After administration of 13.8 million doses of Pfizer-BioNTech and Moderna COVID-19 vaccines to the U.S. population during the first month of the vaccination program, the postauthorization safety profiles for both vaccines are reassuring. Most (90.9%) VAERS reports were for nonserious events and involved local and systemic symptoms; transient local and systemic reactions were also frequently reported in v-safe.
Reports of anaphylaxis have been observed after administration of both vaccines (5). The occurrence of anaphylaxis after receipt of COVID-19 vaccines during the analytic period, 4.5 cases per million doses administered, is within the range reported after receipt of inactivated influenza vaccine (1.4 per million), pneumococcal polysaccharide vaccine (2.5 per million), and live attenuated herpes zoster vaccine (9.6 per million); effective treatments for anaphylaxis exist (6).
VAERS received 113 reports of death after COVID-19 vaccinations; two thirds of these deaths occurred among LTCF residents.
All-cause mortality is high in LTCF populations because underlying medical conditions are common. Based on expected rates of background mortality, among the approximately 1 million LTCF residents vaccinated in the first month of the U.S. COVID-19 vaccination program, approximately 7,000 coincidental, temporally associated deaths from all causes would be expected during the analytic period (7).
In contrast, VAERS received 78 reports of death after COVID-19 vaccination in LTCF residents, and approximately one half were in residents who were in hospice or who had a do-not-resuscitate status.
Reported causes of death in LTCF residents after COVID-19 vaccination are consistent with expected all-cause mortality in this population. Among deaths in persons with available death certificate and autopsy information who were not LTCF residents, causes of death were consistent with background all-cause mortality and did not indicate any unexpected pattern that might suggest a causal relationship with vaccination (8).