Adverse reactions following COVID-19 vaccination: An Ecuadorian experience.
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ABSTRACT: Background
Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.Methods
We conducted an observational cross-sectional study to assess the potential adverse reactions to the Pfizer-BioNTech COVID-19 vaccine among a sample of healthcare workers (HCWs) in the city of Guayaquil, Ecuador, from March to May 2021.Results
The sample comprised 1291 patients, with a mean age of 39.3 years (SD, 13.5). In general, 79% (N = 1020) of participants presented an adverse effect of any type at first dose, while 75.1% (N = 969) did so at the second dose. Pain at the puncture site was the most common adverse effect overall after either the first (68.4%) and second (55.6%) dose. Regarding anaphylaxis, no participant developed the condition after the first dose, and only 0.2% (N = 2) developing it at the second dose. No fatalities were reported.Conclusion
Our findings suggest that adverse reactions following COVID-19 vaccination with the Pfizer-BioNTech vaccine are relatively common, albeit often mild and self-limited. Consistent with the literature there were few cases of anaphylaxis, and no deaths that could be attributed to the inoculation with the vaccine. We hope our findings can help to reassure the public that benefits of vaccination highly outweigh the risks and contribute to the effort of reducing vaccine hesitancy among those who are concerned about the safety and potential side effects.
SUBMITTER: Vanegas E
PROVIDER: S-EPMC8598282 | biostudies-literature |
REPOSITORIES: biostudies-literature
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2016-08-02 | ST000440 | MetabolomicsWorkbench
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Project description:The coronavirus disease 2019 (COVID-19) vaccination frequently leads to minor side-effects, that may be more intense after the second dose, but more serious side effects have been reported. We report a case of a 24-year-old man who presented to the hospital with acute substernal chest pain, 4 days after his second COVID-19 Moderna vaccination. Laboratory studies revealed elevated troponins and negative viral serologies. Cardiac magnetic resonance imaging (cMRI) demonstrated edema and delayed gadolinium enhancement of the left ventricle in a midmyocardial and epicardial distribution. The patient was diagnosed with myocarditis following Moderna vaccination. Our case report raises concern that myocarditis is a rare side effect of COVID-19 vaccine. Despite our report, it appears that there is a significantly higher risk of cardiac involvement from COVID-19 infection compared to COVID-19 vaccination.
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Project description:BackgroundDuring coronavirus disease 2019 (COVID-19) pandemic, several COVID-19 vaccines were licensed with fast-track procedures. Although these vaccines have demonstrated high immunogenicity, there has been concerns on the serious adverse events (AEs) following COVID-19 vaccination among adolescents. We aimed to analyze comparative safety of COVID-19 vaccination in adolescents.MethodsIn this pharmacovigilance study, we performed a disproportionality analysis using VigiBase, the World Health Organization's global individual case safety report (ICSR) database. To compare serious AEs reported following COVID-19 vaccines vs. all other vaccines in adolescents aged 12-17 years, ICSRs following any vaccines on adolescents aged 12-17 years were included, defining cases as reports with the AEs of interest, with all other AEs as non-cases. The AEs of interest were myocarditis/pericarditis, multisystem inflammatory syndrome/Kawasaki disease (MIS/KD), anaphylaxis, Guillain-Barré syndrome (GBS), and immune thrombocytopenia (ITP). We conducted a disproportionality analysis to estimate reporting odds ratio (ROR) with 95% confidence interval (CI) for each AE of interest, adjusted for sex by using logistic regression.ResultsOf 99,735 AE reports after vaccination in adolescents, 80,018 reports were from COVID-19 vaccinated adolescents (52.9% females; 56.3% America). The AEs of interest were predominantly reported as serious AE (76.1%) with mRNA vaccines (99.4%). Generally, higher reporting odds for the AEs were identified following COVID-19 vaccination in adolescents; myocarditis/pericarditis (2,829 reports for the COVID-19 vaccine vs. 35 for all other vaccines, adjusted ROR [aROR], 19.61; 95% CI, 14.05-27.39), and MIS/KD (104 vs. 6, aROR, 4.33; 95% CI, 1.89-9.88). The reporting odds for anaphylaxis (515 vs. 165, aROR, 0.86; 95% CI, 0.72-1.02), GBS (94 vs. 40, aROR, 0.64; 95% CI, 0.44-0.92) and ITP (52 vs. 12, aROR, 1.12; 95% CI, 0.59-2.09) were not significantly higher following COVID-19 vaccination.ConclusionIn this study, there were disproportionate reporting of immune-related AEs following COVID-19 vaccination. While awaiting definitive evidence, there is a need to closely monitor for any signs of immune-related AEs following COVID-19 vaccination among adolescents.
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