Association of Facial Paralysis With mRNA COVID-19 Vaccines

Renoud, Lucie; Khouri, Charles; Revol, Bruno; Lepelley, Marion; Perez, Justine; Roustit, Matthieu; Cracowski, Jean Luc

doi:10.1001/jamainternmed.2021.2219

Cited by 94 publications

(41 citation statements)

References 6 publications

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“…Therefore, by broadening the spectrum of safety reports of interest to those with COVID-19 vaccines (of all technologies) suspected of being associated with FP/BP onset, the present study controverts the one previously performed in VigiBase by Renoud et al, which found that the reporting rate of FP/BP after mRNA COVID-19 vaccines was not higher than that observed with other viral vaccines [12]. In that study, authors used stratification to control confounding factors (including sex and age) and, assuming the absence of risk variation across strata, provided a single combined (not significant) disproportionality measure [12]. Nevertheless, ignoring the diversity within a dataset may result in signals being masked.…”

Section: Discussioncontrasting

confidence: 95%

“…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%

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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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Section: Discussioncontrasting

confidence: 95%

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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“…4 9 A recent disproportionality analysis using the WHO pharmacovigilance database showed no difference between the reporting rate of facial nerve paralysis with COVID-19 mRNA vaccines when compared with other viral vaccines. 10 Unilateral facial nerve palsies occurring after each COVID-19 vaccine dose were not reported in any of the three vaccine trials, nor has this been reported in the literature.…”

Section: Introductionmentioning

confidence: 92%

Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses

et al. 2021

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A 61-year-old man presented to the ENT emergency clinic with a history of unilateral facial nerve palsy occurring shortly after each dose of the Pfizer-BioNTech COVID-19 vaccine. The first episode developed 5 hours after administration of the first dose and the second 2 days after administration of the second dose. Investigations at initial presentation to the emergency department were unremarkable, and the patient was diagnosed with Bell’s palsy on both occasions. We describe the first case of Bell’s palsy occurring after each dose of any UK-approved COVID-19 vaccine. Single episodes of unilateral facial nerve palsies have been reported in clinical trials and in subsequent case reports. There has been no evidence, however, of an episode after each dose. We also describe the earliest onset of symptoms from timing of administration of the vaccine, further suggesting the Bell’s palsy was associated with the vaccine.

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“…They found no higher safety signal for facial palsy after mRNA Covid-19 vaccines when compared with all other viral vaccines or restricted to influenza vaccines. [58] Eric Wan et al found an overall increased risk of Bell's palsy after vaccinated with CoronaVac, an inactivated virus COVID-19 vaccine, but no increased risk after BNT162b2 vaccination. [59] In our study, we found no elevated risk of Bell's palsy with BNT162b2, but a small increased risk with ChAdOx1.…”

Section: Findings In Contextmentioning

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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Association of Facial Paralysis With mRNA COVID-19 Vaccines

Cited by 94 publications

References 6 publications

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

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

Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses

“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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