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Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents
BACKGROUND: The devastating impact of the SARS-CoV-2 pandemic prompted the development and emergency use authorization of two mRNA vaccines in early 2020. Vaccine trials excluded nursing home (NH) residents, limiting adverse event data that directly apply to this population. METHODS: To prospectivel...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Ltd.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162901/ https://www.ncbi.nlm.nih.gov/pubmed/34092431 http://dx.doi.org/10.1016/j.vaccine.2021.05.088 |
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author | Bardenheier, Barbara H. Gravenstein, Stefan Blackman, Carolyn Gutman, Roee Sarkar, Indra Neil Feifer, Richard A. White, Elizabeth M. McConeghy, Kevin Nanda, Aman Mor, Vincent |
author_facet | Bardenheier, Barbara H. Gravenstein, Stefan Blackman, Carolyn Gutman, Roee Sarkar, Indra Neil Feifer, Richard A. White, Elizabeth M. McConeghy, Kevin Nanda, Aman Mor, Vincent |
author_sort | Bardenheier, Barbara H. |
collection | PubMed |
description | BACKGROUND: The devastating impact of the SARS-CoV-2 pandemic prompted the development and emergency use authorization of two mRNA vaccines in early 2020. Vaccine trials excluded nursing home (NH) residents, limiting adverse event data that directly apply to this population. METHODS: To prospectively monitor for potential adverse events associated with vaccination, we used Electronic Health Record (EHR) data from Genesis HealthCare, the largest NH provider in the United States. EHR data on vaccinations and pre-specified adverse events were updated daily and monitored for signal detection among residents of 147 facilities who received the first dose of vaccine between December 18, 2020 and January 3, 2021. For comparison, unvaccinated residents during the same time period were included from 137 facilities that started vaccinating at least 15 days after the vaccinating-facilities. RESULTS: As of January 3, 2021, 8553 NH residents had received one dose of SARS-CoV-2 vaccine and by February 20, 2021, 8371 residents had received their second dose of vaccine; 11,072 were included in the unvaccinated comparator group. No significant associations were noted for neurologic outcomes, anaphylaxis, or cardiac events. CONCLUSIONS: No major safety problems were detected following the first or second dose of the vaccine to prevent COVID-19 in the study cohort from December 18, 2020 through March 7, 2021. |
format | Online Article Text |
id | pubmed-8162901 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-81629012021-06-01 Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents Bardenheier, Barbara H. Gravenstein, Stefan Blackman, Carolyn Gutman, Roee Sarkar, Indra Neil Feifer, Richard A. White, Elizabeth M. McConeghy, Kevin Nanda, Aman Mor, Vincent Vaccine Article BACKGROUND: The devastating impact of the SARS-CoV-2 pandemic prompted the development and emergency use authorization of two mRNA vaccines in early 2020. Vaccine trials excluded nursing home (NH) residents, limiting adverse event data that directly apply to this population. METHODS: To prospectively monitor for potential adverse events associated with vaccination, we used Electronic Health Record (EHR) data from Genesis HealthCare, the largest NH provider in the United States. EHR data on vaccinations and pre-specified adverse events were updated daily and monitored for signal detection among residents of 147 facilities who received the first dose of vaccine between December 18, 2020 and January 3, 2021. For comparison, unvaccinated residents during the same time period were included from 137 facilities that started vaccinating at least 15 days after the vaccinating-facilities. RESULTS: As of January 3, 2021, 8553 NH residents had received one dose of SARS-CoV-2 vaccine and by February 20, 2021, 8371 residents had received their second dose of vaccine; 11,072 were included in the unvaccinated comparator group. No significant associations were noted for neurologic outcomes, anaphylaxis, or cardiac events. CONCLUSIONS: No major safety problems were detected following the first or second dose of the vaccine to prevent COVID-19 in the study cohort from December 18, 2020 through March 7, 2021. Elsevier Ltd. 2021-06-29 2021-05-28 /pmc/articles/PMC8162901/ /pubmed/34092431 http://dx.doi.org/10.1016/j.vaccine.2021.05.088 Text en © 2021 Elsevier Ltd. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Bardenheier, Barbara H. Gravenstein, Stefan Blackman, Carolyn Gutman, Roee Sarkar, Indra Neil Feifer, Richard A. White, Elizabeth M. McConeghy, Kevin Nanda, Aman Mor, Vincent Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents |
title | Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents |
title_full | Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents |
title_fullStr | Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents |
title_full_unstemmed | Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents |
title_short | Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents |
title_sort | adverse events following mrna sars-cov-2 vaccination among u.s. nursing home residents |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162901/ https://www.ncbi.nlm.nih.gov/pubmed/34092431 http://dx.doi.org/10.1016/j.vaccine.2021.05.088 |
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