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Are Adverse Events in COVID-19 Vaccine Trials Under-Reported?

vaccine adverse events

Opinion | Phase III controlled trials are considered the ‘gold standard’ for assessing vaccine efficacy and safety in humans. These are the trials upon which authorities have assured the public that COVID-19 vaccines are “safe and effective.”

The benefits of the vaccines in reducing disease severity and hospitalizations are well-known, but what do we know about the adverse events?

Data on adverse events is vital for effective decision-making by regulators, policy makers, doctors, and patients. But there are serious concerns about publication bias or selective omission of data, whereby adverse events are less likely to be published than positive results. A systematic review in PLOS journal analyzed 28 studies and found that adverse events were less likely to appear in published journal articles than unpublished studies (e.g. industry-held data).

Experts now suggest that the pivotal COVID-19 vaccine trials may have under-reported adverse events in several ways.

Virtual Monitoring With Digital Apps

In the Pfizer and AstraZeneca vaccine trials, participants were given digital apps to record adverse events remotely—a more convenient, time efficient and cost-effective way of gathering patient data. A major problem however, is that the pre-determined options on the digital apps have a narrow focus on particular adverse events.

For example, the app only allows a participant to record what the company deems as ‘expected’ events such as fever, pain at injection site, temperature, redness, swelling, fatigue, headache, diarrhea, chills, muscle and joint pain. But if they experience a serious adverse event like myocarditis or early signs of transverse myelitis, Guillain-Barré syndrome, a myopathic disorder, myocarditis or thrombosis, there is no option for them to record it on the app.

Case in point: Brianne Dressen, a participant in the AstraZeneca (AZD1222) trial. She suffered a severe adverse event after her first injection and became disabled. But her smartphone app did not allow her to record the particular type of adverse event, nor did it allow her to record her symptoms in her own words.

Once hospitalized, Ms. Dressen was ‘unblinded’ from the trial. She was informed that she had been given the AstraZeneca vaccine, not the placebo, and advised not to have the second injection.

The investigators subsequently “withdrew” Ms. Dressen from the trial, they disabled her smartphone app, and all her data from that day onwards, were never documented despite still experiencing disability today.

Ms. Dressen was concerned about the lack of reporting of her adverse event (and others) in the trial’s publication in the top-tiered New England Journal of Medicine. She wrote to the journal seeking to “request inaccuracies in the trial publication be corrected, and to demand complete reporting of the trial publication and results.”

Editor-in-chief Dr. Eric Rubin refused to correct the inaccurate data in his journal. The full email exchange has been made public.

If vaccine manufacturers selectively withdraw subjects who experience serious adverse events (as in the case of Brianne Dressen and others) it may explain why the trials mostly found “statistically significant” increases in minor adverse events (fever, chills, headaches) but not in serious harms.

Blaming an Underlying Condition

When Pfizer recruited 12-15 year olds for its mRNA vaccine trial, the published data in the New England Journal of Medicine, stated that there were “no serious vaccine-related adverse events.”

One of the participants in the trial was 13-year-old Maddie De Garay. She was randomly assigned to the vaccine group and following her first injection, Ms. De Garay suffered a severe adverse reaction, leaving her in a wheelchair and fed by a nasogastric tube. She was referred to hospital for a full assessment and a doctor diagnosed Ms. De Garay with a “functional disorder.” Put simply, this doctor decided that a pre-disposition to “hysteria,” was to blame for her physical disability—not the vaccine—and on this basis, she was referred to a mental health facility.

Dr. David Healy, a psychiatrist based in Ontario, Canada, subsequently conducted a thorough review of Ms. De Garay’s medical records, including an interview with her family and found no such history of pre-existing conditions or mental illness. “This trial designation is not just wrong, but quite unbelievable,” said Dr. Healy, who feared that the erroneous diagnosis would jeopardize Ms. De Garay’s treatment and progress.

“It is perhaps even sociopathic as it appears that, in order to maintain Pfizer’s position, this young woman is not getting the treatment that would be ordinarily indicated for the kind of problems she has. Instead based on a claimed ‘functional disorder’, she has been directed to a mental health facility,” said Dr. Healy. “If there is any chance that you have a pre-existing condition, then they do not blame the vaccine,” he says. “And so they can claim there were no serious vaccine-related events because they do not believe her reaction was ‘vaccine-related’. It is quite unbelievable.”

Dr. Healy says he has seen it before—in Study 329—which looked at antidepressants (SSRIs) in children and adolescents. A 15-year-old boy was dropped from the trial after being diagnosed with an “intercurrent illness”.

