Update on Coronavirus Vaccines — Fall 2022 — Related Adverse Events
While the distribution of Covid-19 vaccines is underway, there have been reports of a small number of people experiencing adverse events after receiving the vaccine. This has led to some concern and confusion about the safety of the vaccine. In this blog post, we will update you on the latest information regarding Covid vaccine related adverse events. We will also provide some tips on what to do if you or someone you know experiences an adverse event after receiving the vaccine.
Since the beginning of reporting on the COVID-19 infection in the United States (US), between 93,077,167 and 96,952,033 cases have been reported. The total number of deaths from the virus, SARS-CoV-2, is between 1,048,874 and 1,065,109. The variance in these figures is due in part on who is reporting them and the actual start and end dates.
As an example, the US Centers for Disease Control and Prevention (CDC) reports that as of February 12th 2021, there have been 93,077,167 confirmed cases of COVID-19 in the US with 1,048,874 fatalities attributed to the virus. The CDC’s data is based on information received from state health departments. However, according to data compiled by Johns Hopkins University & Medicine as of February 13th 2021 there have been 96,952,033 confirmed cases of COVID-19 in the US with 1,065,109 fatalities attributed to the virus. Their figures are based on data from numerous sources including state and local health agencies.
It’s important to note that these numbers are subject to change as more information becomes available and that there may be a lag in reporting. For example, CDC data shows that there were 2.8 million confirmed cases of COVID-19 in the US as of December 31st 2020 but Johns Hopkins University & Medicine puts the number much higher.
The Vaccine Adverse Event Reporting System (VAERS) was established in 1990 and is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. Indeed I did a VAERS search of all Covid Vaccines administered between 2020 and 2022 under a specific set of criteria and observed only nine deaths. It is not clear from the notations for each case that death was caused solely by the vaccine.
It is important to note that VAERS is a passive surveillance system, which means that it relies on individuals or health care providers to report adverse events. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem.
To further investigate if there is a possible link between Covid-19 vaccines and adverse events, CDC and FDA scientists review all reports in VAERS. They also look at data from other sources, such as clinical trials conducted before a vaccine is licensed and large studies conducted after licensure. When scientists identify possible patterns in the data that suggest a safety concern, they conduct additional studies to determine if there is a cause-and-effect relationship (i.e., whether the vaccine actually caused the event).
The picture is clearer when considering other adverse events like anaphylaxis, thrombosis with thrombocytopenia syndrome, Guillain-Barré Syndrome, and myocarditis and pericarditis. According to the CDC, based partially on peer reviewed papers and VAERS reporting, all of the foregoing rarely occurs upon administration of any of the Covid vaccines.
Anaphylaxis, thrombosis with thrombocytopenia syndrome, Guillain-Barré Syndrome, and myocarditis and pericarditis are all rare adverse events associated with the Covid vaccine. However, the CDC does acknowledge that these events have been reported in a small number of cases.
The CDC has viewed essentially all of these rare adverse, but serious events, not a sufficient reason to stop the vaccinations. Indeed it has been estimated by Malia Jones, Ph.D., et al. in JAMA that of the over 1 million deaths caused by the coronavirus, approximately 58% more deaths were averted as a direct result of administering the vaccine. Results from other studies report similar findings. Notwithstanding, the methods used, while potentially robust, have limited utility due to the fact that a pandemic of this nature has not been observed in recent history for comparison purposes and corroboration of the methods.
Since the inception of the coronavirus vaccine, there have been a handful of reports of rare but serious adverse events. However, the CDC has reviewed all of these events and has determined that they are not a sufficient reason to stop the vaccinations. In fact, it is estimated that the vaccination has prevented 58% more deaths than it has caused. This estimate comes from Malia Jones, Ph.D., et al. in JAMA. However, it should be noted that the methods used to come to this conclusion have limited utility due to the fact that there is no recent history of pandemics for comparison purposes. There is corroborating evidence from other institutions (e.g. UK, WHO).
If you have received a vaccine, in particular a Covid vaccine, reports should be made on the CDC VAERS Website or contact (800) 822–7967. All requested information should be recorded. Depending on the severity, you may choose to call 911 first. If you receive a Covid vaccine, the patient’s cell phone number is provided to the institution and person administrating the vaccine who in turn provides it with your permission to the CDC. CDC will contact you by text message to determine on a periodic basis how you are feeling.
