Health Division, Maccabi Healthcare Services, Tel Aviv, Israel.
Euro Surveill. 2022 Mar;27(13). doi: 10.2807/1560-7917.ES.2022.27.13.2100540.
BackgroundCOVID-19 vaccine safety is of major interest worldwide, since there is no prior experience with it. Israel was one of the first countries to widely use the Comirnaty vaccine.AimWe aimed to assess the vaccine's short-term side effects directly from a large population and to predict influencing factors for self-reporting side effects.MethodsIn a retrospective cohort study, we investigated self-reported systemic vaccine side-effects using electronic surveys sent to vaccinated individuals between 20 December 2020 and 11 March 2021, within 3 days following administration of the first and second dose. We determined predictors for reporting systemic side effects by logistic regression.ResultsA total of 1,213,693 patients received at least one vaccine dose and 301,537 (24.8%) answered at least one survey. Among them, 68,162 (30.4%) and 89,854 (59.9%) individuals filled the first and the second dose surveys, respectively, and reported one or more side effects. Most common side effects were fatigue, headache and myalgia. Several respondents reported facial paraesthesia after first and second dose, respectively (n = 1,675; 0.7% and n = 1,601; 1.1%). Individuals younger than 40 years and women reported side effects more frequently than others, but pregnant women reported less. Pregnancy was a weak predictor for reporting any side effect in general and in particular fatigue, myalgia, headache, chills and fever.ConclusionsWe found further support for minor short-term side effects, within 3 days of receiving the Comirnaty vaccine. These findings from vaccine recipients in general and pregnant women in particular can improve vaccine acceptance.
COVID-19 疫苗的安全性是全球关注的主要问题,因为此前没有相关经验。以色列是最早广泛使用 Comirnaty 疫苗的国家之一。
我们旨在从大量人群中直接评估疫苗的短期副作用,并预测报告副作用的影响因素。
在一项回顾性队列研究中,我们使用电子调查在接种疫苗后 3 天内对接种疫苗个体进行了调查,以调查接种第一剂和第二剂疫苗后报告的全身疫苗副作用。我们通过逻辑回归确定报告全身副作用的预测因素。
共有 1213693 名患者至少接种了一剂疫苗,其中 301537 名(24.8%)至少回答了一次调查。在这些患者中,68162 名(30.4%)和 89854 名(59.9%)个体分别填写了第一剂和第二剂疫苗的调查,并报告了一种或多种副作用。最常见的副作用是疲劳、头痛和肌痛。一些受访者在接种第一剂和第二剂后分别报告了面部感觉异常(n=1675;0.7%和 n=1601;1.1%)。年龄小于 40 岁和女性比其他人更常报告副作用,但孕妇报告的副作用较少。怀孕一般和特别是疲劳、肌痛、头痛、寒战和发热是报告任何副作用的较弱预测因素。
我们发现了 Comirnaty 疫苗接种后 3 天内的轻微短期副作用的进一步支持。这些来自一般疫苗接种者特别是孕妇的发现可以提高疫苗的接受程度。