Association of COVID-19 Vaccination and Facial Nerve Palsy: A Case-Control Study.

IMPORTANCE

Peripheral facial nerve (Bell) palsy has been reported and widely suggested as a possible adverse effect of the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine. Israel is currently the leading country in vaccination rates per capita, exclusively using the BNT162b2 vaccine, and all residents of Israel are obligatory members of a national digital health registry system. These factors enable early analysis of adverse events.

OBJECTIVE

To examine whether the BNT162b2 vaccine is associated with an increased risk of acute-onset peripheral facial nerve palsy.

DESIGN, SETTING, AND PARTICIPANTS: This case-control study was performed from January 1 to February 28, 2021, at the emergency department of a tertiary referral center in central Israel. Patients admitted for facial nerve palsy were matched by age, sex, and date of admission with control patients admitted for other reasons.

EXPOSURES

Recent vaccination with the BNT162b2 vaccine.

MAIN OUTCOMES AND MEASURES

Adjusted odds ratio for recent exposure to the BNT162b2 vaccine among patients with acute-onset peripheral facial nerve palsy. The proportion of patients with Bell palsy exposed to the BNT162b2 vaccine was compared between groups, and raw and adjusted odds ratios for exposure to the vaccine were calculated. A secondary comparison with the overall number of patients with facial nerve palsy in preceding years was performed.

RESULTS

Thirty-seven patients were admitted for facial nerve palsy during the study period, 22 (59.5%) of whom were male, and their mean (SD) age was 50.9 (20.2) years. Among recently vaccinated patients (21 [56.7%]), the mean (SD) time from vaccination to occurrence of palsy was 9.3 (4.2 [range, 3-14]) days from the first dose and 14.0 (12.6 [range, 1-23]) days from the second dose. Among 74 matched controls (2:1 ratio) with identical age, sex, and admittance date, a similar proportion were vaccinated recently (44 [59.5%]). The adjusted odds ratio for exposure was 0.84 (95% CI, 0.37-1.90; P = .67). Furthermore, analysis of the number of admissions for facial nerve palsy during the same period in preceding years (2015-2020) revealed a relatively stable trend (mean [SD], 26.8 [5.8]; median, 27.5 [range, 17-35]).

CONCLUSIONS AND RELEVANCE

In this case-control analysis, no association was found between recent vaccination with the BNT162b2 vaccine and risk of facial nerve palsy.