Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey

被引:94
作者
Mathioudakis, Alexander G. [1 ,2 ]
Ghrew, Murad [3 ,4 ,5 ]
Ustianowski, Andrew [5 ,6 ]
Ahmad, Shazaad [7 ]
Borrow, Ray [8 ]
Papavasileiou, Lida Pieretta [9 ]
Petrakis, Dimitrios [10 ]
Bakerly, Nawar Diar [3 ,11 ]
机构
[1] Univ Manchester, Sch Biol Sci, Div Infect Immun & Resp Med, Manchester M23 9LT, Lancs, England
[2] Manchester Univ NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, North West Lung Ctr Wythenshawe Hosp, Manchester M23 9LT, Lancs, England
[3] Salford Royal Hosp NHS Fdn Trust, Dept Resp Med, Manchester M6 8HD, Lancs, England
[4] Salford Royal Hosp NHS Fdn Trust, Dept Intens Care Med, Manchester M6 8HD, Lancs, England
[5] Univ Manchester, Sch Biol Sci, Fac Biol Med & Hlth, Manchester M13 9PL, Lancs, England
[6] North Manchester Gen Hosp, Reg Infect Dis Unit, Manchester M8 5RB, Lancs, England
[7] Manchester Univ NHS Fdn Trust, Manchester Med Microbiol Partnership, Dept Virol, Manchester M13 9WL, Lancs, England
[8] Manchester Univ NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, Manchester Royal Infirm, Vaccine Evaluat Unit,Publ Hlth England, Manchester M13 9WL, Lancs, England
[9] Hygeia Hosp, Dept Cardiol, Athens 15123, Greece
[10] Petrakis Allergy Care, Allergy Clin, Thessaloniki 55133, Greece
[11] Manchester Metropolitan Univ, Sch Healthcare Sci, Manchester M15 6BH, Lancs, England
来源
LIFE-BASEL | 2021年 / 11卷 / 03期
关键词
Coronavirus Disease 2019; COVID-19; vaccine; safety; reactogenicity; tolerability; adverse events;
D O I
10.3390/life11030249
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
An online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups. This survey was launched in February 2021 and ran for 11 days. Recipients of a first COVID-19 vaccine dose >= 7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed. The survey was completed by 2002 respondents of whom 26.6% had a prior COVID-19 infection. A prior COVID-19 infection was associated with an increased risk of any side effect (risk ratio 1.08, 95% confidence intervals (1.05-1.11)), fever (2.24 (1.86-2.70)), breathlessness (2.05 (1.28-3.29)), flu-like illness (1.78 (1.51-2.10)), fatigue (1.34 (1.20-1.49)) and local reactions (1.10 (1.06-1.15)). It was also associated with an increased risk of severe side effects leading to hospital care (1.56 (1.14-2.12)). While mRNA vaccines were associated with a higher incidence of any side effect (1.06 (1.01-1.11)) compared with viral vector-based vaccines, these were generally milder (p < 0.001), mostly local reactions. Importantly, mRNA vaccine recipients reported a considerably lower incidence of systemic reactions (RR < 0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue and of side effects requiring hospital care (0.42 (0.31-0.58)). Our study confirms the findings of recent randomised controlled trials (RCTs) demonstrating that COVID-19 vaccines are generally safe with limited severe side effects. For the first time, our study links prior COVID-19 illness with an increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects but more local reactions.
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相关论文
共 11 条
[1]  
[Anonymous], FREQUENTLY ASKED QUE
[2]   Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort [J].
Arnold, David T. ;
Hamilton, Fergus W. ;
Milne, Alice ;
Morley, Anna J. ;
Viner, Jason ;
Attwood, Marie ;
Noel, Alan ;
Gunning, Samuel ;
Hatrick, Jessica ;
Hamilton, Sassa ;
Elvers, Karen T. ;
Hyams, Catherine ;
Bibby, Anna ;
Moran, Ed ;
Adamali, Huzaifa, I ;
Dodd, James William ;
Maskell, Nicholas A. ;
Barratt, Shaney L. .
THORAX, 2021, 76 (04) :399-401
[3]   Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine [J].
Baden, Lindsey R. ;
El Sahly, Hana M. ;
Essink, Brandon ;
Kotloff, Karen ;
Frey, Sharon ;
Novak, Rick ;
Diemert, David ;
Spector, Stephen A. ;
Rouphael, Nadine ;
Creech, C. Buddy ;
McGettigan, John ;
Khetan, Shishir ;
Segall, Nathan ;
Solis, Joel ;
Brosz, Adam ;
Fierro, Carlos ;
Schwartz, Howard ;
Neuzil, Kathleen ;
Corey, Larry ;
Gilbert, Peter ;
Janes, Holly ;
Follmann, Dean ;
Marovich, Mary ;
Mascola, John ;
Polakowski, Laura ;
Ledgerwood, Julie ;
Graham, Barney S. ;
Bennett, Hamilton ;
Pajon, Rolando ;
Knightly, Conor ;
Leav, Brett ;
Deng, Weiping ;
Zhou, Honghong ;
Han, Shu ;
Ivarsson, Melanie ;
Miller, Jacqueline ;
Zaks, Tal .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (05) :403-416
[4]   Antibody Responses in Seropositive Persons after a Single Dose of SARS-CoV-2 mRNA Vaccine [J].
Krammer, Florian ;
Srivastava, Komal ;
Simon, Viviana .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (14) :1372-1374
[5]  
Lee K, 2009, GLOB INST, P1
[6]   Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine [J].
Polack, Fernando P. ;
Thomas, Stephen J. ;
Kitchin, Nicholas ;
Absalon, Judith ;
Gurtman, Alejandra ;
Lockhart, Stephen ;
Perez, John L. ;
Perez Marc, Gonzalo ;
Moreira, Edson D. ;
Zerbini, Cristiano ;
Bailey, Ruth ;
Swanson, Kena A. ;
Roychoudhury, Satrajit ;
Koury, Kenneth ;
Li, Ping ;
Kalina, Warren V. ;
Cooper, David ;
Frenck, Robert W., Jr. ;
Hammitt, Laura L. ;
Tureci, Ozlem ;
Nell, Haylene ;
Schaefer, Axel ;
Unal, Serhat ;
Tresnan, Dina B. ;
Mather, Susan ;
Dormitzer, Philip R. ;
Sahin, Ugur ;
Jansen, Kathrin U. ;
Gruber, William C. .
NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (27) :2603-2615
[7]  
Pradenas E., 2020, STABLE NEUTRALIZING, V2, DOI [10.1101/2020.11.22.389056, DOI 10.1101/2020.11.22.389056]
[8]   Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial [J].
Ramasamy, Maheshi N. ;
Minassian, Angela M. ;
Ewer, Katie J. ;
Flaxman, Amy L. ;
Folegatti, Pedro M. ;
Owens, Daniel R. ;
Voysey, Merryn ;
Aley, Parvinder K. ;
Angus, Brian ;
Babbage, Gavin ;
Belij-Rammerstorfer, Sandra ;
Berry, Lisa ;
Bibi, Sagida ;
Bittaye, Mustapha ;
Cathie, Katrina ;
Chappell, Harry ;
Charlton, Sue ;
Cicconi, Paola ;
Clutterbuck, Elizabeth A. ;
Colin-Jones, Rachel ;
Dold, Christina ;
Emary, Katherine R. W. ;
Fedosyuk, Sofiya ;
Fuskova, Michelle ;
Gbesemete, Diane ;
Green, Catherine ;
Hallis, Bassam ;
Hou, Mimi M. ;
Jenkin, Daniel ;
Joe, Carina C. D. ;
Kelly, Elizabeth J. ;
Kerridge, Simon ;
Lawrie, Alison M. ;
Lelliott, Alice ;
Lwin, May N. ;
Makinson, Rebecca ;
Marchevsky, Natalie G. ;
Mujadidi, Yama ;
Munro, Alasdair P. S. ;
Pacurar, Mihaela ;
Plested, Emma ;
Rand, Jade ;
Rawlinson, Thomas ;
Rhead, Sarah ;
Robinson, Hannah ;
Ritchie, Adam J. ;
Ross-Russell, Amy L. ;
Saich, Stephen ;
Singh, Nisha ;
Smith, Catherine C. .
LANCET, 2020, 396 (10267) :1979-1993
[9]   Binding and Neutralization Antibody Titers After a Single Vaccine Dose in Health Care Workers Previously Infected With SARS-CoV-2 [J].
Saadat, Saman ;
Tehrani, Zahra Rikhtegaran ;
Logue, James ;
Newman, Michelle ;
Frieman, Matthew B. ;
Harris, Anthony D. ;
Sajadi, Mohammad M. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2021, 325 (14) :1467-1469
[10]   Are overwhelmed health systems an inevitable consequence of covid-19? Experiences from China, Thailand, and New York State [J].
Tangcharoensathien, Viroj ;
Bassett, Mary T. ;
Meng, Qingyue ;
Mills, Anne .
BMJ-BRITISH MEDICAL JOURNAL, 2021, 372