-, Woo EJ, MbaJonas A, Dimova RB, et al. V, Michos FH, All in all, these limitations may have affected heterogeneity among studies, leading to potential confounders for analysis. 2023 Feb;12(2):338-351. doi: 10.4103/jfmpc.jfmpc_1574_22. Clipboard, Search History, and several other advanced features are temporarily unavailable. , Tamaki et al. For the mRNA vaccine subgroup, there were significantly increased odds of BP in the vaccinated group compared with the placebo group (OR, 3.57; 95% CI, 1.09-11.67; I2=0%; Cochran Q P value=0.46). G, Prasad The patient received high doses of corticosteroids, with improvement of symptoms. In the case of overlapping studies, the study with the highest score in terms of quality assessment was deemed appropriate and was included in the study. Intramuscular route (Suspension) Although the licensed vaccine (Comirnaty) is FDA-approved in patients aged 16 or older for 2 doses , Pfizer-BioNTech N, Lim , Sadeghalvad [9] https://assets.publishing.service.gov.uk/government/uploads/system/uploa G, Gil Daz 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. P. We performed a systematic search through MEDLINE (via PubMed), Web of Science, Scopus, Cochrane Library, and Google Scholar from the inception of the COVID-19 report (December 2019) to August 15, 2022. O, Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. Phase 3 safety and efficacy of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine. SARS-CoV-2 vaccines (mRNA and viral vector) in the analysis of RCTs demonstrated significantly increased odds of developing BP vs placebo. et al; COVID-NET Surveillance Team. Bells palsy following COVID-19 vaccination: a case report. Overall, no publication bias was observed among the studies with the Peter test P value of 0.34 (eFigure 5 in Supplement 1). Main Outcomes and Measures Vaccine Adverse Event Reporting System (VAERS) [online]. , Falsey July 2, 2022. et al. Albakri K, Khaity A, Atwan H, Saleh O, Al-Hajali M, Cadri S, Diab RA, Albazee E, Negida A. W. MJ, McKenzie Turner S, Khan MA, Putrino D, Woodcock A, Kell DB, Pretorius E. Trends Endocrinol Metab. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. , Eom , Mason Bells palsy following COVID-19 vaccination. , Viechtbauer P, Awasthi The risk of developing BP subsequent to SARS-CoV-2 infection significantly surpassed the risk of developing BP after receipt of the SARS-CoV-2 vaccine (RR, 3.23; 95% CI, 1.57-6.62; I2=95%; Cochran Q P value<.001). It was also not possible to control for some of the known BP risk factors, such as diabetes, obesity, hypertension, upper respiratory tract disease, or pregnancy, because most studies have not provided sufficient data on these risk factors.102 In addition, the recorded BP cases following vaccination might have been prone to a reporting bias from heightened awareness because researchers have constantly sought to record adverse events during the COVID-19 pandemic. KE, Goddard Leave-One-Out Analysis for Studies on SARS-Cov-2 Infections vs SARS-Cov-2 Vaccine, eFigure 8. [10] https://casereports.bmj.com/content/bmjcr/14/4/e242956.full.pdf Ependymal cells in cerebrospinal fluid: A traumatic occurrence. Bells palsy during interferon alpha 2a treatment in a case with Behet uveitis. April 9, 2021. et al. The BP diagnosis was determined based on the neurologist-confirmed clinical criteria and/or the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes, as mentioned by each study. Hum Vaccin Immunother. (2022). A. R, Ripellino Peripheral neuropathy is rarely fatal. These include: Although the above factors have an association with the vaccines, factors unconnected to the vaccine may be responsible for or contribute to peripheral neuropathy. