CDC Contractor Reported 70,000 Unprocessed VAERS Reports Before Agency Said No Safety Concerns Were Found

FOIA documents obtained by Informed Consent Action Network (ICAN) show that General Dynamics Information Technology (GDIT), the CDC contractor processing incoming reports for the Vaccine Adverse Event Reporting System (VAERS), reported an “ever-growing backlog” of more than 70,000 expired, unprocessed reports on February 10, 2021.

In the same communication, GDIT said it could not process incoming reports in a timely manner and that volumes had exceeded the government’s “worst-case scenario” estimate of 1,000 COVID-19 vaccine reports per day.

Two days later, a CDC contracting official wrote that the agency believed incoming reports would reach 4,000 to 5,000 per day. The CDC subsequently increased GDIT’s processing capacity to 25,000 reports per week.

The current FDA page about the VAERS system states, “The CDC and FDA had hundreds of people working on vaccine safety, and serious reports were followed up within five days.” The agency clarifies that there was a backlog of reports and references the requirements for FDA emergency use authorizations that “require manufacturers and vaccination providers to report any serious adverse event, regardless of whether it was believed the vaccine caused the event.”

According to the FDA, serious reports were cleared within a month, and non-serious reports within three months.

A CDC report on the first month of COVID-19 vaccine safety monitoring said 6,994 VAERS reports were received from December 14 to January 13, including 9.2% considered serious, and 113 deaths. A month later, GDIT told the CDC it had a backlog of 70,000 reports.

Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, offered the current status of VAERS reports during a vaccine safety committee presentation. There were 104,763 “reports to VAERS” identified as the “total pre-processed reports received through February 16, 2021.” A total of 6,081 reports were classified as serious, including 966 reports of death following the Moderna or Pfizer BioNTech vaccines.

On February 19, CDC Director Rochelle Walensky spoke with reporters and said, “In the first month of experience, a total of 113 deaths were reported, of which approximately 65 percent were among long-term care facility residents. A thorough review of the available data indicated that these deaths were not related to the Covid-19 vaccine.” Walensky added, “I want to be sure that you know the facts and not the myths about the vaccine’s safety and about vaccine safety — the fact is they are safe, and they will save lives.”

Walensky chose to give the media death data that was over a month old, despite the fact that data collected through February 16, according to Shimabukuro’s presentation, shows in small print that VAERS had 966 reports of death following vaccination.

The CDC stated on March 5, 2021, that “no safety concerns have been found during early COVID-19 vaccine safety monitoring, except rare reports of anaphylaxis.” The records reviewed do not establish how much of the backlog had been processed by the time the CDC made this statement.

BMJ published an investigation this week into how public health agencies used VAERS during the vaccine rollout. David Willman, the author, concluded, “US officials embraced an algorithm for detecting signals of harm from mRNA COVID-19 vaccines that they knew was broken and suppressed efforts to fix it.”

The primary issue is that the FDA Bayesian tool compared myocarditis rates internally across all VAERS reports. More than 90% of VAERS reports were for COVID-19 mRNA shots. The algorithm essentially compared the mRNA Moderna vaccine with the mRNA Pfizer-BioNTech vaccine. Since these vaccines had similar rates of myocarditis, no alert was issued. If the algorithm had been adjusted to compare rates against the normal background rate in the population, both vaccines would have triggered an alert to officials about the rate of myocarditis following mRNA vaccination.

“Yet instead of fixing the safety deficiency—or shutting down the unreliable signal detection system—officials continued to rely on the FDA’s broken algorithm,” Willman wrote. “The officials also cited the absence of signals when assuring clinicians and the public of the vaccines’ safety.”

Walensky held a press conference in April, stating that the agency had not found a link between the mRNA vaccinations and myocarditis despite looking specifically for that link. Shimabukuro showed during a June 2021 presentation that there were between 29 and 347 times more myocarditis and pericarditis reports for young males aged 12-24 than the agency expected. Despite the data showing this detail, he stated myocarditis was an “extremely rare side effect.”

The day before his presentation, he spoke with agency colleagues and said he was “perplexed” that there was no alert for myocarditis for either mRNA vaccine.

The HighWire has reported on concerning entries from the V-Safe after ICAN obtained the free-text data following a court victory. Health agencies previously did not disclose these details, and the first batch of information was released in February 2024.

Canadians held a 4-day hearing called the Allison Inquiry, where they heard from individuals who have experienced injuries attributed to the COVID-19 vaccine. Many of them have reported being dismissed by authorities and doctors while having a difficult time receiving care for their injuries.