In this video from MedCram, Dr. Seheult delves into a deep dive of the VAERS reporting system. He states it is important that we review the VAERS report for the COVID-19 vaccines especially as we continue to use boosters and the “cold” season is coming upon us and more people will be making decisions as to whether or not to take the boosters.
What is VAERS?
The VAERS is the vaccine adverse event reporting system. It is the main way anyone can put in a report if there is an adverse event. It is cumbersome and more than likely with vaccine adverse events there is probably much underreporting. From the disclaimer on the VAERS website, it states that anyone including healthcare providers, vaccine manufacturers, and the public can submit reports to the system. They state, while very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event of illness. VAERS reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable and reports to VAERS may also be biased. As a result, there are limitations on how the data can be used scientifically and data from VAERS reports needs to be interpreted with these limitations in mind.
However, the VAERS report despite its limitations has been very useful in the past. For example in April 2021 with the Johnson and Johnson vaccine, there were 6 cases of intracranial clot formation out of 6 million doses given. It is important that we know about side effects. We need to understand that there is no intervention that is not free from harm, even something as innocuous as drinking water too quickly or too much can cause harm. Another example is anticoagulation in atrial fibrillation. Patients are risk stratified as to whether they should take anticoagulants; however, patients still come in with bleeding. So it is important to know side effects and risk benefit ratio in any drug or intervention one is doing. In mRNA vaccines, we know that myocarditis is a risk factor especially in males. The study noted it was higher in males younger than 40 and typically with the second dose and particularly with Moderna from a study that was published.
Study on first six months of COVID-19 vaccine VAERS reporting
As of May 2023, almost 250 million people in the U.S. have received at least one dose of a COVID-19 vaccine. In a study of the first six months of data from vaccine dose administration, they found the median vaccination was 50 years for the Pfizer-BioNTech dose and 56 years for the Moderna vaccine.
When looking at the graph for the number of reported deaths by days after dose for the mRNA COVID-19 vaccines a few things to note is that the graph is based on days since the last dose which will be important to remember as the majority of people received 2 doses of the vaccine.
It is important to note that it will be important to get what is the normal death rate on any given day in the U.S. This is what insurance companies and organizations use to determine what types of budgets they should create to spend on a particular population, etc based on this article. On the graph that is shown, it is noted that as you get older, your chances of dying increase significantly. If you look at the age adjusted death rate on average in 2019 it was 715.6 deaths per 100,000/year with a median age of 38.4 and in 2021 it was 879.78 deaths per 100,000/year with a median age of 38.8 years. It should be noted that the median age of the people receiving the vaccine was higher at 50 years for the Pfizer-BioNTech dose and 56 years for the Moderna vaccine, so the age adjusted death rate is probably going to underestimate some of the deaths.
Going back to the study for the first six months of data (183 days), it was noted from our world in data, that by 6/14/2021 (183 days), 11.61 million people had received the J&J vaccine. These people were removed from the mRNA data as this wasn’t a mRNA vaccine. From usafacts.org, we know that on 6/14/2021, 174, 234,573 people had received at least one dose of a mRNA vaccine and 144,919,339 people were fully vaccinated. So removing the J&J data, we would have162.6 million people having received at least one dose of the mRNA vaccine and fully vaccinated (two doses) would be 133.3 million persons on 6/14/2021.
What did VAERS data show?
