Adverse events associated with CoronaVac in a university hospital
DOI:
https://doi.org/10.30968/rbfhss.2022.134.0805Abstract
Objective: The present study aimed to describe suspected adverse events (AEs) reported in employees of a teaching hospital in the state of Sergipe after vaccination with CoronaVac. Methods: This is a cross-sectional study based on reports of post-vaccination adverse event notification forms (APVs) from the Hospital Surveillance application (Vigihosp) of the University Hospital of Sergipe, during the months of January to March 2021. analysis included hospital workers aged ≥ 18 years and who received at least one dose of CoronaVac. Results: In total, 406 notifications were identified, of which 251 were selected. The nursing technician was the professional category that was not identified the most (38%), followed by the nurse (20%). Women of mixed race and younger age group (<50 years) were more likely to have AEFIs. The most frequent reactions at both doses include pain at the injection site, headache, fatigue and drowsiness. As for severity, most were of mild to moderate intensity. Conclusion: The data reinforce the safety of CoronaVac available in Brazil.
Downloads
References
Castro MC, Kim S, Barberia L, Ribeiro AF, Gurzenda S, Ribeiro KB, et al. Spatiotemporal pattern of Covid-19 spread in Brazil. Science. 2021; 21 (6544) [acesso em 02 fev 2022]. Disponível: http://dx.doi.org/10.1126/science.abh1558.
World Health Organization (WHO). Coronavirus disease (Covid-19). Situation Report-130.[Internet] [acesso em 02 fev 2022]. Disponível: https://www.who.int/docs/default-source/coronaviruse/situationreports/20200529-covid--19-sitrep-130.pdf?sfvrsn=bf7e7f0c_4.
Ministério da Saúde (BR). Covid-19 painel coronavírus. [Internet]
[acesso em 02 fev 2022].Disponível: https://covid.saude.gov.br Brasil.
Goldblatt D, Fiore-Gartland A, Johnson M, et al. Towards a population-based threshold of protection for Covid-19 vaccines. Vaccine. 2022;40(2) [acesso em 02 fev 2021]. Disponível: http://dx.doi.org/10.1016/j.vaccine.2021.12.006.
Shahcheraghi SH, Ayatollahi J, Aljabali AA, et al. An overview of vaccine development for Covid-19.Ther Deliv. 2021;12(3) [acesso em 02 fev 2022].Disponível: http://dx.doi.org/doi:10.4155/tde-2020-0129.
World Health Organization (WHO). DRAFT landscape of Covid-19 candidate vaccines.[Internet] [acesso 2 fev 2022]. Disponível: https://www.who.int/who-documents-detail/draft-landscape-of-covid-19-candidate.
Ministério da Saúde (BR). Plano Nacional de Operacionalização da Vacinação Contra a COVID-19. [Internet] Brasília: Ministério da Saúde; 2021 [acesso em 03 fev 2022]. Disponível: https://www.gov.br/saude/pt-br/coronavirus/publicacoes-tecnicas/guias-e-planos/plano-nacional-de-vacinacao-covid-19.
Ministério da Saúde (BR). Opendatasus. campanha nacional de resistência contra o COVID-19.[Internet] Brasília: Ministério da Saúde; 2021 [acesso em 02 de fev de 2022]. Disponível:https://opendatasus.saude.gov.br/dataset/covid-19-vacinacao.
Globo G1. Mapa do Brasil contra Covid-19. [Internet] [acesso em 11 de agosto de 2021].Disponível em: https://covid.saude.gov.br.
Bartsch SM, O’Shea KJ, Ferguson MC, et al. Vaccine efficacy needed for a Covid-19 coronavirus vaccine to prevent or stop an epidemic as the sole intervention. Am J Prev Med. 2020; 59 (4) [acesso em 03 fev 2022]. Disponível: https://doi.org/10.1016/j.amepre.2020.06.011.
Brown AL, Sperandio M, Turssi CP, et al. Vaccine confidence and hesitancy in Brazil. Cad Saúde Pública. 2018; 34:00011618 [acesso em 03 fev 2022]. Disponível: https://doi.org/10.1590/0102-311X00011618.
