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; Christina Hu; Somesh Selvachandran; Michela Antonelli; Benjamin Murray; Liane S Canas; Erika Molteni; Mark S Graham; Marc Modat; Amit D Joshi; Massimo Mangino; Alexander Hammers; Anna L Goodman; Andrew T Chan; Jonathan Wolf; Claire J Steves; Ana M Valdes; Sebastien Ourselin; Tim D Spector

doi:10.1016/S1473-3099(21)00224-3

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, Christina Hu, Somesh Selvachandran, Michela Antonelli, Benjamin Murray, Liane S Canas, Erika Molteni, Mark S Graham, Marc Modat, Amit D Joshi, Massimo ManginoAlexander Hammers, Anna L Goodman, Andrew T Chan, Jonathan Wolf, Claire J Steves, Ana M Valdes, Sebastien Ourselin, Tim D Spector

Research output: Contribution to journal › Article › peer-review

696 Citations (Scopus)

Abstract

Background: The 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. Methods: In 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 ² vs ≥30 kg/m ²), and comorbidities (binary variable, with or without comorbidities). Findings: Between 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. Interpretation: Systemic 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. Funding: ZOE 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.

Original language	English
Pages (from-to)	939-949
Number of pages	11
Journal	The Lancet infectious diseases
Volume	21
Issue number	7
Early online date	27 Apr 2021
DOIs	https://doi.org/10.1016/S1473-3099(21)00224-3
Publication status	Published - Jul 2021

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Menni, C., Klaser, K., May, A., Polidori, L., Capdevila, J., Louca, P., Sudre, C. H., Nguyen, L. H., Drew, D. A., Merino, J., Hu, C., Selvachandran, S., Antonelli, M., Murray, B., Canas, L. S., Molteni, E., Graham, M. S., Modat, M., Joshi, A. D., ... Spector, T. D. (2021). 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. The Lancet infectious diseases, 21(7), 939-949. https://doi.org/10.1016/S1473-3099(21)00224-3

@article{de1a62b31b5d45da808ea235fecda1b9,

title = "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",

abstract = "Background: The 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. Methods: In 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 2 vs ≥30 kg/m 2), and comorbidities (binary variable, with or without comorbidities). Findings: Between 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. Interpretation: Systemic 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. Funding: ZOE 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. ",

author = "Cristina Menni and Kerstin Klaser and Anna May and Lorenzo Polidori and Joan Capdevila and Panayiotis Louca and Sudre, {Carole H} and Nguyen, {Long H} and Drew, {David A} and Jordi Merino and Christina Hu and Somesh Selvachandran and Michela Antonelli and Benjamin Murray and Canas, {Liane S} and Erika Molteni and Graham, {Mark S} and Marc Modat and Joshi, {Amit D} and Massimo Mangino and Alexander Hammers and Goodman, {Anna L} and Chan, {Andrew T} and Jonathan Wolf and Steves, {Claire J} and Valdes, {Ana M} and Sebastien Ourselin and Spector, {Tim D}",

