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The Centers for Disease Control and Prevention today released new data showing a total of 946,463 reports of adverse events following COVID vaccines were submitted between Dec. 14, 2020, and Dec. 3, 2021, to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.
The data included a total of 19,886 reports of deaths — an increase of 354 over the previous week — and 150,946 reports of serious injuries, including deaths, during the same time period — up 4,226 compared with the previous week.
Foreign reports are reports received by U.S. manufacturers from their foreign subsidiaries. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.
Of the 9,136 U.S. deaths reported as of Dec. 3, 20% occurred within 24 hours of vaccination, 25% occurred within 48 hours of vaccination and 61% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 466 million COVID vaccine doses had been administered as of Dec. 3. This includes 271 million doses of Pfizer, 178 million doses of Moderna and 17 million doses of Johnson & Johnson (J&J).
Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed. Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
U.S. VAERS data from Dec. 14, 2020, to Dec. 3, 2021 for 5- to 11-year-olds show:
- 3,301 adverse events, including 58 rated as serious and 2 reported deaths. One death occurred in an 11-year-old girl from Georgia vaccinated Sept. 14, prior to the authorization of Pfizer’s COVID vaccine in the 5 to 11 age group.
The second death (VAERS I.D. 1890705) occurred in a 5-year-old girl who died four days after receiving her first dose of Pfizer.
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U.S. VAERS data from Dec. 14, 2020, to Dec. 3, 2021 for 12- to 17-year-olds show:
The most recent deaths involve a 13-year-old girl from Texas (VAERS I.D. 1913198) who died 31 days after receiving her COVID vaccine. According to her VAERS report, the girl received her first dose of Pfizer on Aug. 1. Two weeks later, she complained of vague upper back pain and was diagnosed with a rare soft tissue cancer located on her heart despite having no previous medical history. Parents requested a VAERS report be filed in case her cancer was related to the vaccine. Her cancer and heart condition rapidly and progressively worsened and she died Dec 1.
The second death involves a 17-year-old girl from Minnesota (VAERS I.D. 1912785) who experienced cardiac arrest and died at home after receiving her first dose of Pfizer’s COVID vaccine.
- 60 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 96% of cases
attributed to Pfizer’s vaccine.
- 567 reports of myocarditis and pericarditis (heart inflammation) with 557 cases attributed to Pfizer’s vaccine.
- 141 reports of blood clotting disorders, with all cases attributed to Pfizer.
U.S. VAERS data from Dec. 14, 2020, to Dec. 3, 2021, for all age groups combined, show:
- 19% of deaths were related to cardiac disorders.
- 54% of those who died were male, 42% were female and the remaining death reports did not include gender of the deceased.
- The average age of death was 72.7.
- As of Dec. 3, 4,538 pregnant women reported adverse events related to COVID vaccines, including 1,428 reports of miscarriage or premature birth.
- Of the 3,249 cases of Bell’s Palsy reported, 51% were attributed to Pfizer vaccinations, 41% to Moderna and 8% to J&J.
- 784 reports of Guillain-Barré syndrome (GBS), with 42% of cases attributed to Pfizer, 29% to Moderna and 27% to J&J.
- 2,184 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
- 11,514 reports of blood clotting disorders. Of those, 5,112 reports were attributed to Pfizer, 4,101 reports to Moderna and 2,249 reports to J&J.
- 3,333 cases of myocarditis and pericarditis with 2,074 cases attributed to Pfizer, 1,109 cases to Moderna and 140 cases to J&J’s COVID vaccine.
FDA, CDC sign off on Pfizer boosters for 16- and 17-year-olds, suggest 3rd shot for younger kids may come soon The CDC on Thursday signed off on Emergency Use Authorization of booster doses of the Pfizer-BioNTech vaccine for 16- and 17- year olds.
Approval from CDC Director Dr. Rochelle Walensky came hours after the U.S. Food and Drug Administration (FDA) authorized booster doses for the same age group.
Walensky said in a statement initial data suggest a third shot will help strengthen protection against Omicron and other variants, and she urged older teens to get the booster.
The FDA on Thursday authorized the booster doses for 16- and 17-year-olds at least six months after receiving their second dose of the vaccine, the New York Times reported.
