Increased odds ratio for Bell’s palsy following COVID -19 infection or vaccination in a large Health Center

doi:10.21203/rs.3.rs-3206968/v1

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Increased odds ratio for Bell’s palsy following COVID -19 infection or vaccination in a large Health Center

https://doi.org/10.21203/rs.3.rs-3206968/v1

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Objective: Bell’s palsy is a paralysis of the facial muscles on one side of the face caused by a viral infection. Studies have indicated an increase of Bell’s palsy following infection or vaccination for COVID-19. The study examined the association of these variables with Bell’s palsy in a large hospital cohort.

Materials and Methods: Using the deidentified data i2b2 of subjects visiting the University of Florida during October 2015- October 2022 we have identified subjects with an ICD-10 diagnoses of COVID -19, Bell’s palsy and vaccination for COVID-19.

Results: From a total population of 1314924, 38005 had a history of COVID-19, 2072 had a diagnosis of Bell’s palsy, 112 both Bell’s Palsy and COVID-19

and 196279 were vaccinated. Diagnosis of COVID-19 was associated with increased risk for Bell’s palsy (odds ratio 1.87, 95% CI 1.54 -2.26 p<0.0001). COVID -19 vaccination was associated with increased risk for Bell’s palsy at odds ratio1.98 (95%CI 1.79-2.18, p<0.0001).

COVID -19 infection or vaccination were associated with an increased risk for Bell’s palsy.

Conclusions:Although causality cannot be attributed to cross sectional studies, these findings may indicate that exposure to the viral antigen may be related to the neurological sequalae of COVID- 19.

Clinical Relevance: The Dental professionals should be aware of Bell’s palsy and the potential link of the appearance of Bell’s palsy post COVID-19 infection or vaccination

COVID -19

vaccine

Bell’s palsy

odds ratio

viruses

Bell’s Palsy (BP) is a condition that results in either the partial or complete inability to move facial muscles due to the paralysis of the seventh cranial nerve, affecting between 11.5–53.3 per 100,000 people a year (1). More specific symptoms include the inability to close the eye completely, excessive tearing, pain in or behind the ear, and increased sensitivity to noise (2). Clinically, Bell’s palsy has been found to be associated with the rapid onset of unilateral, lower facial weakness as well as symptoms of postauricular pain, dysgeusia, subjective change in facial sensation, and hyperacusis (3).

No single cause for the development of BP has been identified and despite its severe effects, the exact etiology of BP remains unclear although some risk factors have been determined. Some research suggests that BP is more common in patients that have diabetes and are around the age of 40 (4). Other data has proposed that hypertension, the male sex, residence outside of metropolitan cities (or the capital), and advanced age were significant risk factors (5). A possible etiology of BP is viral infections such as herpes simplex virus type one (HSV-1), the varicella zoster virus (VZV), human herpes virus 6, and the Usutu virus (1). In addition, inflammation, ischemia and immune dysregulation have been suggested (6).

While there’s a plethora of possible causes for the development of this condition, research during the COVID-19 pandemic has increasingly shown a potential relationship between the virus and Bell’s Palsy, including studies where it was found to be the first observed symptom (7). It was also found that, even after adjusting for other possible diseases including respiratory disease, endocrine disease, obesity, and diabetes, the prevalence of HSV-1 and VZV was significantly increased by the contraction of COVID-19 (8).

It has been suggested that COVID- 19 and the vaccination for COVID − 19 may cause reactivation Herpes Zoster and Simplex and cause an autoimmune reaction (9).

Most of the data presented in the literature on the association between COVID − 19 and BP is retrieved from a single case report or case series. Data from a large-scale epidemiological research is still missing.

The purpose of the present study was to investigate the association of BP with confirmed diagnosis of COVID-19 and in patients that have been vaccinated with COVID − 19 vaccines in a large cohort at the University of Florida’s health centers.

The University of Florida (UF) Integrated Data (IDR) i2b2, supported by the National Institute

of Health (NIH) and the UF Health Office of the Chief Data Officer was used to retrieve the data on subjects diagnosed with COVID -19, BP and patients who received at least one dose of COVID-19 vaccination during the period from October 2015 to April 2023.

The different diagnoses were coded using the international coding systems ICD 10.

The patient population analyzed was mixed, presenting with different disease conditions

including COVID 19 confirmed cases (ICD 10 – U07.1) and patients diagnosed with Bell’s palsy ICD 10 -G51.0.

We have included data from 2015 before onset of COVID- 19 to establish prevalence of non COVID-19 BP.

All types of COVID -19 vaccination have been included.

Inclusion criteria included the corresponding diagnostic code for these conditions.

There were no exclusion criteria since all codes were computerized, and specific.

