August 10, 2021
vaccine data
One of my more interesting jobs was working for an HIV clinic conducting clinical trials of new medications for both HIV and Hepatitis C patients. I learned how detail oriented clinical research is and the importance of good data collection. We had specialists who helped us maintain our records to ensure we met the protocols. We saw the patients initially, reviewing a long consent form, prior to starting any protocol. We then saw them regularly, recording any new symptoms they had between visits. This could include symptoms probably related to the medication, such as nausea, or something unrelated, like a sprained ankle. Any and every symptom was recorded. This allowed for patterns and associations to arise, including unexpected ones. This was necessary to ensure we didn’t miss something that seemed unrelated at the time.
The Vaccine Adverse Event Reporting System (VAERS) is designed to work in the same way. VAERS is managed by the CDC and the FDA to monitor the safety of all licensed vaccines. It is a clearing house where any adverse event or side effect of a vaccine can be reported, similar to a clinical trial. Anyone can make a report. Data is also available to everyone. The data is collected and reviewed, with further investigation as indicated to see if the event was actually related to the vaccine. The CDC encouraged this data collection with the V Safe App which collected data from thousands of people who volunteered after vaccination.
The VAERS data is unfiltered and can be confusing, since it has not been investigated. If you look at the data, someone might be alarmed at the deaths listed after vaccination. However, keep in mind this is a passive system, based on the honor system. The site lists multiple disclaimers that this data has limitations, including “The inclusion of events in VAERS data does not imply causality”. Deaths are included in the data and then investigated to see if they may be vaccine related. For instance, an 89 year old may have a stroke a month after the vaccine, but had other risk factors for that stroke, thus the vaccine is not thought to be the cause.
The CDC and FDA have reviewed all reports so far with reassuring data about safety. Their data show that the benefits of vaccination outweighs the risks. Death has been rare from all 3 vaccines. Both this website and “Your Local Epidemiologist” Katelyn Jetelina have clear explanations of the differences.
Breakthrough infections happen but are usually mild to moderate with fewer hospitalizations and deaths. Most hospitalizations and deaths in our present surge are in the unvaccinated. You can check your state out to see how many breakthrough infections there are at this New York Times interactive article. We will see more breakthrough cases as the outbreak grows, simply because of increased exposure. There is no doubt that the Delta variant has thrown our hope for a reprieve into disarray. We are still learning about it. The real danger is to the unvaccinated since the immunized have a much lower rate of hospitalizations and deaths. This is what the vaccines were designed for.
Wash your hands, cover your nose as needed, keep safe six, and don’t spread rumors.
And finally, my caveat is that this is my experience and my opinions, which are subject to change as more information is available, and not related to the organization I work for. Thanks for reading.
https://vaers.hhs.gov
https://www.cdc.gov/vaccinesafety/pdf/vaers_factsheet1.pdf
https://vaers.hhs.gov/eSubDownload/index.jsp?fn=2021VAERSData.csv
https://vsafe.cdc.gov/en/
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
https://www.seattletimes.com/nation-world/vaccine-side-effects-rare-and-outweighed-by-benefits-cdc-reports/
https://covid-101.org/science/how-many-people-have-died-from-the-vaccine-in-the-u-s/
https://www.nytimes.com/interactive/2021/08/10/us/covid-breakthrough-infections-vaccines.html
https://www.nytimes.com/article/covid-breakthrough-delta-variant.html