The Centers for Disease Control and Prevention (CDC) has identified hundreds of safety signals for the two most commonly administered COVID-19 vaccines, according to surveillance findings from The Epoch Times.
Bell’s palsy, blood clotting and death were among the signals flagged by analysis of adverse event reports submitted to the Vaccine Adverse Event Reporting System (VAERS). The CDC, which operates VAERS in conjunction with the Food and Drug Administration (FDA), describes it as “the national early warning system” for vaccination problems.
The CDC’s primary analysis compared the reports of specific events suffered after receiving a Moderna or Pfizer COVID-19 vaccine with the reports received after vaccination with another vaccine or all non-COVID-19 vaccines were submitted. The type of analysis is known as Proportional Reporting Ratio (PRR).
Safety signals mean that a disease can be linked to a vaccine. Signals require further analysis to confirm a possible connection.
The CDC analysis was performed on adverse events reported from December 14, 2020 to July 29, 2022.
The Epoch Times obtained the results through a Freedom of Information Act request after the CDC refused to release the results.
VAERS is a passive reporting system that accepts reports from anyone, but most are submitted by healthcare professionals who have been told during the COVID-19 pandemic that they must report if problems arise after vaccination. People who make false reports face penalties.
Reports show no causality or association between an event and a vaccine. At the same time, studies show that the number of reports is often lower than the actual number of post-vaccination events.
“Responsibility lies with the regulators”
The CDC and FDA said in operating procedures documents that officials would monitor VAERS to identify “potential emerging safety concerns for COVID-19 vaccines,” with the CDC conducting a PRR analysis. The CDC has made several false statements about the data mining, but ultimately conceded that it didn’t start implementing the surveillance technique until 2022 — more than a year after Pfizer and Moderna’s vaccines were approved.
PRR involves comparing the incidence of a specific adverse event after a specific vaccine with the incidence after all other vaccines. According to the CDC, a signal is triggered when three thresholds are met: a PRR of at least two, a chi-square statistic of at least four, and three or more instances of the event after receiving the vaccine being analyzed. Chi-square tests are a form of statistical analysis used to examine data.
The results obtained by The Epoch Times show that there are hundreds of adverse events (AEs) that fit the definition, including serious conditions such as blood clotting in the lungs, bleeding between strokes, lack of oxygen in the heart and even death. The high numbers, especially the chi-square numbers, worried experts.
For many of the events, “the chi-square is so high that, from a Bayesian perspective, the probability that the true rate of AE of the COVID vaccines is not higher than that of the non-COVID vaccines is essentially zero. Norman Fenton, a professor of risk management at Queen Mary University of London, told The Epoch Times in an email after running the numbers through a Bayesian model that provides probabilities based on available information.
For example, the likelihood of liver cirrhosis after a COVID-19 vaccination was less than that of a non-COVID-19 vaccination was less than 0.5 percent. The probability of myocarditis or heart inflammation in the group of 12 to 17 year olds was close to zero.
The CDC’s findings also show that a much higher proportion of post-COVID-19 vaccination events were serious. For adults, for example, the proportion was 11.1 percent, compared to 5.5 percent after non-COVID-19 vaccines. The proportion of adult deaths was 15.4 percent after the COVID-19 vaccination, significantly higher than the 2.5 percent after other vaccinations.
“The responsibility lies with regulators to find another causal explanation for this difference if they are to claim that a COVID vaccine is not significantly more likely to cause AE to die than other vaccines,” Fenton said.
The CDC and FDA have not responded to Epoch Times requests for comment as of press time.
A CDC spokesman previously told The Epoch Times in an email that the PRR results are “generally consistent with EB data mining and reveal no additional unexpected safety signals.”
The agency’s archives office said in a letter accompanying the results that the results “generally confirmed findings from Empirical Bayesian (EB) data mining,” a method used by the FDA. The FDA has refused to release the EB mining results.
A portion of the CDC’s PRR results. Click to enlarge. The full results can be downloaded at the end of the article. (Screenshot via The Epoch Times)
“Should be taken seriously and investigated”
US health officials have been cautious about associating any adverse events or side effects with the COVID-19 vaccines. However, they have acknowledged that some side effects are caused by Moderna’s and Pfizer’s vaccines, both of which use messenger RNA (mRNA) technology, including myocarditis and a related condition called pericarditis.
Some age groups are actually at higher risk of myocarditis and pericarditis after vaccination than after COVID-19 infection, prompting a growing number of experts to caution against vaccinating certain individuals.
The newly obtained PRR results identified more than 500 adverse events greater than myocarditis and pericarditis.
“We know that the signal for myocarditis is linked to something caused by the mRNA vaccines, so it’s more than reasonable to say that anything with a signal larger than myocarditis/pericarditis is taken seriously and investigated should be,” Josh Guetzkow, an Israeli professor trained in statistics at Princeton University and who has studied VAERS data during the pandemic, told The Epoch Times via email.
The CDC and FDA stated in their operating instructions that safety signals would be “reviewed as appropriate.”
“The pattern or trend of PRR and data mining results over a period of time (e.g. several weeks) will be monitored before a clinical review is initiated. Other factors, such as clinical significance, whether AEs are unexpected, severity, and whether a specific syndrome or diagnosis is identified rather than non-specific symptoms, will be considered when deciding whether to conduct a clinical review,” the documents read.
If a clinical review was triggered, this would include reviewing reports and associated medical records of the adverse event, confirming the time from vaccination to symptom onset, and other work.
The FDA recently announced that of four signals identified for older people after vaccination with Moderna or Pfizer, three were ruled out by further analysis, but one — pulmonary embolism — continued to meet criteria. Pulmonary embolism was identified as a signal in the PRR analysis for subjects 12 years and older.
Download the files
The results of the analysis are available in Excel spreadsheets. The results can be downloaded from the links below. Tables one and two were not provided.
7.29.22 Table 3 PRR of PTs for COVID19 Pfizer versus Moderna
7.29.22 Table 4 PRR of PTs for COVID19 Moderna versus Pfizer
7.29.22 Table 5 PRR of PTs for COVID19 mRNA versus non-COVID
7.22.29 Table 3 PRR of PTs for COVID19 Pfizer versus Moderna
7.22.29 Table 4 PRR of PTs for COVID19 Moderna versus Pfizer
7.22.29 Table 5 PRR of PTs for COVID19 mRNA versus non-COVID
7.15.22 Table 3 PRR of PTs for COVID19 Pfizer versus Moderna
7.15.22 Table 4 PRR of PTs for COVID19 Moderna versus Pfizer
7.15.29 Table 5 PRR of PTs for COVID19 mRNA versus non-COVID
Zachary Stieber is senior reporter for The Epoch Times, based in Maryland. He reports on US and world news.