2 More Teen Deaths Reported to VAERS, as FDA Panel Recommends Moderna, J&J Booster Shots
Data released Friday by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Oct. 8, 2021, a total of 798,636 adverse events following COVID vaccines were reported to the Vaccine Adverse Event Reporting System (VAERS). The data included a total of 16,766 reports of deaths — an increase of 456 over the previous week, and two more reports of teens who died after being vaccinated.
There were 117,399 reports of serious injuries, including deaths, during the same time period — up 5,478 compared with the previous week.
Excluding “foreign reports” to VAERS, 604,160 adverse events, including 7,674 deaths and 48,958 serious injuries, were reported in the U.S. between Dec. 14, 2020 and Oct. 8, 2021.
Of the 7,674 U.S. deaths reported as of Oct. 8, 11% occurred within 24 hours of vaccination, 16% occurred within 48 hours of vaccination and 28% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 400.3 million COVID vaccine doses had been administered as of Oct. 8. This includes: 232 million doses of Pfizer, 153 million doses of Moderna and 15 million doses of Johnson & Johnson (J&J).
The data come directly from reports submitted to VAERS, the primary government-funded system for reporting adverse vaccine reactions in the U.S.
Every Friday, VAERS makes public all vaccine injury reports received as of a specified date, usually about a week prior to the release 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.
This week’s U.S. data for 12- to 17-year-olds show:
- 21,652 total adverse events, including 1,304 rated as serious and 24 reported deaths. Two of the 24 deaths were suicides.
The most recent death involves a 15-year-old male who died six days after receiving his first dose of Pfizer’s COVID vaccine. According to his VAERS report (VAERS I.D. 1764974), the previously healthy teen complained of brief unilateral shoulder pain five days after receiving his COVID vaccine. The next day he played with two friends at a community pond, swung on a rope swing, flipped into the air, and landed in the water feet first. He surfaced, laughed and told his friends “Wow, that hurt!” He then swam toward shore underwater, as was his usual routine, but did not re-emerge.
An autopsy showed no external indication of a head injury, but there was a small subgaleal hemorrhage — a rare, but lethal bleeding disorder — over the left occiput. In addition, the boy had a mildly elevated cardiac mass, increased left ventricular wall thickness and small foci of myocardial inflammation of the lateral wall of the left ventricle with myocyte necrosis consistent with myocardial infarction.
Another recent death includes a 16-year-old female (VAERS I.D. 1757635) who complained of fatigue and died one day after receiving Pfizer’s COVID vaccine.
- 57 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. - 529 reports of myocarditis and pericarditis (heart inflammation) with 508 cases attributed to Pfizer’s vaccine.
- 117 reports of blood clotting disorders, with all cases attributed to Pfizer.
This week’s U.S. VAERS data, from Dec. 14, 2020 to Oct. 8, 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.
- Of the 2,973 cases of Bell’s Palsy reported, 51% were attributed to Pfizer vaccinations, 41% to Moderna and 8% to J&J.
- 661 reports of Guillain-Barré syndrome, with 40% of cases attributed to Pfizer, 31% to Moderna and 28% to J&J.
- 1,995 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
- 10,131 reports of blood clotting disorders. Of those, 4,407 reports were attributed to Pfizer, 3,654 reports to Moderna and 2,018 reports to J&J.
- 2,818 cases of myocarditis and pericarditis with 1,782 cases attributed to Pfizer, 915 cases to Moderna and 111 cases to J&J’s COVID vaccine.
FDA panel unanimously backs Moderna, J&J booster shots for older and high-risk people
According to CNBC, an advisory panel to the U.S. Food and Drug Administration (FDA) today unanimously voted to recommend J&J’s single-dose COVID vaccine to the more than 15 million Americans who have already received the first dose.
The panel recommended boosters for everyone 18 and over, at least two months after they received the first dose.
Many committee members said it should be considered a two-dose vaccine, much like the Moderna and Pfizer vaccines.
On Thursday, the FDA’s advisory panel unanimously recommended booster doses of Moderna’s COVID vaccine for Americans 65 and older and those at high risk of severe illness or occupational exposure to the virus, Reuters reported.
