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CDC Report Shows No Evidence of Unexpected Adverse Events With COVID-19 Vaccines

MONDAY, Feb. 22, 2021 -- Initial findings do not indicate evidence of unexpected serious adverse events among individuals receiving the Pfizer-BioNTech and Moderna COVID-19 vaccines, according to research published in the Feb. 19 early-release issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Julianne Gee, M.P.H., from the CDC COVID-19 Response Team, and colleagues conducted descriptive analyses of safety data from the first month of vaccination (Dec. 14, 2020, to Jan. 13, 2021), during which time 13,794,904 vaccine doses were administered.

The researchers found that the Vaccine Adverse Event Reporting System (VAERS) received and processed 6,994 reports of adverse events after vaccination; of these, 90.8 and 9.2 percent were classified as nonserious and serious, respectively. Headache, fatigue, and dizziness were the symptoms most frequently reported to the VAERS (22.4, 16.5, and 16.5 percent, respectively). One hundred thirteen deaths were reported to the VAERS, 65 percent of which occurred among long-term care facility residents. There was no suggestion for any causal relationship between COVID-19 vaccination and death in an analysis of data from death certificates, autopsy reports, medical reports, or clinical descriptions from the VAERS and health care providers. After receipt of both vaccines, rare cases of anaphylaxis were reported (4.5 reported cases per million doses administered). Reactions reported to the v-safe system were more frequent after receipt of the second than the first dose among those receiving the Pfizer-BioNTech vaccine.

"These initial findings should provide reassurance to health care providers and to vaccine recipients and promote confidence in the safety of COVID-19 vaccine," the authors write.

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Posted: February 2021