Unanswered Questions Regarding Covid Vaccine Injuries and Reported Deaths

The Defender first reached out to the Centers for Disease Control and Prevention on March 8 with a list of questions about COVID vaccine injury reports in VAERS, including ongoing investigations into reported deaths. Our questions remain unanswered.

Since Pfizer, Moderna and Johnson & Johnson (J&J) COVID vaccines received Emergency Use Authorization (EUA), The Defender has tracked post-vaccine injuries reported by healthcare workers and vaccine recipients to the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS).

We’ve also covered media reports of deaths and injuries among people recently vaccinated for COVID.

The latest VAERS data show that between Dec. 14, 2020 and April 30, a total of 157,277 total adverse events were reported to VAERS, including 3,837 deaths and 16,014 serious injuries following vaccination with Pfizer, Moderna and J&J vaccines.

According to the CDC website, “the CDC follows up on any report of death to request additional information and learn more about what occurred and to determine whether the death was a result of the vaccine or unrelated.”

On March 8, The Defender contacted the CDC with a written list of questions about reported deaths and injuries related to COVID vaccines. We requested information about how the CDC conducts investigations into reported deaths, the status of ongoing investigations into deaths and injuries reported by the media, if autopsies were being conducted, the standard for determining whether an injury is causally connected to a vaccine, and education initiatives to encourage and facilitate proper and accurate reporting.

After repeated attempts, by phone and email, to obtain a response to our questions, a health communications specialist from the CDC’s Vaccine Task Force contacted us on March 29 — three weeks after our initial inquiry.

The individual received our request for information from VAERS, but said she had never received our list of questions, even though employees we talked to several times said CDC press officers were working through the questions and confirmed the representative had received them. We provided the list of questions again along with a new deadline, but never received a response.

The Defender also followed up with the CDC’s media department, which told us  the COVID response unit would be informed that the health communications specialist never responded. No explanation was given as to why our inquiries were ignored. We were told to call back, which we did numerous times.

We asked why the taxpayer-funded CDC seemed to respond to other news media outlets in a timely manner, but hasn’t responded to The Defender. No answer was provided. We were told someone would get back to us.

It has been 64 days since we sent our first email inquiring into VAERS data and reports, but still no response.

CDC investigations into reported deaths

Since EUA was granted for experimental COVID vaccines, the mainstream media has reported on many deaths following vaccines, and in those reports, stated the deaths were under investigation by the CDC.

We questioned the CDC about several of these investigations, whether autopsies were performed, what determines whether a vaccine causes or contributes to a death and where the public could access findings of investigations.

On Jan. 3, the Florida Health Department and CDC announced it was conducting an investigation into the death of Dr. Gregory Michael who died shortly after receiving Pfizer’s COVID vaccine. Dr. Jerry L. Spivak, an expert on blood disorders at Johns Hopkins University, told the New York Times he believed it was a “medical certainty” Pfizer’s vaccine caused Michael’s death.

On April 8, medical examiners established that Michael died of complications from ITP, but officially categorized the death as natural because, according to Darren Caprara, director of operations for the Miami-Dade County Medical Examiner Department, there was “no medical certainty” the vaccine caused Michael’s death.

On Feb. 4, the media reported state and federal officials were investigating the death of a 58-year-old woman, Drene Keyes, in Virginia, who died from anaphylactic shock hours after receiving the first dose of Pfizer’s vaccine. An article published March 7 disclosed health officials had not conducted an autopsy on Keyes, leaving the family to procure an autopsy on their own.

Virginia State Health Commissioner Norman Oliver told public information officers in an email Feb. 5 that if reporters asked whether an autopsy was done, they should say “a full autopsy was not needed in order to ascertain whether the death was related to the vaccination.”

Oliver’s email was part of a public records request which revealed officials inside and outside the health department were concerned the death of Keyes, who is Black, could worsen vaccine hesitancy among minorities.