We will look at at the deaths reported to VAERS graph from 12/14/2020 to 6/14/2021 for mRNA vaccines versus days since last dose. We will make an assumption that for the total of 183 days they vaccinated the same amount of people each day. Taking the 162.6 million persons we calculated earlier and dividing by 183 days, the average number of people being vaccinated each day with at least one dose of a mRNA vaccine would be 888,525. So there will be 183 cohorts each with 888,525 persons as a result each one followed separately for 183 days. So to determine the number of expected persons that would die each day as the baseline death rate, we used the 2019 rate of 715.5 and the 2021 rate of 879.7 as mentioned above. Calculating this out gives you a daily death rate for 2021 of 0.00002410 deaths/day and for 2019 0.00001960 deaths/day. This comes out to about 1 person out of 50,000 people a day. So for the study and the cohort of 888,525 people that were vaccinated each day, for 2021 numbers we should have approximately 21.4 people die each day and using 2019 numbers with 17.4 people dying each day. So the expected number of deaths for this population that was evaluated should be for 2021 numbers of 3916 persons and for 2019 there should be 3184 each day. Another point is that this study was based on days out from the last dose of the vaccine. For Pfizer, people had to come back again in 21 days and for Moderna they had to come back again in 28 days, so the clock would restart. So the data from day 1-21 for Pfizer and for day 1-28 for Moderna is amplified due to counting people twice because the population goes through two Day 1’s through Day 21 and throughout Day 28 for Moderna. So when reviewing the lines on the VAERS death report, the black lines for the Pfizer cohort were doubled because everyone had to pass through this same time frame twice for those that received the full vaccine dose and the blue lines for Moderna had the same effect. It wasn’t until after day 21 for Pfizer that the death dropped as it is only counting it one time and same for Moderna after day 28. Plus the further days out you go, the increased amount of underreporting you will be getting. The closer the timeframe to the vaccine the better reporting there is when a death occurred.
Per the VAERS the underreporting is one of main limitations of a passive surveillance system and that it receives reports for only a small fraction of actual adverse events. For this study there were a total of 4,472 non-duplicate reports of deaths made to VAERS with 46.7% of deaths coming after the Pfizer-BioNTech vaccination and 53.5% of deaths reported after Moderna vaccination. They found that 80% of the deaths came from people 60 years or older with the median age being 76 and 18.3% of deaths came from residents admitted to a long-term care facility. Per the authors of the study they noted that “compared to expected background rates of death from all causes per million vaccinated persons, deaths reported to VAERS following mRNA vaccination were consistently 15-30 times less frequent within 7 days of vaccination, and 50 times less frequent within 42 days of vaccination by age.” Hence in this study, the final conclusion was, “Under the COVID-19 vaccine EUA regulations, health-care providers are required to report deaths and life-threatening adverse health events after COVID-19 vaccinations to VAERS regardless of their potential association with vaccinations. Initially, the US COVID-19 vaccinations were prioritized for individuals aged 65 years and older and those in long-term care facilities. These populations have the highest baseline mortality risk complicating comparisons with mortality reporting for other adult populations. Similar to general morality in the adult population, reporting rates for deaths in this analysis increased with increasing age. The concentrated reporting of deaths on the first few days after vaccination follows patterns similar to those observed for other adult vaccinations. The pattern might represent reporting bias because the likelihood to report a serious adverse event might increase when it occurs in close temporal proximity to vaccination.”
Is there underreporting on the VAERS?
The number of deaths reported to the VAERS is significantly underreported as based on normal background death rates for a population of 162.6 million and a 2021 death rate of 0.00002410 dead/day for 183 days you would expect 717,115 deaths at baseline. This is a 160x underreporting to what was seen. The purpose of this video was to explain why certain things were found on the graph from the VAERS and how that was manifested based on how data was collected.
LINKS / REFERENCES:
VAERS Data (VAERS) | https://vaers.hhs.gov/data.html
Large U.S. study finds majority of mRNA COVID-19 side effects are mild and temporary (News Medical) | https://www.news-medical.net/news/202…
WHY ACTUARIES ARE INTERESTED IN POPULATION ISSUES AND WHY OTHER ORGANISATIONS INTERESTED IN POPULATION ISSUES SHOULD TALK TO ACTUARIES? (Actuaries) | https://www.actuaries.org/CTTEES_PIWG…
Mortality in the United States, 2021 (CDC) | https://www.cdc.gov/nchs/products/dat…
US Coronavirus vaccine tracker (USA Facts) | https://usafacts.org/visualizations/c…
COVID-19 vaccine doses administered by manufacturer, United States (Our World in Data) | https://ourworldindata.org/grapher/co…
Guide to Interpreting VAERS Data (VAERS) | https://vaers.hhs.gov/data/dataguide….
Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe (Lancet) | https://www.thelancet.com/action/show…