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Where can I find information on adverse reactions from the vaccines? How are they being reported and made public?

Update

Most regulatory policies require COVID-19 vaccine candidates to go through rigorous clinical trials, which include documentation of adverse reactions. The vast majority of participants in COVID-19 vaccine clinical trials did not experience severe adverse reactions. Results from the clinical studies are published and publicly available. One platform that consolidates the results is the COVID-19 Real-Time Learning Network, which is made available thanks to a collaboration between the U.S. Centers for Disease Control and Prevention (CDC) and the Infectious Diseases Society of America (IDSA). Additionally, now that COVID-19 vaccine candidates have been given to millions of people around the world, more data is becoming available from countries that are monitoring the vaccine distribution and collecting information. For example, in the United States, adverse reactions can be reported by providers of the COVID-19 vaccines, as well as by recipients on the national VAERS (Vaccine Adverse Event Reporting System) online platform. This reporting system is part of the many expanded vaccine safety monitoring systems that have been developed. Based on early data from these reporting systems, the U.S. CDC released a report in January 2021 on anaphylaxis, a severe and potentially life-threatening allergic reaction that rarely occurs after vaccination. This report is publicly available, along with several other reports and resources, and includes recommendations such as ensuring that patients with previous history of similar allergic reactions are monitored for 15-30 minutes following COVID-19 vaccination and are taught how to recognize signs of anaphylaxis. If someone has questions about potential adverse reactions because of their health status, including any pre-existing health conditions, please consult with a healthcare provider. If someone has received a COVID-19 vaccine dose and has experienced serious adverse side effects, please consult with a healthcare provider and report the adverse effects to a vaccine safety monitoring system as appropriate. For reference, the U.S. CDC has provided a list of what is normal to expect after COVID-19 vaccination, including typical minor side effects: <https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html>

This article was published on
February 5, 2021

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What our experts say

Most regulatory policies require COVID-19 vaccine candidates to go through rigorous clinical trials, which include documentation of adverse reactions. The vast majority of participants in COVID-19 vaccine clinical trials did not experience severe adverse reactions.

Results from the clinical studies are published and publicly available. One platform that consolidates the results is the COVID-19 Real-Time Learning Network, which is made available thanks to a collaboration between the U.S. Centers for Disease Control and Prevention (CDC) and the Infectious Diseases Society of America (IDSA).

Additionally, now that COVID-19 vaccine candidates have been given to millions of people around the world, more data is becoming available from countries that are monitoring the vaccine distribution and collecting information. For example, in the United States, adverse reactions can be reported by providers of the COVID-19 vaccines, as well as by recipients on the national VAERS (Vaccine Adverse Event Reporting System) online platform. This reporting system is part of the many expanded vaccine safety monitoring systems that have been developed.

Based on early data from these reporting systems, the U.S. CDC released a report in January 2021 on anaphylaxis, a severe and potentially life-threatening allergic reaction that rarely occurs after vaccination. This report is publicly available, along with several other reports and resources, and includes recommendations such as ensuring that patients with previous history of similar allergic reactions are monitored for 15-30 minutes following COVID-19 vaccination and are taught how to recognize signs of anaphylaxis.

If someone has questions about potential adverse reactions because of their health status, including any pre-existing health conditions, please consult with a healthcare provider. If someone has received a COVID-19 vaccine dose and has experienced serious adverse side effects, please consult with a healthcare provider and report the adverse effects to a vaccine safety monitoring system as appropriate.

For reference, the U.S. CDC has provided a list of what is normal to expect after COVID-19 vaccination, including typical minor side effects: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html

Context and background

As COVID-19 vaccines become available to more people around the world, there is widespread interest in any potential adverse reactions from the vaccines. While there has been media coverage of some minor side effects and rare allergic reactions, the COVID-19 vaccines are widely considered safe.

Despite the strong evidence for COVID-19 vaccine safety, misinformation is spreading about adverse reactions, which can contribute to dangerous vaccine hesitancy. Without vaccination, more people face worse health consequences from the COVID-19 disease.

Since the COVID-19 vaccines are new, researchers are still learning about potential adverse reactions in different people. For example, the clinical trials to date have included less diverse participants when compared to the general population. More studies are underway for demographics that were not included in the major clinical trials, such as children under 18 and pregnant adults. Based on preliminary data from monitoring recent COVID-19 vaccine recipients, including over 10,000 pregnant adults in the United States, leading scientists including Dr. Anthony Fauci have stated that there are currently no "red flags" regarding serious adverse reactions.

Resources

  1. Ensuring the Safety of COVID-19 Vaccines in the United States (U.S. CDC)
  2. COVID-19 Real-Time Learning Network (U.S. CDC and IDSA)
  3. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020 (U.S. CDC)
  4. VAERS (Vaccine Adverse Event Reporting System) (U.S. Department of Health and Human Services)
  5. What to Expect after Getting a COVID-19 Vaccine (U.S. CDC)
  6. Fauci says ‘no red flags’ seen in 10,000 pregnant women who’ve received Covid shots so far (CNBC)

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