CKH, Lau , Saltagi S. Misra Corresponding Authors: Amir Kheradmand, MD, Department of Neurology, Johns Hopkins University, School of Medicine, 600 N Wolfe St, Path 2-210, Baltimore, MD 21287 (akherad@jhu.edu); Mehran Rahimlou, PhD, Department of Nutrition, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran (rahimlum@gmail.com). Front Pharmacol. Bell Palsy Events in Groups of Vaccine Recipients vs Saline Placebo Recipients, With Data From Randomized Clinical Trials, Figure 2. Non-Arteritic Ischemic Optic Neuropathy Following COVID-19 Vaccination in Korea: A Case Series. Most people fully recover from GBS, but some have permanent nerve damage. Quantifying heterogeneity in a meta-analysis. et al; C4591001 Clinical Trial Group. See this image and copyright information in PMC. The https:// ensures that you are connecting to the retinopathy, which is damage to the retina. The analysis of the observational studies showed that mRNA SARS-CoV-2vaccinated participants had no significant increase in BP incidence vs the unvaccinated participants. Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy: A Systematic Review and Meta-analysis. Dentists: Unexplained Pain, Tooth Loss and Bone Problems May Be 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. side Accepted for Publication: February 13, 2023. Accessed July 1, 2022. Dashed line indicates the point estimate of the overall effect; dotted line, no effect; diamonds, overall effects. , Sohrabi Epub 2023 Feb 28. SARS-CoV-2 vaccination-induced transverse myelitis. Hospital-based observational study of neurological disorders in patients recently vaccinated with COVID-19 mRNA vaccines. Because this study found a strong association between the SARS-CoV-2 vaccine and BP in 4 RCTs, we conclude that BP is a result of SARS-CoV-2 vaccine exposure. This heterogeneity could be attributable to different inclusion criteria or sampling methods. Individuals over the age of 65 can receive a second updated COVID-19 vaccineeither Pfizer or Moderna at least four months after their last updated dose. , Huang Association of COVID-19 vaccination and facial nerve palsy: a case-control study. A systematic search of 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. Unauthorized use of these marks is strictly prohibited. , Higgins The vaccine distribution to the sciatic nerves may lead to conditions like sciatica that has been previously linked to the viral infection of the sciatic nerve, such as herpes. Events of BP in a 21-day interval after the vaccination were compared between 22760698 first-dose Pfizer/BioNTech recipients and 22978880 first-dose Oxford/AstraZeneca recipients54,56,57 (Figure 3). Butler M, Tamborska A, Wood GK, et al. Keywords: et al. Nath is convinced they are extremely rare. Long Covid, in contrast, affects anywhere from about 5% Results J, Gray Z, K, Prasad LS, Chen [7] https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93537 , Shasha DR, Abrams SG. PT, Zisman RF, Basura Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study. Fifty studies were included, of which 17 entered the quantitative synthesis. et al. 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. , Repajic , Davidov COVID-19 Vaccine Side Effects N, Ben-Shlomo G. , Sadoff FTT, Huang COVID vaccine Neurological symptoms and neuroimaging alterations related with COVID-19 vaccine: cause or coincidence? Results: Leave-One-Out Analysis for Studies on SARS-Cov-2 Infections vs SARS-Cov-2 Vaccine, eFigure 8. 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. et al; AstraZeneca AZD1222 Clinical Study Group. EWW, MF, , Anand References J, Zhang Association of Receipt of the Ad26.COV2.S COVID19 vaccine with presumptive GuillainBarre syndrome, FebruaryJuly 2021. , Zhou Y, JAMA Otolaryngol Head Neck Surg. People who had severe illness with COVID-19 might experience organ damage affecting the heart, kidneys, skin and brain. E, For details on possible side effects for each vaccine, see: Comirnaty (Pfizer) Spikevax (Moderna) Nuvaxovid (Novavax). Z, , Castaldo Vaccine diarrhea. muscle or joint pain. No restriction on the study design, age of the participants, literature language, or any other factors was imposed. et al. M, Sobherakhshankhah , Kennedy P, Stahel Quality Assessment of the Self-controlled Cases Series Studies Using the Newcastle-Ottawa Scale (NOS) Modified for Self-controlled Cases Series Studies, eFigure 1. , Mussatto People who had severe illness with COVID-19 might experience organ damage affecting the heart, kidneys, skin and brain. T, Wu SJ, Moreira Results: Incidence of headache after COVID-19 vaccination in patients with history of headache: a cross-sectional study. VP. Customize your JAMA Network experience by selecting one or more topics from the list below. Some of these conditions affect the peripheral nervous system (PNS), the network of nerves that sends and receives messages to and from the brain and spinal cord. The funnel plots for the publication bias are represented in eFigure 6 in Supplement 1. Vaccine Side Effects All Rights Reserved. Some information may be out of date. R, Korkmazer We utilized publicly available data from the U.S. government site. A summary of the inclusion process is represented in a PRISMA flow diagram in eFigure 1 in Supplement 