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Their vaccine injury reports disappeared from VAERS — So they developed a tool for anyone to track their own reports

By Brenda Baletti, Ph.D. | The Defender | September 11, 2024

A team of researchers is developing a tool to track reports in the Vaccine Adverse Event Reporting System (VAERS), so vaccine-injured people can follow what happens to the reports they submit.

As part of a broader effort to hold public health agencies accountable, the tool will also make it possible to audit the VAERS system by identifying what types of reports are deleted, insufficiently updated or contain errors.

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), which jointly oversee VAERS, have refused to do this work despite multiple appeals by advocates for the vaccine-injured, according to React19, the group leading the initiative.

React19, founded by a small group of medical professionals injured by COVID-19 vaccines, works with institutions and providers to increase understanding and awareness of patients experiencing lasting effects following COVID-19 and/or COVID-19 vaccines.

The group is teaming up with computer programmer Liz Wilner, founder of OpenVAERS — a website that provides tools for more easily accessing and searching VAERS data — and Children’s Health Defense (CHD) to develop the tool.

The idea for developing the automatic VAERS report tracking tool came out of a VAERS audit the group conducted in 2022 to assess how the FDA and CDC were following up on COVID-19 vaccine injury reports.

React19 worked with outside experts to review a sample of 126 VAERS reports filed by some of its members who wanted to know what happened to their reports.

After tracking down each person’s reports and following them through the VAERS system, they “were kind of shocked at how bad it is,” members of React19 told The Defender.

They found that only 61% of the reports filed were correctly logged and published in VAERS. Twenty-two percent of the reports were never issued a permanent ID and are therefore not publicly visible, 12% were deleted and in 5% of the cases, a report couldn’t be filed or their report number remains unknown due to system errors.

That means more than 1 in 3 reports searched couldn’t be found in a database that is meant to be publicly accessible and transparent. It also suggests that problems of “omission of data and underreporting may be even greater than estimated,” according to the audit report.

The group also found that the medical status of the deleted reports, “by and large, had a worse outcome than the ones that were still in the system,” they said. For example, they said, in the public-facing VAERS system, 23% of reports were for permanent disabilities — but in the deleted reports, 53% were for permanent disability.

“One of the more alarming things we found out was that not all death reports are investigated,” Brianne Dressen, React19 founder, told The Defender.

The group brought this to the attention of public health officials in their meetings, sharing examples of reports that had been updated by people’s families when they died, but didn’t show up on the public system.

They also found that many follow-up reports containing updates on worsening symptoms were gone from the system.

At the time, the group was meeting regularly with top officials, including Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, to discuss vaccine injuries and why the agencies were doing nothing to address them.

In those meetings, according to Dressen and React19 member Dr. Joel Wallskog, when they raised the issue that the agencies weren’t following up on VAERS reports, the FDA told them VAERS wasn’t a reliable indicator for vaccine injuries, because anyone could file an injury complaint, including “Mickey Mouse or Michael Jackson.”

“We told them we know thousands of people that have not had any follow-up on their VAERS reports that are not Mickey Mouse, and they’re suffering it every single day waiting for you guys to get back to them to investigate what happened to them,” Dressen said.

“And of course then they never did anything. So we were like, OK, fine. If they’re not going to generate the evidence, then we will ourselves.”

The group submitted their findings to Marks during a meeting with him and his team. Based on their findings they also requested an external audit of the entire VAERS system and posed a series of questions listed on their audit report webpage.

They never heard from the agencies again.

“We were like, really?” Dressen said. “We were having these regular meetings with them every one month or every two months, and then after that, they wouldn’t meet with us anymore.”

Dressen, who was injured in the AstraZeneca clinical trials and whose diagnosis of post-vaccine neuropathy and other vaccine-related disorders was confirmed by the National Institutes of Health, said her own VAERS report is not visible to the public. The agencies haven’t told her why.

More recently, still hoping for accountability from the public health agencies, React19 submitted its audit and complaint to the Office of Inspector General at the U.S. Department of Health and Human Services.

The only response they received was an autoresponse confirming receipt of the complaint.

Attempt to ‘bring power back to the people’

In its small pilot audit, React19 found the VAERS system is “obviously broken from top to bottom.” According to Dressen, “One thing we can easily conclude is that the FDA and CDC have no interest in addressing these issues.”

Now, the group is scaling up the project to do a larger audit with more data.

