Small percentage of adverse events reported in first few days of US vaccine distribution

Coronavirus

(WPRI) — Though each COVID-19 vaccine on the market has been tested for safety, there are still sometimes what’s known as “adverse events” reported in some recipients.

The events are reported to the Vaccine Adverse Events Reporting System (VAERS), co-managed by the U.S. Centers for Disease Control and Prevention (CDC), and U.S. Food and Drug Administration (FDA).

The FDA requires vaccination providers to report vaccination administration errors, serious adverse events, cases of multi-system inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of the vaccine under the vaccine’s Emergency Use Authorization.

Reporting is also encouraged for any clinically significant adverse event, whether or not it is clear if a vaccine caused it.

The VAERS released data from the first ten days of the vaccine rollout, when roughly 1.8 million first doses of the Pfizer-BioNTech vaccine were administered, and reports 4,393 (0.2%) adverse events as of Dec. 23, 2020.

From Dec. 14-23, 2020, the system detected 21 cases of anaphylaxis, a severe, sometimes life-threatening allergic reaction.

The system notes 71% of those reactions occurred within 15 minutes of vaccination, the standard time period most patients will be monitored for such events. Anyone with a history of severe allergic reactions is monitored for 30 minutes.

The CDC says all clinics should be prepared with epinephrine, also known as Epi-Pens, but anyone who had a severe allergic reaction to the first dose should not get the second one.

Health experts say a reaction like anaphylaxis is extremely rare and shouldn’t discourage most people with allergies from getting the vaccine, since the benefits far outweigh the potential risks.

“The relative risk right now of having a reaction to the vaccine is extremely low, as far as we can tell,” Dr. Mitchell Grayson, an advisor of the Asthma and Allergy Foundation of America said. “Your risk of having a bad outcome from COVID is much greater.”

Grayson said for those who are worried, to talk to their provider before getting the vaccine.

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