The odds ratio (OR) for the presence of BP and its association with history of COVID and COVID-19 vaccination were determined. Adjustments of the OR for diabetic patients was done separately.

The OR were calculated with a 95% confidence interval and the statistical difference between the

study groups were assessed using MedCalc software (medcalc.org). A standard normal deviate (z- value) was calculated as follows: ln (OR)/SE {ln(OR)}. The p-value was the area of the normal

distribution that falls outside ±z. A value of p < 0.05 was considered statistically significant.

Ethical approval: The study was compliant with the University of Florida Institutional review board (IRB) for the UF health Center. Informed consent was waived by the IRB as the data did not contain PHI and was deidentified in the aggregates

The Hospital population included a total of 1587042 patients. Of this total, 46% were males and 54% were females. 10% were black or African American, 48% were white, and 42% were of other races. The patients in the hospital were made up of 86% percent adults and 14% children.

Out of the total 54993 COVID-19 cases recorded, 43% were males and 57% were females (p< 0.00001), 82% were adults while 18% were children, p< 0.00001), and 24% were black or African American (p< 0.00001), 56% were white (significant, p< 0.00001), and 20% included other races (p<0.00001).

There were 3614 recorded cases of Bell’s Palsy, 48% were males and 52% were females (p= .049448). 18% were black or African American (p< 0.00001), 69% were white (p< 0.00001), and another 11% belonged to other races (p<0.00001). Additionally, 92% were adults while 18% were children (p< 0.00001). (Table 1). 307 cases were found of patients with both Bell’s Palsy and COVID-19, 56% were males while 44% were females (p< .05). 36% were black or African American, 52% percent were white (p = 0.356545), and 12% were of other races (p= 0.000012). 91% of patients were adults while 9% were children (p = 0.128733). (Tables 2 and 3). 224352 subjects had a history of COVID-19 vaccination.

Diagnosis of COVID-19 was associated with increased OR for BP (2.45,95%CI 2.18 to 2.75, p<0.0001) (Table 2). Nonwhite adult males were more susceptible for BP (Table 3).

When comparing the COVID -19 vaccinated against non-vaccinated the OR were 2.46 (95% CI 2.18 to 2.75, p<0.0001) table 4.

When adjusted for comorbidities such as diabetes, the OR for BP after COVID- 19 and Vaccination was 2.16, 2.24 respectively (Table 5).

In the present study, it was found that Bell’s Palsy was more prevalent in post COVID-19 patients than it was in the general population of patients in the hospital. (OR 2.45, 95%CI 2.25 to 2.67). The OR remained significant (2.24) even after adjustment for diabetes. These findings are in accordance with some previous studies that have found associations between BP and COVID-19 infections (10-29). Females were more affected by BP following COVID-19 than in the general population. Other studies have reported conflicted results (2, 6,10, 11,12,). When investigating pre-COVID-19 versus post-COVID-19 populations, a study found that the percentage of people with BP before COVID-19 was 50% male and 50% female whereas it became 42% female and 58% male after COVID-19 begun (2).

Our study found that the percentage of African Americans with COVID-19 was more than twice the percentage of African Americans in the hospital in general. A related study using 37 cross-sectional studies, 15 ecological studies, and data from the Centers for Disease control and prevention also found that “African American/Black populations experience disproportionately higher rates of SARS-CoV-2 infection, hospitalization, and COVID-19 related mortality than non-Hispanic White populations (30). These findings are supported by research demonstrating that African American/Black communities are disproportionately affected by poverty, limited health access, and health related conditions (31).

We conducted a separate analysis to study the relationship between Bell’s palsy and COVID-19 vaccine to accurately assess possible risk factors for BP. We found an OR value of 2.46 for those who had been vaccinated compared to those who hadn’t, signifying a strong relationship between Bell’s Palsy and the COVID-19 vaccine. In contrast, another study on the relationship between Bell’s Palsy and the COVID-19 vaccine at the emergency department of a tertiary referral center in central Israel found (after adjusting for existence of immune or inflammatory related disorders, diabetes, and pervious episodes or peripheral nerve palsy) an OR of .84 (95%Cl, 0.37-1.90, P=.67), signifying a lack of correlation between Bell’s Palsy and the BNT162b2 COVID-19 vaccine (9).

