Potential association between COVID-19 vaccination and facial palsy: three cases with neuroimaging findings. Accessed July 1, 2022. R, Pan M, Mansourabadi S, Of note, the study by Voysey et al58 was not included in the meta-analysis because these investigators reported 4 RCTs of Oxford/AstraZeneca in 3 distinct geographic regions in which the placebo was not solely specified as saline but was a viral vaccine other than a SARS-CoV-2 vaccine (ie, meningococcal group A, C, W, and Y conjugate vaccine). [10] https://casereports.bmj.com/content/bmjcr/14/4/e242956.full.pdf 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. The TGA closely monitors reports of suspected side effects (also known as adverse events) to the Covid-19 vaccines. A similar warning has been issued by the United States FDA for the GBS followed by Janssen (J&J) Covid vaccine [3]. Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study. J AAPOS. VK, Peixoto MK, Taneja 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. Fifty studies were included, of which 17 entered the quantitative synthesis. et al. CC, Sokol muscle or joint pain. , Cellina Accepted for Publication: February 13, 2023. J, Walker E, We also asked whether BP occurrence is different among various types of SARS-CoV-2 vaccines, and whether it is different among SARS-CoV-2infected vs SARS-CoV-2vaccinated individuals. Symptoms following COVID vaccination. O, Abu-Full This rate is comparable with the previous reports55,57 with an incidence of 19 or lower per 100000 population after SARS-CoV-2 vaccination. BMJ Case Rep. 2021;14(7):e243829. B, Roel 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. , Sadeghalvad Reports of serious neurological events following COVID vaccination are rare. US Food and Drug Administration. G, Carrafiello 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). J Korean Med Sci. Epub 2022 Apr 27. Vaccine-induced immune thrombotic thrombocytopenia. eCollection 2023. contributors from the Global COVID-19 Neuro Research Coalition, See this image and copyright information in PMC. C, Persson The key words However, the surrogate studies using similar formulations by Pfizer [8] and Moderna [9] did confirm a biodistribution of mRNA vaccines beyond the injection site. LS, Ackerson Addressing the publication bias, the funnel plots are provided in eFigure 3 in Supplement 1. 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. eCollection 2022. Accessed March 2, 2023. K-H, Hung Quality Assessment of the Randomized Controlled Trials Using the Cochrane Risk of Bias (ROB1) Tool, eFigure 3. N, Ben-Shlomo G, Vandebosch Acute liver failure after vaccination against of COVID-19: a case report and review literature. et al; SAFECOVAC study group. G, Schwarzer , Filippatos LAQ, Dos Santos , Ab Rahman Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. . eTable 1. 2023 American Medical Association. Left Bells palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: a case report. The observed-to-expected ratios for GBS, CVT and seizure following Janssen vaccination were 1.5-fold higher than background rates. S, Bertoli Bells palsy following a single dose of mRNA SARS-CoV-2 vaccine: a case report. MMWR Morb Mortal Wkly Rep 2021;70:10941099. L, Saatci The biodistribution of the vaccine to other nerves is not known as the study 514559 checked for sciatic nerves only being anatomically closer to the injection site (hind limb) in mice. Bias and efficiency of meta-analytic variance estimators in the random-effects model. S. GT, Chan , Frontera Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19 related symptoms, hospital admissions, and mortality in The outcomes of interest were to compare BP incidence among (1) SARS-CoV-2 vaccine recipients, (2) nonrecipients in the placebo or unvaccinated cohorts, (3) different types of SARS-CoV-2 vaccines, and (4) SARS-CoV-2infected vs SARS-CoV-2vaccinated individuals. J, 2022 Nov 7;13:921760. doi: 10.3389/fphar.2022.921760. M, Davey Smith The study was exempt from ethical approval by the local institutional ethics committee because we used previously published data. 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. Most people fully recover from GBS, but some have permanent nerve damage. Patients generally experience. , Klein Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine through 6 months. F. WebThe damage to the nerves causes muscle weakness and sometimes paralysis. Bells palsy after 24 hours of mRNA-1273 SARS-CoV-2 vaccine. et al; C4591001 Clinical Trial Group. Bell Palsy Events in Groups of Vaccine Recipients vs Saline Placebo Recipients, With Data From Randomized Clinical Trials, Figure 2. We urge regulatory authorities to mandate manufacturers to perform adequate biodistribution studies on vaccine formulations and request further data to better understand the implications of vaccine transfection in distant tissues before mass vaccine rollout in children or recommending additional adult booster doses. So far, the most common physical reactions to the mRNA