Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Aug 18:46:e110.
doi: 10.26633/RPSP.2022.110. eCollection 2022.

Surveillance of adverse events associated with 145 000 doses of COVID-19 vaccines in a Brazilian municipality

Paulo Ricardo Martins-Filho  1 , Ricardo Ruan Rocha Santana  2 , Taise Ferreira Cavalcante  3 , Waneska de Souza Barboza  4 , Mércia Feitosa de Souza  5 , Marco Aurelio de Oliveira Góes  2 , Ângela Marinho Barreto Fontes  5 , Marcia Estela Lopes da Silva  5 , Diego Moura Tanajura  1
Affiliations

Surveillance of adverse events associated with 145 000 doses of COVID-19 vaccines in a Brazilian municipality

Paulo Ricardo Martins-Filho et al. Rev Panam Salud Publica. .

Abstract
in English, Spanish, Portuguese

There is a lack of real-world surveillance studies on reports of adverse events associated with COVID-19 vaccination, as well as comparative analyses of adverse events from vaccines with different platforms. This observational, descriptive, retrospective study based on secondary data describes the adverse events following immunization (AEFIs) related to the first 145 000 doses of COVID-19 vaccines delivered in Aracaju municipality, Sergipe state, northeast Brazil. Records of AEFIs were collected using the e-SUS Notifica database for January 19 to April 30, 2021. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for AEFIs and the type of COVID-19 vaccine, either CoronaVac (Sinovac-Butantan) or Oxford-AstraZeneca (Fiocruz). A total of 474 AEFIs (32.7 events/10 000 doses) from 254 individuals were reported and analyzed, and all of them were classified as non-serious. There was an association between the use of the CoronaVac vaccine and headache (OR = 2.1; 95% CI: 1.4-3.2), pain at the injection site (OR = 9.6; 95% CI: 3.9-23.8), lethargy (OR = 5.2; 95% CI: 1.8-14.8), fatigue (OR = 10.1; 95% CI: 2.4-42.3), diarrhea (OR = 4.4; 95% CI: 1.5-12.5) and cold-like symptoms (OR = 8.0; 95% CI: 1.9-34.0). However, the proportion of individuals reporting fever was higher among those who received the Oxford-AstraZeneca vaccine (OR = 3.1; 95% CI 1.5-6.4). This population-based observational study strengthens the evidence for the safety and tolerability of the CoronaVac and Oxford-AstraZeneca vaccines used against COVID-19.

Hay una carencia de estudios de vigilancia en el mundo real sobre la notificación de eventos adversos asociados a la vacunación contra la COVID-19, así como de análisis comparativos de los eventos adversos de vacunas con diferentes plataformas. En este estudio observacional, descriptivo y retrospectivo basado en datos secundarios se describen los eventos adversos supuestamente atribuibles a la vacunación o inmunización (ESAVI) relacionados con las primeras 145 000 dosis de vacunas contra la COVID-19 administradas en el municipio de Aracaju, estado de Sergipe, en la región Noreste de Brasil. Se recopilaron registros de los ESAVI del 19 de enero al 30 de abril del 2021 con la base de datos e-SUS Notifica. Se calcularon las razones de posibilidades (OR, por su sigla en inglés) y los intervalos de confianza (IC) del 95 % para los ESAVI y el tipo de vacuna contra la COVID-19 (CoronaVac [Sinovac-Butantan] o bien Oxford-AstraZeneca [Fiocruz]). Se notificaron y analizaron un total de 474 ESAVI (32,7 eventos/10 000 dosis) de 254 personas, y todos se clasificaron como no graves. Se encontró una relación entre el empleo de la vacuna CoronaVac y la cefalea (OR = 2,1; IC del 95 %: 1,4–3,2), dolor en el lugar de la inyección (OR = 9,6; IC del 95 %: 3,9–23,8), letargo (OR = 5,2; IC del 95 %: 1,8–14,8), cansancio (OR = 10,1; IC del 95 %: 2,4–42,3), diarrea (OR = 4,4; IC del 95 %: 1,5–12,5) y síntomas similares al resfriado (OR = 8,0; IC del 95 %: 1,9 a 34,0). Sin embargo, la proporción de pacientes que notificaron fiebre fue mayor entre los que recibieron la vacuna de Oxford-AstraZeneca (OR = 3,1; IC del 95 %: 1,5 a 6,4). Este estudio observacional poblacional refuerza la evidencia sobre la seguridad y tolerabilidad de las vacunas CoronaVac y Oxford-AstraZeneca empleadas contra la COVID-19.

Faltam estudos de vigilância no mundo real sobre relatórios de eventos adversos associados à vacinação contra a COVID-19, bem como análises comparativas de eventos adversos decorrentes de vacinas com diferentes plataformas. Este estudo observacional, descritivo e retrospectivo baseado em dados secundários descreve os eventos adversos pós-vacinação (EAPV) relacionados com as primeiras 145 mil doses de vacinas contra a COVID-19 entregues no município de Aracaju, capital do estado de Sergipe, na região Nordeste do Brasil. Os registros de EAPV foram coletados usando o sistema e-SUS Notifica com referência ao período de 19 de janeiro a 30 de abril de 2021. Razões de chances (odds ratios, ORs) e intervalos de confiança (IC) de 95% foram calculados para os EAPV e o tipo de vacina contra a COVID-19: CoronaVac (Sinovac-Butantan) ou Oxford-AstraZeneca (Fiocruz). Um total de 474 EAPV (32,7 eventos/10 mil doses) de 254 indivíduos foram relatados e analisados, e todos foram classificados como não graves. Houve uma associação entre o uso da vacina CoronaVac e cefaleia (OR = 2,1; IC 95%: 1,4-3,2), dor no local da injeção (OR = 9,6; IC 95%: 3,9-23,8), letargia (OR = 5,2; IC 95%: 1,8-14,8), cansaço (OR = 10,1; IC 95%: 2,4-42,3), diarreia (OR = 4,4; IC 95%: 1,5-12,5 e sintomas gripais (OR = 8,0; IC 95%: 1,9-34,0). Contudo, a proporção de indivíduos que relataram febre foi superior entre os que receberam a vacina Oxford-AstraZeneca (OR = 3,1; IC 95%: 1,5-6,4). Este estudo observacional de base populacional reforça as evidências da segurança e tolerabilidade das vacinas CoronaVac e Oxford-AstraZeneca usadas contra a COVID-19.

Keywords: COVID-19; COVID-19 vaccines; SARS-CoV-2; drug-related side effects and adverse reactions; injection site reaction.

PubMed Disclaimer

Similar articles

See all similar articles

References

    1. Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397:99–111. - PMC - PubMed
    2. Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397:99-111. - PMC - PubMed
    1. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384:403–416. - PMC - PubMed
    2. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384:403-16. - PMC - PubMed
    1. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383:2603–2615. - PMC - PubMed
    2. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383:2603-15. - PMC - PubMed
    1. Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, et al. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. N Engl J Med. 2021;384:2187–2201. - PMC - PubMed
    2. Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, et al. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. N Engl J Med. 2021;384:2187-201. - PMC - PubMed
    1. Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21:803–812. - PMC - PubMed
    2. Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21:803-12. - PMC - PubMed

LinkOut - more resources