Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
In a “huge win for transparency,” a federal judge this month ordered the Centers for Disease Control and Prevention (CDC) to disclose the entirety of a critical COVID-19 vaccine safety database to independent researchers and the public.
The ruling requires the CDC to produce more than 7.8 million free-text reports detailing adverse reactions submitted by COVID-19 vaccine recipients through the V-safe monitoring app. The agency must release the texts according to a strict schedule over the next year.
The judge rejected the CDC’s claims that confidentiality concerns and resource limitations prevented the agency from publicly releasing the trove of first-hand testimonies.
Instead, U.S. District Judge Matthew Kacsmaryk for the Northern District of Texas, Amarillo Division, embraced arguments from the plaintiffs — the nonprofit watchdog group Freedom Coalition of Doctors for Choice — that obscuring the data enabled potentially misleading safety conclusions by hindering full understanding of the vaccines’ impacts.
Prior lawsuits forced the CDC to release superficial, check-the-box summaries of common symptoms generated by the V-safe system. However, the free-text fields that the CDC is now required to release represent the lone channel for reporting serious conditions like myocarditis, blood clots or strokes.
The CDC so far has analyzed data only from the first one to two weeks after vaccination, painting an incomplete picture of the long-term dangers of the mRNA shots. The release of the full qualitative accounts offers the public the opportunity to undertake more detailed and accurate safety assessments.
In his ruling, Kacsmaryk wrote:
“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.’ …
“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.”
“This is a huge win for transparency,” Aaron Siri, attorney for the plaintiff, told Del Bigtree on the Jan. 11 episode of The Highwire. “It’ll be an incredible opportunity to actually see what was being told to the CDC by the public.”
THIS. IS. SO. AWESOME.
If the vaccine is so safe and effective, the CDC should be tripping over itself to publish this information widely rather than trying everything it can to withhold it.
A HUGE victory.
Epidemiologists worldwide are CELEBRATING. https://t.co/UFqQEwhbIj
— Steve Kirsch (@stkirsch) January 12, 2024
“There is substantial public interest in the data that supported, and continues to support, the government’s promotion of the COVID-19 vaccines and boosters,” Kacsmaryk wrote, adding that the data should be provided to “treating physicians, researchers, parents, [vaccine] recipients, and non-recipients.”
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, told The Defender, “It is criminal that the CDC would not make this information public automatically.”
“It belies the fact that they don’t want the American people to know the extent of the damage from the COVID-19 vaccine,” Hooker added. “The judge’s order represents a clarion call for transparency around vaccine harms and stands to impact pivotal decision-making processes for future public health emergencies.”
“I think this is going to be the death blow to this cover-up,” speculated Bigtree. “This may change this whole conversation forever.”
The first tranche of nearly 400,000 free-text entries, which the judge ordered to be released by Feb. 15, will be available for public viewing and analysis on the Informed Consent Action Network’s (ICAN) V-safe data page.
Details on lawsuit and court ruling
The legal effort to unseal the V-safe data originated with a Freedom of Information Act (FOIA) request for the free-text entries and associated registration codes filed Jan. 3, 2023, by the Freedom Coalition of Doctors for Choice.
The Texas-based group was formed specifically to procure and circulate the V-safe’s user-reported vaccine impacts to enable outside evaluation.
Despite acknowledging that some redaction of respondents’ identifying details could prove necessary, the CDC refused to produce any records, citing confidentiality concerns and resource limitations.
“The non-exempt information within the Free-Text Responses is not reasonably segregable, because having to review and redact 7.8 million Free-Text Responses to segregate non-exempt information would impose an unreasonable burden on the agency,” the CDC contended, according to court documents.
The plaintiff coalition pushed back on those claims in follow-up appeals, arguing the urgency of understanding the vaccines’ complete safety profile justified the effort to supply the raw narratives.
Coalition attorney Siri specifically called the single week of data the CDC wanted to disclose “misleading,” adding, “Those free text fields and the data in those free text fields are so critical,” because “those 10 million individuals [who took the COVID-19 vaccine] could write in whatever they wanted.”
The 10 million who signed up for the V-safe were “clearly all fans of the vaccine,” who were “not forced” to get the shots and “wanted the vaccine to work for them … [and] to track [their] health,” Bigtree said.
The fact that 7.8 million entries were made “should be troubling, because I don’t think people are writing in, ‘Thank you,’” Siri said. “They’re writing in symptoms, they’re writing in issues of concern.”