With help from OpenVAERS and CHD, the team built a backend, automated administrative tracking system that eliminates the need to manually search for each report and its journey through VAERS — something the analysts had to do for the first iteration of their audit.

Participants will register on the React19 website and will be invited — if they are interested — to share their stories as part of the organization’s project to collect and publish vaccine injury testimonials.

Users can share any information they have about their VAERS report — their ID number if they have one, or if not, details about their case. Then they will receive a monthly email with the status of their report.

For example, someone who has a user ID and a public-facing report will be informed if their report disappears. In the case of those people who filed a VAERS complaint but never got an ID number, the system will search each month for the record and try to find the ID.

“We’ll be able to track these reports through the system and figure out what happens to them,” Wilner said. “Do they disappear? Do they appear and the person doesn’t get notified? Do they appear incorrectly?”

“So people will be able to track their own reports with less effort and React19 will be able to audit a much larger user base than they initially did.”

Wilner said auditing VAERS in this way also reveals details about how the agencies are “either lying or deliberately obfuscating the process.” In the first audit, it was clear there was no systematic or automated way that, for example, reports were deleted.

The tracker and the audit will provide valuable data that no one else has. Rather than having only the stories, Wilner said, they will have the data backing up those stories. “Now we have a group of injured people that are all talking with one voice.”

“Without more pressure and more discovery,” Wallskog said, “I don’t think we’re ever going to get the truth out. Ultimately, we want to get this information to the masses of people that just don’t know what’s happening, particularly with this data, and that we’ve all been duped.”

Dressen said the project is an attempt to “bring the power back to the people.”

The COVID-19 vaccine produced a large swath of vaccine injuries all at the same time, she said. Auditing the COVID-19 entries in VAERS will provide an opportunity “to show through massive numbers where those problems are, not just with the systems that are supposed to be monitoring vaccine safety, but also the actual harms themselves and what those are, but the government’s not doing their job on that.”

The two faces of VAERS and the problem of accountability

Wilner said Dressen’s injury report, sitting in VAERS limbo, spoke to one of the major issues around claims of transparency in the database — that there are two versions of VAERS, a public-facing database and a private one.

The BMJ reported last year that it investigated the VAERS database and found that the public facing database contains only initial reports. And “a private, back end system containing all updates and corrections — such as a formal diagnosis, recovery, or death.”

The CDC told The BMJ that this was part of patient confidentiality, but the publication found that in the FDA’s Adverse Event Reporting System, they do update the database — “raising the question of why VAERS can’t do the same.”

And during the React19 audit, the group found that VAERS was sometimes deleting people’s legitimate reports or the more detailed updated reports that some people were submitting.

Another problem, Wilner noted, is that a lot of key information — such as race, pregnancy and report provider — is unnecessarily withheld from public VAERS reports. She also said the agencies sometimes leave reports on there that are clearly false or jokes, which then discredits the database in the public’s eyes.

On the CDC website, Wilner said, “you’re basically looking at a doctored set of books.”

Wallskog said the agencies “try to live on both sides of the fence” with VAERS, presenting it as a key tool for monitoring vaccine injuries. But when it shows a safety signal or an issue with vaccines, they discredit it as a problematic surveillance system with a lot of limitations that can’t be trusted.

“It’s incredibly frustrating for injured people,” he said.

The team working on the new VAERS tracking system and audit said they hope it will raise public awareness and force the public health agencies to take responsibility for the vaccine injuries.

“Rochelle Walensky said the CDC is charged with finding legitimate vaccine injuries and reporting them,” Wilner said. She added:

“If that’s the case, where is that? We don’t have access to the actual database to figure it out so we want to know where is the report from the CDC on the people that were actually injured by the COVID vaccine that the government accepts were legitimately injured? That report doesn’t exist.”

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

September 11, 2024 Posted by | Aletho News | , , , , | Leave a comment

Public VAERS Data May Be Woefully Out of Date

By Dr. Joseph Mercola | February 15, 2022

In this short video posted on BitChute in December 2021, Brittany Galvin gives an overview of what she had to do in the previous six months to report her vaccine adverse events to VAERS. She begins by sharing that she has once again received an email asking for information on her VAERS report1 that was initially entered in May 2021.

VAERS is the Vaccine Adverse Event Reporting System2 that was first established in 1990. It is coadministered by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration (FDA). The system is supposed to be an early warning signal for vaccine manufacturers and health experts to identify vaccines that may be triggering a higher than expected number of adverse events. One of the primary objectives of the program is to:3

“Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.”

