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Selected Adverse Events Reported after COVID-19 Vaccination

August 12, 2022

What You Need to Know

The benefits of COVID-19 vaccination continue to outweigh any potential risks.

CDC is providing timely updates on the following adverse events of interest:

  • Anaphylaxis after COVID-19 vaccination is rare and has occurred at a rate of approximately 5 cases per one million vaccine doses administered. Anaphylaxis, a severe type of allergic reaction, can occur after any kind of vaccination. If it happens, healthcare providers can effectively and immediately treat the reaction. Learn more about COVID-19 vaccines and allergic reactions, including anaphylaxis.

CDC scientists have conducted detailed reviews of cases of anaphylaxis and made the information available to healthcare providers and the public:

A review of reports indicates a causal relationship between the J&J/Janssen COVID-19 vaccine and TTS. CDC scientists have conducted detailed reviews of TTS cases and made the information available to healthcare providers and the public:

Based on a recent analysis of data from the Vaccine Safety Datalink, the rate of GBS within the first 21 days following J&J/Janssen COVID-19 vaccination was found to be 21 times higher than after Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines). After the first 42 days, the rate of GBS was 11 times higher following J&J/Janssen COVID-19 vaccination. The analysis found no increased risk of GBS after Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines). CDC and FDA will continue to monitor for and evaluate reports of GBS occurring after COVID-19 vaccination and will share more information as it becomes available.

  • Myocarditis and pericarditis after COVID-19 vaccination are rare. Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. Most patients with myocarditis or pericarditis after COVID-19 vaccination responded well to medicine and rest and felt better quickly. Most cases have been reported after receiving Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines), particularly in male adolescents and young adults.

review of vaccine safety data in VAERS from December 2020–August 2021 found a small but increased risk of myocarditis after mRNA COVID-19 vaccines. Over 350 million mRNA vaccines were given during the study period and CDC scientists found that rates of myocarditis were highest following the second dose of an mRNA vaccine among males in the following age groups:

  • 12–15 years (70.7 cases per one million doses of Pfizer-BioNTech)
  • 16–17 years (105.9 cases per one million doses of Pfizer-BioNTech)
  • 18–24 years (52.4 cases and 56.3 cases per million doses of Pfizer-BioNTech and Moderna, respectively)

Multiple studies and reviews of data from vaccine safety monitoring systems continue to show that vaccines are safe. As a result, the agency will refocus enhanced surveillance and safety monitoring efforts toward children and adolescents.

As of July 28, 2022, there have been 1,010 preliminary reports in VAERS among people younger than age 18 years under review for potential cases of myocarditis and pericarditis. Of these, 258 remain under review. Through confirmation of symptoms and diagnostics by provider interview or review of medical records, 665 reports have been verified to meet CDC’s working case definition for myocarditis. See below for counts of verified reports of myocarditis by age group.

5-11 years: 22 verified reports of myocarditis after 20,404,074 doses administered

12-15 years: 346 verified reports of myocarditis after 24,198,309 doses administered

16-17 years: 297 verified reports of myocarditis after 13,326,016 doses administered

As the COVID-19 vaccines are authorized for younger children, CDC and FDA will continue to monitor for and evaluate reports of myocarditis and pericarditis after COVID-19 vaccination and will share more information as it becomes available. Learn more about myocarditis and pericarditis, including clinical considerations, after mRNA COVID-19 vaccination.

  • Reports of death after COVID-19 vaccination are rare. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. More than 603 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through July 27, 2022. During this time, VAERS received 15,700 preliminary reports of death (0.0026%) among people who received a COVID-19 vaccine. CDC and FDA clinicians review reports of death to VAERS including death certificates, autopsy, and medical records.

Continued monitoring has identified nine deaths causally associated with J&J/Janssen COVID-19 vaccination. CDC and FDA continue to review reports of death following COVID-19 vaccination and update information as it becomes available.

To learn more, please visit https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html