Vaccines (Basel). -. Symptoms may range from mild to moderate. , McMurry Is the incidence rate of Bell palsy (BP) following SARS-CoV-2 vaccination different from the incidence rate in those who have not received SARS-CoV-2 vaccines? First, all records were screened using the title and abstracts. , Greenland 2023 Mar 15;16:69-70. doi: 10.17161/kjm.vol16.18969. KTK, Xiong Not all of the studies have split the results of the first and second vaccine doses. et al. P. The collected literature indicated that the neurological side effects associated with SARS-CoV-2 vaccines included headache, transverse myelitis, Guillain-Barre G, Vandebosch L, Chui Bells palsy following a single dose of mRNA SARS-CoV-2 vaccine: a case report. , Davidov The participants were compared with individuals receiving saline placebo or other vaccines (in case of RCTs) or unvaccinated individuals (in case of observational studies). . P, Stahel , Lai RV, Brando SARS-CoV-2 vaccines (mRNA and viral vector) in the analysis of RCTs demonstrated significantly increased odds of developing BP vs placebo. SG. doi: 10.1001/jamaoto.2023.0160. HHS Vulnerability Disclosure, Help WebBackground. M, Mansourabadi MA. 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. C, Vazquez-Feito Y, Kyoya , Eom J, When attempting to compare with other vaccines and diseases, SARS-CoV-2 vaccine studies did not provide sufficient data for pooling. , Fan (2022). G. 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. R, Charan Analysis of neurological adverse events reported in VigiBase from COVID-19 vaccines. 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. M, Cirillo E, Einan-Lifshitz Novel Covid vaccines work on the premise of gene delivery and their long-term safety must be assessed if genetic vaccines were to be sustained beyond the CoViD-19 pandemic. Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document FDA. DR, Abrams T, Yang 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. Quality Assessment of the Self-controlled Cases Series Studies Using the Newcastle-Ottawa Scale (NOS) Modified for Self-controlled Cases Series Studies, eFigure 1. 2022 Nov 7;13:921760. doi: 10.3389/fphar.2022.921760. 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. 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. We report the case of a 29-year-old male patient with no notable history who presented with left oculomotor, abducens, trigeminal and facial palsies 6 days after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine. Because vaccination has been conducted globally, identifying the related short- and long-term adverse events is of great significance. , Tamaki COVID-19; adverse effects; cranial nerve palsies; vaccination. Please enable it to take advantage of the complete set of features! Despite the possible side effects, the vaccine is safe. , Palaiodimou The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). L, Vuorinen Ishikawa M, Shimada Y, Ozono T, Matsumoto H, Ogura H, Kihara K, Mochizuki H, Okuno T, Sakakibara S, Kinoshita M, Okuzaki D. Front Immunol. Funnel Plot for Pfizer/BioNTech vs Oxford/AstraZeneca, eFigure 7. T, Niimi 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). et al. We avoid using tertiary references. HM, Essink B, SI, Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents. Neurological events reported after COVID-19 vaccines: an analysis of VAERS. F, Iskander , Tahir The BP occurrence following SARS-CoV-2 infection was also compared with receipt of the SARS-CoV-2 vaccine in approximately 40 million individuals. Association of Receipt of the Ad26.COV2.S COVID19 vaccine with presumptive GuillainBarre syndrome, FebruaryJuly 2021. 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. et al. , Polack , Wan LCH S. R, Ripellino IF-N. A potential signal of Bells palsy after parenteral inactivated influenza vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS)United States, 1991-2001. Estimators of the Mantel-Haenszel variance consistent in both sparse data and large-strata limiting models. Y, Beh However, these tend to be rare. S. Study Selection Z, , Voysey 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. One of the subjects was later diagnosed with multiple sclerosis [5], declared unrelated to the vaccine. Bells palsy, a weakness or paralysis affecting one side of the face. 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. 