On Feb. 5, a 39-year-old woman from Ogden, Utah, died four days after receiving a second dose of Moderna’s vaccine. Kassidi Kurill died of organ failure after her liver, heart and kidneys shut down. She had no known medical issues or pre-existing conditions, according to her family. News reports noted Kurill’s death had been reported to VAERS.

Under-reporting to VAERS

The Defender asked the CDC if there is any mechanism in place to confirm whether healthcare providers are reporting to VAERS, or if the agency has any education initiatives in place to improve the rate and quality of reporting.

According to the CDC’s website and the U.S Food and Drug Administration’s EUA approval materials, healthcare providers are required by law to report certain adverse events to VAERS.

Yet according to a 2013 survey in “Vaccine,” 37% of healthcare providers had identified an adverse event following immunization, yet only 17% of those indicated they had ever reported to VAERS. Factors associated with healthcare providers not reporting included: unfamiliarity with how to file a paper VAERS report; type of practice; and the provider being unfamiliar versus very familiar with the requirements for filing a VAERS report.

H1N1 vaccine campaign shut down after fewer than 50 deaths

In March 1976, the federal government rushed the H1N1 vaccine to market, after hundreds of soldiers at Fort Dix, New Jersey, contracted the new virus strain. Of the 45 million people who received the vaccine, 450 developed Guillain-Barré syndrome and of those, more than 30 died.

Months later — in December 1976 — the government suspended the H1N1 mass vaccination campaign, after the National Academy of Medicine concluded people who received the vaccine had an increased risk for developing Guillain-Barré.

The Defender asked the CDC how many deaths, as a percentage of the total number of administrations of a vaccine, it would take for the FDA to remove that vaccine from the market.

CDC says VAERS indicates no safety concerns with vaccines

The CDC’s website states: “To date, VAERS has not detected patterns in cause of death that would indicate a safety problem with COVID-19 vaccines.”

Yet, on its website, the agency acknowledges 4,178 reported deaths among people who received a COVID vaccine between Dec. 14, 2020, and May 3, and determined that “a review of available clinical information including death certificates, autopsy and medical records revealed no evidence that vaccination contributed to patient deaths.”

We asked how the CDC arrived at this conclusion, where the public could access information regarding autopsies, what would be required to confirm a vaccine was the cause of death and whether there is an option to list the vaccine as a cause of death on an autopsy form.

Reports of blood clots with mRNA vaccines

We recently supplemented our questions with the most recent VAERS numbers on vaccine injury as evidence increases that the Pfizer and Moderna vaccines cause similar rare blood clotting disorders as those reported after AstraZeneca and J&J vaccines.

As The Defender reported April 30, VAERS yielded a total of 2,808 reports associated with the formation of clotting disorders for all three vaccines from Dec. 14, 2020 through April 30.

Of the 2,808 cases reported, there were 1,043 reports attributed to Pfizer, 893 reports to Moderna and 860 reports to J&J. U.S. health officials only acknowledged 15 blood clot cases associated with the J&J vaccine at the April 16 meeting where a vote was taken to lift the pause on the shot and resume use without restrictions.

CDC reduces Ct threshold for COVID testing

As of April 26, 2021 more than 9,245 COVID cases had been reported in the fully vaccinated, known as “breakthrough cases.” The CDC recently recommended reducing the RT-PCR Ct value to 28 cycles when testing fully vaccinated people for COVID.

The lower threshold would result in a decrease in positive breakthrough cases, calling into question COVID vaccine efficacy data.

Dr. Fauci recommends a Ct value of 35. Globally, the accepted cut-off for Ct value for COVID ranges between 35 and 40, depending on instructions from manufacturers of testing equipment.

According to the Indian Council of Medical Research (ICMR), a patient is considered positive for COVID if the Ct value is below 35. In other words, if the virus is detectable after 35 cycles or earlier, then the patient is considered positive.

