On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
Emergency Use Authorization Status:
Authorized
Name:
Moderna COVID-19 Vaccine
Manufacturer:
ModernaTX, Inc.
Authorized Use
For the prevention of 2019 coronavirus disease (COVID-19) for individuals 18 years of age and older
Common Side Effects
The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine