Email this article Vaccine safety for COVID-19 prevention
- Authors: Romanov B.K.1, Alpatov S.P.1, Bogush N.V.1, Borozdenko D.A.1, Buyanova N.M.1, Ganshina I.V.1, Dibirova G.O.1, Dmitrieva N.B.1, Kalinina E.V.1, Kirillova A.V.1, Kiseleva N.M.1, Kukushkin G.V.1, Leonteva T.I.1, Maximov M.L.1, Markina E.V.1, Mileshina S.E.1, Tsitsuashvili M.D.1, Yurov D.E.1
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Affiliations:
- N.I. Pirogov Russian National Research Medical University
- Issue: Vol 27, No 3 (2021)
- Pages: 273-280
- Section: Clinical pharmacology and pharmaceuticals
- URL: https://journals.rcsi.science/0869-2106/article/view/101159
- DOI: https://doi.org/10.17816/0869-2106-2021-27-3-273-280
- ID: 101159
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Abstract
BACKGROUND: In 2021, the Uppsala Monitoring Center of the World Health Organization included 52 vaccines for coronavirus disease-2019 (COVID-19) prevention in the international database, VigiBase, and almost immediately, this group of medicines (drugs) took the lead in the increased rate of reported adverse reactions (ARs).
AIM: This study aimed to review the case reports of ARs from COVID-19 vaccines in the VigiBase database.
MATERIALS AND METHODS: Statistical analysis of cases that describe ARs in the international pharmacovigilance VigiBase database was performed.
RESULTS: On May 12, 2021, the VigiBase database included 26,099,906 reports that describe AR cases on drugs, including 585,744 reports of AR on vaccines for COVID-19 prevention. Serious ARs after immunization with these vaccines were registered in 31.5% of reports, including 0.9% fatal and 1.3% life-threatening. Headache (37.1% of reports), pyrexia (31.1%), chills (23.2%), and fatigue (22.7%) were most frequently recorded.
CONCLUSIONS: More data are required to confirm the association between the COVID-19 vaccines and the increased risk of ARs following their use.
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##article.viewOnOriginalSite##About the authors
Boris K. Romanov
N.I. Pirogov Russian National Research Medical University
Author for correspondence.
Email: bkr@ya.ru
ORCID iD: 0000-0001-5429-9528
MD, Dr. Sci. (Med.)
Russian Federation, MoscowSergey P. Alpatov
N.I. Pirogov Russian National Research Medical University
Email: immunosport@rambler.ru
ORCID iD: 0000-0003-2233-7301
MD, Cand. Sci. (Med.)
Russian Federation, MoscowNadezhda V. Bogush
N.I. Pirogov Russian National Research Medical University
Email: nadinbogush@gmail.com
Russian Federation, Moscow
Denis A. Borozdenko
N.I. Pirogov Russian National Research Medical University
Email: borozdenko@phystech.edu
ORCID iD: 0000-0002-6797-9722
Russian Federation, Moscow
Natalia M. Buyanova
N.I. Pirogov Russian National Research Medical University
Email: natasha-buyanova@mail.ru
ORCID iD: 0000-0002-4073-475X
Russian Federation, Moscow
Irina V. Ganshina
N.I. Pirogov Russian National Research Medical University
Email: july1119661@rambler.ru
ORCID iD: 0000-0003-4049-7907
Russian Federation, Moscow
Gulnara O. Dibirova
N.I. Pirogov Russian National Research Medical University
Email: g.dibirova@mail.ru
ORCID iD: 0000-0002-1500-4974
MD, Cand. Sci. (Med.)
Russian Federation, MoscowNatalia B. Dmitrieva
N.I. Pirogov Russian National Research Medical University
Email: natapharm@gmail.com
Scopus Author ID: 7101760859
MD, Cand. Sci. (Med.)
Russian Federation, MoscowElena V. Kalinina
N.I. Pirogov Russian National Research Medical University
Email: lena_vk@mail.ru
Scopus Author ID: 8958305800
MD, Cand. Sci. (Med.)
Russian Federation, MoscowAnna V. Kirillova
N.I. Pirogov Russian National Research Medical University
Email: kirillova6@yandex.ru
ORCID iD: 0000-0003-3966-4448
MD, Cand. Sci. (Med.)
Russian Federation, MoscowNina M. Kiseleva
N.I. Pirogov Russian National Research Medical University
Email: kiseleva.67@mail.ru
ORCID iD: 0000-0003-1754-9051
MD, Cand. Sci. (Biol.), Professor
Russian Federation, MoscowGerman V. Kukushkin
N.I. Pirogov Russian National Research Medical University
Email: germanpharm@yandex.ru
ORCID iD: 0000-0002-1661-1071
MD, Cand. Sci. (Med.)
Russian Federation, MoscowTatiana I. Leonteva
N.I. Pirogov Russian National Research Medical University
Email: leontevati@mail.ru
MD, Cand. Sci. (Biol.)
Russian Federation, MoscowMaxim L. Maximov
N.I. Pirogov Russian National Research Medical University
Email: maksim_maksimov@mail.ru
ORCID iD: 0000-0002-8979-8084
MD, Dr. Sci. (Med.), Professor
Russian Federation, MoscowElena V. Markina
N.I. Pirogov Russian National Research Medical University
Email: elvikmark2015@yandex.ru
ORCID iD: 0000-0002-5943-4423
Russian Federation, Moscow
Svetlana E. Mileshina
N.I. Pirogov Russian National Research Medical University
Email: svetikshrv@rambler.ru
ORCID iD: 0000-0001-8082-9393
MD, Cand. Sci. (Med.)
Russian Federation, MoscowMaia D. Tsitsuashvili
N.I. Pirogov Russian National Research Medical University
Email: mayan318@gmail.com
ORCID iD: 0000-0001-7761-8683
MD, Cand. Sci. (Biol.)
Russian Federation, MoscowDmitry E. Yurov
N.I. Pirogov Russian National Research Medical University
Email: dmpharm@gmail.com
ORCID iD: 0000-0003-0178-8736
MD, Cand. Sci. (Med.)
Russian Federation, MoscowReferences
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