“If the benchmark were to be lowered to 24 it would mean that Ct values in the range 25-34 would not be considered positive. A benchmark of 35, therefore, means that more patients would be considered positive than we would get if the benchmark were 24.”

We asked the CDC to explain why it changed the recommendations for COVID testing in vaccinated patients, the impact this will have on reports of breakthrough COVID cases and why the agency does not apply one RT-PCR testing standard for testing, regardless of vaccination status.

CDC stops counting all breakthrough cases

Federal health officials this month decided to limit how they monitor vaccinated people infected with COVID, drawing concern from some scientists who said the missing data could hinder scientists’ ability to investigate why and how breakthrough cases happen, Bloomberg reported.

Every Friday, the CDC posts the number of breakthrough cases in fully vaccinated individuals on its website. On May 7, the CDC announced it will transition to reporting only patients with COVID breakthrough infection who were hospitalized or died to “help maximize the quality of the data collected on cases of greatest clinical and public health importance.”

The change in reporting, which takes effect May 14, will reduce the number of breakthrough cases reported.

According to Bloomberg, tracking and sequencing cases helps determine who may be more at risk, whether new variants evade vaccines and when protection from shots begins to wane. Those infected — some of whom are suffering widespread medical issues, even if they’re not hospitalized — say they feel lost as a result of the lack of information.

“We shouldn’t be narrowing the focus, we should be broadening and develop a systematic plan,” said Eric Topol, director of the Scripps Research Translational Institute in La Jolla, California.

Tom Clark, head of the vaccine evaluation unit for the CDC’s vaccine task force, said the CDC is maximizing the quality of data collected on cases, and the agency shifted its strategy because there are few worrying patterns in the data collected so far, suggesting the focus should be on the most severe cases.

However, Michael Kinch, associate vice chancellor at Washington University in St. Louis, said as much information as possible should be recorded on breakthroughs. Cases that don’t rise to hospitalization are still important to track, Kinch said, since symptoms that aren’t as severe for someone could eventually lead to hospitalizations. Non-life-threatening symptoms can impact someone’s life greatly, and evolve over time, he added.

We asked the CDC to explain why the agency altered the way it counts COVID breakthrough cases, to explain the effect this will have on breakthrough numbers and how the CDC can monitor vaccine efficacy if it excludes breakthrough cases of COVID that do not result in hospitalization or death.

To date, we have yet to receive a response, but will continue to press the CDC for answers to our inquiries.

Here are our questions:

CDC Questions for Congressional Inquiry

1. According to your website, the CDC follows up on every reported death following vaccination to request additional information and learn more about “what occurred to determine whether the death was a result of the vaccine or unrelated.”

As of April 30, there had been 157,277 adverse events reported to the CDC’s Vaccine Adverse Events Reporting System (VAERS) following COVID vaccination, including 3,837 deaths and 16,014 serious injuries. The CDC’s website acknowledges 4,178 reported deaths among people who had received a COVID vaccine between December 14, 2020 and May 3, 2021.

• How many of these reports has the CDC followed up on so far?
• What criteria determines whether there should be further investigation?
• What does an investigation entail?
• How long does a single investigation take, on average?
• Where can the public access the findings of the investigations conducted into the reported deaths?

2. The CDC’s website states, “To date, VAERS has not detected patterns in cause of death that would indicate a safety problem with COVID-19 vaccines.” However, a search of reports filed as of April 30 shows what appear to be a number of patterns.