While there is no way to establish causality in a correlational study as such, the connection between BP, HSV, VZV, and COVID -19, provides a possible explanation behind the relationship. HSV-1 and VZV were found to be possible etiologies of BP (1) with their prevalence being increased by the contraction of COVID-19 (7). A viral infection or the reactivation of a latent virus could lead to the demyelination of the facial cranial nerve through an autoimmune reaction against peripheral nerve myelin components (32). Additionally, it has been found that BP may be caused by herpes being reactivated from cranial nerve ganglia which can cause inflammation of the facial nerve (33). This inflammation may lead to edema and swelling, which can compress the nerve in the fallopian canal, resulting in hypoperfusion of the nerve and ultimately damaging the axons and myelin sheaths, meaning nerve dysfunction (34). In addition, there has been a rise in the case number of Herpes Zoster (HZ), a reactivation of VZV primary infection, during the COVID-19 pandemic. One study found that the onset of HZ averaged 17 days after COVID-19 infection (35). It was also reported that, in three out of eight patients, facial palsy was the first COVID-19 symptom to develop and in the other five, it appeared from two to ten days after the onset of the virus.

Due to its idiopathic nature of BP, diagnosis is mostly based on anatomical structure, viral infection, ischemia, inflammation, and cold stimulation responsivity (1). Although a thorough investigation is needed to find the specific cause of BP in a patient and to determine a course of treatment, therapy with prednisone with or without antiviral medication and steroid therapy can generally be started as soon as symptoms commence (35, 36,37). Even without treatment, there is a good prognosis for the condition, with about 70% of patients fully recovering in six to nine months (34).

The U.S. Food and Drug Administration has stated the frequency of Bell's palsy in the COVID-19vaccine group is consistent with the expected background rate of Bell's palsy in the population but recommends "surveillance for cases of BP (38). In the present study we have found OR of 2.46 for BP in the vaccinated group including all types of vaccines. The OR was strong even after adjusting for diabetes.

The present study has few limitations, firstly, it is a cross sectional study and as such cannot infer causality, in addition, we could not adjust for all the comorbidities and disease parameters and considered only diabetes. Disease severity, hospitalization and respiratory distress could not be adjusted for.

The present study had identified increased OR for BP both with COVID 19 and COVID - 19 vaccination. With the caveats of study design and limitations, this association may be related to the neurological spectrum of the COVID 19 virus or the induction of innate immune activation from a combined effect of mRNA and lipids, potentially including interferon production that can break peripheral tolerance (39).

The study complies with the University of Florida institutional Review Board (IRB) of the Health Center.

The authors declare no conflict of interests

The authors declare no funding.

Author Contribution

Joseph Katz has conceptualized the study, provided the data and participated in writing the manuscript

Eva Sayman has performed literature reviewed, performed data analysis and participated in writing the manuscript.

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Table 1

Demographic data on study population
	COVID-19	BP	COVID-19 & BP	Hospital population
Male	43% *	48% *	56% *	46%
Female	57% *	52% *	44% *	54%
African American	24% *	18% *	36% *	10%
White	56% *	69% *	52% ^	48%
Others	20% *	11% *	12% *	42%
children	18% *	8% *	9% ^	14%
Adults	82% *	92% *	91% ^	86%
Total	38005	2072	112	1587042
* Significant at p < 0.05
^ not significant

Table 2

Odds Ratio for BP with history for COVID-19
	Bell’s Palsy population	Hospital population
COVID-19 population	307	54993
Hospital population	3614	1587042
OR	2.45
95% CI	2.18 to 2.75
p	< 0.0001

Table 3

odds ratio for BP after CPVID − 19 for different demographic variables
	OR	95% CI	p-value
Total	1.87	1.55–2.26	P < 0.0001
Adults	1.70	1.40–2.08	p < 0.0001
Children	1.51	0.80–2.90	p = 0.21
Others	3.86	2.25–6.618	p < 0.0001
White	1.18	0.91–1.54	p = 0.21
African American	1.60	1.16–2.22	p = 0.0047
Female	1.49	1.12–1.98	p = 0.0067
Male	2.35	1.82–3.04	p < 0.0001

Table 4

– Odds ratio for BP in vaccinated for COVID-19 vs. non-vaccinated
	Vaccinated population	Non -vaccinated population
BP population	751 0.33%	1858 0.13%
Hospital population	224352	1362730
OR	2.46
95% CI	2.25 to 2.67
p	< 0.0001

Table 5

– Odds ratio for BP in vaccinated and non-vaccinated and in COVID − 19 and non COVID-19 after adjustment for diabetes.
	Vaccinated	Non -vaccinated	COVID − 19	Non COVID − 19
BP population non- diabetic	505	1459	142	1826
Hospital population non-diabetic	194874	1262332	54993	1532049
OR	2.2421		2.16
95%CI	2.02 to 2.48			1.82 to 2.57
p	< 0.0001			< 0.0001

No competing interests reported.

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Increased odds ratio for Bell’s palsy following COVID -19 infection or vaccination in a large Health Center

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