,2702.53%PROTEIN SCIENCES CORPORATION8541.70%
Graph 4: Vaccine manufacturers and reported events 2020
The database reveals that COVID-19 vaccines are associated with a vast expansion in VAERS data from 2020 to 2021—at least that’s how individuals are entering reports. However, as TrialSite has cautioned, health authorities, starting with the CDC, continue to declare that the SAE numbers aren’t necessarily linked to the COVID-19 vaccines. There is no causation and it’s often difficult to prove, especially when applying to individuals with comorbidities. In most of the deaths TrialSite has tracked federal investigators deny any proof of causation or even association.
CDC positions to the public that in relation to the over 547 million doses administered, any actual SAE remains an extremely rare event. Given the risk-benefit analysis inputs (e.g., risks associated with SARS-CoV-2 infections including growing incidence of long COVID) the government agency declares not only that the “COVID-19 vaccines are safe and effective” but also that CDC recommends “everyone ages 5 years older get vaccinated as soon as possible to protect against COVID-19 and its potentially severe complications.”
The CDC continues to assure that the vaccines are under rigorous ongoing scrutiny—“the most intense safety monitoring program in U.S. history. Thus, the national public health agency assures the entire American population that the risks of COVID-19 far outweigh any risks associated with the rare probability of a SAE associated with the COVID-19 vaccines. events. Some physicians critical of the public narrative worry about the longer term effects of multiple vaccine boosts. Study data for two doses, let alone three doses are still under way.