Please explain why the CDC does not acknowledge these:

• Of the 3,837 deaths reported as of April 30, 25% occurred within 48 hours of vaccination, 17% occurred within 24 hours and 40% occurred in people who became ill within 48 hours of being vaccinated.
• 21% of deaths were related to cardiac disorders.
• There were 44,348 reports of anaphylaxis with 38% of cases attributed to Pfizer’s vaccine, 47% to Moderna and 14% to J&J.
• As of April 30, there were 2,808 reports of blood clot disorders for all three vaccines in the VAERS system. Of the 2,808 cases reported, there were 1,043 reports attributed to Pfizer, 893 reports to Moderna and 860 reports to J&J.
• As of April 30, 805 pregnant women reported adverse events related to COVID vaccines, including 235 reports of miscarriage or premature birth.
• Of the 1,597 cases of Bell’s Palsy reported, 51% were reported after Pfizer-BioNTechvaccinations, 40% following vaccination with the Moderna vaccine and 131 cases, or 10%, of Bell’s Palsy cases were reported in conjunction with J&J.
• There were 162 reports of Guillain-Barré Syndrome with 41% of cases attributed to Pfizer, 45% to Moderna and 19% to J&J.

3. In reference to the 4,178 reported deaths, the CDC’s website states, “A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.”

• What are the criteria for determining whether the vaccine caused and/or contributed to the reported death?
• Where can the public access the CDC’s review of reported deaths?

4. On Jan 3, the Florida Health Department and CDC announced it was conducting an investigation into the death of Dr. Gregory Michael who died shortly after receiving Pfizer’s COVID vaccine. Dr. Jerry L. Spivak, an expert on blood disorders at Johns Hopkins University, told the New York Times that he believed it was a “medical certainty” that Pfizer’s COVID vaccine caused Michael’s death.

On April 8, medical examiners established that Michael died of complications from ITP, but officially categorized the death as natural because, according to Darren Caprara, director of operations for the Miami-Dade County Medical Examiner Department, there was “no medical certainty” the vaccine caused Michael’s death.

On Feb. 4, the media reported that state and federal officials were investigating the death of a 58-year-old woman, Drene Keyes, in Virginia, who died hours after receiving the first dose of Pfizer’s COVID-19 vaccine from an anaphylaxis. An article published March 7 disclosed that no autopsy was conducted into Keyes cause of death and the family had to procure their own.

State Health Commissioner Norman Oliver told public information officers in an email Feb. 5 if reporters asked whether an autopsy was done, they should say “a full autopsy was not needed in order to ascertain whether the death was related to the vaccination.”

Oliver’s email was part of a public records request that revealed officials inside and outside the health department were concerned the death of Keyes, who is Black, could worsen vaccine hesitancy among minorities.

On Feb. 5, a 39-year-old woman from Ogden, Utah, died four days after receiving a second dose of Moderna’s COVID vaccine. Kassidi Kurill died of organ failure after her liver, heart and kidneys shut down. She had no known medical issues or pre-existing conditions, according to her family.

• Where can the public access the findings of the investigations for Michaels, Keyes and Ogden?
• Does the CDC have any mechanisms in place to ensure that local public health officials properly investigate reported deaths?
• Why did the CDC not request an autopsy be performed on Keyes? 
• Are autopsies considered essential to prove that a vaccine caused a death, or is an autopsy not an effective tool for determining causation and if not, why not? Can a causal relationship be established without an autopsy? 
• If no, what happens in those cases where a report is filed but no autopsy was done — are those reports thrown out? Or is the vaccine ruled out as causing or contributing to the death?

5. Numerous medical examiners and pathologists have stated there is not an option to select a vaccine as a cause of death on their reports. This has obvious implications for determining whether a vaccine is an underlying cause or contributing factor to a reported death.

• Can you verify that both medical examiners and pathologists have the option on their forms to indicate that a vaccine caused and/or contributed to a death?
• Does the CDC differentiate between a vaccine “contributing to a death” and “causing” a death? If yes, what are the criteria for differentiating between “contributing” and “causing?” And are both reported to the public?

6. According to the CDC website and FDA’s EUA approval materials, healthcare providers are required to report certain adverse events to VAERS by law. Yet, according to the CDC, which references a study published by “Vaccine,” only 17% of physicians reported to VAERS despite more than 31% having witnessed a reaction they believed to have been caused by the vaccine.

