Facial nerve palsy after COVID-19 vaccinationa rare association or a coincidence. Guillain-Barre Syndrome (GBS), and cerebral venous thrombosis (CVT) occurred in fewer than 1 per 1,000,000 doses. R, Barnett A. The collected literature indicated that the neurological side effects associated with SARS-CoV-2 vaccines included headache, transverse myelitis, Guillain-Barre S, Kaur WHO coronavirus (COVID-19) dashboard. JP, Thompson et al. et al. Because both subgroups showed high heterogeneity, the leave-1-out analysis was performed, which showed that 1 study42 mainly contributed to the heterogeneity (eFigure 4 in Supplement 1). Fifty studies were included, of which 17 entered the quantitative synthesis. Discrepancies were dealt with through the consensus of 2 authors (A.R. Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document FDA. Woo EJ, Mba-Jonas A, Dimova RB, Alimchandani M, Zinderman CE, Nair N. JAMA. The etiology of Bells palsy: a review. Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. 2023 Jan 20;11(2):236. doi: 10.3390/vaccines11020236. 2022 Mar;145(3):375. doi: 10.1111/ane.13561. , Kennedy Pearls & Oy-sters: facial nerve palsy in COVID-19 infection. Bethesda, MD 20894, Web Policies Careers. The results are given in eFigure 2 and eTables 4 through 7 in Supplement 1. Importance Some people have reported experiencing symptoms of peripheral neuropathy after receiving the vaccine, but this does not confirm that a causal relationship exists. Other effects include: Many people who get the vaccine have muscle aches, headaches, or feel tired. Quality Assessment of the Case Controls Using the Newcastle-Ottawa Scale (NOS) Modified for Case-Control Studies, eTable 6. Adverse effects of the novel COVID-19 vaccinations are ever-evolving and receiving significant attention both in medical journals and the media.1 2 Unilateral facial nerve palsies were reported in the initial clinical trials of all three major vaccines approved for use in the UK.35 In the Pfizer-BioNTech mRNA phase 3 vaccine trial there were four Y, Beh Incidence of Guillain-Barr Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink. Summary of Studies Included in the Meta-analysis on Bell Palsy and SARS-CoV-2 Vaccination, Tiemstra (2021). To the best of our knowledge, this is the first systematic review and meta-analysis addressing the incidence of BP subsequent to SARS-CoV-2 vaccination. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. Epub 2021 May 24. The study was exempt from ethical approval by the local institutional ethics committee because we used previously published data. HM, Baden April 20, 2023. Clipboard, Search History, and several other advanced features are temporarily unavailable. D. M, Krasniqi All statistical analyses were performed using R software, version 4.2.1 (R Foundation for Statistical Computing), implementing the R package meta, version 5.2-0,47 using the Mantel-Haenszel method.48,49 For sections 1 and 2 of data analysis, the metabin function was used to pool the dichotomous data on the incidence of BP, and odds ratios (ORs), with corresponding 95% CIs, were used as the measure of effect. Proposal of a quality assessment tool for the evaluation of the methodological quality of self-controlled case series and self-controlled risk interval study designs. Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. Bells palsy secondary to COVID-19 vaccine Pfizer: case report. This article is protected by copyright. [10] https://casereports.bmj.com/content/bmjcr/14/4/e242956.full.pdf , Assiri Bouattour N, Hdiji O, Sakka S, Fakhfakh E, Moalla K, Daoud S, Farhat N, Damak M, Mhiri C. Neurol Sci. et al; AstraZeneca AZD1222 Clinical Study Group. DR, Thakur Y, Toda ACY. WebShingrix can make the area where you get the shot swell or feel sore. Single-cell RNA-seq analysis identifies distinct myeloid cells in a case with encephalitis temporally associated with COVID-19 vaccination. S, A, Floridi Learn more here. PMC JH. Association of clinical and epidemiological characteristics with COVID-19 BNT162b2 mRNA vaccine short-term adverse reactions in healthcare workers. Bell Palsy Events in Groups of Vaccine Recipients vs Saline Placebo Recipients, With Data From Randomized Clinical Trials, Figure 2. Articles reporting BP incidence with SARS-CoV-2 vaccination were included. T, Iwata A similar issue has been reported with Janssen (J&J) Covid vaccine [7], and we anticipate other viral-vector Covid vaccines such as CanSinoBIO (China) and Sputnik V (Russia) are likely to pose a similar risk. All Rights Reserved. This site needs JavaScript to work properly. JK, Haber The .gov means its official. MHRA is requested to investigate the cases of post-vaccine GBS and related signals of nerve damages in association with wider signals of auto-immune reactions in their database. Quality Assessment of the Cross-Sectional Studies Using the Newcastle-Ottawa Scale (NOS) Modified for Cross-Sectional Studies, eTable 7. Dashed line indicates the point estimate of the overall effect; dotted line, no effect; diamond, overall effect. retinopathy, which is damage to the retina. The records that did not meet the preestablished eligibility criteria were excluded. [8] https://assets.publishing.service.gov.uk/government/uploads/system/uploa Post COVID-19 vaccination-associated neurological complications. Bell palsy has also been reported following vaccination,25 although neither a causative relationship nor a prevalence of the condition higher than the general population has been established. , Polack Association of Receipt of the Ad26.COV2.S COVID-19 Vaccine With Presumptive Guillain-Barr Syndrome, February-July 2021. Interpretation: RV, Brando Addressing the publication bias, the funnel plots are provided in eFigure 3 in Supplement 1. In the United States, health oversight agencies will continue to monitor the Pfizer-BioNTech, Moderna, Johnson & Johnson/Janssen, and Novavax COVID-19 vaccines. These RCTs consisted of the final results of the phase 3 trials of the 4 major SARS-CoV-2 vaccines approved and widely administered worldwide (Pfizer/BioNTech, Moderna, Janssen, and Oxford/AstraZeneca). , Walker et al. et al. Neurological adverse events per 1,000,000, Neurological adverse events per 1,000,000 vaccine doses reported in VAERS stratified by COVID, Median age and sex proportions for each adverse event reported in VAERS between, Median time (days) from vaccine injection to adverse event onset, inclusive of all, MeSH 2023 American Medical Association. Ann Neurol. Bias in meta-analysis detected by a simple, graphical test. MA. The site is secure. More research is necessary to determine whether a cause-effect relationship is present. Guillain-Barr syndrome following the first dose of Pfizer-BioNTech COVID-19 vaccine: case report and review of reported cases. Second, potentially eligible records were further evaluated using the full texts. However, no association between the mRNA vaccines and BP was seen in the observational studies. The data of interest were extracted as follows: (1) study-related variables (first author's name, publication year, sample size, study design, and the presence of control group and its general description); (2) vaccine-related variables, including vaccine type and number of doses received; (3) demographic and baseline variables, including age, sex, past medical history, prior SARS-CoV-2 infection, prior herpes zoster infection, history of BP, and drug history; and (4) clinical and BP-related variables, including number of patients with BP, BP laterality, concomitant signs and symptoms, initial physical examination, duration from vaccination to the event, paraclinical assessments, treatments, outcome, and recurrence if followed up. , Shemer Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: a self-controlled case series study. Impact of COVID-19 vaccines on the health status of young female adults from India: A cross-sectional study. Results: Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses. SAC, Madhi T, Rudd RF, Basura V, Marttila Concept and design: Rafati, Pasebani, Melika Jameie, Mana Jameie, Ilkhani, Amanollahi, Sakhaei, Rahimlou, Kheradmand. Etiology of aseptic meningitis and encephalitis in an adult population. Reports of serious neurological events following COVID vaccination are rare. Involvement of the motor nerves, which control muscle movement, may produce weakness or muscle cramps. eCollection 2023. , Taylor While the authors acknowledge that some of the more serious effects are potentially fatal, nearly all the effects are treatable if doctors find them early. Given that COVID-19 has caused many deaths, the protection that vaccines can offer outweighs the potential for rare harmful effects. Accessibility Statement, Our website uses cookies to enhance your experience. Facial nerve palsy following the administration of COVID-19 mRNA vaccines: analysis of a self-reporting database. , Poudel However, complications