Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study

ABSTRACT: Background: An excess risk of Bell's palsy has been suggested after mRNA vaccines. We examined the association between the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy. Methods: Using the database of the largest healthcare provider in Israel, we retrieved data from different...

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Autores principales: Rana Shibli, Ofra Barnett, Zomoroda Abu-Full, Naomi Gronich, Ronza Najjar-Debbiny, Ilana Doweck, Gad Rennert, Walid Saliba
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Publicado: Elsevier 2021
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spelling oai:doaj.org-article:a4d0dbc2f25d4691a7609a1d56bff0712021-12-02T05:04:19ZAssociation between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study2666-776210.1016/j.lanepe.2021.100236https://doaj.org/article/a4d0dbc2f25d4691a7609a1d56bff0712021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2666776221002222https://doaj.org/toc/2666-7762ABSTRACT: Background: An excess risk of Bell's palsy has been suggested after mRNA vaccines. We examined the association between the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy. Methods: Using the database of the largest healthcare provider in Israel, we retrieved data from different periods in 2018-2021. Observed cases of Bell's palsy occurring within 21-days after the first vaccine dose and within 30-days after the second vaccine dose were compared to the expected cases, based on the experience of the population in 2019. Standardized incidence ratios (SIRs) and attributable risks (ARs) were computed. Findings: Overall, 132 cases of Bell's palsy were reported in 2,594,990 vaccinees with the first dose, and 152 cases in 2,434,674 vaccinees after the second dose. The age and sex weighted SIRs were 1.36(95% CI, 1.14-1.61) and 1.16(0.99-1.36) after the first and second vaccine dose, respectively. SIRs tended to be higher in older age groups after the first and second vaccine doses. The estimates were more pronounced in older females after the first vaccine dose; SIR=1.71(1.10-2.54) at age 45-64, and 2.51(1.65-3.68) at age ≥65 years. The highest AR was 4.46 per 100,000 vaccinees detected in females aged ≥65 years. In patients with previous history of Bell's palsy, only 4 cases of Bell's palsy were reported in 7,567 vaccinees and 10 cases in 7,045 vaccinees after the first and the second dose, respectively. The age and sex weighted SIRs were 1.15(0.36-2.76) and 2.15(1.09-3.83) after the first and second vaccine dose, respectively. Interpretation: This study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of Bell's palsy. The small estimated attributable risks suggest that the impact on public health is relatively minor. The benefits of vaccinations explicitly outweigh the possible link to Bell's palsy that has high recovery rate if timely treated with corticosteroids. Funding: No external funding was available for this study.Rana ShibliOfra BarnettZomoroda Abu-FullNaomi GronichRonza Najjar-DebbinyIlana DoweckGad RennertWalid SalibaElsevierarticleadverse eventsBell's palsyfacial paralysisBNT162b2 mRNA COVID-19 vaccineCOVID-19mRNA vaccinesPublic aspects of medicineRA1-1270ENThe Lancet Regional Health. Europe, Vol 11, Iss , Pp 100236- (2021)
institution DOAJ
collection DOAJ
language EN
topic adverse events
Bell's palsy
facial paralysis
BNT162b2 mRNA COVID-19 vaccine
COVID-19
mRNA vaccines
Public aspects of medicine
RA1-1270
spellingShingle adverse events
Bell's palsy
facial paralysis
BNT162b2 mRNA COVID-19 vaccine
COVID-19
mRNA vaccines
Public aspects of medicine
RA1-1270
Rana Shibli
Ofra Barnett
Zomoroda Abu-Full
Naomi Gronich
Ronza Najjar-Debbiny
Ilana Doweck
Gad Rennert
Walid Saliba
Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study
description ABSTRACT: Background: An excess risk of Bell's palsy has been suggested after mRNA vaccines. We examined the association between the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy. Methods: Using the database of the largest healthcare provider in Israel, we retrieved data from different periods in 2018-2021. Observed cases of Bell's palsy occurring within 21-days after the first vaccine dose and within 30-days after the second vaccine dose were compared to the expected cases, based on the experience of the population in 2019. Standardized incidence ratios (SIRs) and attributable risks (ARs) were computed. Findings: Overall, 132 cases of Bell's palsy were reported in 2,594,990 vaccinees with the first dose, and 152 cases in 2,434,674 vaccinees after the second dose. The age and sex weighted SIRs were 1.36(95% CI, 1.14-1.61) and 1.16(0.99-1.36) after the first and second vaccine dose, respectively. SIRs tended to be higher in older age groups after the first and second vaccine doses. The estimates were more pronounced in older females after the first vaccine dose; SIR=1.71(1.10-2.54) at age 45-64, and 2.51(1.65-3.68) at age ≥65 years. The highest AR was 4.46 per 100,000 vaccinees detected in females aged ≥65 years. In patients with previous history of Bell's palsy, only 4 cases of Bell's palsy were reported in 7,567 vaccinees and 10 cases in 7,045 vaccinees after the first and the second dose, respectively. The age and sex weighted SIRs were 1.15(0.36-2.76) and 2.15(1.09-3.83) after the first and second vaccine dose, respectively. Interpretation: This study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of Bell's palsy. The small estimated attributable risks suggest that the impact on public health is relatively minor. The benefits of vaccinations explicitly outweigh the possible link to Bell's palsy that has high recovery rate if timely treated with corticosteroids. Funding: No external funding was available for this study.
format article
author Rana Shibli
Ofra Barnett
Zomoroda Abu-Full
Naomi Gronich
Ronza Najjar-Debbiny
Ilana Doweck
Gad Rennert
Walid Saliba
author_facet Rana Shibli
Ofra Barnett
Zomoroda Abu-Full
Naomi Gronich
Ronza Najjar-Debbiny
Ilana Doweck
Gad Rennert
Walid Saliba
author_sort Rana Shibli
title Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study
title_short Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study
title_full Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study
title_fullStr Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study
title_full_unstemmed Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study
title_sort association between vaccination with the bnt162b2 mrna covid-19 vaccine and bell's palsy: a population-based study
publisher Elsevier
publishDate 2021
url https://doaj.org/article/a4d0dbc2f25d4691a7609a1d56bff071
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