The FDA broadened Pfizer’s authorization to cover the younger age group on an emergency basis as initial research suggested the new Omicron variant undermines antibody protection of two doses of Pfizer’s vaccine.
Pfizer boosters will be available to 16- and 17-year-olds at least six months after they received their initial two doses of Pfizer’s COVID vaccine. The Moderna and Johnson & Johnson vaccines remain authorized only for adults Meanwhile, the CDC today said it was “considering” boosters for 5- to 11-year-olds.
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“We’re first starting to get our 5- to 11-year-olds vaccinated,” Walensky said. “We’ll look again at the 12- to 15-year-olds, of course, as with the FDA, in real-time.”
Roughly two-thirds of parents of elementary school-aged children are either holding off on getting their younger kids vaccinated or refuse to do so, according to ABC7 in New York.
Breakthrough cases surge in Missouri, Massachusetts, Connecticut
The latest data from Missouri show 730 people died from COVID despite being fully vaccinated. According to the Missouri Department of Health and Senior Services, the state recorded 760,035 COVID cases as of Dec. 9.
More than 11,321 fully vaccinated people in Massachusetts tested positive for COVID last week — an increase of 71% over the 6,610 breakthrough infections reported the previous week.
Breakthrough cases in Massachusetts account for 40% of the state’s overall cases in recent months as the vaccine’s effectiveness wanes after six months. In all, 88,968 fully vaccinated people have tested positive for the virus since Dec. 14, according to data from the state’s Department of Public Health on Tuesday.
Data provided by the Connecticut Department of Public Health showed an increase in breakthrough cases over the past four weeks. A total of 4,143 breakthrough cases were reported over the previous week ending Wednesday — an increase from Dec. 2, when there were a total of 2,553 new breakthrough cases.
Of the 4,143 identified breakthrough cases in Connecticut most occurred among patients between the ages of 35 and 64. There were 802 breakthrough cases in patients 35 to 44, 842 cases in patients aged 55 to 64, 33 breakthrough infections among children aged 12 to 15 and 321 cases in patients 75 and older.
Definition of fully vaccinated will change to include 3rd dose
It’s only a matter of time before the definition of fully vaccinated is changed to include a third dose, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday.
According to the CDC website, “fully vaccinated persons are those who are ≥14 days post completion of the primary series of an FDA-authorized COVID-19 vaccine.”
The term fully vaccinated refers to a person who has received two doses of Pfizer or Moderna COVID vaccines or a single shot of Johnson & Johnson. The definition has implications because it is used by those imposing vaccine mandates across the country, including federal mandates for healthcare workers, government contractors and private businesses with more than 100 employees.
Four doses of COVID vaccine likely needed to combat Omicron variant
Pfizer CEO Albert Bourla said Wednesday people may need a fourth dose of the COVID vaccine sooner than expected after preliminary research showed the Omicron variant can undermine antibody protection in people who only received two doses.
Pfizer and BioNTech released results from their initial lab study showing a third dose was protective against the new variant, but the initial two-dose series dropped significantly in its ability to protect against the new strain.
Bourla said three doses against Omicron are equivalent to the two doses’ effectiveness against the original variant, although more data is needed from tests using the actual virus. Real-world results will be more accurate and are expected in the next two weeks, he said.
Bourla previously predicted a fourth dose would be needed 12 months after the third dose, but said with Omicron, “we may need it faster.”
120 teens hospitalized, 3 dead following Pfizer vaccine rollout for 15- to 17-year-olds in Vietnam The Vietnamese province of Thanh Hoa suspended a batch of Pfizer-BioNTech’s COVID vaccine after more than 120 teens were hospitalized after being vaccinated.
According to the province’s CDC, the teens were hospitalized for symptoms ranging from nausea and high fevers to breathing difficulties — with 17 children exhibiting severe reactions.
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Since the rollout began on Nov. 30, three Vietnamese teens died after receiving Pfizer’s vaccine, including two 12-year olds and a 16-year-old. The Health Ministry said the deaths were caused by “overreaction to the vaccine,” not by a problem with the quality of the vaccine or the vaccination process.
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