The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,301,356 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and June 10, 2022, to the Vaccine Adverse Event Reporting System (VAERS). That’s an increase of 6,027 adverse events over the previous week.
VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.
The data included a total of 28,859 reports of deaths — an increase of 327 over the previous week — and 238,412 serious injuries, including deaths, during the same time period — up 1,645 compared with the previous week.
Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. 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 13,293 U.S. deaths reported as of June 10, 16% occurred within 24 hours of vaccination, 20% occurred within 48 hours of vaccination and 59% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 590 million COVID-19 vaccine doses had been administered as of June 10, including 349 million doses of Pfizer, 223 million doses of Moderna and 19 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 June 10, 2022, for 6-month-olds to 5-year-olds show:
- 1,739 adverse events, including 65 cases rated as serious and 3 reported deaths.
- 4 reports of myocarditis and pericarditis (heart inflammation).
The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.
- 13 reports of blood clotting disorders.
U.S. VAERS data from Dec. 14, 2020, to June 10, 2022, for 5- to 11-year-olds show:
- 11,370 adverse events, including 294 rated as serious and 5 reported deaths.
- 22 reports of myocarditis and pericarditis.
The Defender has noticed over previous weeks that reports of myocarditis and pericarditis have been removed by the CDC from the VAERS system in this age group. No explanation was provided.
- 44 reports of blood clotting disorders.
U.S. VAERS data from Dec. 14, 2020, to June 10, 2022, for 12- to 17-year-olds show:
- 32,203 adverse events, including 1,834 rated as serious and 44 reported deaths.
- 62 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 97% of cases attributed to Pfizer’s vaccine.
- 656 reports of myocarditis and pericarditis with 644 cases attributed to Pfizer’s vaccine.
- 166 reports of blood clotting disorders with all cases attributed to Pfizer. VAERS reported 167 cases of blood clotting disorders in the 12- to 17-year-old age group last week.
- 19 cases of postural orthostatic tachycardia syndrome (POTS) with all cases attributed to Pfizer’s vaccine.
U.S. VAERS data from Dec. 14, 2020, to June 10, 2022, for all age groups combined, show:
- 20% of deaths were related to cardiac disorders.
- 53% of those who died were male, 42% were female and the remaining death reports did not include the gender of the deceased.
- The average age of death was 73.
- As of June 10, 5,577 pregnant women reported adverse events related to COVID-19 vaccines, including 1,744 reports of miscarriage or premature birth.
- Of the 3,608 cases of Bell’s Palsy reported, 51% were attributed to Pfizer vaccinations, 40% to Moderna and 8% to J&J.
- 889 reports of Guillain-Barré syndrome, with 42% of cases attributed to Pfizer, 30% to Moderna and 28% to J&J.
- 2,290 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
- 1,724 reports of myocardial infarction.
- 14,102 reports of blood-clotting disorders in the U.S. Of those, 6,309 reports were attributed to Pfizer, 5,054 reports to Moderna and 2,701 reports to J&J.
- 4,229 cases of myocarditis and pericarditis with 2,590 cases attributed to Pfizer, 1,438 cases to Moderna and 186 cases to J&J.
- 11 cases of Creutzfeldt-Jakob disease with 5 cases attributed Pfizer, 5 cases to Moderna and 1 case to J&J.
- 264 cases of POTS with 162 cases attributed to Pfizer, 84 cases to Moderna and 17 cases to J&J.
FDA authorizes Pfizer and Moderna COVID vaccines for younger children
Moderna and Pfizer-BioNTech’s COVID-19 vaccines are now authorized for emergency use in infants and young children as young as 6 months, CNN reported.
The FDA on Friday authorized Moderna’s vaccine for use in children 6 months through 17 years and the Pfizer-BioNTech vaccine for children 6 months through 4 years.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wednesday unanimously voted 21-0 to recommend Pfizer and Moderna’s COVID-19 vaccines for infants and young children, stating the totality of the evidence available shows the benefits of the vaccines outweigh the risks of use.
The panel ignored pleas from experts, the vaccine-injured and a congressman representing 17 other lawmakers to halt authorization until questions about the safety and efficacy of COVID-19 vaccines for the nation’s youngest children could be properly addressed.
Pfizer’s three-dose vaccine would cover children 6 months to 5 years old, while Moderna’s two-dose vaccine covers children 6 months to 6 years old.
White House officials said the administration of vaccines for these age groups could start as early as June 21.
CDC advisors hold impromptu meeting to get vaccines for kids rolled out by White House deadline
During a meeting Thursday, the CDC announced it scheduled a special two-day meeting of the Advisory Committee on Immunization Practices (ACIP) Friday to discuss authorization of Pfizer and Moderna’s COVID-19 vaccines for infants and young children.