Siri shared what one V-safe user reported, without receiving any response from the CDC:
Here is an example of a V-safe entry by a Ph.D. who got the C-19 V to set an example for her students. Soon after the shot, she reported to V-safe serious harm with the plea “Help me!” yet over 100 days later reported to V-safe “still full disability, … 100+ days of speech,… https://t.co/zQko9URgIH
— Aaron Siri (@AaronSiriSG) January 12, 2024
Of the 10.1 million people enrolled in V-safe, 782,913 (7.7%) needed medical care after getting the vaccine, while 2.5 million (25%) suffered a side effect serious enough that it affected their day-to-day lives.
The CDC wanted to deny access to the text fields. Instead, it wanted to categorize the vaccine recipients’ input, and put a code on different issues, according to Bigtree.
“So you ended up getting around that,” Bigtree told Siri. “They didn’t get to code this and say, ‘Well, there was like about 500 that were about some sort of chest pains.’”
Kacsmaryk said the plaintiffs presented information that some of the CDC’s vaccine studies “may be misleading or based upon cherry-picked data.” He wrote:
“One study reported that 0.8% to 1.1% of users reported needing medical care according to the check-the-box data. … However, when the raw data was released pursuant to separate FOIA litigation, it showed some 7.7% of V-safe users reported needing medical care and an additional 25% missing school or work or unable to perform normal activities.”
Kacsmaryk adopted the plaintiff’s transparency stance and downplayed the confidentiality risk with the expectation that names and birthdates could be scrubbed through software review. He wrote:
“Production is not unreasonably burdensome for at least four reasons: the requested records are not so voluminous; only a small percent of records will require any redaction; the redaction process is largely straightforward and capable of automated assistance; and blanket exemption claims covering a mass of records are impermissible.”
While accepting that the assessment could tax CDC resources, Kacsmaryk insisted the unprecedented scale of the vaccination campaign warranted commensurate accountability. “Even if production entails a heavy burden, production is still warranted,” he wrote.
Beyond compelling the release of all entries, the judge also granted the plaintiff’s requests for expedited processing and a fee waiver in acknowledgment of the extreme public benefit.
Free-text data sole channel for conveying full depth of vaccine injuries
The V-safe system was designed to capture survey data from vaccine recipients daily for the first seven days, weekly for the following five weeks, and at three-, six- and 12-month intervals.
While the prior check-the-box disclosures offered a superficial glimpse into common reactions, the free-text narratives represent the sole channel for conveying the full depth of vaccine experiences, including severe and unintended consequences.
The check-box categories focused narrowly on acute symptoms like pain, swelling, fatigue and nausea — symptoms the CDC claimed demonstrate the vaccine is working, according to the court document — and provided little room for conveying substantive harms.
“Any concerning symptoms would necessarily be restricted to only the free-text responses, to date unexamined by independent researchers not sponsored by Defendants,” Kacsmaryk wrote.
“They [CDC policymakers] relegate[d] [serious symptoms] to the free-text fields,” Siri told Bigtree. “And that’s what makes getting that data, those 7.8 million free-text entries, so critical so we could see what symptoms were reported.”
In its analyses, the CDC has thus far predominantly emphasized check-box outcomes from only the first week post-vaccination.
“Notably, Plaintiff points to several studies published and presented by CDC that rely upon … the V-safe data,” Kacsmaryk said in his ruling. “All but one of these studies considered only the first seven days after receiving a vaccine.”
In a Substack article, Siri explained why the V-safe is better than the Vaccine Adverse Event Reporting System (VAERS):
“Unlike VAERS, the data in v-safe is gathered from a known and quantifiable universe of individuals. In fact, v-safe has precisely 10,108,273 registered users as of August 2022. These users are asked to answer the same questions. By aggregating answers to identical questions in v-safe, the rate of an adverse reaction can be calculated. That is not possible with VAERS.”
According to the lawsuit complaint, the CDC’s V-safe protocol clearly anticipated that all data might eventually be shared.
“A final data set at the end of the v-safe program with de-identified aggregate data will be made available for external data requests or through Freedom of Information Act (FOIA) requests,” the protocol stated.
What happens next
The court order mandated the release of the first tranche of at least 390,000 individual V-safe free text submissions by Feb. 15, 2024, and the remainder on a monthly timeline, through Jan. 15, 2025.
ICAN, which bankrolled the FOIA lawsuit, pledged to immediately publish those initial entries upon receipt with no restrictions.
“Scientists around the world are going to be getting real science in their hands, real data that they can start crunching so all of us in the world can actually know what happened here,” Bigtree said, confirming ICAN’s intentions of sharing the revelations publicly.
The ICAN press release stated:
“This ruling sends a clear message to our federal agencies: we are not moving on and forgetting about the pandemic or the actions they. ICAN will not stop until ALL the data is released to the public and there is true transparency and accountability around COVID-19.”