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. In the second section, all observational studies39-46comparing BP in mRNA vaccine recipients and the unvaccinated matched individuals were investigated. S, Rcker This is the most intensive safety monitoring ever , Kupila R, Korkmazer Reports of serious neurological events following COVID vaccination are rare. , Gmez de Terreros Caro However, most scientific literature relates to a handful of cases, using case studies or case series. The vaccine-induced multiple sclerosis (if proven) may also be an autoimmune response to the vaccine distribution and transfection to the nerves. This is not a comprehensive list, so if someone has any symptoms that seem significant, they should call 911. B, Roel A, Disclaimer. SINGAPORE: The family of a woman who died about four days after receiving a COVID-19 vaccine booster jab was given S$225,000 (US$169,122) under the Vaccine Rosenblum HG, Hadler SC, Moulia D, Shimabukuro TT, Su JR, Tepper NK, Ess KC, Woo EJ, Mba-Jonas A, Alimchandani M, Nair N, Klein NP, Hanson KE, Markowitz LE, Wharton M, McNally VV, Romero JR, Talbot HK, Lee GM, Daley MF, Mbaeyi SA, Oliver SE. The observed-to-expected ratios for GBS, CVT and seizure following Janssen vaccination were 1.5-fold higher than background rates. It can cause people to experience pain in their hands and feet. P, Moghadas Bells palsy as a possible complication of mRNA-1273 (Moderna) vaccine against COVID-19. T, Iwata Neurological autoimmune diseases following vaccinations against SARS-CoV-2: a case series. Bells palsy after Sputnik V COVID-19 (Gam-COVID-Vac) vaccination. Abara WE, Gee J, Marquez P, Woo J, Myers TR, DeSantis A, Baumblatt JAG, Woo EJ, Thompson D, Nair N, Su JR, Shimabukuro TT, Shay DK. Facial nerve palsy after COVID-19 vaccinationa rare association or a coincidence. E, H, AtaeeKachuee COVID-19 vaccination of individuals with Down syndromedata from the Trisomy 21 Research Society Survey on safety, efficacy, and factors associated with the decision to Be vaccinated. 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. Before G, Schwarzer V. MT, Lee The regulatory authorities are, therefore, requested to review the cases of GBS in association with various other neuropathies and vaccine biodistribution data from preclinical trials. Guillain-Barr syndrome and vaccines. et al. The between-study heterogeneity was assessed by the Cochran Q statistic, 2 using the restricted maximum-likelihood estimator, and I2 index.50,51 On the basis of the I2 index, it was decided whether to choose between the fixed-effects or random-effects models. MC, Liaqat et al. Administrative, technical, or material support: Yang. eTable 1. Baugh [6] https://doi.org/10.1101/2021.06.29.450356 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. Facial nerve palsy following the administration of COVID-19 mRNA vaccines: analysis of a self-reporting database. , Finsterer Acute liver failure after vaccination against of COVID-19: a case report and review literature. et al. Finsterer, J. 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. CW, Chuang , Wong doi: 10.1136/bcr-2022-253302. PC, EYF, Chui After removing duplicate records, 2 independent researchers (Y.P. Ann Neurol. Yan MM, Zhao H, Li ZR, Chow JW, Zhang Q, Qi YP, Wu SS, Zhong MK, Qiu XY. K, Mano The vaccine encoded gene transfection to distant tissues is likely to attract an immune response against various body tissues that can manifest into various autoimmune conditions. et al. Article in French. , Patone Accessed July 1, 2022. Of the 50 studies, 17 articles35-46,54-58 comparing BP incidence in SARS-CoV-2vaccinated and control groups that could be pooled were included in the meta-analysis, and the remaining 33 articles30,59-90 were included only in the qualitative synthesis (ie, the characteristics of which were extracted and formatted into eTable 2 in Supplement 1). CKH, Au There was, however, no significant increase in BP after administration of the messenger RNA SARS-CoV-2 vaccine in pooling 8 observational studies (13518026 doses vs 13510701 unvaccinated; OR, 0.70; 95% CI, 0.42-1.16; I2=94%). Data Sources Would you like email updates of new search results? About 1 in 4 Y, Hoshina N, Koorapati CI, Li swollen lymph nodes. 