can affect a person's life expectancy. et al. The https:// ensures that you are connecting to the Dashed line indicates the point estimate of the overall effect; dotted line, no effect; diamonds, overall effects. MS, Kim Coronavirus (COVID-19) update: July 13, 2021. , Hamid WebMultiple cranial nerve palsies following COVID-19 vaccination-Case report In our case, the most probable etiology of the patient's multiple cranial neuropathy is the Pfizer-BioNTech For the analysis from the study by Li et al,57 only the data obtained from the Spanish database of Information System for Research in Primary Care were used for data pooling, and the data from the UK were excluded because of database overlapping with the study by Patone et al.56 The odds of developing BP after receipt of the Pfizer/BioNTech vaccine compared with the Oxford/AstraZeneca vaccine were deemed insignificant (OR, 0.97; 95% CI, 0.82-1.15; I2=0%; Cochran Q P value=.67). et al. A review of the literature reveals several studies reporting BP occurrence following SARS-CoV-2 vaccination.28,29 The first documented case was in a 36-year-old woman with a previous history of BP who developed facial palsy 2 days after receiving the first dose of the Sinovac vaccine.30 Currently, it is not known whether BP incidence is associated with SARS-CoV-2 vaccination, because studies differ in their time intervals, vaccine types, follow-up periods, and methods. Privacy Policy| The vaccine transfection and translation in the nerves may spur an immune response against nerve cells potentially resulting in autoimmune nerve damage. Findings , Vilches B, Hecht J, Zhang , Hanson With SARS-CoV-2 infection, however, the reported BP incidence is significantly higher at 32.3 to 82 per 100000 patients.55,57 These results overall suggest that the BP incidence after SARS-CoV-2 vaccines is comparable with the overall incidence in the general population, whereas it clearly exceeds that with SARS-CoV-2 infection. FTT, This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline and was conducted with the random- and fixed-effect models using the Mantel-Haenszel method. About 1 in 4 et al; Cochrane Bias Methods Group; Cochrane Statistical Methods Group. Since April 2021, some people have developed myocarditis (inflammation of the heart [4] https://assets.publishing.service.gov.uk/government/uploads/system/uploa [5] https://www.statnews.com/2020/09/09/astrazeneca-covid19-vaccine-trial-ho JF, Granath Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Laser treatment for neuropathy: What to know, Debra Rose Wilson, Ph.D., MSN, R.N., IBCLC, AHN-BC, CHT, Non-arteritic ischemic optic neuropathy (NAION): What to know. S, Ish , Gmez de Terreros Caro I, Calvit , Huang et al. Affiliations, Neurological adverse events per 1,000,000 vaccine doses reported in VAERS stratified by COVID vaccine type. Y, All Rights Reserved, Challenges in Clinical Electrocardiography, Clinical Implications of Basic Neuroscience, Health Care Economics, Insurance, Payment, Scientific Discovery and the Future of Medicine, Published online April 27, 2023. doi:10.1001/jamaoto.2023.0160. WebBackground. , Noseda The safety profile of COVID-19 vaccinations in the United States. Quality Assessment of the Randomized Controlled Trials Using the Cochrane Risk of Bias (ROB1) Tool, eFigure 3. ML. Instead, the virus mRNA in the vaccines might interact with the immune cellular membranes and elicit an innate immune response,107 which in turn may trigger BP, similar to the cases reported with interferon treatment.115,116. et al. et al. M, Handunnetthi WebShingrix can make the area where you get the shot swell or feel sore. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Accepted for Publication: February 13, 2023. Three of the 5 RCTs had a low risk of bias,35-37 and 2 were unclear38,58 in the criterion D5: detection bias of the Cochrane assessment tool but were low risk in the rest of the criteria. TB, Cash , Singh Despite this, rates of neurological complications following acute SARS-CoV-2 infection are up to 617-fold higher than after COVID vaccination. , Mason While the S, Prez Al N, World J Clin Cases. S, Ishikawa M, Shimada Y, Ozono T, Matsumoto H, Ogura H, Kihara K, Mochizuki H, Okuno T, Sakakibara S, Kinoshita M, Okuzaki D. Front Immunol. M, Lai The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis. , Obermann N. Funnel Plot for RCTs: vaccinated vs saline placebo, eFigure 4. N, Koorapati 2023 Apr 