Multiple reports have determined that as few as 1% of adverse reactions post-vaccine are ever reported to VAERS. Physicians receive little or no training in how to recognize a vaccine adverse reaction, nor are they trained in medical school on how to file a report in VAERS.

• Is there any mechanism in place by which the CDC can confirm whether healthcare providers are reporting to VAERS?
• What, if any, measures is the CDC taking to improve VAERS, including ensuring that all healthcare providers fully report on all adverse reactions to COVID vaccines, which were developed in record time and are still, by definition, experimental products?

7. On the CDC website it states: “To date, VAERS has not detected patterns in cause of death that would indicate a safety problem with COVID-19 vaccines.”

• Can you explain how the CDC arrived at this conclusion considering there have been 3,544 reported deaths (with 25% having occurred within 48 hours of vaccination), 12,619 serious injuries and more than 118,902 adverse reactions –– many of which were reported by healthcare providers?

8. As of April 30, there were 2,808 reports of blood clot disorders for all three vaccines in the VAERS system. Of the 2,808 cases reported, there were 1,043 reports attributed to Pfizer, 893 reports to Moderna and 860 reports to J&J.

A Utah teen was hospitalized with three blood clots in and near his brain that developed after he received the first dose of Pfizer’s COVID vaccine. Everest Romney, 17, received the vaccine April 21 and began experiencing neck pain, fever and severe headaches one day later. The teen was diagnosed with two blood clots inside his brain, and one on the outside.

• Is the CDC investigating reports of clotting disorders with mRNA vaccines?

9. In March 1976, the federal government rushed the H1N1 vaccine to market after hundreds of soldiers at Fort Dix, New Jersey, contracted the new virus strain. Of the 45 million people who received the vaccine, 450 developed Guillain-Barré syndrome and of those, more than 30 died.

Months later — in December 1976 — the government suspended the H1N1 mass vaccination campaign, after the National Academy of Medicine concluded people who received the vaccine had an increased risk for developing Guillain-Barré.

• How many deaths, as a percentage of the total number of administrations of a vaccine, would it take for the FDA to remove a vaccine from the market? And how do the criteria for removing vaccines from the market compare with criteria for removing other types of drugs?

10. As of April 26 more than 9,245 COVID cases had been reported in the fully vaccinated. These are referred to as “breakthrough cases.”

In early May, the CDC recommended reducing the RT-PCR Ct value to 28 cycles for those being tested for COVID after having been fully vaccinated. A lower Ct value indicates a higher viral load in the sample, and vice versa. A PCR test commonly uses 40 cycles of amplification, Dr. Fauci recommends 35 and the global standard is 35.

Lowering the Ct values to 28 (excluding Ct values between 29 and 35) for vaccinated individuals will reduce the number of positive COVID breakthrough cases, calling into question COVID vaccine efficacy data.

• Can you explain why the CDC recommends a lower Ct value for those having been vaccinated for COVID?
• Can you explain the impact of reducing the RT-PCR threshold to 28 on breakthrough COVID cases?
• Can you explain why the CDC does not require one RT-PCR testing standard?
• Why did the CDC change their reporting on breakthrough cases May 7 to exclude cases of COVID in the fully vaccinated unless they result in hospitalization or death?
• The vaccine is designed to prevent COVID and/or moderate to severe COVID. How can the CDC monitor vaccine efficacy if it excludes COVID cases that do not result in hospitalization or death?

11. In December 2020, the CDC launched taxpayer-funded V-safe, a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after receiving a COVID-19 vaccine. According to the CDC’s website, you can quickly tell the CDC via this app if you have any side effects after getting vaccinated.

• Where can the public access the information from V-safe? And if this information isn’t being made available to the public, why isn’t it and who is privy to the data?

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Megan Redshaw is a freelance reporter for The Defender. She has a background in political science, a law degree and extensive training in natural health.

Featured image is from Children’s Health Defense

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