Evidence map›Paper›PMID 33930320›Full record

Observational studyThe Lancet. Infectious diseases2021

Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study.

Cristina Menni, Kerstin Klaser, Anna May, Lorenzo Polidori, Joan Capdevila, Panayiotis Louca, Carole H Sudre, Long H Nguyen, David A Drew, Jordi Merino and 18 more

Open access · hybridAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in The Lancet. Infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 590 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
590citing papers in PubMed, 6 pooled it
65.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

590 citing papers in PubMed, 6 syntheses or guidelines pooled it, 1,078 citations in OpenAlex.

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  3. Characteristics of sudden hearing loss after different COVID-19 vaccinations: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023
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530 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 6 institutions in 2 countries.

Cristina MenniDepartment of Twin Research & Genetic Epidemiology, King's College London, London, UK. Electronic address: cristina.menni@kcl.ac.uk.
Kerstin KlaserSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Anna MayZOE Global, London, UK.
Lorenzo PolidoriZOE Global, London, UK.
Joan CapdevilaZOE Global, London, UK.
Panayiotis LoucaDepartment of Twin Research & Genetic Epidemiology, King's College London, London, UK.
Carole H SudreSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK; Medical Research Council Unit for Lifelong Health and Ageing, Department of Population Science and Experimental Medicine, and Centre for Medical Image Computing, Department of Computer Science, University College London, London, UK.
Long H NguyenClinical & Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
David A DrewClinical & Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Jordi MerinoDiabetes Unit and Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA; Program in Medical and Population Genetics, Broad Institute, Cambridge, MA, USA.
Christina HuZOE Global, London, UK.
Somesh SelvachandranZOE Global, London, UK.
Michela AntonelliSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Benjamin MurraySchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Liane S CanasSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Erika MolteniSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Mark S GrahamSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Marc ModatSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Amit D JoshiClinical & Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Massimo ManginoDepartment of Twin Research & Genetic Epidemiology, King's College London, London, UK; National Institute for Health Research (NIHR) Biomedical Research Centre at Guy's and St Thomas' Foundation Trust, London, UK.
Alexander HammersSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Anna L GoodmanDepartment of Infection, Guy's and St Thomas' Foundation Trust, St Thomas Hospital, London, UK.
Andrew T ChanClinical & Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Jonathan WolfZOE Global, London, UK.
Claire J StevesDepartment of Twin Research & Genetic Epidemiology, King's College London, London, UK.
Ana M ValdesDepartment of Twin Research & Genetic Epidemiology, King's College London, London, UK; Nottingham NIHR Biomedical Research Centre at the School of Medicine, University of Nottingham, Nottingham City Hospital, Nottingham, UK.
Sebastien OurselinSchool of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Tim D SpectorDepartment of Twin Research & Genetic Epidemiology, King's College London, London, UK.
King's College London · GBZOE (United Kingdom) · GBHarvard University · USGuy's and St Thomas' NHS Foundation Trust · GBMassachusetts General Hospital · USNottingham Biomedical Research Centre · GB

Funding

ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Alessio Fasano · 1994 to 2026
$31.6M
Dietary strategies for rational manipulation of the gut microbiome in inflammatory bowel diseaseK23DK125838 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI NGUYEN, LONG H · 2020 to 2024
$1.0M
Impact of Aspirin on the Gut Microbiome and Mucosal MicroenvironmentK01DK120742 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI DREW, DAVID A · 2020 to 2024
$793k
EPA EP-W-17-011Medical Research Council MC_UU_00004/04Medical Research Council MR/V027883/1NIDDK NIH HHS K01 DK120742NIDDK NIH HHS K23 DK125838NIDDK NIH HHS P30 DK040561Wellcome Trust 203148/Z/16/Z
6 · The paper itself

Abstract

backgroundThe Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccines have shown excellent safety and efficacy in phase 3 trials. We aimed to investigate the safety and effectiveness of these vaccines in a UK community setting.

methodsIn this prospective observational study, we examined the proportion and probability of self-reported systemic and local side-effects within 8 days of vaccination in individuals using the COVID Symptom Study app who received one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 nCoV-19 vaccine. We also compared infection rates in a subset of vaccinated individuals subsequently tested for SARS-CoV-2 with PCR or lateral flow tests with infection rates in unvaccinated controls. All analyses were adjusted by age (≤55 years vs >55 years), sex, health-care worker status (binary variable), obesity (BMI <30 kg/m

findingsBetween Dec 8, and March 10, 2021, 627 383 individuals reported being vaccinated with 655 590 doses: 282 103 received one dose of BNT162b2, of whom 28 207 received a second dose, and 345 280 received one dose of ChAdOx1 nCoV-19. Systemic side-effects were reported by 13·5% (38 155 of 282 103) of individuals after the first dose of BNT162b2, by 22·0% (6216 of 28 207) after the second dose of BNT162b2, and by 33·7% (116 473 of 345 280) after the first dose of ChAdOx1 nCoV-19. Local side-effects were reported by 71·9% (150 023 of 208 767) of individuals after the first dose of BNT162b2, by 68·5% (9025 of 13 179) after the second dose of BNT162b2, and by 58·7% (104 282 of 177 655) after the first dose of ChAdOx1 nCoV-19. Systemic side-effects were more common (1·6 times after the first dose of ChAdOx1 nCoV-19 and 2·9 times after the first dose of BNT162b2) among individuals with previous SARS-CoV-2 infection than among those without known past infection. Local effects were similarly higher in individuals previously infected than in those without known past infection (1·4 times after the first dose of ChAdOx1 nCoV-19 and 1·2 times after the first dose of BNT162b2). 3106 of 103 622 vaccinated individuals and 50 340 of 464 356 unvaccinated controls tested positive for SARS-CoV-2 infection. Significant reductions in infection risk were seen starting at 12 days after the first dose, reaching 60% (95% CI 49-68) for ChAdOx1 nCoV-19 and 69% (66-72) for BNT162b2 at 21-44 days and 72% (63-79) for BNT162b2 after 45-59 days.

interpretationSystemic and local side-effects after BNT162b2 and ChAdOx1 nCoV-19 vaccination occur at frequencies lower than reported in phase 3 trials. Both vaccines decrease the risk of SARS-CoV-2 infection after 12 days.

fundingZOE Global, National Institute for Health Research, Chronic Disease Research Foundation, National Institutes of Health, UK Medical Research Council, Wellcome Trust, UK Research and Innovation, American Gastroenterological Association.

Indexed as

COVID-19COVID-19 VaccinesDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMiddle AgedProspective StudiesSafetySARS-CoV-2Self ReportUnited KingdomVaccinationCOVID-19 Vaccines

Identifiers

PMID33930320
PMCPMC8078878
OpenAlexW3158373340

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.