note = "Funding Information: CM reports grants from Chronic Disease Research Foundation (CDRF) during the conduct of the study. JW, AM, LP, CH, SS, and JC report being employees of ZOE Global during the conduct of the study. ATC reports grants from Massachusetts Consortium on Pathogen Readiness during the conduct of the study, and personal fees from Bayer Pharma, Pfizer, and Boehringer Ingelheim, outside the submitted work. DAD reports grants from National Institutes of Health (NIH), Massachusetts Consortium on Pathogen Readiness, and American Gastroenterological Association, during the conduct of the study, and that he served as a co-investigator on an unrelated nutrition trial sponsored by ZOE Global. CHS reports grants from Alzheimer's Society during the conduct of the study. AMV reports grants from Medical Research Council (MRC) and personal fees from ZOE Global, during the conduct of the study. ALG reports having shares in AstraZeneca and receiving grants from Novavax, outside the submitted work. CJS reports grants from CDRF, MRC, and Wellcome Trust, during the conduct of the study. SO reports grants from Wellcome Trust, UK Research and Innovation (UKRI), and CDRF, during the conduct of the study. TDS reports being a consultant for ZOE Global, during the conduct of the study. All other authors declare no competing interests. Funding Information: ZOE Global provided in-kind support for all aspects of building, running, and supporting the app and service to all users worldwide. The Department of Twin Research & Genetic Epidemiology at King's College London receives grant support from the Wellcome Trust ( 212904/Z/18/Z ), the MRC British Heart Foundation Ancestry and Biological Informative Markers for Stratification of Hypertension (AIMHY; MR/M016560/1 ), the European Union, CDRF, ZOE Global, NIH, the National Institute for Health Research (NIHR)-funded BioResource, and Clinical Research Facility and Biomedical Research Centre based at Guy's and St Thomas' National Health Service (NHS) Foundation Trust, in partnership with King's College London. SO is funded by the Wellcome Engineering and Physical Sciences Research Council (EPSRC) Centre for Medical Engineering (WT203148/Z/16/Z) and the Wellcome Flagship Programme (WT213038/Z/18/Z). CM is funded by the CDRF and the MRC AIMHY project grant. CHS is an Alzheimer's Society junior fellow (AS-JF-17-011). The School of Biomedical Engineering & Imaging Sciences is supported by the Wellcome EPSRC Centre for Medical Engineering at King's College London (WT203148/Z/16/Z) and the Department of Health via the NIHR comprehensive Biomedical Research Centre award to Guy's and St Thomas' NHS Foundation Trust, in partnership with King's College London and King's College Hospital NHS Foundation Trust. ATC is a Stuart and Suzanne Steele MGH Research Scholar. LHN is supported by an NIH K23DK125838 award, the American Gastroenterological Association Research Scholar Award, and the Crohn's and Colitis Foundation Career Development Award. DAD and LHN are supported by the American Gastroenterological Association-Takeda COVID-19 Rapid Response Research Award (AGA2021-5102). DAD is supported by NIH/National Institute of Health Diabetes and Digestive and Kidney Diseases (K01DK120742). ATC, LHN, and DAD are supported by the Massachusetts Consortium on Pathogen Readiness. JM is partially supported by the NIH (DK40561) and the American Diabetes Association (7-21-JDFM-005). PL is funded by the CDRF. AMV is funded by a UKRI and MRC Covid-Rapid Response grant (MR/V027883/1). We thank all participants, including study volunteers enrolled in cohorts within the COPE consortium. We thank the staff of ZOE Global, the Department of Twin Research & Genetic Epidemiology at King's College London, the Clinical & Translational Epidemiology Unit at Massachusetts General Hospital, and researchers and staff at Lund University in Sweden for their tireless work in contributing to the running of the study and data collection. Funding Information: ZOE Global provided in-kind support for all aspects of building, running, and supporting the app and service to all users worldwide. The Department of Twin Research & Genetic Epidemiology at King's College London receives grant support from the Wellcome Trust (212904/Z/18/Z), the MRC British Heart Foundation Ancestry and Biological Informative Markers for Stratification of Hypertension (AIMHY; MR/M016560/1), the European Union, CDRF, ZOE Global, NIH, the National Institute for Health Research (NIHR)-funded BioResource, and Clinical Research Facility and Biomedical Research Centre based at Guy's and St Thomas' National Health Service (NHS) Foundation Trust, in partnership with King's College London. SO is funded by the Wellcome Engineering and Physical Sciences Research Council (EPSRC) Centre for Medical Engineering (WT203148/Z/16/Z) and the Wellcome Flagship Programme (WT213038/Z/18/Z). CM is funded by the CDRF and the MRC AIMHY project grant. CHS is an Alzheimer's Society junior fellow (AS-JF-17-011). The School of Biomedical Engineering & Imaging Sciences is supported by the Wellcome EPSRC Centre for Medical Engineering at King's College London (WT203148/Z/16/Z) and the Department of Health via the NIHR comprehensive Biomedical Research Centre award to Guy's and St Thomas' NHS Foundation Trust, in partnership with King's College London and King's College Hospital NHS Foundation Trust. ATC is a Stuart and Suzanne Steele MGH Research Scholar. LHN is supported by an NIH K23DK125838 award, the American Gastroenterological Association Research Scholar Award, and the Crohn's and Colitis Foundation Career Development Award. DAD and LHN are supported by the American Gastroenterological Association-Takeda COVID-19 Rapid Response Research Award (AGA2021-5102). DAD is supported by NIH/National Institute of Health Diabetes and Digestive and Kidney Diseases (K01DK120742). ATC, LHN, and DAD are supported by the Massachusetts Consortium on Pathogen Readiness. JM is partially supported by the NIH (DK40561) and the American Diabetes Association (7-21-JDFM-005). PL is funded by the CDRF. AMV is funded by a UKRI and MRC Covid-Rapid Response grant (MR/V027883/1). We thank all participants, including study volunteers enrolled in cohorts within the COPE consortium. We thank the staff of ZOE Global, the Department of Twin Research & Genetic Epidemiology at King's College London, the Clinical & Translational Epidemiology Unit at Massachusetts General Hospital, and researchers and staff at Lund University in Sweden for their tireless work in contributing to the running of the study and data collection. Publisher Copyright: {\textcopyright} 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

