MEMO Research, University of Dundee, Dundee, UK
MEMO Research, University of Dundee, Dundee, UK.
BMJ Open. 2022 Jun 1;12(6):e060583. doi: 10.1136/bmjopen-2021-060583.
To describe the incidence of adverse events (AEs), reactogenicity symptoms, menstrual changes and overall self-rated improvement in health and well-being after COVID-19 vaccination.
VAC4COVID is an ongoing prospective, active observational, post-authorisation cohort safety study (PASS) of UK-approved vaccines for COVID-19 disease.
The study is conducted through a secure website (www.vac4covid.com) by MEMO Research, University of Dundee, UK.
16 265 adult (18 years or older) UK residents with a valid email address and internet access.
Any UK-authorised COVID-19 vaccination.
The outcomes reported in this interim analysis include AEs, reactogenicity-type AEs (headache, fatigue, muscle or joint pain, fever, nausea, dizziness or local vaccine reaction), menstrual changes and reported improvement in overall health and well-being.
11 475 consented participants (mean age 54.8 years) provided follow-up data between 2 February and 5 October 2021 (mean follow-up duration 184 days), by which date 89.2% of participants had received two vaccine doses. 89.8% of 5222 participants who completed a follow-up questionnaire in the 7 days after any COVID-19 vaccination reported no AEs. The risk of experiencing any event (not necessarily vaccine-related) requiring hospitalisation was less than 0.2%. 43.7% of post-vaccination follow-up records reported improvement in health and well-being. Reactogenicity-type reactions were more common in the week after the first dose of ChAdOx1 than BNT162b2 (7.8% vs 1.6%), but this relationship was reversed after the second dose (1.3% vs 3.1%). 0.3% of women reported menstrual symptoms after vaccination; no differences between vaccine type or dose order were detected.
The study provides reassuring data on low rates of AEs after COVID-19 vaccination. Differences in reactogenicity-type AE profiles between ChAdOx1 and BNT162b2 and between first and second doses of these vaccines were observed.
ISRCTN95881792; Pre-results.
描述 COVID-19 疫苗接种后的不良事件（AE）、类反应症状、月经变化以及整体健康和幸福感的自我评估改善情况。
VAC4COVID 是一项正在进行的、前瞻性的、主动的、上市后批准的 COVID-19 疾病疫苗安全性研究（PASS）。
该研究通过 MEMO 研究，英国邓迪大学的一个安全网站（www.vac4covid.com）进行。
16265 名英国成年（18 岁及以上）居民，他们有有效的电子邮件地址和互联网接入。
任何英国批准的 COVID-19 疫苗接种。
本中期分析报告的结果包括 AE、类反应性 AE（头痛、疲劳、肌肉或关节疼痛、发热、恶心、头晕或局部疫苗反应）、月经变化以及整体健康和幸福感的报告改善情况。
在 2021 年 2 月 2 日至 10 月 5 日期间，11475 名同意参与的参与者（平均年龄 54.8 岁）提供了随访数据（平均随访时间 184 天），截至该日期，89.2%的参与者已接种两剂疫苗。在任何 COVID-19 疫苗接种后 7 天内完成随访问卷的 5222 名参与者中，89.8%的人报告没有 AE。因任何事件（不一定与疫苗相关）需要住院治疗的风险小于 0.2%。43.7%的疫苗接种后随访记录报告了健康和幸福感的改善。与 BNT162b2 相比，在接种第一剂 ChAdOx1 后一周内，类反应性 AE 更为常见（7.8%比 1.6%），但在接种第二剂后，这种关系则相反（1.3%比 3.1%）。接种疫苗后，0.3%的女性报告有月经症状；未发现疫苗类型或剂量顺序之间存在差异。
该研究提供了 COVID-19 疫苗接种后 AE 发生率较低的可靠数据。观察到 ChAdOx1 和 BNT162b2 之间以及这些疫苗的第一剂和第二剂之间的类反应性 AE 特征存在差异。
ISRCTN95881792；预结果。