It was only by chance, that later, Dr. Healy found out that the trial participant developed homicidal behaviors two weeks after taking the SSRI, which Dr. Healy says was almost certainly induced by the drug. But because the young boy was diagnosed with an “intercurrent illness” in the trial, it meant that the investigators did not have to write up a narrative explaining why this patient was dropped from the trial.

In AstraZeneca’s Phase III trial of its vaccine, the one in which Brianne Dressen was a participant, the study stated:

Deaths that were adjudicated as not related to COVID-19 were treated as intercurrent events and therefore censored at the date of death.

Dr. Healy said, “This may well be a sink-hole into which deaths from the vaccine have vanished. Patients with strokes, heart attacks or thrombotic events may have all vanished here, the justification being that they must have had a dodgy heart or another pre-existing [or intercurrent] illness.”

Vaccine-Related Deaths

When publishing deaths in the trials, Dr. Healy points out that investigators do not link the vaccine with any deaths that occur immediately after the first dose of the vaccine, up to 14 days after the second dose of the vaccine. In other words: 1) first injection, 2) wait for three weeks before having second injection, 3) wait a further two weeks. That is a total of five weeks where deaths are not considered to be vaccine related.

The investigators say it is because participants are not “fully immune” until two weeks after their second dose. That is true. However, it fails to capture any deaths that might be caused by the vaccine in that five-week period. Dr. Healy was very critical of this method of data collection.

“Randomized controlled trials are not supposed to allow decisions like this. All deaths should be reported. The company can say that they do not think the deaths were caused by the vaccine, but we need a chance to know how many there were and decide if these need further investigation,” said Dr Healy.

It is important to know because real world data obtained from the CDC (as of June 25, 2021) shows that the majority of reported deaths after a COVID-19 vaccine, occur within 30 days. This surveillance data cannot establish a causal link with the vaccine, but the signal is considered significant, especially if deaths linked to the vaccine are not being captured in the controlled trials.

The Lesson from “Controlled Trials”

Data about the safety of vaccines are just as important as the efficacy, although, the media and public health officials often focus on the latter. So far, reports of serious, life-threatening adverse events linked to the vaccines have not been found in the “gold standard” controlled trials. They were only detected once hundreds of thousands of people had been vaccinated.

Myocarditis, for example, only emerged from Israel once they started rolling out the Pfizer vaccine to the population. And reports of vaccine-induced thrombotic thrombocytopenia (VITT) linked with the AstraZeneca vaccine first emerged from European surveillance systems, not controlled trials.

If all COVID-19 vaccine trials are funded, designed, conducted, and analyzed by the manufacturers—which is known to distort the results to favor the sponsor’s aims—then more should be done to gain access to the data to allow for independent scrutiny.


This article was reprinted with the author’s permission. It was originally published at MaryanneDemasi.com. Maryanne DeMasi is an investigative journalist and TV producer/presenter. She is a former medical scientist. 

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Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers.  The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.

17 Responses

  1. It’s about time that this information has been published. Many doctors and research scientists have been warning us about the under reporting of the VAERS and I am greatly pleased that the general public has a chance to see the other side of the dangers of the covid vaccinations.

  2. Trust Big pHRMA? No way. Add in the government, whose goal is to achieve a almost 100% vaccinated population, excluding illegals, you have a recipe for huge disaster.

  3. Trust Big pHRMA? No way. Add in the government, whose goal is to achieve a 100% vaccinated population, excluding illegals, you have a recipe for huge disaster.

  4. Trust Big pHRMA? No way. Add in the government, whose goal is to achieve a 100% vaccinated population, undocumented people, you have a recipe for huge disaster.

  5. Trust Big pHRMA? No way. Add in the government, whose goal is to achieve a 100% vaccinated population, excluding illegals, you have a recipe for huge disaster.

  6. I am one who had a reaction to the second shot. Within 10 days after the shot I began experiencing pain in left shoulder that progressed to right shoulder eventually affecting shoulders and both knees with extreme pain. Not long after that the hands began and today I have lost a lot of flexibility in hands which are in constant pain. Medications have not helped. I don’t know where to get help since tests suggest mild arthritis. I know mild arthritis and this is not it.

    1. It is called reactive arthritis and can be caused by vaccines. A friend of mine had such a reaction and described her quality of life as zero. She has since gotten better but will not be receiving any more covid vaccines.

