Risk signal analysis of venous thrombosis induced by two types of COVID-19 vaccines based on VAERS
OBJECTIVE To explore the trends in reporting venous thromboembolism(VTE)for two types of COVID-19 vaccinations based upon the data of Vaccine Adverse Event Reporting System(VAERS).METHODS Raw data on COVID-19 vaccines associated with adverse drug reactions(ADR)were retrieved from the database of VAERS from January 2020 to June 2023.Demographic profiles of messenger RNA(mRNA)vaccine and adenovirus vector-based vaccine associated with、VTE were statistically examined.ADR signals of two types of vaccines were detected by reporting odds ratio(ROR)and Fisher's exact test and plotted on a volcano graph.Weibull distribution was utilized for time-to-onset analysis.RESULTS A total of 7 764 cases of COVID-19 vaccines associated with VTE were retrieved,including mRNA vaccine(n=6 445).A higher percentage of VTE occurred in 61-80-year-old subjects mostly after a second dose of vaccination(n=2 684,41.64％).Among 1 319 cases of adeno-virus vector-based vaccine,VTE primarily occurred after an initial dose of immunization(n=843,63.91％).As compared with other vaccines,two types of COVID-19 vaccines carried the risk signals of VTE by proportional imbalance method with a ROR of 10.91(95％CI:8.07-14.76)for mRNA vaccine and 29.63(95％CI:21.83-40.22)for adenovirus vector-based vaccine.ROR for total VTE of adenovirus vector-based vaccine versus mRNA vaccine was 2.71(95％CI:2.56-2.88)and 8 risk signals of VTE were detected for adenovirus vector-based vaccine.Weibull distribution results indicated that VTE occurred at Day 9(3-23),23(5-83)and 25(6-107)post-vaccination for 3 doses of mRNA vaccine and Day 17(8-46)and 16(5-182)post-vaccination for 2 doses of adenovirus vector-based vaccine.CONCLUSION There is a risk of VTE associated with COVID-19 vaccination.And VTE is prone to occur during early post-vaccination period for both vaccines.As compared with mRNA vac-cine,adenovirus-vectored vaccine has a stronger risk signal of VTE and VTE should be monitored during preventive COVID-19 vaccination.
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