Bell’s palsy following a single dose of mRNA SARS-CoV-2 vaccine: a case report

Martín-Villares, Cristina; Vazquez-Feito, A.; González‐Gimeno, Maria Jose; Nogal-Fernandez, B. de la

doi:10.1007/s00415-021-10617-3

Cited by 31 publications

(29 citation statements)

References 4 publications

(4 reference statements)

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“…Until recently, the data available in the literature about the development of Bell's palsy after administration of post-mRNA vaccines in the general population were limited, consisting mainly of case reports 5. , 6. , 7.…”

Section: Discussionmentioning

confidence: 99%

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Left Bell's palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: A case report

et al. 2022

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Section: Discussionmentioning

confidence: 99%

“…and mRNA-1273 (Moderna), 9. , 11. and the COVID-19 Vaccine Vaxzevria (ex-COVID-19 AstraZeneca), whilst less frequently were associated with the Ad26.COV2.S (Janssen) vaccination, 9.…”

Section: Discussionmentioning

confidence: 99%

Left Bell's palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: A case report

et al. 2022

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“…Because of the new technology, the use by a large number of individuals in a brief period, and the recommendation of an additional dose at least for immunocompromised patients, concerns about the safety of mRNA COVID-19 vaccines have emerged. Cases of FP/BP were reported with mRNA COVID-19 vaccines but have also occurred with COVID-19 vaccines of different technologies [6][7][8]. Indeed, the biological mechanism linking FP/BP onset and COVID-19 vaccines is likely related to immune activation and independent on vaccine technology [16].…”

Section: Discussionmentioning

confidence: 99%

“…Since marketing authorization, cases of NA, FP/BP and GBS were reported with COVID-19 vaccines [4][5][6][7][8][9][10][11]. A recent pharmacovigilance study in VigiBase, the World Health Organization's (WHO) global database of suspected adverse drug reactions (ADRs) found that the reporting frequency of FP/BP with mRNA COVID-19 vaccines was similar to that with other viral vaccines [12].…”

Section: Introductionmentioning

confidence: 99%

Reporting of Acute Inflammatory Neuropathies with COVID-19 Vaccines: Subgroup Disproportionality Analyses in VigiBase

et al. 2021

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Since marketing authorization, cases of neuralgic amyotrophy (NA), facial paralysis/Bell’s palsy (FP/BP), and Guillain-Barré syndrome (GBS) were reported with COVID-19 vaccines of different technologies. This study aimed to assess whether NA, FP/BP, and GBS were more frequently reported in VigiBase with COVID-19 vaccines (of any technologies) than with other viral vaccines, over the full database and across potential risk groups by sex and age. The reporting odds ratio (ROR) with 95% confidence interval (95% CI) was used as the measure of disproportionality and subgroup disproportionality analyses were performed by sex and age. Out of 808,906 safety reports with COVID-19 vaccines, 57 (0.01%) reported NA, 3320 (0.4%) FP/BP, and 632 (0.1%) GBS. There were not signals of disproportionate reporting for NA and GBS with COVID-19 vaccines against other viral vaccines. FP/BP was disproportionately more frequently reported with COVID-19 vaccines than with other viral vaccines over the full database (ROR 1.12, 95%CI 1.07–1.17), in males (ROR 1.65, 95%CI 1.54–1.78) and in age subgroups 65–74 years (ROR 1.21, 95%CI 1.05–1.39) and ≥75 years (ROR 1.84, 95%CI 1.52–2.22). Albeit not proving causation, these findings might support clinicians in decision-making for patients potentially at risk for developing an acute inflammatory neuropathy with COVID-19 vaccines.

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“…[27] Data from the BNT162b2 and mRNA-1273vaccines trials also suggested a possible association with Bell's palsy, with seven cases in the active arms compared with one case in the placebo arms of the trials, and six subsequent reports. [28][29][30][31][32][33] The clinical trial of the Johnson & Johnson viral vector vaccine Ad26.COV2.S reported one case of GBS in each of the placebo and active trial arms 10 days after the injection. [34,35] There were 2 reports of the GBS variant with bifacial weakness in the US, [26,36] and a warning of the US Food and Drug Administration about the Ad26.COV2.S vaccine and rare but serious cases of GBS.…”

Section: Main Text [3177words] Introductionmentioning

confidence: 99%

“Association between COVID-19 vaccination, infection, and risk of Guillain-Barre syndrome, Bell’s palsy, encephalomyelitis and transverse myelitis: a population-based cohort and self-controlled case series analysis”

Martínez‐Hernández

Herranz

et al. 2021

Preprint

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OBJECTIVE We aimed to study the association between COVID-19 vaccines, SARS-CoV-2 infection, and the risk of immune-mediated neurological events. METHODS Design Population-based historical rate comparison study and self-controlled case series (SCCS) analysis. Setting Primary care records from the United Kingdom. Participants Individuals who received the first dose of ChAdOx1 or BNT162b2 between 8 December 2020 and 6 March 2021. A cohort with a first positive RT-PCR test for SARS-CoV-2 between 1 September 2020 and 28 February 2021 was used for comparison. Main outcome measures Outcomes included Guillain-Barre syndrome (GBS), Bell's palsy, encephalomyelitis, and transverse myelitis. Incidence rates were estimated in the 28 days post first-dose vaccine, 90 days post-COVID-19, and between 2017 to 2019 for the general population cohort for background rates. Indirectly standardised incidence ratios (SIRs) were estimated. Adjusted incidence rate ratios (IRR) were estimated from the SCCS when sufficient statistical power was reached. Results We included 1,868,767 ChAdOx1 and 1,661,139 BNT162b2 vaccinees; 299,311 people infected with COVID-19; and 2,290,537 from the general population. SIRs for GBS were 1.91 [95% CI: 0.86 to 4.26] after ChAdOx1, 1.29 [0.49 to 3.45] after BNT162b2, and 5.20 [1.95 to 13.85] after COVID-19. In the same cohorts, SIRs for Bell's palsy were 1.34 [1.05 to 1.72], 1.15 [0.88 to 1.50], and 1.23 [0.80 to 1.89], and for encephalomyelitis 1.62 [0.61 to 4.31], 0.86 [0.22 to 3.46], and 11.05 [5.27 to 23.17], respectively. Transverse myelitis was too rare to analyse (n<5 in all cohorts). SCCS analysis was only conducted for Bell's palsy due to limited statistical power. We found no association between either vaccine and Bell's palsy, with an IRR of 1.10 [0.81 to 1.46] and 1.15 [0.87 to 1.49] for BNT162b2 and ChAdOx1, respectively. Conclusions We found no consistent association between either vaccine and any of the studied neuro-immune adverse events studied. Conversely, we found a 5-fold increase in risk of GBS and an 11-fold of encephalomyelitis following COVID-19.

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Bell’s palsy following a single dose of mRNA SARS-CoV-2 vaccine: a case report

Cited by 31 publications

References 4 publications

Left Bell's palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: A case report

Left Bell's palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: A case report

Reporting of Acute Inflammatory Neuropathies with COVID-19 Vaccines: Subgroup Disproportionality Analyses in VigiBase

“Association between COVID-19 vaccination, infection, and risk of Guillain-Barre syndrome, Bell’s palsy, encephalomyelitis and transverse myelitis: a population-based cohort and self-controlled case series analysis”

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