The Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS) is the principal government-funded system for reporting adverse vaccine reactions in the U.S. New data shows a total of 1,268,008 reports of adverse events following COVID-19 vaccines were submitted between December 14, 2020, and May 13, 2022. This data included a total of 28,141 reports of deaths, an increase of 173 over last week, and 230,364 serious injuries, including deaths, during the same time, up 1,887 compared with last week. There were 6,859 additional total adverse events reported to VAERS over the previous week.
“The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,268,008 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and May 13, 2022, 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 28,141 reports of deaths — an increase of 173 over the previous week — and 230,364 serious injuries, including deaths, during the same time period — up 1,887 compared with the previous week. There were 6,859 additional total adverse events reported to VAERS over the previous week.
Excluding “foreign reports” to VAERS, 817,538 adverse events, including 12,961 deaths and 82,544 serious injuries, were reported in the U.S. between Dec. 14, 2020, and May 13, 2022.
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 12,961 U.S. deaths reported as of May 13, 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., 581 million COVID-19 vaccine doses had been administered as of May 13, including 343 million doses of Pfizer, 219 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 May 13, 2022, for 5- to 11-year-olds show:
- 10,745 adverse events, including 279 rated as seriousand 5 reported deaths.
- 22 reportsof 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.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.
- 43 reportsof blood clotting disorders.
U.S. VAERS data from Dec. 14, 2020, to May 13, 2022, for 12- to 17-year-olds show:
- 31,572 adverse events, including 1,824 rated as seriousand 44 reported deaths. VAERS reported 44 deaths in the 12- to 17-year-old age group last week.
- 64 reportsof 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.
- 651 reportsof myocarditis and pericarditis with 639 cases attributed to Pfizer’s vaccine.
- 168 reportsof blood clotting disorders with all cases attributed to Pfizer.
U.S. VAERS data from Dec. 14, 2020, to May 13, 2022, for all age groups combined, show:
- 20% of deaths were related to cardiac disorders.
- 54% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
- The average ageof death was 73.
- As of May 13, 5,527 pregnant womenreported adverse events related to COVID-19 vaccines, including 1,732 reports of miscarriage or premature birth.
- Of the 3,622 cases of Bell’s Palsyreported, 51% were attributed to Pfizer vaccinations, 40% to Moderna and 8% to J&J.
- 880 reports of Guillain-Barré syndrome, with 42% of cases attributed to Pfizer, 30% to Modernaand 28% to J&J.
- 2,291 reportsof anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
- 1,707 reportsof myocardial infarction.
- 13,972 reportsof blood-clotting disorders in the U.S. Of those, 6,266 reports were attributed to Pfizer, 4,989 reports to Moderna and 2,679 reports to J&J.
- 4,194 casesof myocarditis and pericarditis with 2,570 cases attributed to Pfizer’s, 1,427 cases to Moderna’s and 183 cases to J&J’s COVID-19 vaccines.
Children’s Health Defense (CHD) asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.
CDC vaccine advisory panel follows FDA lead, endorses 3rd Pfizer shot for kids 5 to 11
The CDC’s independent vaccine advisory panel on Thursday endorsed a third dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.
CDC Director Dr. Rochelle Walensky signed off on the Advisory Committee on Immunization Practices (ACIP) recommendation, clearing the way for healthcare workers to begin administering the shots.
The ACIP recommendation came two days after the FDA granted Pfizer’s request for Emergency Use Authorization (EUA) of a single booster dose for this age group, saying the third shot should be administered at least five months after the initial two-dose primary series with the Pfizer-BioNTech vaccine.
The FDA granted the EUA without convening its vaccine advisory panel of independent experts to discuss Pfizer’s data on 5- to 11-year-olds.
The authorization was based on a study subset of only 67 children who exhibited higher antibody levels one month after receiving a booster dose.
The FDA granted EUA for the boosters despite data showing higher infection rates among fully vaccinated children in the 5-to-11 age group compared to unvaccinated children, no studies testing the efficacy of the vaccine against the current dominant BA.2 COVID-19 variant and two new studies showing that for vaccinated people who get Omicron, the infection provides better protection against future infections than a second booster dose.
The FDA said it did not identify any new safety concerns and found the children in the trial experienced the same mild side effects other people do after receiving a booster.
However, a subset of only 67 children is not large enough to detect potential adverse events like myocarditis, and it is unknown how rapidly any protection provided wanes because trial participants were not followed beyond a 28-day period.
Pfizer documents show many adverse events deemed ‘unrelated’ to vaccine
The latest release by the FDA of Pfizer vaccine documents raises questions about how frequently adverse events experienced by clinical trial participants were reported as “unrelated” to the vaccine.
The 80,000-page document cache released May 2 includes an extensive set of Case Report Forms (CRFs) from Pfizer trials conducted at various locations in the U.S.
The reports are from participants who suffered some type of adverse event during their participation in Pfizer’s vaccine trials.
As the documents reveal, despite the occurrence of a wide range of symptoms including serious cardiovascular events, almost none were identified as being “related” to the vaccine.
Only one adverse event is clearly specified as being related to the vaccination: a participant who suffered from psoriatic arthritis, with no prior history of the condition.
In addition, several CRFs indicated exposure during pregnancy or during a partner’s pregnancy. However, the documents provided do not appear to have provided any follow-ups regarding any outcomes or potential adverse events for the participants, their partners or their newborn babies once born.
In some instances, while the CRFs claimed the adverse events suffered by patients were unrelated to the vaccine, their cause was unspecified — simply indicated as “other” — while in another case, a participant’s “unplanned” small bowel obstruction and panic attacks were listed as being unrelated to the vaccination despite no relevant medical history pertaining to the severe adverse events in question.”