Risk of Repeated Adverse Effects following Booster Dose of mRNA COVID-19 Vaccine: Results from the MOSAICO Study

Abstract

The successful deployment of safe and effective vaccines against coronavirus disease 2019 (COVID-19) has been crucial in reducing the global disease burden. Owing to the need for vaccination series over time, continuous observational studies are needed to estimate the COVID-19 vaccine response in real-world conditions. In particular, the detection, assessment, and understanding of adverse effects following immunization (AEFI) with a COVID-19 vaccine are crucial to better address vaccination strategies. Therefore, this study aimed to investigate the risk of repeated AEFI post-administration of a booster dose of mRNA COVID-19 vaccine in a sample of healthcare workers (HCWs) in an Italian teaching hospital. The data on any local and systemic AEFI were studied in multivariate Poisson regression analyses to model the association between the incidence of each postvaccination symptom and its prior reporting after the administration of the previous doses. Overall, compared with the primary vaccination series, the majority of post-third dose AEFI were less reported. The results from multivariable models showed that the likelihood of reporting an AEFI after the third dose was higher in those who experienced the same postvaccination symptom after the second dose (all AEFI except for itch at injection site) and, although not significant for all AEFI, after the first dose. Any associations with age, gender, smoking habits, previous SARS-CoV-2 infection and other characteristics, as well as the health impact of AEFI were also assessed. Taken together, the results from this research support reframe AEFI symptoms as signals of a robust postvaccination reaction as well as of common vaccine response, and they add important data to inform booster vaccination strategies in HCWs and, extensively, in the adult population.

Prevalence and risk factors of adverse effects after the first COVID-19 booster dose: evidence from Greece

“…Our study showed that the most frequent adverse effects were pain at the injection site, fatigue, muscle pain, swelling at the injection site, headache, fever and chills. These findings are in accordance with the literature regarding the adverse effects of the first booster dose [14–18,22,23]. Moreover, a recent systematic review investigated the prevalence of adverse effects after the primary COVID-19 vaccine doses and found that the most frequent adverse effects among 10,632 participants were pain at the injection site (77.3%), muscle pain (39.7%), swelling at the injection site (34%), headache (33.3%), chills (18.3%), fever (18%), swollen lymph nodes (8%), nausea (7.9%), and shortness of breath (7.6%) [11].…”

“…Literature supports this finding since two other studies found that all participants had adverse effects after the first booster dose [20,21]. Other studies found also high prevalence of adverse effect after the first booster dose ranging from 74.7% to 89% [14][15][16][17]22,23]. Slight differences in prevalence of adverse effects among studies could be attributed to different study designs, populations, and definitions.…”

“…According to our results females developed more adverse effects than males. Several studies confirm the fact that adverse effects are more common among females after the first booster dose [14,16,17,20]. Several theories could explain this gender-based difference in adverse effects after COVID-19 vaccination.…”

“…To date, few studies have investigated adverse effects after the first COVID-19 booster dose focusing only on demographic variables such as gender and age as possible risk factors [14][15][16][17][18][19]. Adverse effects after the first COVID-19 booster dose are similar with those after the primary doses and are analyzed above.…”

“…To date, few studies have investigated adverse effects after the first COVID-19 booster dose focusing only on demographic variables such as gender and age as possible risk factors [14–19]. Adverse effects after the first COVID-19 booster dose are similar with those after the primary doses and are analyzed above.…”