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Dataset Open Access

Dataset and additional info for "Serious adverse events of special interest following mRNA vaccination in randomized trials" (Fraiman et al. 2022)

Fraiman, Joseph; Erviti, Juan; Jones, Mark; Greenland, Sander; Whelan, Patrick; Kaplan, Robert; Doshi, Peter

Dataset for:

Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022 Aug 30;40(40):5798–805. doi: 10.1016/j.vaccine.2022.08.036. Epub ahead of print. PMID: 36055877; PMCID: PMC9428332. https://doi.org/10.1016/j.vaccine.2022.08.036 

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Dataset - Final (20220721).xlsx
md5:94a91eb83538086542a2bac3a7ac627c 		388.5 kB Download
Examples of AESI matching decision process.pdf
md5:08ae27d292ccc181b1afa7481d7b8575 		52.8 kB Download
Response to FDA critique (20220916).pdf
md5:59fb275b6e4e7d30be6806b9f039e7e3 		194.5 kB Download
Sensitivity analysis excluding SAEs requiring clinical judgments.pdf
md5:3d6f4ab969103187e0dc68ab32b236dc 		29.8 kB Download
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Publication date:
September 16, 2022
DOI:
10.5281/zenodo.7087668

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Version 8 10.5281/zenodo.7251306 Oct 26, 2022
Version 7 10.5281/zenodo.7196784 Oct 13, 2022
Version 6 10.5281/zenodo.7105425 Sep 22, 2022
Version 5 10.5281/zenodo.7087668 Sep 16, 2022
Version 4 10.5281/zenodo.7065516 Sep 9, 2022
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