COVID-19 vaccines are tiredness, headache, muscle pain, chills, fever, nausea, sore throat, diarrhea, and vomiting. The CDC does not list brain aneurysms as a common side effect after COVID-19 vaccination in any age group. MC, Liaqat D. Multimorbidity and adverse events of special interest associated with Covid-19 vaccines in Hong Kong. CSL, Ng W, Xu Instead, they have reported the combined data, and their analyses were based on the events per vaccine dose and not based on the events per participant. J, Gray D, Sullivan Management of Bells palsy. FND involves a disruption in normal brain mechanisms for controlling the body. B, Overall, no publication bias was observed among the studies with the Peter test P value of 0.34 (eFigure 5 in Supplement 1). Final analysis of efficacy and safety of single-dose Ad26.COV2.S. The funnel plots for the publication bias are represented in eFigure 6 in Supplement 1. VP. 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. , Castaldo Results: et al. et al. -. The third section compared the odds of BP in Pfizer/BioNTech vs Oxford/AstraZeneca recipients. 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. , Tamaki Multiple cranial nerve palsies and COVID-19 vaccination. Published by John Wiley & Sons Ltd. An overall 643 records were identified through our systematic search method. (C) The contrast enhancement of the facial nerve persists upon repeated examination a month later (blue arrow). MS, Kim 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. SARS-CoV-2 vaccines (mRNA and viral vector) in the analysis of RCTs demonstrated significantly increased odds of developing BP vs placebo. Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain. Kharoubi The TGA closely monitors reports of suspected side effects (also known as adverse events) to the Covid-19 vaccines. More discrete side effects connected to COVID-19 vaccines have been recognized, including a rare but severe clotting disorder that occurs after the AstraZeneca 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 N. Bookshelf Yan MM, Zhao H, Li ZR, Chow JW, Zhang Q, Qi YP, Wu SS, Zhong MK, Qiu XY. et al. SM, S. Albakri K, Khaity A, Atwan H, Saleh O, Al-Hajali M, Cadri S, Diab RA, Albazee E, Negida A. BMJ Case Rep. 2023 Jan 30;16(1):e253302. The site is secure. et al. W, Rhodes J, Gray However, most scientific literature relates to a handful of cases, using case studies or case series. , Dutta S, FPNs Scientific Advisory Board Chairman, Dr. Ahmet Hoke of Johns Hopkins University, encourages patients to get the COVID-19 vaccine when offered. C, Vazquez-Feito , Lai A, Khillan M, GAC, de Oliveira et al. Notably, SARS-CoV-2 infection was linked with a 3.23-fold increased risk of BP compared with SARS-CoV-2 vaccines, which favors a protective role of the vaccine in reducing the incidence of BP associated with exposure to SARS-CoV-2. EB, Dellis , Xiong FOIA (D) The contrast enhancement of the trigeminal nerve persists upon repeated examination a month later (blue arrow). J, Chan 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). Careers. Several mechanisms have been considered to explicate the underlying pathophysiology of BP. 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. In the second section, all observational studies39-46comparing BP in mRNA vaccine recipients and the unvaccinated matched individuals were investigated. K, It can affect the PNS. The quality of the studies was evaluated by the Newcastle-Ottawa Scale. , Anand Bethesda, MD 20894, Web Policies AA, Doheim 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. , Sekiguchi , Viechtbauer The facial (cranial) nerves, on the contrary, are anatomically closer to the vaccine injection site in humans (deltoid muscle). Therefore, the benefits outweigh the risks for most people, according to the review authors. Hospital-based observational study of neurological disorders in patients recently vaccinated with COVID-19 mRNA vaccines. JF, Granath 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. SJ, Kitchin , Taylor Learn more here. JH. Use or keep moving your arm. official website and that any information you provide is encrypted et al. C. In rare cases, serious side effects occur. Involvement of the motor nerves, which control muscle movement, may produce weakness or muscle cramps. RMM, Alswat Symptoms may range from mild to moderate. The symptoms also include fatigue, severe headaches, nerve pain, blood pressure swings, and short-term memory problems. 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. S, Kolappa Terms of Use| MHRA later also concluded that as a precautionary measure they will also be adding a warning for GBS in the product information [2]. , Burrows Pearls & Oy-sters: facial nerve palsy in COVID-19 infection. et al. Bells palsy after second dose of Moderna covid-19 vaccine: coincidence or causation? et al; Oxford COVID Vaccine Trial Group. , Fan , Yalinda Y-J, Chan O, Barzegar SAC, Madhi T, Wu 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 PRISMA Flow Diagram of the Systematic Search, eFigure 2. FY, et al. Vaccines for COVID-19. 