Ranzani OT, Bastos LSL, Gelli JGM, et al. Characterisation of the first 250 000 hospital admissions for Covid-19 in Brazil: a retrospective analysis of nationwide data. The Lancet Respiratory Medicine. 2021;9(4) [acesso em 03 fev 2022]. Disponível: https://10.1016/s2213-2600(20)30560-9.
Lin Y, Hu Z, Zhao Q, Alias H, et al. Understanding Covid-19 vaccine demand and hesitancy: A nationwide online survey in China. PLOS Neglected Tropical Diseases. 2020;14(12) [acesso em 03 fev 2022]. Disponível: https://doi.org/10.1371/journal.pntd.0008961.
Lazarus JV, Ratzan SC, Palayew A, et al. A global survey of potential acceptance of a Covid-19 vaccine. Nat Med. 2021; 27 [acesso em 03 fev 2022]. Disponível: https://doi.org/10.1038/s41591-020-1124-9.
Palacios R, Patiño EG, de Oliveira P, et al. Double-Blind,Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety oftreating Healthcare Professionals with the Adsorbed Covid-19 (Inactivated) Vaccine Manufactured by Sinovac – PROFISCOV: A structured summary of 2020; 21 (1) [acesso em 03 fev 2022]. Disponível: https://doi.org/10.1186/s13063-020-04775-4.
Tanriover MD, Doğanay HL, Akova M, et al. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. The Lancet. 2021; 398(10296) [acesso em 03 fev 2022]. Disponível: https://10.1016/s0140-6736(21)01429-x.
Chun JY, Park S, Jung J, Kim SH, et al. Guillain-Barré syndrome after vaccination against Covid-19. Lancet Neurol. 2022;21(2):117-119 [acesso em 03 fev 2022]. Disponível: https://doi.org/10.1016/S1474-4422(21)00416-6.
Wan EYF, Chui CSL, et al. Bell’s palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study. TheLancet Infectious Diseases. 2021 [acesso em 03 fev 2022]. Disponível: https://doi.org/ 10.1016/s1473-3099(21)00451-5.
Takuva S, Takalani A, Garrett N, Goga A, et al. Thromboembolic Events in the South African Ad26.COV2.S Vaccine Study. N Engl J Med. 2021;385(6):570-571 [acesso em 03 fev 2022]. Disponível:https://doi.org/10.1056/NEJMc2107920.
Pisani D, Gianluca L, Pasquale V, et al.Sudden sensorineural hearing loss after covid-19 vaccine; A possible adverse reaction?. Otolaryngology Case Reports. 2021; 100384(1) [acesso em 05 fev 2022]. Disponível: https://doi.org/10.1016/j.xocr.2021.100384
Barda N, Dagan N, Ben-Shlomo, et al. Safety of the BNT162b-2mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021;385(12):1078-1090 [acessoem 04 fev 2022]. Disponível: https://doi.org/10.1056/NEJMoa2110475.
Naniche D, Hotez P, Bottazzi ME, et al. Beyond the jab: A need for global coordination of pharmacovigilance for Covid-19 vaccine deployment. E clinical Medicine 2021; 36 [acesso em 04 fev 2022].Disponível:https://doi.org/10.1016/j.eclinm.2021.100925.
Ministério da Saúde da Saúde (BR). Secretaria de Vigilância em Saúde Agência Nacional deVigilância Sanitária. Estratégia de Vacinação contra o Vírus SARS-CoV-2 Covid-19: Protocolo de Vigilância Epidemiológica e Sanitária de Eventos Adversos Pós-Vacinação. [Internet] Brasília:Ministério da Saúde; 2020 [acesso em 04 fev 2022]. Disponível: https://www.gov.br/saude/pt-br/media/pdf/2020/dezembro/21/estrategia_vacinacao_covid19.pdf.