month = jul,

doi = "10.1016/S1473-3099(21)00224-3",

language = "English",

volume = "21",

pages = "939--949",

journal = "The Lancet infectious diseases",

issn = "1473-3099",

publisher = "Elsevier",

number = "7",

}

Menni, C , Klaser, K, May, A, Polidori, L, Capdevila, J, Louca, P , Sudre, CH, Nguyen, LH, Drew, DA, Merino, J, Hu, C, Selvachandran, S, Antonelli, M , Murray, B, Canas, LS, Molteni, E , Graham, MS , Modat, M, Joshi, AD, Mangino, M, Hammers, A, Goodman, AL, Chan, AT, Wolf, J, Steves, CJ , Valdes, AM , Ourselin, S & Spector, TD 2021, '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', The Lancet infectious diseases, vol. 21, no. 7, pp. 939-949. https://doi.org/10.1016/S1473-3099(21)00224-3

TY - JOUR

T1 - Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK

T2 - a prospective observational study

AU - Menni, Cristina

AU - Klaser, Kerstin

AU - May, Anna

AU - Polidori, Lorenzo

AU - Capdevila, Joan

AU - Louca, Panayiotis

AU - Sudre, Carole H

AU - Nguyen, Long H

AU - Drew, David A

AU - Merino, Jordi

AU - Hu, Christina

AU - Selvachandran, Somesh

AU - Antonelli, Michela

AU - Murray, Benjamin

AU - Canas, Liane S

AU - Molteni, Erika

AU - Graham, Mark S

AU - Modat, Marc

AU - Joshi, Amit D

AU - Mangino, Massimo

AU - Hammers, Alexander

AU - Goodman, Anna L

AU - Chan, Andrew T

AU - Wolf, Jonathan

AU - Steves, Claire J

AU - Valdes, Ana M

AU - Ourselin, Sebastien

AU - Spector, Tim D

N1 - Funding Information: CM reports grants from Chronic Disease Research Foundation (CDRF) during the conduct of the study. JW, AM, LP, CH, SS, and JC report being employees of ZOE Global during the conduct of the study. ATC reports grants from Massachusetts Consortium on Pathogen Readiness during the conduct of the study, and personal fees from Bayer Pharma, Pfizer, and Boehringer Ingelheim, outside the submitted work. DAD reports grants from National Institutes of Health (NIH), Massachusetts Consortium on Pathogen Readiness, and American Gastroenterological Association, during the conduct of the study, and that he served as a co-investigator on an unrelated nutrition trial sponsored by ZOE Global. CHS reports grants from Alzheimer's Society during the conduct of the study. AMV reports grants from Medical Research Council (MRC) and personal fees from ZOE Global, during the conduct of the study. ALG reports having shares in AstraZeneca and receiving grants from Novavax, outside the submitted work. CJS reports grants from CDRF, MRC, and Wellcome Trust, during the conduct of the study. SO reports grants from Wellcome Trust, UK Research and Innovation (UKRI), and CDRF, during the conduct of the study. TDS reports being a consultant for ZOE Global, during the conduct of the study. All other authors declare no competing interests. Funding Information: ZOE Global provided in-kind support for all aspects of building, running, and supporting the app and service to all users worldwide. The Department of Twin Research & Genetic Epidemiology at King's College London receives grant support from the Wellcome Trust ( 212904/Z/18/Z ), the MRC British Heart Foundation Ancestry and Biological Informative Markers for Stratification of Hypertension (AIMHY; MR/M016560/1 ), the European Union, CDRF, ZOE Global, NIH, the National Institute for Health Research (NIHR)-funded BioResource, and Clinical Research Facility and Biomedical Research Centre based at Guy's and St Thomas' National Health Service (NHS) Foundation Trust, in partnership with King's College London. SO is funded by the Wellcome Engineering and Physical Sciences Research Council (EPSRC) Centre for Medical Engineering (WT203148/Z/16/Z) and the Wellcome Flagship Programme (WT213038/Z/18/Z). CM is funded by the CDRF and the MRC AIMHY project grant. CHS is an Alzheimer's Society junior fellow (AS-JF-17-011). The School of Biomedical Engineering & Imaging Sciences is supported by the Wellcome EPSRC Centre for Medical Engineering at King's College London (WT203148/Z/16/Z) and the Department of Health via the NIHR comprehensive Biomedical Research Centre award to Guy's and St Thomas' NHS Foundation Trust, in partnership with King's College London and King's College Hospital NHS Foundation Trust. ATC is a Stuart and Suzanne Steele MGH Research Scholar. LHN is supported by an NIH K23DK125838 award, the American Gastroenterological Association Research Scholar Award, and the Crohn's and Colitis Foundation Career Development Award. DAD and LHN are supported by the American Gastroenterological Association-Takeda COVID-19 Rapid Response Research Award (AGA2021-5102). DAD is supported by NIH/National Institute of Health Diabetes and Digestive and Kidney Diseases (K01DK120742). ATC, LHN, and DAD are supported by the