The FINANCIAL — Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history. CDC recommends everyone ages 5 years and older get vaccinated as soon as possible to help protect against COVID-19 and the related, potentially severe complications that can occur. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem.Serious adverse events after COVID-19 vaccination are rare but may occur.Reports of death after COVID-19 vaccination are rare. More than 442 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through November 15, 2021. During this time, VAERS received 9,810 reports of death (0.0022%) among people who received a COVID-19 vaccine. 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. A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal link to COVID-19 vaccines.
CDC, the U.S. Food and Drug Administration (FDA), and other federal agencies are monitoring the safety of COVID-19 vaccines.
Serious adverse events of interest:
Anaphylaxis, a severe type of allergic reaction, following administration of COVID-19 vaccination is rare and has occurred in approximately 2 to 5 people per million vaccinated in the United States. Anaphylaxis 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.
Thrombosis with thrombocytopenia syndrome (TTS) occurring after Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccination is rare. As of November 10, 2021, more than 16 million doses of the J&J/Janssen COVID-19 vaccine have been given in the United States. CDC and FDA have identified 50 confirmed reports of people who got the J&J/Janssen COVID-19 vaccine and later developed TTS, including 5 confirmed reports of death. Women ages 18-49, especially, should be aware of the rare but increased risk of this adverse event. There are other COVID-19 vaccine options available for which this risk has not been seen. Learn more about J&J/Janssen COVID-19 vaccine and TTS.
To date, two confirmed cases of TTS following mRNA COVID-19 vaccination (Moderna) have been reported to VAERS after more than 418 million doses of mRNA COVID-19 vaccines administered in the United States. Based on available data, there is not an increased risk for TTS after mRNA COVID-19 vaccination.
CDC and FDA are monitoring reports of Guillain-Barré Syndrome (GBS) in people who have received the J&J/Janssen COVID-19 vaccine. GBS is a rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. Most people fully recover from GBS, but some have permanent nerve damage. After more than 16 million J&J/Janssen COVID-19 vaccine doses administered, there have been around 258 preliminary reports of GBS identified in VAERS as of November 10, 2021. These cases have largely been reported about 2 weeks after vaccination and mostly in men, many ages 50 years and older. CDC 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 occurring after COVID-19 vaccination are rare. As of November 10, 2021, VAERS has received 1,793 reports of myocarditis or pericarditis among people ages 12–29 years who received COVID-19 vaccines. Most cases have been reported after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), particularly in male adolescents and young adults after the second dose. Through follow-up, including medical record reviews, CDC and FDA have confirmed 1,049 reports of myocarditis or pericarditis. Learn more about myocarditis and pericarditis after mRNA COVID-19 vaccination.
