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COVID-19 Vaccination Did Not Increase the Risk of Potentially Related Serious Adverse Events: 18-Month Cohort Study in an Italian Province.
Flacco, Maria Elena; Acuti Martellucci, Cecilia; Soldato, Graziella; Di Martino, Giuseppe; Carota, Roberto; De Benedictis, Marco; Di Marco, Graziano; Parruti, Giustino; Di Luzio, Rossano; Caponetti, Antonio; Manzoli, Lamberto.
Afiliación
  • Flacco ME; Department of Environmental and Prevention Sciences, University of Ferrara, 44121 Ferrara, Italy.
  • Acuti Martellucci C; Department of Environmental and Prevention Sciences, University of Ferrara, 44121 Ferrara, Italy.
  • Soldato G; Local Health Unit of Pescara, 65124 Pescara, Italy.
  • Di Martino G; Local Health Unit of Pescara, 65124 Pescara, Italy.
  • Carota R; Local Health Unit of Pescara, 65124 Pescara, Italy.
  • De Benedictis M; Local Health Unit of Pescara, 65124 Pescara, Italy.
  • Di Marco G; Local Health Unit of Pescara, 65124 Pescara, Italy.
  • Parruti G; Local Health Unit of Pescara, 65124 Pescara, Italy.
  • Di Luzio R; Local Health Unit of Pescara, 65124 Pescara, Italy.
  • Caponetti A; Local Health Unit of Pescara, 65124 Pescara, Italy.
  • Manzoli L; Department of Medical and Surgical Sciences, University of Bologna, 40100 Bologna, Italy.
Vaccines (Basel) ; 11(1)2022 Dec 23.
Article en En | MEDLINE | ID: mdl-36679876
This cohort study on the entire population of an Italian Province assessed the incidence of potentially vaccine-related serious adverse events (PVR-SAEs) by COVID-19 vaccination status. From January 2021 to July 2022, we extracted all deaths and hospitalizations due to several cardiovascular diseases, pulmonary embolism, and deep vein thrombosis from National Healthcare System official data. During the follow-up, 5743 individuals died, and 2097 were hospitalized for PVR-SAEs. Vaccinated subjects (n = 259,821) did not show an increased risk of all-cause death, non-COVID death, or any PVR-SAEs, as compared to the unvaccinated (n = 56,494). These results were consistent across genders, age-classes, vaccine types, and SARS-CoV-2 infection status and did not vary in Cox models adjusting for age, gender, SARS-CoV-2 infection, and selected comorbidities. In the infected population, any dose of vaccine was associated with a lower likelihood of death and PVR-SAE. In the uninfected population, subjects who received one or two doses showed a significantly higher incidence of most outcomes, likely due to a large selection bias introduced by the Italian restriction policies targeting uninfected subjects who received less than three doses. In conclusion, COVID-19 vaccination was not associated with an increase of mortality or selected PVR-SAEs incidence. Further research is warranted to evaluate the long-term safety of COVID-19 vaccines.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Idioma: En Revista: Vaccines (Basel) Año: 2022 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Idioma: En Revista: Vaccines (Basel) Año: 2022 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Suiza