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. Case reports of acute transverse myelitis associated with mRNA vaccine for COVID-19. WebShingrix can make the area where you get the shot swell or feel sore. Epub 2021 Nov 18. GBS is a rare but serious condition in which the immune system starts attacking the bodys healthy nerve cells in the peripheral nervous system that can result in pain, numbness, muscle weakness usually in the feet, hands and limbs) that can also spread to the chest and the face. JH. Keywords: EB, Dellis Burrows A, Bartholomew T, Rudd J, Walker D. BMJ Case Rep. 2021 Jul 19;14(7):e243829. et al. et al. Lopez Bernal, J. et al. Updated 31 March 2021. et al; COVE Study Group. G, Vandebosch L, Chui Articles reporting BP incidence with SARS-CoV-2 vaccination were included. C, Teoh TH. , Zhou X, Woo EJ, Winiecki SK, Ou AC. F. Accessed March 2, 2023. 2023 Mar 27;38(12):e95. N, Doan 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, Two independent researchers (Mana Jameie and S.I.) This study shows evidence for the association between SARS-CoV-2 and BP; however, this finding does not equate to causality, and further research is required to verify this association and investigate possible mechanisms. . A, Feany Results: C, Vazquez-Feito Other effects include: Many people who get the vaccine have muscle aches, headaches, or feel tired. By July 13, 2021, healthcare professionals had administered 12.5 million vaccine doses and reported only 100 cases of GBS. Since April 2021, some people have developed myocarditis (inflammation of the heart Learn more about the link between the COVID-19 vaccine and Bells palsy. , Tan 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. Careers. , Nishizawa Therefore, further research using larger-scale studies is necessary to determine the link between COVID-19 vaccines and peripheral neuropathy. K-H, Hung Background: Clipboard, Search History, and several other advanced features are temporarily unavailable. LS, Chen V, Marttila DR, Abrams Still, rare reports have involved serious neurological conditions. 10.1136/bcr-2021-243829 Inflammation BD, Holtzmuller et al. J AAPOS. 2022 Nov 7;13:921760. doi: 10.3389/fphar.2022.921760. The detailed tissue-specific distribution of mRNA vaccines encoding SARS-CoV-2 spike proteins (Pfizer or Moderna) is not fully known that could offer invaluable insights into the long-term safety of mRNA vaccines. Motor palsies of cranial nerves (excluding VII) after vaccination: reports to the US vaccine adverse event reporting system. AA. Patients generally experience. (C) The contrast enhancement of the facial nerve persists upon repeated examination a month later (blue arrow). JAMA 2021;326:16061613. Impact of COVID-19 vaccines on the health status of young female adults from India: A cross-sectional study. Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis. The outcome of interest was BP occurring as an adverse event in the time frame after the vaccination or the respective time frame in the placebo recipients or unvaccinated matched participants. -, Rosenblum HG, Hadler SC, Moulia D, et al. Our analysis of the RCTs shows that among all SARS-CoV-2 vaccine recipients, the odds of BP occurrence were significantly increased in the mRNA vaccine subgroup compared with the saline placebo recipients. However, there is no evidence of a causal relationship. The number of reports of serious peripheral neuropathies is very small compared with the number of people who have received the vaccines. Final analysis of efficacy and safety of single-dose Ad26.COV2.S. eCollection 2023. contributors from the Global COVID-19 Neuro Research Coalition, See this image and copyright information in PMC. Results M. EMA has advised people to seek immediate medical attention if they develop weakness and paralysis in the extremities progressing to the chest or face following the Covid vaccine. M, Koutsokera This heterogeneity could be attributable to different inclusion criteria or sampling methods. et al; Oxford COVID Vaccine Trial Group. Bias in meta-analysis detected by a simple, graphical test. 2023 Apr 18:S1043-2760(23)00055-3. doi: 10.1016/j.tem.2023.03.002. One of the subjects was later diagnosed with multiple sclerosis [5], declared unrelated to the vaccine. MNT is the registered trade mark of Healthline Media. B, Privacy Policy| Involvement of the motor nerves, which control muscle movement, may produce weakness or muscle cramps. WebBackground. , Huang AR, Sobieszczyk Question The etiology of Bells palsy: a review. 