18:S1043-2760(23)00055-3. doi: 10.1016/j.tem.2023.03.002. MNT is the registered trade mark of Healthline Media. doi: 10.1136/bcr-2021-243829. [7] https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93537 Most importantly, we used previously published data, and no individual patient-level data were available in this study. Fifty studies were included, of which 17 entered the quantitative synthesis. Hanson KE, Goddard K, Lewis N, Fireman B, Myers TR, Bakshi N, Weintraub E, Donahue JG, Nelson JC, Xu S, Glanz JM, Williams JTB, Alpern JD, Klein NP. A potential signal of Bells palsy after parenteral inactivated influenza vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)United States, 1991-2001. The meta-analysis was composed of 2 subgroups of mRNA vaccines (Pfizer/BioNTech and Moderna) and viral vector vaccines (Janssen and Oxford/AstraZeneca) (Figure 1). Bell Palsy in Groups of SARS-CoV-2 Infection vs SARS-CoV-2 Vaccine Recipients, With Data From Observational Studies, Table. SG. Published online April 27, 2023. doi:10.1001/jamaoto.2023.0160. This systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2vaccinated vs placebo groups. Rafati A, Pasebani Y, Jameie M, Yang Y, Jameie M, Ilkhani S, Amanollahi M, Sakhaei D, Rahimlou M, Kheradmand A. JAMA Otolaryngol Head Neck Surg. Article in French. HF, Sy Finally, on the basis of our analysis, the SARS-CoV-2 infection contributes to a significant 3.23-fold increase in BP risk compared with SARS-CoV-2 vaccines. AR, Sobieszczyk V. , Kupila C, However, the Food and Drug Administration (FDA) reported that out of 43,252 participants in the Pfizer-BioNTech trial, only 4 people developed Bells palsy. K, Prasad We investigated BP incidence by measuring the pooled effect estimates in the following sets of comparisons: all phase 3 randomized clinical trial (RCT)derived data on vaccine vs saline placebo recipients, messenger RNA (mRNA) SARS-CoV-2 vaccines vs unvaccinated participants in observational studies, Pfizer/BioNTech vs Oxford/AstraZeneca SARS-CoV-2 vaccines, and SARS-CoV-2 infections vs SARS-CoV-2 vaccines. L, Khouri BY, Cen MC, Liaqat , Corra E, Einan-Lifshitz A, Gonzalez-Gimeno Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy: A Systematic Review and Meta-analysis. Bell palsy (BP), also known as idiopathic facial nerve palsy, is the most prevalent cause of acute spontaneous peripheral facial paralysis, with a reported annual incidence rate of 15 to 30 cases per 100000 population.1,2 Although the exact cause of BP is unclear, viral infections (such as herpes simplex virus), ischemia, and inflammation are some of the suggested underlying mechanisms.3 Notably, BP is also reported following SARS-CoV-2 infection.4 COVID-19, caused by SARS-CoV-2, is a contagious respiratory syndrome with a wide range of manifestations, from asymptomatic and mild infection to hospitalization and death,5 as well as a wide variety of neurologic manifestations.6. Peripheral neuropathy has a link to the COVID vaccine. EYF, Chui Analysis of neurological adverse events reported in VigiBase from COVID-19 vaccines. , Mutsch Inflammation The intranasal inactivated influenza vaccine was suggested to be strongly linked with BP through mediating inflammation due to containing Escherichia coli heat-labile enterotoxin. Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS. J, When to seek help Contact your doctor as soon as possible or go directly to a hospital if you have: a reaction that you think is severe or unexpected shortness of breath chest pain swelling in your leg S, Jawanda (D) The contrast enhancement of the trigeminal nerve persists upon repeated examination a month later (blue arrow). L, Saatci F, Iskander et al. Aside from those mentioned previously, these can include: Deaths are rare, but they have occurred. No significant difference was found in BP among 22978880 first-dose recipients of the Pfizer/BioNTech vaccine compared with 22978880 first-dose recipients of the Oxford/AstraZeneca vaccine (OR, 0.97; 95% CI, 0.82-1.15; I2=0%). The CDC does not list brain aneurysms as a common side effect after COVID-19 vaccination in any age group. , Sadeghalvad It can [6] https://doi.org/10.1101/2021.06.29.450356 Because of the high heterogeneity, a random-effects model was implemented, and a subgroup analysis was performed based on the study design (cohort or case-control study). , Balduzzi P, Awasthi Reuters, "COVID vaccine injury plaintiffs face long odds in U.S. compensation program," June 16, 2022 Federal Aviation Administration statements, April 27 and April 28, 2023 To compare the incidence of BP in SARS-CoV-2 vaccine recipients vs unvaccinated individuals or placebo recipients. The incidence of BP in those who received the Pfizer/BioNTech or Oxford/AstraZeneca vaccines did not differ significantly. SA, , Martin-Villares BD, Holtzmuller Warning. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. The funnel plots for the publication bias are represented in eFigure 6 in Supplement 1. , Yu Rare Side Effects of COVID Vaccines Myocarditis and the COVID-19 Vaccines. RT; VAERS Working Group. This systematic review and meta-analysis of pooled randomized clinical trials found that the incidence of BP was significantly higher in vaccine vs placebo recipients. MF, , Lai et al. The number of reports of serious peripheral neuropathies is very small compared with the number of people who have received the vaccines. The patient received high doses of corticosteroids, with improvement of symptoms. Small fiber neuropathy as a complication of SARS-CoV-2 vaccinations. C, Sun Acquisition, analysis, or interpretation of data: All authors. S, Nepali JAMA Otolaryngol Head Neck Surg. Data Extraction and Synthesis Other causes were excluded by laboratory tests. (B) Contrast enhancement in the intracisternal length of the trigeminal nerve (blue arrow). JAMA Netw Open. References , El Sahly The BP occurrence following SARS-CoV-2 infection was also compared with receipt of the SARS-CoV-2 vaccine in approximately 40 million individuals. However, most scientific literature relates to a handful of cases, using case studies or case series. Rafati A, Pasebani Y, Jameie M, et al. et al. The vaccine-induced multiple sclerosis (if proven) may also be an autoimmune response to the vaccine distribution and transfection to the nerves. It also discusses the vaccines safety and when to seek emergency treatment. Considerations for causality assessment of neurological and neuropsychiatric complications of SARSCoV2 vaccines: from cerebral venous sinus thrombosis to functional neurological disorder. Study 514559 showed that the Covid vaccine AZ was distributed to sciatic nerves in almost all animals and the distributed fractions did not clear throughout the study. GJ, Ishii J AAPOS. Bells palsy following the Ad26.COV2.S COVID-19 vaccination. . Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of , Palaiodimou EMA recently investigated the cases of Guillain-Barre syndrome (GBS) following Covid vaccine AstraZeneca (AZ) and have issued a warning to raise awareness of healthcare professionals and the public about GBS cases following Covid vaccinations and recommended revising the product information for Covid vaccine AZ [1]. Federal government websites often end in .gov or .mil. Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. After internal reviews of the reports, the CDC "did not find any data suggesting a link between Covid-19 vaccines and tinnitus," an agency spokesperson said in an email. Potential association between COVID-19 vaccination and facial palsy: three cases with neuroimaging findings. 2022 Apr 1;5(4):e228879. , Filippatos The symptoms below require emergency care and relate to the main serious side effects. , Goh BMJ Case Rep. 2023 Jan 30;16(1):e253302. J Family Med Prim Care. , Kamath The TGA closely monitors reports of suspected side effects (also known as adverse events) to the Covid-19 vaccines. A summary of the inclusion process is represented in a PRISMA flow diagram in eFigure 1 in Supplement 1. It can cause people to experience pain in their hands and feet. PC, Results The most commonly reported side effects were: Fever Headache Fatigue (tiredness) Pain at the injection site Helpful tips to relieve side effects Adults To relieve pain or swelling on the arm where you got the shot: Apply a clean, cool, wet washcloth over the area. The EMA could not find enough evidence to confirm the association of GBS with the vaccine, however, this may be explained by the vaccine biodistribution to the nerves following intramuscular injection. et al; ENSEMBLE Study Group. Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study. If a person experiences any serious effects after getting the vaccine, such as symptoms of anaphylaxis or a blood clot, they should seek emergency treatment. , Sadoff The BP occurrence was compared between vaccine and saline placebo recipients within subgroups of viral vector and mRNA vaccines.