COVID-19 Vaccine Safety: What We Know So Far About Side Effects, Deaths and Blood Clots
Apr 09, 2021

NOTE: This post is no longer being updated. Please check out our posts on vaccine side effects, deaths, and blood clots or visit Vaccinate Your Family’s science-based website for the latest information.

 

 

NOTE: This content originally appeared in Vaccinate Your Family’s Immunization Alerts e-newsletter, sent March 31, 2021. You can sign up for future alerts on our website.

April 9, 2021: An update was made to this post detailing WHO’s interim statement on April 7, 2021

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The United States is four months into the effort to vaccinate people against COVID-19. Here’s what we know so far about side effects, anaphylaxis and deaths after COVID vaccinations, as well as the use of AstraZeneca’s COVID vaccines being paused in some countries.

No Deaths Have Been Causally Linked to the Vaccine 

Public health officials take vaccine safety very seriously, which is why every single report of death following a COVID-19 vaccination is investigated. According to the Centers for Disease Control and Prevention (CDC), there were 2,216 reports of death following a COVID vaccination from December 14, 2020, through March 22, 2021 — but investigations into the reports, including reviewing “death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.”

When you see reports or social media posts about someone dying after a COVID vaccine or a count of overall deaths, there are a couple of things you should keep in mind: 

• Early doses were given to older individuals and those with underlying medical conditions. Sadly, these are the same people most likely to die from a number of causes unrelated to the vaccines.
• The total number of reported deaths represent only about 0.0018% of those who’ve received COVID vaccinations — nowhere near the case fatality ratio of COVID-19.

Anaphylaxis Is Rare

Reports of serious allergic reactions (known as anaphylaxis) early on in the COVID vaccine rollout sparked a lot of headlines and concerns among those with a history of allergies.

Here’s what you should know:

• In response to those early reports, public health officials expanded their recommendations and updated their clinical guidance to prevent serious reactions from happening and manage them better if they do. They also dug deeper into the data.
• Serious reactions after any vaccination are extremely rare, and COVID-19 vaccines are no exception. Research so far has found that out of one million people vaccinated with mRNA COVID vaccines, about 2-5 people will experience anaphylaxis.
• These reactions tend to happen quickly (within minutes or hours), which is why you’re asked to wait 15-30 minutes after getting a COVID vaccination. If you do have a serious reaction, vaccine providers should be able to help immediately.

If you’re concerned you might have a serious reaction to a COVID vaccine, talk to your healthcare provider before getting vaccinated. If you have had a serious reaction after vaccination, please remember to report it to V-Safe or VAERS and to tell your healthcare provider about CISA, a special program designed to help providers understand rare reactions to vaccines.

WHO and EMA Still Recommend AstraZeneca’s COVID-19 Vaccine Despite Reports of Blood Clots

Some countries paused use of AstraZeneca’s COVID-19 vaccine (which has yet to be authorized in the U.S.) while they investigate reports of blood clots in a small number of people who had received the vaccine. Some things to note:

• The European Medicines Agency (EMA) found there were 25 reports of blood clots out of about 20 million doses (~0.0001% of people who received the vaccine).
• A lot of things can cause blood clots — including COVID-19, so it’s possible the reports could be coincidental and unrelated to the vaccine.
• According to the EMA, the number of reports “was lower than [would be] expected in the general population,” and that given how bad COVID-19 can be, the benefits of the vaccine still outweigh the risks — a point the WHO echoed in its own statement the next day.
• Both organizations, however, said that the issue should be studied further, especially among younger people where there are still concerns of a possible link.

Update: In their interim statement on April 7, the WHO stated that their COVID-19 subcommittee (GACVS) reviewed latest information from the European Medicines Agency, United Kingdom’s Medicines and other Health products Regulatory Agency (MHRA), and other Member States. They noted:

• • Based on current information, a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed. Specialized studies are needed to fully understand the potential relationship between vaccination and possible risk factors.
  • While concerning, the events under assessment are very rare, with low numbers reported among the almost 200 million individuals who have received the AstraZeneca COVID-19 vaccine around the world.
  • WHO’s GACVS subcommittee will continue to gather and review further data.
  • WHO is carefully monitoring the rollout of all COVID-19 vaccines and will continue to work closely with countries to manage potential risks, and to use science and data to drive response and recommendations. In extensive vaccination campaigns, it is normal for countries to identify potential adverse events following immunization. This does not necessarily mean that the events are linked to vaccination itself, but they must be investigated to ensure that any safety concerns are addressed quickly. 

AstraZeneca is expected to apply for an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) in the coming weeks, and when it does, Dr. Anthony Fauci said, “You can rest assured that the FDA will take a great deal of scrutiny in every aspect of these data.”

Side Effects Reported in the U.S. So Far Track with What Was Expected

Safety monitoring of COVID vaccines shows that some people have discomfort after getting vaccinated. While these side effects can be a little disruptive, they generally go away after only a few days — and are actually a sign that your body responded to the vaccine.

Here’s what you might feel after getting a COVID vaccine:

• Pain, redness or swelling on the arm where you got the vaccine
• Feeling tired
• Headache
• Muscle pain or body aches
• Fever or chills
• Nausea

There have been a few reports of people getting a red, itchy, swollen, or painful rash where they got their first COVID shot. These rashes, also known as “COVID arm” can start a few days to more than a week after the first vaccine dose and are sometimes quite large. If you experience “COVID arm” after getting the first COVID shot, you should still get the second COVID shot at the recommended time.

For more information on side effects and what can help you manage them, check out our COVID-19 Vaccine Q&A page on the Vaccinate Your Family website.

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