دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: Surveillance of adverse events associated with 145 000 doses of COVID-19 vaccines in a Brazilian municipality.
المؤلفون: Martins-Filho PR; Investigative Pathology Laboratory Federal University of Sergipe AracajuSergipe Brazil Investigative Pathology Laboratory, Federal University of Sergipe, Aracaju, Sergipe, Brazil., Santana RRR; Department of Medicine Federal University of Sergipe LagartoSergipe Brazil Department of Medicine, Federal University of Sergipe, Lagarto, Sergipe, Brazil., Cavalcante TF; Health Sciences Graduate Program Federal University of Sergipe AracajuSergipe Brazil Health Sciences Graduate Program, Federal University of Sergipe, Aracaju, Sergipe, Brazil., Barboza WS; Municipal Health Secretariat Aracaju City Hall Aracaju Brazil Municipal Health Secretariat, Aracaju City Hall, Aracaju, Brazil., de Souza MF; State Health Secretariat Government of Sergipe State Aracaju Brazil State Health Secretariat, Government of Sergipe State, Aracaju, Brazil., Góes MAO; Department of Medicine Federal University of Sergipe LagartoSergipe Brazil Department of Medicine, Federal University of Sergipe, Lagarto, Sergipe, Brazil., Fontes ÂMB; State Health Secretariat Government of Sergipe State Aracaju Brazil State Health Secretariat, Government of Sergipe State, Aracaju, Brazil., da Silva MEL; State Health Secretariat Government of Sergipe State Aracaju Brazil State Health Secretariat, Government of Sergipe State, Aracaju, Brazil., Tanajura DM; Investigative Pathology Laboratory Federal University of Sergipe AracajuSergipe Brazil Investigative Pathology Laboratory, Federal University of Sergipe, Aracaju, Sergipe, Brazil.
المصدر: Revista panamericana de salud publica = Pan American journal of public health [Rev Panam Salud Publica] 2022 Aug 18; Vol. 46, pp. e110. Date of Electronic Publication: 2022 Aug 18 (Print Publication: 2022).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Pan American Health Organization Country of Publication: United States NLM ID: 9705400 Publication Model: eCollection Cited Medium: Internet ISSN: 1680-5348 (Electronic) Linking ISSN: 10204989 NLM ISO Abbreviation: Rev Panam Salud Publica Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Washington, D.C. : Pan American Health Organization, [1997?-
مستخلص: 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.
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فهرسة مساهمة: Keywords: COVID-19; COVID-19 vaccines; SARS-CoV-2; drug-related side effects and adverse reactions; injection site reaction
Local Abstract: [Publisher, Spanish; Castilian] 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. [Publisher, Portuguese] 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.
تواريخ الأحداث: Date Created: 20220826 Latest Revision: 20220827
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC9395276
DOI: 10.26633/RPSP.2022.110
PMID: 36016838
قاعدة البيانات: MEDLINE
الوصف
تدمد:1680-5348
DOI:10.26633/RPSP.2022.110