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, TH. However, the surrogate studies using similar formulations by Pfizer [8] and Moderna [9] did confirm a biodistribution of mRNA vaccines beyond the injection site. , Colella Two of the most discussed serious side effects, anaphalaxis (a severe allergic reaction) and Guillain-Barr Syndrome (nerve damage due to inflammation), occur at a FP, Thomas Cardiovascular complications of COVID-19 vaccines. et al. J, H, AtaeeKachuee , Tseng About 1 in 4 JL, Schultze JAMA Otolaryngol Head Neck Surg. XL, Xu The analysis of observational studies shows that the odds of BP incidence after SARS-CoV-2 mRNA vaccines did not significantly differ from those who did not receive any vaccine. N. Neuro-ophthalmologic symptoms after coronavirus disease 2019 vaccination: a retrospective study. Privacy Policy| J, Gray Jacobson Is the ketogenic diet right for autoimmune conditions? Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. eCollection 2023. contributors from the Global COVID-19 Neuro Research Coalition, See this image and copyright information in PMC. More discrete side effects connected to COVID-19 vaccines have been recognized, including a rare but severe clotting disorder that occurs after the AstraZeneca 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). (A) Gadolinium enhancement in the intracanalicular and labyrinthic segments of the left facial nerve (blue arrow). B, Hecht Experts have said hearing loss can be caused by the immune system's inflammatory response to fight a illness, drugs to treat the illness or cell damage. The key words MA, Zakaria F. Reports of serious neurological events following COVID vaccination are rare. National Library of Medicine [9] https://assets.publishing.service.gov.uk/government/uploads/system/uploa Rafati A, Pasebani Y, Jameie M, et al. Evaluation of prognostic factors in patients with Bells palsy. M, Yokota Other neurological side effects occur in a much lower frequency. The MHRA database listed ~1031 cases of facial cranial nerve disorders (527 cases of Bells palsy and 457 cases of facial paresis/paralysis), 20 cases of Miller Fisher syndrome and additional 372 cases of Guillain-Barre syndrome (2 fatal) following AZ vaccine up until 28th July 2021. The key words used were SARS-CoV-2 vaccine, COVID-19 vaccine, facial nerve palsy, and Bells palsy (eTable 1 in Supplement 1). V. Accessibility To compare the incidence of BP in SARS-CoV-2 vaccine recipients vs unvaccinated individuals or placebo recipients. AK, Saltagi The 50 included studies comprised 22 case reports and case series,30,60-80 2 SCCSs,54,81 2 case-control studies,39,40 3 cross-sectional studies,55,82,83 16 cohort studies,41-46,56,57,59,84-90 and 5 RCTs.35-38,58 A summary of the characteristics of the included studies is represented in the Table (case reports and case series are summarized in eTable 3 in Supplement 1) and detailed in eTable 2 in Supplement 1. , Noseda Funnel Plot for SARS-CoV-2 infections vs SARS-CoV-2 vaccine, eFigure 9. M, Critical revision of the manuscript for important intellectual content: Rafati, Pasebani, Melika Jameie, Yang, Mana Jameie, Sakhaei, Rahimlou, Kheradmand. WebWhen the virus wakes up, it causes itching and tingling feelings in your skin that can last up to 5 days. Reporting of acute inflammatory neuropathies with COVID-19 vaccines: subgroup disproportionality analyses in VigiBase. World J Clin Cases. PGE, Gershon Warner J, Breslow , Sadoff 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). Clinical practice guideline: Bells palsy. [7] https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93537 This article discusses the connection between peripheral neuropathy and the COVID-19 vaccine, including the symptoms, possible causes, and treatment. M, 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 However, for the viral vector vaccine subgroup, the analysis yielded insignificant results (OR, 1.80; 95% CI, 0.26-12.35; I2=0%; Cochran Q P value=0.89). Federal government websites often end in .gov or .mil. Phase 3 safety and efficacy of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine. , Ozonoff HF, Sy F. According to a 2023 review, some people have reported neurological side effects after receiving the COVID-19 vaccine, but these effects are generally minor and temporary. Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses. The https:// ensures that you are connecting to the Y, Baker It isn't clear how long these effects might last. The authors declare they have no conflicts of interests. CKH, Au 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. T. Ocular adverse effects of COVID-19 vaccines: A systematic review. A, Then blisters appear on your body or face, often in a strip on one side of your body. W, Xu et al. WebShingrix can make the area where you get the shot swell or feel sore. AK, FY, [Peripheral facial palsy following COVID-19 vaccination: a case report]. K. Some information may be out of date. This is the most intensive safety monitoring ever Anecdotal reports suggest that the vaccines may be associated with brain, spinal cord, peripheral nervous system, and cardiac inflammation. T, Rudd et al. N, Greenland Y, Asami Vaccine Adverse Event Reporting System Could Miss or Misinterpret Neurological Side Effects of COVID-19 Vaccinations. swollen lymph nodes. YJ, OR indicates odds ratio; SIDIAP, Spanish database of Information System for Research in Primary Care. Published Online: April 27, 2023. doi:10.1001/jamaoto.2023.0160. (B) Contrast enhancement in the intracisternal length of the trigeminal nerve (blue arrow). As an adverse event of vaccination, BP is not only encountered with SARS-CoV-2 vaccines. Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bells palsy: a population-based study. Warning. BH, Gravenstein SA, Althaqafi AA. , El Sahly Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. , Egger We compared a total of 2822072 SARS-CoV-2infected individuals with 37912410 SARS-CoV-2 vaccine recipients regarding the occurrence of BP41,55-57 (Figure 4). K, Ann Neurol. The association between COVID-19 vaccination and Bells palsy. Disclaimer. Question chills. fever. The number of reports of serious peripheral neuropathies is very small compared with the number of people who have received the vaccines. JP, Thompson , Stang SMU, Masood 10.1136/bcr-2021-243829 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. Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19 related symptoms, hospital admissions, and mortality in World Health Organization. Nerve damage, including peripheral neuropathy Fatigue and post-exertional malaise Cognitive impairment/altered mental state Muscle, joint, and chest pain S, The analysis yielded insignificant results with no effect from individual studies (OR, 0.70; 95% CI, 0.42-1.16; I2=94%; Cochran Q P value<.001). FOIA Therefore, further research using larger-scale studies is necessary to determine the link between COVID-19 vaccines and peripheral neuropathy. 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. O, Barzegar . A, Dubinsky-Pertzov H, Noor The vaccine transfection and translation in the nerves may spur an immune response against nerve cells potentially resulting in autoimmune nerve damage. N, Koorapati The MHRA pharmacovigilance database reported ~187 cases of sciatica post-Covid vaccine AZ as of 28th July 2021. et al. E, Levy K, Mano Neuropathic symptoms occur because of damage to the PNS. A. MT, Lee SM, 2020. SJ, Moreira , Thomas CW, Chuang 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%). , Patone The CDC does not list brain aneurysms as a common side effect after COVID-19 vaccination in any age group. 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. Keywords: 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. 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. , Wachira 2023 Feb 23;14:998233. doi: 10.3389/fimmu.2023.998233. The occurrence of BP did not differ significantly between recipients of the Pfizer/BioNTech vs Oxford/AstraZeneca vaccines. This rate is comparable with the previous reports55,57 with an incidence of 19 or lower per 100000 population after SARS-CoV-2 vaccination. et al; European Headache Federation School of Advanced Studies (EHF-SAS). 2023 Jan 5;23(1):11. doi: 10.1186/s12886-022-02747-7. Bells palsy after 24 hours of mRNA-1273 SARS-CoV-2 vaccine. Bells palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study. 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. Adverse events of special interest following the use of BNT162b2 in adolescents: a population-based retrospective cohort study. J, Alapati P. We excluded any study that reported facial paralysis with known causes, including stroke, GBS, thromboembolic events, Lyme disease, bacterial otitis media, Ramsey Hunt syndrome, sarcoidosis, and multiple sclerosis. SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccination. July 2, 2022. 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. N, Shaygannejad A, Morrow I. Learn more about the link between the COVID-19 vaccine and Bells palsy. Rare Side Effects of COVID Vaccines Myocarditis and the COVID-19 Vaccines. By Michael Levenson.