Anyone can make a report to VAERS — both patients and health professionals can use this system to report health concerns they suspect may be connected to a vaccine. Health professionals are required to use it for all adverse events that occur after the COVID-19 emergency use shots, but since the system is passive, whether the reports actually get filed depends entirely on each individual living up to that responsibility.

The reports must contain all hospital records and any other relevant medical information. Unfortunately, as Galvin succinctly notes in her video, the system is not efficient, and the data may be woefully out of date. This has a significant impact on monitoring the effects of the COVID inoculation program since it’s possible the currently published death and adverse event rates may be reprehensibly different from reality.

Magnetized Mom Tries to Report Injury to VAERS

Galvin has created many social media videos to document her journey. This four-minute synopsis begins with her vaccinations in May and ends in November 2021. In June 2021, in an interview with Stew Peters4 during her third hospitalization in two weeks, Galvin recalls that after her first injection, she immediately experienced chills, fever and many of the symptoms that others are reporting.

In addition to this, within four to five hours after the first shot, her legs felt heavy, which she described as feeling like she was walking through mud or cement. The experience left her nervous before the second dose. She put off getting the second shot for as long as she could. While she experienced no immediate symptoms after the second injection, on Day 13 her life changed.

Initially, she thought she had a seizure but later learned that her muscles had suddenly “seized up.” She passed out and reported severe pain in her head when she regained consciousness. Originally, the doctors believe she had had either a stroke or a seizure.

She was sent home from the first hospitalization with a diagnosis of pericarditis but when her symptoms didn’t get better, she was admitted two more times. On the third admission in two weeks, a neurologist told her that she had Guillain-Barre Syndrome (GBS) because of the Moderna injection. In addition, she was also diagnosed with postural orthostatic tachycardia syndrome (POTS).

Stew Peters comments that this was the first time he and others on his team had heard a doctor admit the adverse events were from a genetic therapy COVID-19 shot, yet Galvin reports that the physicians and nurses who treated her told her they had seen many patients with adverse events after the shots.5

Galvin reports the first question she was asked at each of the three ER visits was had she gotten a vaccine, when and which one? This suggests that health care officials and hospitals are aware of adverse events that are not reported in mainstream media.

She told Peters that she has never been against vaccines but didn’t want this one. She took it so she could go back to work. Instead of listening to her intuition, she listened to the shaming and the commercials that said if you didn’t have a vaccine you’d have to live differently. Now she wonders why all the people who have been concerned about people who died from the infection aren’t as concerned about dying from the vaccine.

Galvin’s social media page was originally filled with videos she had taken of herself, placing metal objects on her body that stuck because she was inexplicably “magnetized.” She reports that the doctors in the hospital have also placed metal objects on her skin and have seen with their own eyes that she is magnetized.

In addition, the MRI tech discovered that his body was also magnetized after seeing Galvin demonstrate how a spoon could attach to her body. As of January 2022, she is eight months into the reporting process to VAERS and has been advised by VAERS staff that it may be another six to 12 months before her case is posted.6

VAERS Has Only 50 People Processing Reports

Galvin has created several videos talking about the journey she’s been on trying to report her adverse events to VAERS. In a video posted in January 2022 on Odysee,7 Galvin recorded her phone conversation with an investigator from VAERS to discuss why her report filed in late May 2021 had not yet been counted in the system.

In one conversation she learned that the process takes many steps through different departments. The first stop for the VAERS reports is in a department with only 50 employees.8 Once the package of information is completed by this department, it is sent to a team of nurses who read and review every page.

If the staff have any concerns or if they feel they need more information, the package will be sent back to the first department for further information gathering.9 According to the recorded conversation, one investigator suggested that since anyone can make a report to the system, it’s possible there could be multiple reports for an individual and that this may be a reason why Galvin received multiple requests for information to complete her VAERS report.

And, that’s what did happen: There were two VAERS reports in the system for Galvin, one submitted by Galvin, and another submitted by Moderna. The VAERS report was still missing hospital information, which had been requested several times through the medical records department of the hospital. The VAERS investigator acknowledged that the reporting is a long process and explained:10

“The hospitals, a lot of them are not sending the records. My last two reports where they said, “We didn’t receive the requests.” Well, I’m like, OK, is this your fax number. “Yes, this is our fax number” … so, a lot of them are not sending the records when we ask for it.”