“The data itself is not strong, but it is certainly going in the direction that is supportable of this vote,” said Dr. Patrick Moore of the University of Pittsburgh School of Medicine. Moore said he voted in favor of Moderna boosters based largely on a “gut feeling rather than truly serious data.”
Moderna shares were up nearly 3% at $330.71 after the vote.
If the FDA signs off on the panel’s recommendation for booster doses of J&J and Moderna’s COVID vaccines, the CDC will make specific recommendations on who should get the shots. The CDC’s vaccine advisers are scheduled to meet next week.
White House tells governors to get ready to vaccinate young kids, even though FDA hasn’t approved it
In a private phone call Tuesday with the nation’s governors, the White House told states to prepare to vaccinate children as young as 5 by early November, even though the FDA has not yet granted Emergency Use Authorization for COVID vaccines for the 5 to 11 age group.
According to NBC News, the Biden administration purchased 65 million pediatric doses of the Pfizer/BioNTech vaccine — enough to vaccinate an estimated 28 million children who would be eligible should the FDA approve Pfizer’s request to vaccinate the younger age group.
The administration told providers last week the vaccine for children will be delivered to thousands of sites, including states, pharmacies, schools and medical groups within one week of FDA authorization. The pediatric Pfizer vaccine will be one-third of what is given to adults.
Indiana parents say children are suffering adverse reactions after mistakenly given adult dose of COVID vaccine
Joshua and Alexandra Price took their four-year-old son and five-year-old daughter to a Walgreens in Indiana for the flu shot a week ago, but the children and parents were all mistakenly given the Pfizer COVID vaccine, The Hill reported.
The parents say their children, Sophia and Lukas, are experiencing side effects from the vaccine — which is only approved for ages 12 and older — including fever, body aches, cough, headache and nausea. The children received a dose three times higher than is being tested for children in clinical trials.
“The 4- and 5-year-old are also under treatment of a pediatric cardiologist for tachycardia and elevated blood pressure, respectively,” the Prices’ attorney, Dan Tuley, said in a statement.
For the parents, Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told CNN, the COVID shot would essentially be a booster shot since the parents were already vaccinated back in April.
New data links Parsonage-Turner syndrome to mRNA COVID vaccines
According to an article published in Medscape Oct. 14, Parsonage-Turner syndrome (PTS) has been highlighted as a potential adverse effect of mRNA COVID vaccines in a recent pharmacovigilance monitoring report from the French National Agency for the Safety of Medicines and Health Products (ANSM).
PTS is a rare condition characterized by the sudden onset of severe shoulder pain, followed by arm paralysis. The reaction appears to be more common in men than in women.
Six serious cases of the syndrome related to the Pfizer’s Comirnaty vaccine were reported since the start of the monitoring program, with four cases occurring from Sept. 3 and 16.
All six cases associated with Pfizer’s vaccine involved patients 19 to 69 years old two women and four men — who developed symptoms within 50 days after vaccination. Half of the cases occurred after the first dose and half after the second. Four patients are currently recovering, and the outcomes of the other two are unknown.
In the case of Moderna’s COVID vaccine, two cases of PTS were reported. Two cases occurred in men — one in his early 30s and one in his early 60s — within 18 days after vaccination. One case occurred after the first dose and one after the second dose.
This timing indicates a possible link between the syndrome and the vaccine, the report stated. A third case occurred more than 50 days after vaccination.
This signal of mRNA vaccines is now “officially recognized,” according to the report. It is also considered a “potential signal” of the AstraZeneca vaccine, according to a pharmacovigilance report, released Oct. 8, which describes eight cases of PTS after vaccination.
Data show COVID risk for kids ‘not extraordinary threat’
As The Defender reported Oct. 12, new data from King County, Washington — which contains some of the country’s most detailed COVID data — showed risks for unvaccinated children look similar to the risks for vaccinated people in their 50s.
According to The New York Times, nationwide statistics from the UK showed an even larger age gap. Unvaccinated children under 12 appeared to be at a lower risk of COVID infection than vaccinated people in their 40s, if not 30s.
For children without a serious medical condition, the danger of severe COVID was so low as to be difficult to quantify. For children with such a condition, the danger is higher but still lower than many people believe, the Times reported.
Children’s Health Defense asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.
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