Empresa Brasileira de Serviços Hospitalares (Ebserh). Plano de Reestruturação Hospital Universitário da Universidade Federal de Sergipe. [Internet] Brasília: Ebserh; 2013 [acesso em 07 fev 2022].Disponível:https://www.gov.br/ebserh/pt br/hospitais-universitarios/contratos-de-gestao/regiao--nordeste/hu-ufs/plano-de-reestruturacao.
Ministério da Saúde (BR). Secretaria de Vigilância em Saúde, Departamento de Imunizações e Doenças Transmissíveis. Manual de Vigilância Epidemiológica de Eventos Adversos Pós- Vacinação. [Internet] Brasília: Ministério da Saúde; 2020 [acesso em 07 fev 2022]. Disponível: https://bvsms.saude.gov.br/bvs/publicacoes/manual_vigilancia_epidemiologica_evento vacinacao_4ed.pdf.
Kitagawa H, Kaiki Y, Sugiyama A, et al. Adverse reactions to the BNT162b2 and mRNA-1273 mRNA Covid-19 vaccines in Japan. Journal of Infection and Chemotherapy. 2022 [acesso em 07 fev 2022].Disponível: https://doi.org/10.1016/j.jiac.2021.12.034.
Riad A, Sağıroğlu D, Üstün B, et al. Prevalence and Risk Factors of CoronaVac Side Effects: An Independent Cross-Sectional Study among Healthcare Workers in Turkey. Journal of Clinical Medicine. 2021;10(12), 2629. [acesso em 07 fev 2022] Disponível: https://doi.org/10.1007/s10557-020-07024-7
World Health Organization (WHO). Background document on the inactivated vaccine Sinovac-CoronaVac against Covid-19: background document to the WHO Interim recommendations for use of the inactivated Covid-19 vaccine, CoronaVac, developed by Sinovac. [Internet] World Health Organization; 2021. [acesso em 07 fev 2022] Disponível:https://apps.who.int/iris/handle/10665/341455. Licença: CC BY-NC-SA 3.0 IGO.
Demirbakan H, Koçer I, Erdoğan M, et al. Assessing humoral immune response after two doses of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthcare workers. Public Health. 2022. [acesso em 07 fev 2022] Disponível: https://doi.org/10.1016/j.puhe.2022.01.011.
Palacios R, Batista AP, Nascimento ACS, et al. Efficacy and safety of a Covid-19 inactivated vaccine in healthcare 2 professionals in Brazil: The PROFISCOV study. SSRN Journal. 2021. [acesso em 10 fev 2022] Disponível: https://doi.org/10.2139/ssrn.3822780.
Instituto Batantan. Dizeres de texto de bula – Profissional da Saude. [Internet] Instituto Batantan;2021.[acesso em 10 fev 2022] Disponível:https://vacinacovid.butantan.gov.br/assets/arquivos/Bulas_Anvisa/2021.04.23
Zhang Y, Zeng G, Pan H, Li C, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021; 21. [acesso em 10 fev 2022] Disponível: https://doi.org/10.1016/S1473-3099(20)30843-4.
Beatty AL, Peyser ND, Butcher XE, et al. Analysis of Covid-19 Vaccine Type and Adverse Effects Following Vaccination. JAMA Netw Open. 2021;4(12) e2140364. [acesso em 10 fev 2022] Disponível: https://doi.org/10.1001.2021.40364
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2022 Authors
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
The authors hereby transfer, assign, or otherwise convey to RBFHSS: (1) the right to grant permission to republish or reprint the stated material, in whole or in part, without a fee; (2) the right to print republish copies for free distribution or sale; and (3) the right to republish the stated material in any format (electronic or printed). In addition, the undersigned affirms that the article described above has not previously been published, in whole or part, is not subject to copyright or other rights except by the author(s), and has not been submitted for publication elsewhere, except as communicated in writing to RHFHSS with this document.
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License (CC-BY-NC-ND) that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
Serlf-archiving policy
This journal permits and encourages authors to post and archive the final pdf of the articles submitted to the journal on personal websites or institutional repositories after publication, while providing bibliographic details that credit its publication in this journal.
