The top U.S. public health agency must disclose information provided by people who experienced problems following COVID-19 vaccination, a federal court has ruled.
The U.S. Centers for Disease Control and Prevention (CDC) is being ordered to produce 7.8 million free-text entries from V-safe, one of its vaccine surveillance systems.
Data from the system released under court order in 2022 showed that 25 percent of V-safe participants missed school, work, or other normal activities due to post-vaccination issues, and nearly 8 percent of participants reported seeking medical attention, such as hospitalization after receiving a shot. That data, from boxes checked by users, came through an order in a case that started as a Freedom of Information Act (FOIA) request.
But the CDC resisted releasing the free-text entries, arguing that many of them include information that should remain private.
“CDC determined that many of these responses contain personally identifiable information, the disclosure of which would publicly link participants to highly sensitive health information,” government lawyers representing the agency said in one brief. “And because it would take tens of thousands of workhours to manually review and redact millions of free-text responses, CDC determined that segregating the non-exempt information within these responses would be unreasonably burdensome and was therefore beyond its FOIA obligations.”
The CDC said it would take one worker 59 years to complete the work if it were ordered.
The government’s arguments were rejected by U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, in response to a fresh lawsuit.
“While the burden to produce the requested free-text responses may be heavy, this court does not find that it is unreasonable,” he said in the new ruling.
The CDC can go through the records and redact personally identifiable information as allowed by FOIA but must do the work and produce the records with the redactions, he added later. Evidence produced in the case indicates that about 93 percent of the records will require no redactions.
The materials will be important for people who experienced problems following vaccination, the judge said.
“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,” he said. He noted that CDC studies on v-safe data only covered data from the first week or two after vaccination but that the surveys collected data for up to one year after receipt of a shot.
The CDC must produce at least 390,000 free-text entries by Feb. 15. Freedom Coalition of Doctors for Choice, which brought the case in 2023, said the entries would be posted to its website.
The CDC did not respond to a request for comment.
V-safe is a system run by the CDC. Introduced during the COVID-19 pandemic, it features people inputting information through a phone application. Participants are asked to provide basic information such as their name and check boxes that answer various questions, such as whether they missed school or work after vaccination. They can add additional information in a free-text area.
The portion where participants checked boxes did not include many adverse events the CDC thought the COVID-19 vaccines might end up causing, according to previously released documents.
Lawyers say the free-text entries will provide crucial details on those health issues and others.
The Informed Consent Action Network, which brought the case that resulted in the disclosure of some of the V-safe data, obtained a free-text entry from a V-safe user that showed her writing, at one point, “Help me!” She said she suffered from a number of symptoms, including nausea and vomiting, and went to the emergency department. Six months later, she wrote, “Still no response from CDC, no help from public health.”
“This ruling,” the network said in a statement, “sends a clear message to our federal agencies: we are not moving on and forgetting about the pandemic or the actions they took.”
