Data released Sept. 17 by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Sept. 10, 2021, a total of 701,561 adverse events following COVID vaccines were reported to the Vaccine Adverse Event Reporting System (VAERS). The data included a total of 14,925 reports of deaths — an increase of 419 over the previous week.
There were 91,523 reports of serious injuries, including the reports of deaths, during the same time period — up 3,352 compared with the previous week.
Excluding “foreign reports” filed in VAERS, 559,462 adverse events, including 6,756 deaths and 43,073 serious injuries, were reported in the U.S. between Dec. 14, 2020 and Sept. 10, 2021.
Of the 6,756 U.S. deaths reported as of Sept. 10, 12% occurred within 24 hours of vaccination, 17% occurredwithin 48 hours of vaccination and 31% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 378.2 million COVID vaccine doses had been administered as of Sept. 10. This includes: 216 million doses of Pfizer, 148 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.
This week’s U.S. data for 12- to 17-year-olds show:
- 19,827 total adverse events, including 1,169 rated as serious and 19 reported deaths. Two of the 19 deaths were suicides.
The most recent deaths involve one report of two patients [VAERS I.D. 1655100] who died after their second dose of Pfizer, including a 13-year-old female.
Other recent reported deaths include a 15-year-old boy (VAERS I.D. 1498080) who previously had COVID, was diagnosed with cardiomyopathy in May 2021 and died four days after receiving his second dose of Pfizer’s vaccine on June 18, when he collapsed on the soccer field and went into ventricular tachycardia; and a 13-year-old girl (VAERS I.D. 1505250) who died after suffering a heart condition after receiving her first dose of Pfizer.
- 2,972 reports of anaphylaxis among 12- to 17-year-olds with 99% of cases
attributed to Pfizer’s vaccine. - 488 reports of myocarditis and pericarditis (heart inflammation) with 481 cases attributed to Pfizer’s vaccine.
- 106 reports of blood clotting disorders, with all cases attributed to Pfizer.
- 20% 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 72.9.
- As of Sept. 10, 3,650 pregnant women reported adverse events related to COVID vaccines, including 1076 reports of miscarriage or premature birth.
- Of the 2,783 cases of Bell’s Palsy reported, 50% were attributed to Pfizer vaccinations, 42% to Moderna and 8% to J&J.
- 593 reports of Guillain-Barré syndrome, with 39% of cases attributed to Pfizer, 33% to Moderna and 27% to J&J.
- 149,681 reports of anaphylaxis with 42% of cases attributed to Pfizer’s vaccine, 51% to Moderna and 7% to J&J.
- 9,260 reports of blood clotting disorders. Of those, 3,968 reports were attributed to Pfizer, 3,376 reports to Moderna and 1,866 reports to J&J.
- 2,452 cases of myocarditis and pericarditis with 1,545 cases attributed to Pfizer, 806 cases to Moderna and 93 cases to J&J’s COVID vaccine.
FDA panel overwhelmingly rejects Pfizer boosters for healthy people 16 to 65 years old
On Sept. 17, a panel of scientific advisors to the U.S. Food and Drug Administration (FDA) voted 16 to 2 againstrecommending a third shot of Pfizer’s COVID vaccine for healthy people 16 and older, but voted unanimously in favor of recommending the booster shot for the immunocompromised and all people 65 or older.
The vote came after a sharp debate in which many of the panel’s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified a broad rollout of extra shots when the vaccines appear to still offer robust protection against severe COVID-19 disease and hospitalization, at least in the U.S.
Officials at the FDA previously had expressed skepticismabout the need for Pfizer COVID vaccine booster shots in a 23-page document released Sept. 16, prior to the meeting, on the agency’s website.
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