First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021
Julianne Gee, Paige Marquez, John R. Su, Geoffrey M. Calvert, Ruiling Liu, Tanya R. Myers, Narayan Nair, Stacey W. Martin, Thomas A. Clark, Lauri E. Markowitz, Nicole P. Lindsey, Bicheng Zhang, Charles Licata, Amelia Jazwa, Mark J. Sotir, Tom T. Shimabukuro
Abstract
The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.