Today’s media seems to have difficulty reporting the good news that comes from developments in the COVID-19 pandemic. Such is the case with the first dose of Pfizer- BioNtech vaccine. It seems from my perspective, they couldn’t wait to tell the public about serious allergic reactions that occurred soon after patients received the shot. Reports of anaphylaxis appeared in the news within hours of the roll-out of the vaccine. Why would they do that? Americans needed some good news.
Just how bad were these reactions? How frequently did they occur? Were there any fatalities? The answers to these and other questions never came. If they did, I missed them.
But there is good news. A very thorough article in JAMA (Journal of the American Medical Association) reports on data compiled by the Vaccine Adverse Event Reporting System (VAERS), the national system for reporting adverse events from immunizations. What I learned from this article was that during a 10-day period in December, beginning just 3 days after the Pfizer vaccine received Emergency Use Authorization (EUA) by the FDA, there were only 21 adverse events reported. That means that out of 1,893,630 first doses, only 21people had a severe reaction. That amounts to .0011% of the total. That’s pretty insignificant. But you say “any severe reaction is one too many!” Maybe so, but until now science has not developed the perfect drug, the perfect vaccine—one that is completely free of side effects. It’s virtually impossible.
A detailed look at the reactions by severity, treatment, and outcome tells us the following:
- Of the 21 patients, 4 needed hospitalization (3 in ICU)
- 17 patents were treated in the ER and released
- 20 patients were known to have been discharged to home or recovered at time of report
- NO DEATHS from Anaphylaxis, or other cause, occurred
- 17 of the 21 had a documented history of a previous allergic reaction to drugs, vaccines, or food
- 7 had experienced an anaphylactic reaction in the past
Symptoms seen in the four patients with severe reactions were generalized hives, wheezing, difficulty breathing, nausea, and a diffuse red rash.
The most common adverse reactions were diffuse red rash, hives, and swollen lips, tongue, or throat.
The oldest patient was 60. The youngest was 27. There were only 5 patients over age 40 years.
Patients who had experienced anaphylaxis previously probably should NOT have received the vaccine.
During the same 10-day period, VAERS reported only 83 cases of reactions that were not considered anaphylactic—symptomatic but not life-threatening, ie. itching, rash, scratchy throat, mild respiratory symptoms.
Dr. G’s Opinion: Pfizer’s vaccine is SAFE. Media reports placed undue emphasis on the extremely rare adverse occurrences and ignored the many benefits that could bring an end to the pandemic. A large number of Americans are skeptics and need encouragement and reassurance to come to that realization. This information will surely help.
The most important data I see are the following:
There were NO DEATHS from the reactions
81% of patients with reactions had had A SERIOUS ALLERGIC REACTION BEFORE
There were only 4 PATIENTS WHO REQUIRED HOSPITALIZATION
So I can happily report that Pfizer’s COVID-19 vaccine is safe and effective. The impression given by skeptics that this vaccine is unsafe because it “was rushed to market” simply isn’t true. Twenty-one reactions out of nearly 2 million doses given is not a trend to worry about. Now, if we can just get the CDC and Dr. Fauci to require masks of only the non-vaccinated. Otherwise, why have we bothered to go to the trouble to get our shots. In the past, once you were vaccinated, you didn’t need to worry about polio, measles, chicken pox, etc. Is something different now? We knew COVID-19 was bad but is it worse than initially thought? I wish I knew.
Reference: Shimabukuro T, Nair N. Allergic Reactions including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine JAMA 2021 Feb 23;325(8):780-781.