Massachusetts Consortium on Pathogen Readiness. JM is partially supported by the NIH (DK40561) and the American Diabetes Association (7-21-JDFM-005). PL is funded by the CDRF. AMV is funded by a UKRI and MRC Covid-Rapid Response grant (MR/V027883/1). We thank all participants, including study volunteers enrolled in cohorts within the COPE consortium. We thank the staff of ZOE Global, the Department of Twin Research & Genetic Epidemiology at King's College London, the Clinical & Translational Epidemiology Unit at Massachusetts General Hospital, and researchers and staff at Lund University in Sweden for their tireless work in contributing to the running of the study and data collection. Funding Information: ZOE Global provided in-kind support for all aspects of building, running, and supporting the app and service to all users worldwide. The Department of Twin Research & Genetic Epidemiology at King's College London receives grant support from the Wellcome Trust (212904/Z/18/Z), the MRC British Heart Foundation Ancestry and Biological Informative Markers for Stratification of Hypertension (AIMHY; MR/M016560/1), the European Union, CDRF, ZOE Global, NIH, the National Institute for Health Research (NIHR)-funded BioResource, and Clinical Research Facility and Biomedical Research Centre based at Guy's and St Thomas' National Health Service (NHS) Foundation Trust, in partnership with King's College London. SO is funded by the Wellcome Engineering and Physical Sciences Research Council (EPSRC) Centre for Medical Engineering (WT203148/Z/16/Z) and the Wellcome Flagship Programme (WT213038/Z/18/Z). CM is funded by the CDRF and the MRC AIMHY project grant. CHS is an Alzheimer's Society junior fellow (AS-JF-17-011). The School of Biomedical Engineering & Imaging Sciences is supported by the Wellcome EPSRC Centre for Medical Engineering at King's College London (WT203148/Z/16/Z) and the Department of Health via the NIHR comprehensive Biomedical Research Centre award to Guy's and St Thomas' NHS Foundation Trust, in partnership with King's College London and King's College Hospital NHS Foundation Trust. ATC is a Stuart and Suzanne Steele MGH Research Scholar. LHN is supported by an NIH K23DK125838 award, the American Gastroenterological Association Research Scholar Award, and the Crohn's and Colitis Foundation Career Development Award. DAD and LHN are supported by the American Gastroenterological Association-Takeda COVID-19 Rapid Response Research Award (AGA2021-5102). DAD is supported by NIH/National Institute of Health Diabetes and Digestive and Kidney Diseases (K01DK120742). ATC, LHN, and DAD are supported by the Massachusetts Consortium on Pathogen Readiness. JM is partially supported by the NIH (DK40561) and the American Diabetes Association (7-21-JDFM-005). PL is funded by the CDRF. AMV is funded by a UKRI and MRC Covid-Rapid Response grant (MR/V027883/1). We thank all participants, including study volunteers enrolled in cohorts within the COPE consortium. We thank the staff of ZOE Global, the Department of Twin Research & Genetic Epidemiology at King's College London, the Clinical & Translational Epidemiology Unit at Massachusetts General Hospital, and researchers and staff at Lund University in Sweden for their tireless work in contributing to the running of the study and data collection. Publisher Copyright: © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/7

Y1 - 2021/7

N2 - Background: The 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. Methods: In 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 2 vs ≥30 kg/m 2), and comorbidities (binary variable, with or without comorbidities). Findings: Between 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. Interpretation: Systemic 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. Funding: ZOE 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.

AB - Background: The 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. Methods: In 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 2 vs ≥30 kg/m 2), and comorbidities (binary variable, with or without comorbidities). Findings: Between 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. Interpretation: Systemic 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. Funding: ZOE 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.

UR - http://www.scopus.com/inward/record.url?scp=85107405913&partnerID=8YFLogxK

U2 - 10.1016/S1473-3099(21)00224-3

DO - 10.1016/S1473-3099(21)00224-3

M3 - Article

C2 - 33930320

SN - 1473-3099

VL - 21

SP - 939

EP - 949

JO - The Lancet infectious diseases

JF - The Lancet infectious diseases

IS - 7

ER -

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

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