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. Jr. L, Khouri AA, Doheim Incidence and characteristics of delayed injection site reaction to the mRNA-1273 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Moderna) in a cohort of hospital employees. US Food and Drug Administration. et al. Federal government websites often end in .gov or .mil. A, Maung J Family Med Prim Care. The incidence of BP in those who received the Pfizer/BioNTech or Oxford/AstraZeneca vaccines did not differ significantly. [3] https://www.fda.gov/media/150723/download It is worth noting that the Covid vaccine AZ clinical trials were paused twice and, on both occasions, the trial subjects developed a neurological condition, transverse myelitis. T, Vainionp Three studies94-96 met the inclusion criteria; however, they used the same patient databases, hence overlapping considerably with the included studies from Hong Kong. It is speculated that the vaccine antigens that can reactivate T cells by mimicking human cell surface molecules may elicit an autoimmune response.40 To look for evidence of vaccines triggering BP, Ozonoff et al107 conducted a brief review that found an association of BP with intranasal influenza vaccine, seasonal influenza vaccine, H1N1 influenza vaccines, and meningococcal conjugate vaccine. Leave-One-Out Analysis for Observational Studies on mRNA Vaccines: Vaccinated vs Unvaccinated, eFigure 5. , Sadoff The occurrence of BP did not differ between recipients of the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, and there was a greater risk of BP with SARS-CoV-2 infection compared with SARS-CoV-2 vaccination. K, Watanabe Last week, the U.S. Centers for Disease Control and Prevention said it had not found a link between heart inflammation and COVID-19 vaccines. J, Basso Four RCTs35-38,101 that reported BP as an adverse event were included in the first meta-analysis. Moreover, there are additional 56 cases of multiple sclerosis and another 49 cases reporting a relapse of multiple sclerosis within the MHRA database. optic neuritis, a swelling of the optic nerve. Y, Kyoya 2022 Mar;145(3):375. doi: 10.1111/ane.13561. When attempting to compare with other vaccines and diseases, SARS-CoV-2 vaccine studies did not provide sufficient data for pooling. N. Incidence of Guillain-Barr Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink. S. J, Gray WebThe most frequent neurological side effects of SARS-CoV-2 vaccines are headache, Guillain-Barre syndrome (GBS), venous sinus thrombosis (VST), and transverse myelitis. DLL, Makmur , Hanson While the The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. J, , Sekiguchi B, Hecht Kharoubi Among them, 17 records overlapped other studies, 9 records were commentaries and corrections on other articles, and 8 did not meet the inclusion criteria. E, , Higgins Coronavirus (COVID-19) update: July 13, 2021. 2023 Healthline Media UK Ltd, Brighton, UK. Another condition of the PNS that may have associations with the COVID-19 vaccine is small fiber neuropathy. BMC Ophthalmol. Please enable it to take advantage of the complete set of features! However, such an association is confirmed solely in animal studies.108,109 Likewise, the seasonal parenteral inactivated influenza vaccine was shown in the surveys of the VAERS database to have a potential association with BP incidence, as manifested by surveys of the VAERS database.110,111 Monovalent H1N1 influenza vaccines with immunologic adjuvants were also significantly associated with BP.112,113 Similarly, the quadrivalent meningococcal conjugate vaccine was also significantly associated with an increased incidence of BP.114 SARS-CoV-2 vaccines, however, do not contain adjuvants that mediate the immune response. Bell Palsy in Groups of SARS-CoV-2 Infection vs SARS-CoV-2 Vaccine Recipients, With Data From Observational Studies, Table.
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