  7. Perhaps this is why the FDA wanted to take 75 years to release the Pfizer trial data–at the rate of 500 pages per day. Fortunately, the judge decided that the FDA can, and should, release 55,000 pages per day.

  8. Hysteria? Are you kidding me. Are we heading back to the time when they used that diagnosis to institutionalize women? What a crock! Anyone who trusts big pharma needs to see “The Crime of the Century” documentary and “Dopesick”.

  9. It’s nothing new to those with common sense, I had 2 family members and 2 friends all suddenly die within 48 hours of taking the 1st jab, but not one was shown to be vaccine related, 2 was shown stoke, and 1 was heart attack and 1 was liver failure. None of the four had ever been diagnosied with heart disease, organ damage or blood problems like high colosterol , 1 was taking blood pressure meds, but it was under control. Could not get any medical personnel or EMTs to report these as vaccine problems , if they did it was declined as any problem with vax. One last thought, Pfizer, Moderna and Astra Zenaca were all approved for EUA to start with. Then Astra Zenaca was no longer able to be used in the US. Then both mRNAs were still in use, but all of a sudden Pfizer got approved and forced on everyone,no longer an EUA , but here it is 2 years later and Moderna still hasnt been licensed ,and still used under EUA, question, WHY

  10. The doctor that developed the mRNA technology has a YouTube video warning of the damages may come down the road 3 to 5 years from continual boosters. Its already being reported that countries like Isreal that had started the 4th shot are starting to show a weakened immune system to other severe disease, even if they do stop the Covid virus, which has been proven to ease the symptoms ,but you can still catch and transmit the virus. Ask the question also, why the definition of vaccine was changed on Wikipedia and the encyclopedia in Jan. 2021. Answer, because they knew it didn’t stop the virus, but have called the pandemic a matter of the UNVACCINATED. And 1. million illegals poured accross the border with a 10% covid positive rate, then flew into large cities, they gave the illegals the option of taking or refusing the vaccine, yet trying to force every taxpaying US citizen to take the jab. Oh by the way ,do the math, 10% means 170000 postive cases let into the country but Fauci is telling you not to have Christmas or go to a ballgame, if you do it’s a SUPERSPREADER

  11. The doctor that developed the mRNA technology has a YouTube video warning of the damages may come down the road 3 to 5 years from continual boosters. Its already being reported that countries like Isreal that had started the 4th shot are starting to show a weakened immune system to other severe disease, even if they do stop the Covid virus, which has been proven to ease the symptoms ,but you can still catch and transmit the virus. Ask the question also, why the definition of vaccine was changed on Wikipedia and the encyclopedia in Jan. 2021. Answer, because they knew it didn’t stop the virus, but have called the pandemic a matter of the UNVACCINATED. And 1. million illegals poured accross the border with a 10% covid positive rate, then flew into large cities, they gave the illegals the option of taking or refusing the vaccine, yet trying to force every taxpaying US citizen to take the jab. Oh by the way ,do the math, 10% means 170000 postive cases let into the country but Fauci is telling you not to have Christmas or go to a ballgame, if you do it’s a SUPERSPREADER

  12. Ask why the definition of vaccine was changed on Wikipedia and encyclopedia in Jan 2021, because the shots they deem as vaccines did not meet the actual defininition of vaccine because they dont work

  13. To answer the title of this article. Understanding how rare it is for most people to even make the connection of an adverse reaction in the first place, then most likely always being met by a doctor that denies it even being possible because of their own ignorance. I would wager that the truth is that absolutely yes, they are incredibly under-reported!!!!!

  14. I never trust the science of vaccines in general, not only covid one. Good article yet very disturbing and upsetting. And policy makers, physicians and among others are supposed to publish accurate deaths or adverse reactions, they have failed to do so. I know they know the danger of three different markets of vaccine, but they are tongue tied evidently. Nothing is news. All they want is ———? You know the answer. (Hint: ????).

    P.S. I’m referring “they” as scientists, doctors, health officials, cdc and policy makers. That’s what I know so far.

  15. As this “vaccine” push was beginning I told anyone who would listen to just wait until at least the beginning of 2022 to see what happens to the early jab recipients. Now the chickens are coming home to roost, those who got the early jabs are now wishing they would have waited and not gotten them.
    The problems from the jab will only get worse as the effects of it will become increasingly obvious to everyone who has any access to the statistics, even if just peripherally.
    Increasingly greater numbers of “vaxxed” people will either become totally incapacitated or dead from the shots and the blame will be placed on everything but the shots.

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