基于 VAERS 对两类不同 COVID-19 疫苗引起静脉血栓栓塞的风险信号分析

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 adenovirus 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 vaccine，adenovirus-vectored vaccine has a stronger risk signal of VTE and VTE should be monitored during preventive COVID-19 vaccination.