1. V, DeStefano Left Bells palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: a case report. Bells palsy after second dose of Moderna covid-19 vaccine: coincidence or causation? Shingles Vaccine Information, Side Effects, and More - WebMD Burrows A, Bartholomew T, Rudd J, Walker D. BMJ Case Rep. 2021 Jul 19;14(7):e243829. Furthermore, studies comparing the BP incidence after SARS-CoV-2 infection with SARS-CoV-2 vaccines included different study intervals and did not mention the prevalent SARS-CoV-2 subtypes at the time each study was conducted. B, Kochan Kizilkilic All rights reserved. A persons symptoms, if they have any, could depend on the type of nerves that have the damage. Objective FPNs Scientific Advisory Board Chairman, Dr. Ahmet Hoke of Johns Hopkins University, encourages patients to get the COVID-19 vaccine when offered. The COVID-19 vaccine has some associations with Bells palsy. M, SJ, Kitchin Y, Beh 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. 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, COVID X. X, Wong Y, Baker doi: 10.1136/bcr-2021-243829. [Color figure can be viewed at. 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. Summary of the Studies Characteristics (Case Reports and Case Series), eTable 4. Neurological autoimmune diseases following vaccinations against SARS-CoV-2: a case series. Y, Kyoya J, Varacallo According to the Centers for Disease Control and Prevention (CDC), GBS has occurred after people received the Johnson and Johnson (Janssen) vaccine but not after the Pfizer-BioNTech or Moderna vaccine. EYF, Chui Adverse reactions and safety profile of the mRNA COVID-19 vaccines among Asian military personnel. P, 8600 Rockville Pike In the second section, all observational studies39-46comparing BP in mRNA vaccine recipients and the unvaccinated matched individuals were investigated. S, 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. Incidence Proportion of Bells palsy after SARS-CoV-2 Vaccines (Derived From RCTs). Learn more here. Dotted line indicates no effect; diamond, overall effect. Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses. KE, Goddard Pooling 4 phase 3 randomized clinical trials showed significantly higher BP in recipients of SARS-CoV-2 vaccines (77525 vaccine recipients vs 66682 placebo recipients; odds ratio [OR], 3.00; 95% CI, 1.10-8.18; This systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2vaccinated vs placebo groups. et al. F, Iskander Pooling 4 phase 3 randomized clinical trials showed significantly higher BP in recipients of SARS-CoV-2 vaccines (77525 vaccine recipients vs 66682 placebo recipients; odds ratio [OR], 3.00; 95% CI, 1.10-8.18; I2=0%). Jr, Kitchin B, All free text symptoms that were reported within 42 days of vaccine administration were manually reviewed and grouped into 36 individual neurological diagnostic categories. Bethesda, MD 20894, Web Policies Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. Further research is required to verify this association and investigate possible mechanisms. 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. Concurrent facial and trigeminal nerve palsies in a child following COVID-19 vaccination with the Pfizer vaccine. M, Mansourabadi Anecdotal reports suggest that the vaccines may be associated with brain, spinal cord, peripheral nervous system, and cardiac inflammation. 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. The Egger test yielded a P value of .96, thus showing no publication bias. The mean NOS scores were 6.87 for cohort studies, 7.50 for case-control studies, 4.00 for cross-sectional studies, and 8.50 for SCCSs. N, Shaygannejad The facial (cranial) nerves, on the contrary, are anatomically closer to the vaccine injection site in humans (deltoid muscle). et al. Use or keep moving your arm. Rafati A, Pasebani Y, Jameie M, et al. SMU, Masood Bilateral facial nerve palsy and COVID-19 vaccination: causation or coincidence? M, Ewers Learn more about the GBS and a possible vaccine link. A, Tazare Autoimmune damage to the nerves following Covid vaccines: EMA Author Contributions: Drs Kheradmand and Rafati had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. How to perform a meta-analysis with R: a practical tutorial. Learn more about the link between the COVID-19 vaccine and Bells palsy. Is the ketogenic diet right for autoimmune conditions? J, Walker By continuing to use our site, or clicking "Continue," you are agreeing to our, Figure 1. April 20, 2023. Critical revision of the manuscript for important intellectual content: Rafati, Pasebani, Melika Jameie, Yang, Mana Jameie, Sakhaei, Rahimlou, Kheradmand. DG, Gtzsche Most of the adults in UK are already vaccinated, therefore, early recognition of post-vaccine autoimmune conditions like GBS may help in offering early therapeutic interventions to those who are potentially affected with the condition that can help to prevent disease progression and chronic illness. Finally, there was some heterogeneity among the studies that compared BP incidence in mRNA vaccinated vs unvaccinated individuals and among the studies that compared vaccination with SARS-CoV-2 infection. K, Mano J, Gray Intramuscular route (Suspension) Although the licensed vaccine (Comirnaty) is FDA-approved in patients aged 16 or older for 2 doses , Pfizer-BioNTech Side Effects After Getting a COVID-19 Vaccine , Obermann HM, Essink They found an increased risk of haemorrhagic stroke, a brain bleed, in the 28 days after vaccination with the BioNTech/Pfizer shot, at an estimated 60 extra cases per 10m people. B, Acta Neurol Scand. 