I know a lot of people are still hesitant about getting the COVID-19 vaccine. I can sympathize with that feeling. I was there six months ago. Everything seemed to be moving so fast. It seemed like there was pressure on FDA to release vaccines. Plus, I dreaded that the pressure put on people in manufacturing might lead to mistakes.
I over came my hesitancy by reviewing the data. If you’re one of my regular readers, you might remember my post: Knowledge Jabs my Hesitancy.
Still, all of the vaccines available through FDA are Authorized for Emergency Use, not approved. I was happy to see that the documents provided by my hospital clearly stated that. Even though that’s the case, all adverse events, are tracked by FDA and CDC. Manufacturers and doctors are required to report any adverse events, even if they don’t seem to be related to the vaccine.
The CDC added another layer of monitoring that we all can do: V-safe — A new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-safe uses text messaging and web surveys from CDC to check in with vaccine recipients following COVID-19 vaccination. V-safe also provides second vaccine dose reminders if needed, and telephone follow up to anyone who reports medically significant (important) adverse events.
I use V-Safe. Do you?
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The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. Note: the CDC collects these events through a variety of data bases, so there are several weeks delay between an event and when it shows up in VAERS.
I decided to check out the adverse events myself. There were a lot of people who had the expected results of arm soreness, fatigue, and a slight fever. We all expected that. So, I limited my search to events that involved a healthcare provider visit or a trip to the emergency room.
169 million people received at least one dose of a Covid-19 vaccine. Of those people, 29 people experienced an adverse event serious enough for them to seek medical attention. Symptoms of all but two patients resolved quickly. Those two patients, over 65 years old, had strokes. One had a stroke before they received the vaccination.
The vaccine manufactured by Moderna had 7 adverse events:
The vaccine manufactured by Johnson&Johnson reported no adverse events.
The vaccine manufactured by Pfizer had 22 adverse events.
What about deaths and serious conditions?
There’s no way for me to determine cause and effect. The range of reasons for deaths and serious conditions run the gamut from appendicitis to cardiac stint, rash through cardiac arrest. I compiled the numbers for all deaths and for serious reactions on day 0, 1, and 2. The vast majority of deaths were in the 65+ age category.
| Manufacturer | Category | Number | Comments |
| Johnson&Johnson | Death | 3 | 2 were 65+, 1 was 43 years old. |
| Johnson&Johnson | Serious | 15 | 10 after 0 days; 4 after 1 day; 1 after 2 days |
| Moderna | Death | 102 | 70 were 65+; 14 were 60-64; 3 were 50-59; 2 were 40-49; 1 was 18-29 years old. |
| Moderna | Serious | 253 | 178 after 0 days; 73 after 1 day; 32 after 2 days. |
| Pfizer | Death | 56 | 49 were 65+; 4 were 60-64; 4 were 50-59; 1 was 40-49; 2 were 30-39; 1 was 18-29; 1 was 1-2 years old. |
| Pfizer | Serious | 539 | 210 after 0 days; 73 after 1 day; 32 after 2 days. |
I tried to compare this to the event reporting associated with influenza vaccine, but I could not find the number of flu vaccinations for 2021. Without that number the number of adverse events seemed meaningless. However, for all ages, 58 deaths and 204 serious events were reported for all flu vaccines in 2021. My suspicion is that most of the flu vaccine is administered at the beginning of the season, which would be fall of 2020. An estimated 154 million people were vaccinated during the 2020-21 season.
So what about manufacturing errors?
Johnson&Johnson had an ingredient mix-up during manufacturing. Although this sounds bad, I am relieved to know that J&J’s quality checks and balances caught the error and nothing got into the distribution system. J&J destroyed every one of the nearly 15 million doses.
Of course I’m unhappy that many fewer people got vaccinated, but I still have faith in J&J. The whole purpose of their quality system is to assure people get a safe and effective dose. That means making sure any mistakes are caught before the vaccine gets to people.
By the way, there have been no recalls of COVID-19 vaccine. A recall happens when a problem is identified after the drug is in the distribution system. Yay! Another reason not to fear.
I hope I helped change the minds of a few more hesitant people.
I know getting a vaccine is a very personal decision. Of course, you need to take your own health situation into account. But if you’re afraid for the same reasons I was, maybe this information helps.
I still think we face more danger from Covid-19 than from the vaccines.
Soon I’ll be feeling this free. Even though I’ll never be able to jump like this again. (On second thought, I doubt I ever could.)