Over 1,200 Adverse Events in US From Moderna COVID-19 Vaccine

Over 1,200 adverse events were reported after receipt of the Moderna COVID-19 vaccine as of Jan. 10, with 10 cases determined to be anaphylaxis, according to a report released by the U.S. Centers for Disease Control and Prevention (CDC) on Friday.

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The U.S. Food and Drug Administration issued an Emergency Use Authorization for Moderna COVID-19 vaccine on Dec. 18, 2020, administered in 2 doses, one month apart, to prevent COVID-19.

As of Jan. 10, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System, according to the CDC.

Among these, 108 case reports were identified for further review as possible cases of a severe allergic reaction, including anaphylaxis.

Anaphylaxis is a life-threatening allergic reaction that rarely occurs after vaccination, with onset typically within minutes to hours.

Among these case reports, 10 cases were determined to be anaphylaxis, a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered, said the CDC.

The median interval from vaccine receipt to symptom onset was 7.5 minutes.

The CDC urged locations administering COVID-19 vaccines to adhere to CDC guidance, including screening recipients for contraindications and precautions, having necessary supplies and staff members available to manage anaphylaxis, implementing recommended post-vaccination observation periods, and immediately treating suspected anaphylaxis with intramuscular epinephrine injection.