Galvin expressed her concern that there were hundreds of thousands of people like her and just 50 VAERS employees trying to process these reports. It could be months before the CDC receives the report of her vaccine injuries that can be published.11

“Meanwhile the whole government is trying to force everyone to get this thing. Lying to the people telling them that “no one has gotten GBS from it” but here I sit barely able to walk and my case isn’t going to be ‘technically’ reported because the CDC hasn’t investigated yet because the hospitals are dragging their feet … it’s like a revolving crazy door and all of us humans on this planet and in this country are being lied to, and it’s unfair.”

More Reasons Why Adverse Events Are Underreported

At the end of the conversation with the investigator, Galvin learned that while her report was filed in May 2021, it wasn’t assigned to someone at VAERS until September or November 2021.12 In addition to short-staffing at VAERS and hospitals dragging their feet to produce the documentation needed to support claims, there are other reasons why there is a significant underreporting factor in the system.

In the latter months of 2021, Deborah Conrad, certified physician assistant who worked as a hospitalist at a local hospital, stepped forward to speak to Del Bigtree at “The Highwire” about the lack of reporting to VAERS within her hospital. She also provided a voice recording of a conversation with the chief medical officer who chastised her for spending her time off to make the reports to VAERS for other physicians.13

The chief medical officer said: “There is a risk to the organization from a perspective of both underreporting and overreporting.”14 In other words, the lives of the patients were not the issue. And, despite the diligence done by VAERS investigators to ensure the reports are complete and accurate, the hospital must not overreport any injury.

It’s shocking that many physicians are still not aware of VAERS. Before 2020, the system was used primarily by pediatricians to report adverse events from childhood vaccines. Doctors were not educated on how to identify potential injuries, how to report them, or that they have a legal requirement to report all emergency use vaccine injuries.

In fact, this was one of the reasons used by Dr. Anne Schuchat, principal deputy director of the CDC, for pausing administration of the Johnson & Johnson jab when it was first revealed that individuals who took it had a higher risk of blood clots. She told ABC News:15

“One of the reasons for the pause was to make sure clinicians knew how to diagnose and treat this, but also to report it. Because we don’t know if we’ve missed some cases, whether the risk really is 1 in 1 million, or perhaps more than that.”

In addition to the lack of education, another reason why so few physicians report suspected injuries is because there are no penalties for failing to fulfill this legal responsibility. In other words, this passive reporting system is not enforced. As Conrad described in her interview with Bigtree, the forms are also long and tedious to fill out.16

Additionally, not all of Conrad’s colleagues agreed that the injuries should be reported because they didn’t want to believe that the vaccines could cause injury. Historically, vaccine injuries have been routinely underreported, even among pediatricians. A report published in late 2010, which has become known as the Lazarus Report after the principal investigator Ross Lazarus, found:17

“Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA).”

More recently, a group of scientists used an engineering algorithm to determine the underreporting factor and found it had improved to 41, not less than 1% as had been reported 11 years earlier.18,19 This may be due in part to the media attention on VAERS. Nonetheless, there continues to be a significant underreporting factor indicating the numbers in VAERS20 are likely 41 times higher than published.

CDC and NIAID Imply Car Crashes Are Reported in VAERS

In addition to the underreporting factor and overworked VAERS employees that have created a large gap between the number of reports being submitted and the number being published, Dr. Anthony Fauci and Dr. Rochelle Walensky appear bent on completely discrediting VAERS.21

Fauci is the director of the National Institute of Allergy and Infectious Diseases (NIAID) and Walensky is the director of the Centers for Disease Control and Prevention (CDC). Since the CDC co-manages VAERS you would expect that she would have at least a working knowledge of how the reports are accepted and verified before being published.

During testimony January 11, 2022, before the Senate, both Fauci and Walensky very clearly stated that any death after a vaccine could be reported to VAERS. Both used the example of an individual who gets vaccinated, hit by a car and dies.

They implied without outright stating that this death would also be recorded in VAERS and logged as a death related to the vaccine. In other words, they both skirted the issue without outright lying to the Senate. Walensky said:22

“The vaccine adverse event reporting system is a mandatory system of any event that happens after being vaccinated. So, if you get hit by a car tragically after being vaccinated, that gets reported in the vaccine adverse event reporting system, the VAERS system.

So, the vaccines are incredibly safe. They protect us against omicron. They protect us against delta. They protect us against COVID. They don’t protect us against every other form of mortality out there.”

