Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database

Abstract

Background and Objective Several cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rate is higher in those who received influenza vaccination compared with those who received other vaccines. Methods We evaluated reports of facial paralysis in people who received influenza vaccination during January 2015 to October 2019 using Medical Dictionary for Regulatory Activities Preferred Terms. A disproportionality analysis was performed to determine the proportional reporting ratio (PRR), Chi-square statistic, and reporting odds ratio (ROR) with 95% confidence interval (CI). The demographic and clinical characteristics of the cases were also analyzed. Results Two hundred fifty cases of facial paralysis following influenza vaccination were reported during the study period. The median age of the patients was 45 (interquartile range, 30-57) years; 132 (52.8%) patients were females. The majority of the patients received the injected trivalent or quadrivalent seasonal influenza vaccine by intramuscular route. The PRR, Chi-square statistic, and ROR (95% CI) was 2.44, 122.32, and 2.44 (2.08-2.88), respectively; on excluding cases involving concomitant paresis/paralysis of limbs or Guillain-Barre syndrome, the disproportionality statistics were 2.30, 89.37, and 2.30 (1.93-2.75), respectively. Conclusions Our study shows increased reporting of facial paralysis following influenza vaccination as compared with other vaccines. Considering the inherent limitations of the VAERS database analysis, and the fact that disproportionality measures only indicate the presence of a signal, our study findings need to be explored in well-designed prospective pharmacoepidemiologic studies.

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“…Such concerning neurological AEs after vaccines may be more than chance events, and the possibility and causality bear close monitoring. A VAERS analysis previously reported the possible relationship between facial paralysis (0.05% incidence rate) and influenza vaccine (15). The female prevalence in all-cause facial paralysis was 58.2-65.8% in some previous studies (16)(17)(18); however, the 18 AEFI cases with facial paralysis were notably all females in our study.…”

Association of Facial Paralysis With mRNA COVID-19 Vaccines

“…The me- 4 Isolated facial paralysis after vaccination has been reported as case reports for decades with almost all viral vaccines, and it is thought to be immune mediated or induced by viral reactivations (eg, reactivation of a herpes virus infection). 5 However, to date, pharmacoepidemiological studies have failed to identify a higher risk of facial paralysis after vaccination. 5,6 When compared with other viral vaccines, mRNA COVID-19 vaccines did not display a signal of facial paralysis.…”

“…5 However, to date, pharmacoepidemiological studies have failed to identify a higher risk of facial paralysis after vaccination. 5,6 When compared with other viral vaccines, mRNA COVID-19 vaccines did not display a signal of facial paralysis. As of March 9, 2021, more than 320 million COVID-19 vaccine doses had been administered worldwide.…”

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“…The adverse events of IV can be divided into those attributed to the vaccine, its preservatives, inoculation, and the interaction with other drugs and vaccines. The Institute of Medicine (IOM) of the United States National Academy of Sciences found no evidence of causality between IV and a wide range of studied immunologic or neurologic events [ 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 ].…”