Serious Adverse Events and Death Reports for Major COVID Vaccines Increase on VAERS

Serious Adverse Events and Death Reports for Major COVID Vaccines Increase on VAERS
A COVID-19 vaccine is prepared in a file image. (Stephen Zenner/Getty Images)
12/12/2022
Updated:
12/12/2022
According to the Vaccine Adverse Event Reporting System (VAERS), as of Dec. 2, 2022, a total of 906,544 adverse events had been reported regarding all approved COVID-19 vaccines in the United States, including 15,584 deaths.
These COVID-19 vaccines have led to more adverse event reports in the VAERS system than all reports made in the past three decades. Specifically, the number of COVID-19 vaccine-related deaths has exceeded 55 percent of all VAERS vaccine death reports.
Unfortunately, due to various issues, including underreporting, the actual numbers of different adverse events may far exceed the numbers shown in the VAERS system.

Anyone Can Report to the VAERS System

Initiated in 1990, the VAERS system is an outgrowth of the 1986 National Childhood Vaccine Injury Act (NCVIA). As America’s monitoring and early warning system of vaccine safety, VAERS is jointly managed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). 
As VAERS reports do provide the U.S. health authorities important information about vaccine-related health problems, the CDC and FDA monitor the system regularly, and they analyze and investigate specific cases to take necessary actions, if any.  
Anyone, such as vaccine recipients, vaccine recipients’ parents/guardians, medical professionals, vaccine manufacturers, and the general republic, can submit a report on vaccine adverse events to the VAERS system, whether they are mild or serious. However, VAERS cannot prove the causality between a vaccine and an adverse event. 
Serious vaccine adverse events may include emergency room visits, deaths, life-threatening side effects, permanent disability, birth defects, and hospitalizations. And for the purpose of this article, all of these adverse events are examined with regards to specific vaccines. 

Limitations of VAERS

The VAERS system has its limitations, including the serious issue of underreporting. According to the Harvard Pilgrim Health Care study conducted from 2005 to 2009, after the administration of 1.4 million vaccines, only less than 1 percent of adverse events had been reported to the VAERS system. In addition, several independent analysts have estimated that only 2.5 percent of COVID vaccine adverse reactions are reported to VAERS.
Another problem that has been plaguing the reporting system is its redundancy. Specifically, one adverse event may have different names. For instance, injection site pain and vaccine site pain are entered into the system as separate symptoms; and a person reporting the problem may select both symptoms. 
In addition, a study published in the journal Vaccine discovered that people are more likely to report more serious adverse events. 
Furthermore, according to a peer-reviewed study published in October 2021 by Canadian molecular biologist Jessica Rose regarding the VAERS system, due to constant updates and some data not being entered on time, the system has a backlog issue. 
A more troubling issue had also been discovered by Rose’s study. That is, some COVID-19 adverse reports had been removed from the VAERS system without explanation, including 1,516 reports removed between Dec. 17, 2020 to Aug. 6, 2021. As of October 2021, when her study was published, the number of removed VAERS reports on COVID-19 vaccines accounted for 0.4 percent of all VAERS adverse events, as identified by their VAERS IDs. 
At present, there are four COVID-19 vaccines for primary series, and two more bivalent vaccines used as boosters. 

Pfizer–BioNTech COVID-19 Vaccine

Marketed under the brand name Comirnaty, the Pfizer-BioNTech COVID-19 vaccine is produced by German company BioNTech. 
On Dec. 11, 2020, the FDA issued an emergency use authorization (EUA) for the vaccine. The next day, the CDC recommended the vaccine to be used for individuals aged 16 years and older. 
On Aug. 23, 2021, the FDA approved the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years old and older. Thus, the Pfizer-BioNTech COVID-19 vaccine became the first FDA-approved COVID-19 vaccine. Later, the FDA amended the EUA issued for the vaccine, to expand the population approved to receive this vaccine to include individuals over the age of 6 months old. 
On Aug. 31, 2022, the FDA amended the EUA of the Pfizer-BioNTech COVID-19 vaccine to authorize its bivalent vaccine (i.e. “updated booster”) for use as a single booster dose. 
  • VAERS adverse event report numbers: According to VAERS, as of Dec. 2, 2022, a total of 415,244 adverse events had been reported regarding the monovalent Pfizer-BioNTech COVID-19 vaccine, including 47,668 serious adverse events and 7,038 deaths (which are part of the serious adverse events).
  • Vaccine administration number: As per Our World in Data, by Nov. 30, 2022, 390.01 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered in the United States, making it the most used COVID-19 vaccine in the country.
  • Currently approved dosage: Regarding the monovalent Pfizer-BioNTech COVID-19 vaccine, the currently approved dosage is two doses for its primary series. The CDC also recommends the use of the vaccine as a booster for people who have completed their primary series. If someone receives one booster dose, it is his or her third dose overall; if he or she receives a second booster dose, then it is his or her fourth dose. 
The bivalent Pfizer-BioNTech COVID-19 vaccine was later recommended by the CDC for use as an updated booster dose.

