ArticleBMJ open2022
Adverse events and overall health and well-being after COVID-19 vaccination: interim results from the VAC4COVID cohort safety study.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Menstrual disorders following COVID-19 vaccination: a review using a systematic search.Frontiers in drug safety and regulation · 2024Pooled it
- COVID-19 vaccination and menstrual disorders among women: Findings from a meta-analysis study.Journal of infection and public health · 2023Pooled it
- Impact of Comorbidities and Skin Diseases on Post-Vaccination Reactions: A Study on COVID-19 Vaccinations in Poland.Journal of clinical medicine · 2024Article
- Covid-19 vaccination and menstrual bleeding disturbances among women of fertile age: a Norwegian registry study.European journal of epidemiology · 2024Article
- Association between COVID-19 vaccination and menstruation: a state of the science review.BMJ sexual & reproductive health · 2024Review
- Menstrual Cycle Disturbances after COVID-19 Vaccination: A Cross-Sectional Study.International journal of fertility & sterility · 2024Article
- Article
- Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study.BMC medicine · 2023Observational
- Adverse effects, perceptions and attitudes related to BNT162b2, mRNA-1273 or JNJ-78436735 SARS-CoV-2 vaccines: Population-based cohort.NPJ vaccines · 2023Article
- Primary and booster vaccination in reducing severe clinical outcomes associated with Omicron Naïve infection.Journal of infection and public health · 2023Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo 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.
designVAC4COVID is an ongoing prospective, active observational, post-authorisation cohort safety study (PASS) of UK-approved vaccines for COVID-19 disease.
settingThe study is conducted through a secure website (www.vac4covid.com) by MEMO Research, University of Dundee, UK.
participants16 265 adult (18 years or older) UK residents with a valid email address and internet access.
interventionsAny UK-authorised COVID-19 vaccination.
main outcome measuresThe 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.
results11 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.
conclusionsThe 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. TRIAL REGISTRATION NUMBER: ISRCTN95881792; Pre-results.
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