However, it’s evident not all medical professionals are reporting adverse events. Yes, you can report a car accident death after a vaccine, but the verification process will weed out that death.

Overall, the shots have not protected people from getting Omicron, Delta or any other form of COVID, which Walensky made clear in a CNN interview the day before testifying before the Senate.23 And, it goes without saying, that there is no shot that protects anyone from all forms of mortality.

Immediately after her response, Walensky was asked if the CDC kept data on the number of people who have died as a result of the vaccine. And she answered: “Absolutely yes. I couldn’t give you the number off the top of my head, but our staff could absolutely get back in touch with you.”

So, while publicly denying that any deaths have occurred from the jabs, Walensky is basically admitting that the CDC is aware that there have been people who died from this “incredibly safe” vaccine. Fauci was then asked if he knew the number or “had any clue on that, and he said:”24

“I don’t know the number, but I think part of the confusion is that when you do a reporting, when you get vaccinated, and you walk out and get hit by a car that is considered a death.

That’s the thing that gets confusing, that everything that happens after the vaccination, even if you die of something completely obviously unrelated, it’s considered a death. So, if I had metastatic cancer, got vaccinated and died two weeks later, that’s a death that gets counted.”

Fauci’s statement only implies that the death is counted as a vaccine death. That is, until his example of having metastatic cancer, when he says, “that gets counted.” Until that point, neither Fauci nor Walensky said it was anything more than a death. Meaning that they didn’t specifically say it would be recorded as caused by the vaccine.

When Fauci said “that gets counted,” Walensky immediately jumped in to save the explanation with, “And every one of those is adjudicated.”25 In other words, each of the reports of death not in any way associated with the shot are removed from the record. But unless you are listening carefully, you will mistakenly be led to believe that VAERS is riddled with reports of injuries and deaths not caused by the shot.

Sources and References

February 17, 2022 Posted by | Deception, Timeless or most popular, Video | , , , | Leave a comment

FDA admits: Neither VAERS nor its many other pharmacovigilance systems are functional, nor will VAERS be in the future

By Dr. Meryl Nass, MD | August 24, 2021

FDA made an extraordinary admission in its letter to BioNTech yesterday, to justify failing to find safety “signals” better know as serious, common vaccine-induced injuries and deaths. So it asked the fox to please guard the henhouse instead. Pretty please Mr. Pfizer, would you look into myocarditis and other serious problems for us? We are not capable…

Guess FDA thought few would be able to parse its bureaucratize, discussed here and in the prior 5 posts. See page 6 of the document linked above:

“We have determined that an analysis of spontaneous postmarketing adverse events [VAERS reports] reported under section 505(k)(1) of the FDCA [Federal Food, Drug and Cosmetic Act] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. 

Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.”

Let’s parse this some more. VAERS, with about 13,000 deaths reported this year, and about 500,000 adverse events reported this year, is somehow unable to be analyzed to discover what it was established by Congress to discover: serious vaccine-induced adverse events. Reporting to VAERS since the vaccines became available is unprecedented. For example, about 8,000 cumulative deaths were reported to the system during its entire 30 year existence. Yet in 2021, over 12,000 deaths have reported following Covid vaccinations alone.

We already know from Israeli data, and US data presented to CDC’s advisory committee on June 23, that the rate of reported cases of myocarditis in vaccinated teenage boys aged 12-17 is at least 25 times greater than expected, and is 50 times greater than the reported rate in vaccinated males over 65. 

But analysis of VAERS by CDC and FDA, who jointly manage it, cannot properly assess this risk? Even though Congress requires them to do so?

Equally as shocking, FDA can apparently see into the future, and any hopes that it will soon fix its analytic conundrum have been dashed. FDA can already state that VAERS analysis will not be sufficient to assess known myocarditis risks.

What about all the other databases that Steve Anderson, PhD, head of the Office of Biostatistics and Epidemiology, told us in October he would be using to evaluate vaccine safety? I posted screenshots showing databases encompassing over 300 million people that Anderson said FDA would access to evaluate the safety of Covid vaccines. After all, this system is required by Congress to function, and if it doesn’t, FDA is breaking the law:

“the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.”

So there you have it. FDA is required by law to properly use and maintain massive databases for the evaluation of vaccine safety. Yet it says neither is working. But no matter, FDA issued a license for the Comirnaty vaccine anyway yesterday.

August 26, 2021 Posted by | Science and Pseudo-Science | , | Leave a comment