Association of Facial Paralysis With mRNA COVID-19 Vaccines: A Disproportionality Analysis Using the World Health Organization Pharmacovigilance Database During the pivotal phase 3 clinical trials of mRNA COVID-19 vaccines, several cases of facial paralysis were observed in the vaccine groups (7 of 35 654) compared with 1 case among people who received placebo (1 of 35 611).1,2 Although a causal relationship could not be established from clinical trials, the US Food and Drug Administration recommended monitoring vaccine recipients for facial paralysis. We thus explored this potential safety signal through a disproportionality analysis using the World Health Organization pharmacovigilance database, VigiBase.
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Renoud et al. (2021) studied this question.
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