reported in the world health organization pharmacovigilance database are described. association of facial paralysis with mrna covid-19 vaccines: a disproportionality analysis using the world health organization pharmacovigilance database. doi:10.1001/jamainternmed.2021.2219 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.
a total of 749 cases were reported with the pfizer-biontech vaccine, and 95 cases were reported with the moderna vaccine. moreover, we identified 5734 (0.5%) and 2087 (0.7%) cases of facial paralysis among the 1 265 182 cases of adverse drug reactions reported with other viral vaccines and the 314 980 cases reported with influenza vaccines, respectively. therefore, despite selective reporting and a potential delay in reporting and transferring cases among pharmacovigilance databases, the reporting rate of facial paralysis after mrna covid-19 vaccination found in the present study is not higher than that observed with other viral vaccines. the data supplied to vigibase come from a variety of sources, and the likelihood of a causal relationship is not the same in all reports.
in addition, no meaningful increase in the number of admissions for facial nerve palsy was observed compared with preceding years. a secondary comparison with the overall number of patients with facial nerve palsy in preceding years was performed. we conducted a case-control study examining the association between exposure to the bnt162b2 vaccine and facial nerve palsy.
in both groups, the percentage of patients exposed to the bnt162b2 vaccine (first or second dose) within the previous 30 days was calculated and the adjusted and unadjusted odds ratios (ors) for exposure were compared with corresponding 95% cis. during the study period, a total of 37 patients were admitted for an acute-onset facial nerve palsy. in this study, occurrence of acute-onset facial nerve palsy was evaluated for an association with recent sars-cov-2 vaccination with the bnt162b2 vaccine. in addition, despite rapid and extensive vaccination of the population, a similar volume of admissions for facial nerve palsy was seen compared with the same period in preceding years.
isolated facial paralysis after vaccination has been reported as case reports for decades with almost all viral vaccines, and it is thought to previously, facial nerve palsy has been reported as a possible adverse event in other vaccinations, including influenza vaccine and objectives: facial nerve palsy (or bell’s palsy) has occasionally been reported following the administration of coronavirus disease 2019 (covid-19) mrna, .
no association was found between covid-19 vaccination with mrna covid-19 vaccines and risk for facial nerve palsy another study by renoud et al facial nerve palsy as an ae following immunization (aefi) of covid-19 mrna vaccines might be the result of the combined effect of lipids and mrna, leading to the case of a patient who experienced two facial palsies – one after the first and another after the second dose of the pfizer-biontech covid-19 vaccine –, .
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