The meeting to discuss authorization of Moderna’s COVID-19 vaccine for 6- to 17-year-olds is scheduled for June 22 and 23.
The CDC today discussed the safety, immunogenicity and efficacy of the Moderna shot in kids 6 months through 5 years of age and Pfizer’s vaccine in children 6 months through 4 years of age.
The ACIP is scheduled to vote Saturday.
“The entire process is set up to rubber-stamp the VRBPAC meetings from yesterday,” said Toby Rogers, Ph.D.
In a CHD.TV live blog, Dr. Liz Mumper, a pediatrician and Children’s Health Defense board member, said Pfizer showed an estimate of 80.3% vaccine efficacy but based it on only 7 cases in the placebo group and 3 in the vaccine group.
“These numbers are ridiculously small — the 80% may not stand” if more kids are included in the numbers, Mumper said.
Mumper also pointed out the shots being considered at today’s meeting were based on the original Wuhan strain that is no longer circulating.
“It is not so important how good a vaccine is at generating antibodies to Wuhan strain,” Mumper said. “[We] need long-term data about the impact of the shot on the number of kids who get COVID in [the] community and have severe or mild [cases].
“U.S. VAERS data from Dec. 14, 2020, to June 3, 2022, for 6-month-olds to 5-year-olds show 1,658 adverse events, including 63 cases rated as serious and 3 reported deaths.
“The risk of a child dying if they have a diagnosis is 1,086/10,700,00 or 1086/10700000 = 0.00010149532. The risk of any child dying of COVID-19 over this time period is 1,086/73000000 = 0.00001487671.”
“Forty-nine states have already bought vaccines for children in the age groups being debated,” she added. “Seems like a done deal.”
FDA’s vaccine advisors endorse Moderna’s COVID vaccine for kids ages 6 to 17
The FDA’s vaccine advisory panel on Tuesday voted unanimously to recommend Moderna’s COVID-19 vaccine for children ages 6 to 17 after determining the benefits of the vaccine outweigh the risks for use.
VRBPAC voted 22 to 0 to recommend Moderna’s two-dose vaccine for 6- to 11-year-olds at half the strength of the adult version, and 22 to 0 in favor of authorizing the shot for 12- to 17-year-olds at the same strength as adults.
During the public comment session, individuals expressed concern over recommending a vaccine for an age group that has an almost zero risk of experiencing severe illness or death from COVID-19 and has already acquired a high level of natural immunity.
Dr. Tom Shimabukuro, a vaccine safety official at the CDC, said some data suggest a higher risk of myocarditis among people 18 to 39 years old after receiving Moderna’s COVID-19 vaccine, but findings were not consistent across various safety databases and were not statistically significant.
The CDC confirmed 635 cases of myocarditis, or heart inflammation, in the 5-to-17 age group out of almost 55 million doses of the Pfizer-BioNTech vaccine administered. The agency said the condition occurred most often in adolescent boys after receiving their second dose.
29-year-old’s career came ‘crashing’ down after Pfizer COVID vaccine injury
In an exclusive interview with The Defender, Hayley Lopez, 29, said she developed postural orthostatic tachycardia syndrome (POTS) after receiving her first dose of Pfizer’s COVID-19 vaccine and can no longer work.
Lopez, an air traffic controller at one of the U.S. Federal Aviation Administration’s busiest facilities in the country, said she experienced side effects within 15 minutes of receiving the shot.
She first noticed arm and chest pain, and within three days experienced dizziness, shortness of breath, memory issues and stuttering.
Lopez said her symptoms include twitching, nerve pain, fatigue, high blood pressure, high heart rate, palpitations, lightheadedness, a feeling of vertigo and migraines.
She had difficulty locating a doctor who could diagnose her condition and recognize her symptoms were vaccine-related.
Lopez got a diagnosis from a physician after reading about POTS — a condition that affects blood flow and can result in symptoms such as lightheadedness, fainting and increased heartbeat, symptoms which appear when standing up from a reclined position.
Florida only state not to preorder vaccines for young children
Florida is the only state in the nation that did not place an order with the federal government for doses of COVID-19 for young children prior to U.S. health agencies authorizing the vaccines, Politico reported.
The deadline for placing a pre-order was Tuesday and 49 other states met the cutoff date.
The Florida Department of Health (DOH), said in a statement to Politico on Wednesday that it did not pre-order vaccines for kids 5 and under because it doesn’t advise all children get vaccinated.
“States do not need to be involved in the convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,” the DOH statement said.
Jeremy Redfern, press secretary for Florida’s DOH, confirmed the department “chose not to participate” in the vaccination program.
“It is also no surprise we chose not to participate in distribution of the COVID-19 vaccine when the department does not recommend it for all children,” Redfern said. “Doctors can order vaccines if they are in need, and there are currently no orders in the department’s ordering system for the COVID-19 vaccine for this age group.”