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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.
  • Bardenheier BH; Brown University School of Public Health, Providence, RI, USA. Electronic address: barbara_bardenheier@brown.edu.
  • Gravenstein S; Brown University School of Public Health, Providence, RI, USA; Warren Alpert Medical School, Brown University, Providence, RI, USA; Providence Veterans Administration Medical Center, Center on Innovation in Long-Term Services and Supports, Providence, RI, USA.
  • Blackman C; Genesis Healthcare, Kennett Square, PA, USA.
  • Gutman R; Brown University School of Public Health, Providence, RI, USA.
  • Sarkar IN; Brown University School of Public Health, Providence, RI, USA; Warren Alpert Medical School, Brown University, Providence, RI, USA; Rhode Island Quality Institute, Providence, RI, USA.
  • Feifer RA; Genesis Healthcare, Kennett Square, PA, USA.
  • White EM; Brown University School of Public Health, Providence, RI, USA.
  • McConeghy K; Brown University School of Public Health, Providence, RI, USA; Providence Veterans Administration Medical Center, Center on Innovation in Long-Term Services and Supports, Providence, RI, USA.
  • Nanda A; Warren Alpert Medical School, Brown University, Providence, RI, USA.
  • Mor V; Brown University School of Public Health, Providence, RI, USA; Providence Veterans Administration Medical Center, Center on Innovation in Long-Term Services and Supports, Providence, RI, USA.
Vaccine ; 39(29): 3844-3851, 2021 06 29.
Article in English | MEDLINE | ID: covidwho-1253724
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: North America Language: English Journal: Vaccine Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: North America Language: English Journal: Vaccine Year: 2021 Document Type: Article