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Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults
UMB Dataset

UID: 182

Author(s): Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M. Kaplan, Peter Doshi* * Corresponding Author
Description
An adapted version of the Brighton Collaboration priority list was used to evaluate serious adverse events (SAE) of special interest observed in mRNA Covid-19 vaccine trials. In December of 2020, reviewers searched journal publications and trial data on the FDA’s and Health Canada’s websites to locate SAE results tables for these trials. For each trial, blinded SAE tables were prepared. Using these blinded SAE tables, two clinician reviewers judged whether each SAE type was an adverse event of special interest (AESI). Risk ratios and risk differences between vaccine and placebo groups were calculated for the incidence of AESIs and SAEs.
Timeframe
2020
Subject of Study
Subject Domain
Keywords
Access Restrictions
Free to all
Access Instructions
All of the data in the study is available at Zenodo.
Associated Publications
Data Type
Software Used
Microsoft Excel
Study Type
Secondary analysis
Dataset Format(s)
XLSX
Dataset Size
388.5 kB