Senator releases records alleging Biden-era officials downplayed COVID-19 vaccine stroke risk

Sen. Ron Johnson (R-Wis.) has released nearly 2,000 pages of documents that he says show officials in the Biden administration were aware of potential COVID-19 vaccine safety concerns but failed to promptly notify the public.

According to Johnson, the records indicate that in November 2022, federal health officials identified a statistically significant safety signal for ischemic stroke among adults aged 65 and older who received Pfizer’s COVID-19 booster shot.

The signal was detected through the Vaccine Safety Datalink (VSD), a surveillance system managed by the Centers for Disease Control and Prevention (CDC) in collaboration with healthcare organizations.

An ischemic stroke occurs when a blood clot blocks blood flow to the brain and can be fatal if not treated promptly.

Johnson alleges that despite the signal being identified on November 27, 2022, officials at the White House and the U.S. Department of Health and Human Services (HHS) did not immediately alert the public. Instead, he claims federal agencies continued promoting COVID-19 vaccines as safe and effective throughout 2022 and 2023.

“The records provide further evidence of the Biden administration’s awareness of and willingness to downplay the significant safety risks associated with the COVID-19 vaccines,” Johnson said in a statement. He further argued that continuing vaccination campaigns amid emerging safety signals “jeopardized the health of millions of Americans.”

The documents were obtained following a subpoena Johnson issued to HHS in January 2025 seeking records related to COVID-19 vaccine safety monitoring and communications during the pandemic. In a March 23 letter to HHS Secretary Robert F. Kennedy Jr., Johnson said he was sharing preliminary findings to demonstrate what he described as the administration’s “unsupported and unyielding devotion to a harmful vaccine.”

According to a timeline outlined in the documents, CDC officials reviewed 53 reports of ischemic stroke — including three deaths — in the Vaccine Adverse Event Reporting System (VAERS) in late December 2022 following Pfizer booster doses. In January 2023, officials reportedly identified more than 60 additional reports. By February 7, 2023, approximately 226 stroke cases had been logged in VAERS since August 31, 2022.

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The documents also suggest internal discussions about how to communicate the findings publicly. Johnson alleges that the CDC drafted a communication plan roughly two months after the safety signal was first detected. In January 2023, the White House reportedly edited the CDC’s draft language, changing a description of the signal from “moderately elevated” to “slightly elevated.”

Karl Jablonowski, a senior research scientist with Children’s Health Defense, analyzed the released data and disputed the characterization of the signal as slight.

He cited January 2023 data suggesting that adults 65 and older who received Pfizer’s booster had more than double the risk of ischemic stroke compared to those who did not receive the shot.

Critics argue that failing to promptly disclose potential risks undermines informed consent, which requires that individuals have sufficient information to weigh the risks and benefits of medical interventions.

Johnson’s office said it has received “millions” of pages of records in response to the subpoena and is continuing its review. The senator has requested additional documentation from HHS, including internal communications regarding how officials tracked and addressed ischemic stroke safety signals.

Federal health agencies have previously maintained that COVID-19 vaccines underwent rigorous safety monitoring and that the benefits of vaccination outweigh the risks for most populations. As of press time, HHS had not issued a new response specifically addressing Johnson’s latest claims.