CDC Required to Release Free Text Data in V-safe for COVID Vaccines

The CDC has been ordered to release the 7.8 million “free-text” entries of the COVID-19 vaccine data that was collected as part of the V-safe monitoring program. The Informed Consent Action Network (ICAN) won an initial lawsuit over a year ago for the CDC to release V-safe data. The only problem with the initial release is that the CDC was only required to provide the checked box field listing the “standard” reactions, such as pain, fever, and swelling at the injection site, amongst others. However, there was another field where users could input other adverse events they experienced in text format.

Of 10 million V-safe users for the COVID-19 vaccine, 7.8 million input text into the optional free-text field. It can generally be understood that any free-text entries most likely describe more severe reactions that weren’t listed as options in the checked-field portion. These reactions include myocarditis, pericarditis, anaphylaxis, stroke, Guillain–Barré syndrome, and Bell’s palsy, among many others. None of these known vaccine side effects were listed as default options, so individuals experiencing these symptoms could only report them through the free-text field of the V-Safe reporting application. This meant that the mild, ‘expected’ reactions to the vaccines are the only options V-Safe users could report.

These reactions include headache, nausea, fatigue, joint pain, and generalized pain. There are 19 million reports of pain from the 10.1 million registered users on V-Safe. Attorney Aaron Siri provided more information regarding the CDC’s position of reactogenicity, which means these symptoms prove the vaccine is working and are not relevant checks on vaccine safety. “Those are good to have,” Siri stated, referring to the CDC’s position on mild vaccine symptoms. “That means the vaccine is working. In fact, 30, 40, 50, and 60 percent of the V-safe users reported one or more of those symptoms. The CDC published studies going, ‘Oh, wonderful, the vaccine is working.’ So those symptoms- by their own admission, by the way- we know this from other FOIAs. The person who essentially ran the V-safe program at CDC. He said ‘these symptoms are meaningless for assessing safety.’ They certainly are. Remember, the first vaccine was only EUA in December, a month later. They (CDC) could’ve listed, how about just…chest pain. That would give you a sense of some type of cardiovascular…myocarditis. They could’ve done numbness in your extremities, which would indicate Guillain–Barré syndrome.”

Most of the V-Safe users were registered before the vaccine was available, so the people reporting symptoms are individuals who believe in the safety and efficacy of vaccines and were excited to be one of the first subjects. Nearly 8 out of 10 individuals who reported filled-in free-text fields that have not been provided for public or independent scientific review.

The V-safe data is what was used to determine whether these vaccines were safe for emergency use authorization. A robust safety test for any medical product should be a trustworthy evaluation of long-term safety risks. V-safe followed up and received reports for a full year after the vaccine. Over 40 studies have used V-Safe data to declare the COVID-19 vaccines safe, but those studies only refer to the first week of data. The CDC has also pointed to these studies as proof of the vaccine’s safety, but the years of data have not been analyzed or available for the public to view. The federal judge that has ordered the unsealing of the free-text fields described how it is important for the data to be made public for analysis and scrutiny.

Judge Kacsmaryk’s court opinion states, “Because Defendants structured V-safe to collect health and symptomatic responses for a full year after a vaccine or booster, reviewing that data is of great importance to the public. If ‘some scientists’- sponsored or platformed by Defendants – ‘have chosen to use’ only the first week or two of data to report the vaccine is safe and effective, then other scientists should be permitted to access the data to ‘pierce the veil of administrative secrecy,’ ‘open agency action to the light of public scrutiny,’ and ‘promote the disclosure of information.’ Many of the policies previously addressed were enacted because of guidance from Defendants. With billions of taxpayer dollars expended to develop, distribute, administer, and fund messaging campaigns, Plaintiff assumes a hefty and viable public interest in examining the raw clinical data. Production of the free-text data will permit independent researchers to put the government agencies to their proof by considering all of the available data.”

Many journalists and scientists have been referring to the veil of administrative secrecy when attempting to report on the real risks and severe side effects that the mass rollout of these mRNA vaccines has caused. Aaron Siri, Attorney for ICAN, also alluded to the attempt of the CDC to say that releasing this data would be too burdensome.

“They said to this judge it would take about 150,000 working hours to review the 7.8 million free text fields,” Siri said in a conversation with Del Bigtree on The HighWire. “If you divide by 2,000 hours per year working, for one person to review this at the CDC, that would take 75 years. That’s an interesting number. It’s exactly what the FDA tried to do.”

The judge seemed aware of the CDC’s efforts to hide data that could be potentially damaging. The schedule for releasing the free-text data requires several hundred thousand entries by the 15th of every month. The first batch of 390,000 will be released on February 15. The last batch of 780,000 is required to be released by January 15, 2025.

The judge has ruled on the side of transparency and honesty. The opinion even refers to the media and government messaging of “trust the science” as proof that the data should be made public to overcome the “veil of administrative secrecy.” This is the foundation of data that has been cited for the safety of these vaccines, and the CDC has tried exceptionally hard to keep this information classified and out of public view.

Look out for the data when the first batch is released by February 15.