Adverse Events Following One Dose of mRNA COVID-19 Vaccination Among US Nursing Home Residents With and Without a Previous SARS-CoV-2 Infection.

ABSTRACT

OBJECTIVES: To compare rates of adverse events following Coronavirus Disease 2019 (COVID-19) vaccination among nursing home residents with and without previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. DESIGN: Prospective cohort. SETTING AND PARTICIPANTS: A total of 20,918 nursing home residents who received the first dose of messenger RNA COVID-19 vaccine from December 18, 2020, through February 14, 2021, in 284 facilities within Genesis Healthcare, a large nursing home provider spanning 24 US states. METHODS: We screened the electronic health record for adverse events, classified by the Brighton Collaboration, occurring within 15 days of a resident's first COVID-19 vaccine dose. All events were confirmed by physician chart review. To obtain risk ratios, multilevel logistic regression model that accounted for clustering (variability) across nursing homes was implemented. To balance the probability of prior SARS-CoV-2 infection (previous positive test or diagnosis by the International Classification of Diseases, 10th Revision, Clinical Modification) more than 20 days before vaccination, we used inverse probability weighting. To adjust for multiplicity of adverse events tested, we used a false discovery rate procedure. RESULTS: Statistically significant differences existed between those without (n = 13,163) and with previous SARS-CoV-2 infection [symptomatic (n = 5617) and asymptomatic (n = 2138)] for all baseline characteristics assessed. Only 1 adverse event was reported among those with previous SARS-CoV-2 infection (asymptomatic), venous thromboembolism [46.8 per 100,000 residents 95% confidence interval (CI) 8.3-264.5], which was not significantly different from the rate reported for those without previous infection (30.4 per 100,000 95% CI 11.8-78.1). Several other adverse events were observed for those with no previous infection, but were not statistically significantly higher than those reported with previous infection after adjustments for multiple comparisons. CONCLUSIONS AND IMPLICATIONS Although reactogenicity increases with preexisting immunity, we did not find that vaccination among those with previous SARS-CoV-2 infection resulted in higher rates of adverse events than those without previous infection. This study stresses the importance of monitoring novel vaccines for adverse events in this vulnerable population.