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. Accessibility Statement, Our website uses cookies to enhance your experience. X. Y, WebLocal reactions in persons aged 511 years, Pfizer-BioNTech COVID-19 vaccine and placebo a Mild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis et al; C4591001 Clinical Trial Group. Immunogenicity and adverse effects of the 2-dose BNT162b2 messenger RNA vaccine among liver transplantation recipients. Association of COVID-19 vaccination and facial nerve palsy: a case-control study. For details on possible side effects for each vaccine, see: Comirnaty (Pfizer) Spikevax (Moderna) Nuvaxovid (Novavax). Please enable it to take advantage of the complete set of features! 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. The patient received high doses of corticosteroids, with improvement of symptoms. 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). , Noseda JTC, Tan A, Maity JAMA Netw Open. J, Basso The biodistribution (study 514559) also evidenced the vaccine distribution via blood circulation to other tissues notably bone marrow, liver, mammary glands and spleen. D, Incidence of Guillain-Barr Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink. , Page This is the most intensive safety monitoring ever SG. , Gonzlez-Enrquez This study followed the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).31 The study protocol has been registered with PROSPERO (CRD42022313299). et al. -. [6] https://doi.org/10.1101/2021.06.29.450356 J, Vaccines and Related Biological Products Advisory Committee meeting December 10, 2020. 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. Epub 2021 Nov 29. Results Considerations for causality assessment of neurological and neuropsychiatric complications of SARSCoV2 vaccines: from cerebral venous sinus thrombosis to functional neurological disorder. JAMA Otolaryngol Head Neck Surg. Warning. Cerebral venous sinus thrombosis after mRNA-based COVID-19 vaccination. Unauthorized use of these marks is strictly prohibited. Clipboard, Search History, and several other advanced features are temporarily unavailable. R, Korkmazer Before business owner and busy mom Alana Parker experienced severe oral pain and facial swelling after receiving Pfizers COVID-19 vaccine in 2021, she had good dental health with never so much as a cavity. J, Breslow Federal government websites often end in .gov or .mil. H, Noor et al. Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses. SA, This systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2vaccinated vs placebo groups. S, Nepali Scientists use genetic rewiring to increase lifespan of cells, Beyond amyloid and tau: New targets in developing dementia treatments, Napping longer than 30 minutes linked to higher risk of obesity and high blood pressure, Activity 'snacks' could lower blood sugar, complication risk in type 1 diabetes, In Conversation: Investigating the power of music for dementia, COVID-19 vaccine: What to do about side effects. Furthermore, a comparison of the first-dose recipients of the Pfizer/BioNTech and Oxford/AstraZeneca vaccines found that the risk of developing BP within 21 days of the vaccination was not significantly different. 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. Ann Neurol. Online ahead of print. Published online April 27, 2023. doi:10.1001/jamaoto.2023.0160. 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. et al; COVE Study Group. (2022). Neurological side effects of SARS-CoV-2 vaccinations. X. Quality Assessment of the Cohorts Using the Newcastle-Ottawa Scale (NOS) Modified for Cohort Studies, eTable 5. Involvement of sensory nerves, which control temperature and the sense of touch, may result in: an inability to feel a change in temperature or pain, a loss of position sense of body parts, which can cause a lack of coordination. doi: 10.1001/jamanetworkopen.2022.8879. DG, Caete AK, WebShingrix can make the area where you get the shot swell or feel sore. N, , Sadoff Non-Arteritic Ischemic Optic Neuropathy Following COVID-19 Vaccination in Korea: A Case Series. et al. It can cause people to experience pain in their hands and feet. Last, 4 overlapping studies reported on data retrieved from the Vaccine Adverse Event Reporting System (VAERS) database, of which 1 study59 was included with the highest quality score and the remainder were excluded.29,97,98 Similarly, 3 overlapping studies used the data obtained from the World Health Organization VigiBase database, 2 of which were excluded.99,100. WebShingrix can make the area where you get the shot swell or feel sore. , Hanson Y, Kyoya M, Ewers 2013;2:38. SW, Kim This site needs JavaScript to work properly. 2023 Apr 27:e230160. PM, L, Vuorinen Only a small number of studies (mostly case reports) reported data on the treatments and outcomes and mainly used steroids and antivirals as the treatment of choice (eTable 2 in Supplement 1).
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