Moderna COVID-19 Vaccine

Marketed under the brand name Spikevax, the Moderna COVID-19 vaccine is produced by American company Moderna. On Dec. 18, 2020, the FDA issued an EUA for the vaccine to be used for individuals aged 18 years and older. 
On Jan. 31, 2022, the FDA approved the use of the Moderna COVID-19 vaccine in people 18 years old and older. Later, the FDA amended the EUA issued for the vaccine, to expand the population approved to receive this vaccine to include individuals over the age of 6 months old. 
On Aug. 31, 2022, the FDA amended the EUA of the Moderna COVID-19 vaccine to authorize its bivalent vaccine for use as a booster dose. 
  • VAERS adverse event report numbers: According to VAERS, as of Dec. 2, 2022, a total of 409,195 adverse events had been reported regarding the monovalent Moderna COVID-19 vaccine, including 37,704 serious adverse events and 6,615 deaths.
  • Vaccine administration number: As per Our World in Data, by Nov. 30, 2022, 245.51 million doses of the Moderna COVID-19 vaccine had been administered in the United States.
  • Currently approved dosage: Regarding the monovalent Moderna COVID-19 vaccine, the currently approved dosage is two doses for its primary series. The CDC also recommends the use of the vaccine as a booster for people who have completed their primary series. If someone receives one booster dose, it is his or her third dose overall; if he or she receives a second booster dose, then it is his or her fourth dose. 
The bivalent Moderna COVID-19 vaccine is recommended by the CDC for the use as an updated booster dose.

Johnson & Johnson (Janssen) COVID-19 Vaccine

Introduced in early 2021, the Janssen COVID-19 vaccine is produced by a subsidiary of Johnson & Johnson. On Feb. 27, 2021, the FDA issued an EUA for the vaccine to be used for individuals aged 18 years and older. Later, due to reported cases of thrombosis with thrombocytopenia syndrome and Guillain-Barre syndrome after receiving the vaccine, on May 5, 2022, the FDA limited the use of this vaccine to adults over the 18 years of age, for whom other authorized COVID-19 vaccines are unavailable or clinically inappropriate.
  • VAERS adverse event report numbers: According to VAERS, as of Dec. 2, 2022, a total of 71,367 adverse events had been reported regarding the Janssen COVID-19 vaccine, including 9,591 serious adverse events and 1,850 deaths.
  • Vaccine administration number: As per Our World in Data, by Nov. 30, 2022, 18.94 million doses of the Janssen COVID-19 vaccine had been administered in the United States.
  • Currently approved dosage: A single primary vaccine dose is recommended by the FDA for the Janssen COVID-19 vaccine, and the CDC also recommends a single booster dose for this vaccine, which should take place at least two months after the primary dose.

Novavax COVID-19 Vaccine

The Nuvaxovid COVID-19 vaccine is manufactured by American company Novavax, Inc. On Oct. 19, 2022, the company received an FDA-issued EUA for the use of its vaccine against COVID-19 infection. The vaccine is used as a primary series among individuals aged 12 years and older. 
  • VAERS adverse event report numbers: According to VAERS, as of Dec. 2, 2022, a total of 163 adverse events had been reported regarding the Novavax COVID-19 vaccine, including 22 serious adverse events but no deaths.
  • Vaccine administration number: As per Our World in Data, by Nov. 30, 2022, 61,387 doses of the Novavax COVID-19 vaccine had been administered in the United States.
  • Currently approved dosage: Two primary vaccine doses are recommended by the FDA for the Novavax COVID-19 vaccine. And according to a CDC recommendation, after the primary series is completed, another dose of the Novavax vaccine can be used as a booster shot, and it should be three to eight weeks apart from the last dose.

Bivalent Pfizer–BioNTech COVID-19 Vaccine

On Aug. 31, 2022, the FDA amended the EUA of the Pfizer-BioNTech COVID-19 vaccine to authorize its bivalent formulation for use as a booster. This bivalent vaccine targets the SARS-CoV-2 virus’s original Wuhan strain and the Omicron variant. 
On Dec. 8, 2022, the FDA amended the EUA for the bivalent Pfizer-BioNTech COVID-19 vaccine to include use in children 6 months of age or older. 
  • VAERS adverse event report numbers: According to VAERS, as of Dec. 2, 2022, a total of 6,287 adverse events had been reported regarding the bivalent Pfizer-BioNTech COVID-19 vaccine, including 445 serious adverse events and 59 deaths.
  • Vaccine administration number: As per the CDC, by Nov. 30, 2022, 25,468,519 doses of the bivalent Pfizer-BioNTech COVID-19 vaccine had been administered in the United States.
  • Currently approved dosage:  People should receive this “updated booster” at least two months following the primary series or last booster vaccination.

Bivalent Moderna COVID-19 Vaccine

On Aug. 31, 2022, the FDA amended the EUA of the Moderna COVID-19 vaccine to authorize its bivalent formulation for use as a single booster dose. This bivalent vaccine also targets the SARS-CoV-2 virus’s ancestral strain as well as the Omicron variant.
On Dec. 8, 2022, the FDA amended the EUA for the bivalent Moderna COVID-19 vaccine to include use in children 6 months of age or older. 
  • VAERS adverse event report numbers: According to VAERS, as of Dec. 2, 2022, a total of 5,006 adverse events had been reported regarding the bivalent Moderna COVID-19 vaccine, including 243 serious adverse events and 31 deaths.
  • Vaccine administration number: As per the CDC, by Nov. 30, 2022, 14,406,446 doses of the bivalent Moderna COVID-19 vaccine had been administered in the United States.
  • Currently approved dosage: The bivalent Moderna COVID-19 vaccine is recommended to be used as a booster.

Unknown Vaccine Adverse Events Reported on VAERS

According to VAERS, as of Dec. 2, 2022, a total of 4,677 adverse events had been reported regarding unknown vaccines, including 629 serious adverse events and 61 deaths.
Overall, a total of 906,544 adverse events had been reported regarding all approved COVID-19 vaccines in the United States, including 95,695 serious adverse events and 15,584 deaths.
Mercura Wang is a health reporter for The Epoch Times. Have a tip? Email her at: [email protected]
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