2014;10:301. A, Feany COVID-19-associated hospitalizations among adults during SARS-CoV-2 Delta and Omicron variant predominance, by race/ethnicity and vaccination statusCOVID-NET, 14 states, July 2021-January 2022. KR, Rushton Accessed March 2, 2023. Can COVID-19 vaccination lead to neurological complications? Adverse events of special interest following the use of BNT162b2 in adolescents: a population-based retrospective cohort study. K. B, Roel chills. M, Other effects include: Many people who get the vaccine have muscle aches, headaches, or feel tired. Bell palsy (BP) has been reported as an adverse event following the SARS-CoV-2 vaccination, but neither a causative relationship nor a higher prevalence than in the general population has been established. K, Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D. The CARE guidelines: consensusbased clinical case reporting guideline development. fever. Motor palsies of cranial nerves (excluding VII) after vaccination: reports to the US vaccine adverse event reporting system. Article in French. Yan MM, Zhao H, Li ZR, Chow JW, Zhang Q, Qi YP, Wu SS, Zhong MK, Qiu XY. P, Koo Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy Inflammation and problems with the immune system can also happen. Acute abducens nerve palsy following COVID-19 vaccination. B, Li , Eom Pfizer-BioNTech COVID-19 Vaccine Side Effects - Drugs.com NP, Lewis 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. et al; On Behalf Of The Trisomy Research Society Covid-Initiative. LR, Essink et al; C4591001 Clinical Trial Group. V. If I250%, representing substantial heterogeneity, the random-effects model was used; otherwise, the fixed-effects model was used. Guillain-Barr syndrome and vaccines. AA. H, Kim , Sekiguchi Jr. 2022 Apr 1;5(4):e228879. G, Orlandi Coronavirus (COVID-19) update: July 13, 2021. O, , Baden Symptoms following COVID vaccination. Accessed July 2, 2022. Epub 2022 Oct 14. Long COVID: pathophysiological factors and abnormalities of coagulation. This is not a comprehensive list, so if someone has any symptoms that seem significant, they should call 911. Clipboard, Search History, and several other advanced features are temporarily unavailable. Eight observational studies39-46 reported adverse events, including BP, following the administration of the first and/or second dose of the SARS-CoV-2 mRNA vaccines. , Yu 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. Neurological complications after first dose of COVID-19 - Nature 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. Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19 related symptoms, hospital admissions, and mortality in , El-Shitany One of the subjects was later diagnosed with multiple sclerosis [5], declared unrelated to the vaccine. In the cohort studies,41-46 the analysis indicated no significant evidence of increased odds of BP in the vaccinated group compared with the unvaccinated group (OR, 0.59; 95% CI, 0.34-1.01; I2=94%; Cochran Q P value<.001). , Frontera Guillain-Barr syndrome following the first dose of Pfizer-BioNTech COVID-19 vaccine: case report and review of reported cases. WI, Huang Multimorbidity and adverse events of special interest associated with Covid-19 vaccines in Hong Kong. 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. et al; European Headache Federation School of Advanced Studies (EHF-SAS). 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. 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. Learn more. Importantly, although this study shows evidence of increased BP incidence following SARS-CoV-2 vaccination compared with placebo receipt, SARS-CoV-2 infection was associated with a 3.23-fold increase in BP incidence. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. , Hwang , Ab Rahman Data Sharing Statement: See Supplement 2. COVID et al. However, these tend to be rare. WebBackground. (C) The contrast enhancement of the facial nerve persists upon repeated examination a month later (blue arrow). Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy , Lai Safety of the BNT162b2 mRNA Covid-19 vaccine in a nationwide setting. A systematic review of Bells palsy as the only major neurological manifestation in COVID-19 patients. A, Gonzalez-Gimeno First, all records were screened using the title and abstracts. , Ish 2023 Jan 5;23(1):11. doi: 10.1186/s12886-022-02747-7. M, Koutsokera , Corra R, Gujrati coronavirus Vaccine 2011;29:599612. Bells palsy: a rare complication of interferon therapy for hepatitis C., Observational Studies on mRNA Vaccines: Vaccinated vs Unvaccinated, Pfizer/BioNTech vs Oxford/AstraZeneca Vaccines, SARS-CoV-2 Infections vs SARS-CoV-2 Vaccine, Get the latest from JAMA OtolaryngologyHead & Neck Surgery, To register for email alerts, access free PDF, and more, Get unlimited access and a printable PDF ($40.00), 2023 American Medical Association.
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