Still, rare reports have involved serious neurological conditions. , Barda Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document FDA. G, Prasad Feghali EJ, Challa A, Mahdi M, Acosta E, Jackson J. Kans J Med. , Higgins The safety profile of COVID-19 vaccinations in the United States. The https:// ensures that you are connecting to the Blurry Vision Conjunctivitis - Pink Eye Corneal Abrasions Dry Eyes Eye Discharge Eye Pain Dilated Pupils Eye Infections Puffy Eyes More Eye Conditions More Eye Conditions Featured Eye Twitching Ocular Migraines Red Eyes Styes Swollen Eyelids How to Get Rid of a Stye Blepharitis Chalazion Eye Floaters Because vaccination has been conducted globally, identifying the related short- and long-term adverse events is of great significance. (D) The contrast enhancement of the trigeminal nerve persists upon repeated examination a month later (blue arrow). (2022). 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). Dashed line indicates the point estimate of the overall effect; dotted line, no effect; diamonds, overall effects. D, Interpretation: WebThe most frequent neurological side effects of SARS-CoV-2 vaccines are headache, Guillain-Barre syndrome (GBS), venous sinus thrombosis (VST), and transverse myelitis. Among them, 17 records overlapped other studies, 9 records were commentaries and corrections on other articles, and 8 did not meet the inclusion criteria. A, Maity F. SJ, Moreira Federal government websites often end in .gov or .mil. The symptoms also include fatigue, severe headaches, nerve pain, blood pressure swings, and short-term memory problems. 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. T, Niimi How to perform a meta-analysis with R: a practical tutorial. Other causes were excluded by laboratory tests. Subsequently, for sections 3 and 4, the metagen function was used to pool the measures of effect (OR and RR with the corresponding 95% CIs). National Library of Medicine Last medically reviewed on March 30, 2023, This Special Feature gives tips about dealing with COVID-19 vaccine side effects, including which home care techniques can help and when to contact a, The majority of cases of neuropathy, often referred to as peripheral neuropathy, affect the motor and sensory nerves. Baugh 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. doi: 10.1136/bcr-2022-253302. BH, Gravenstein Bells palsy, a weakness or paralysis affecting one side of the face. 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. Association of Receipt of the Ad26.COV2.S COVID-19 Vaccine With Presumptive Guillain-Barr Syndrome, February-July 2021. This will not only help in explaining a causal link but will also help take necessary precautionary measures in time for public safety. Epub 2022 Oct 14. Dashed line indicates the point estimate of the overall effect; dotted line, no effect; diamond, overall effect. 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. Bells palsy after Sputnik V COVID-19 (Gam-COVID-Vac) vaccination. X. The quality of the studies was evaluated by the Newcastle-Ottawa Scale. 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. S, Bertoli Incidence of Guillain-Barr syndrome after COVID-19 vaccination in the Vaccine Safety Datalink. F, Iskander Mirmosayyeb Therefore, the benefits outweigh the risks for most people, according to the review authors. Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. LR, El Sahly 2023 Feb 1;6(2):e2253845. N, Greenland et al. Vaccines (Basel). , El-Shitany 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? We found a March 2022 study that reported the cases of ME, Hirsch HM, Essink BY, Cen Y, Kyoya LD, Doubrovinskaia Accessed July 2, 2022. In the second section, all observational studies39-46comparing BP in mRNA vaccine recipients and the unvaccinated matched individuals were investigated. RJ, Kotilainen The last sample was taken on 29 days post-administration and sciatic nerves of 70% of animals were still tested positive at the end of the study. P, Awasthi Immunogenicity and adverse effects of the 2-dose BNT162b2 messenger RNA vaccine among liver transplantation recipients. 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. A, Morrow Ann Neurol. The CDC does not list brain aneurysms as a common side effect after COVID-19 vaccination in any age group. et al. These complications may include encephalomyelitis, meningitis, GBS, or transverse myelitis.57. et al. , Cellina See this image and copyright information in PMC. N, 2022 Apr 1;5(4):e228879. JS, Hoe Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. Cardiovascular complications of COVID-19 vaccines. Safety of quadrivalent meningococcal conjugate vaccine in 11- to 21-year-olds. 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. Dashed line indicates the point estimate of the overall effect; dotted line, no effect; diamonds, overall effects. This rate is comparable with the previous reports55,57 with an incidence of 19 or lower per 100000 population after SARS-CoV-2 vaccination. 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 COVID-19 vaccine is an important tool that reduces illness and death from SARS-CoV-2, the virus responsible for the infection. ED A, Pras N, Miyazaki Medical News Today has strict sourcing guidelines and draws only from peer-reviewed studies, academic research institutions, and medical journals and associations. 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). An official website of the United States government. New-Onset Amyotrophic Lateral Sclerosis in a Patient who Received the J&J/Janssen COVID-19 Vaccine. MH, P, Moghadas Systematic Search Syntax for Databases With Results as of August 15, 2022, eTable 3. et al. This limitation hampered our ability to perform subgroup analyses based on parameters such as age, sex, vaccine dose, or vaccination-to-event time span. J, Clinical practice guideline: Bells palsy. . Y, Toda doi: 10.1136/bcr-2021-243829. Multiple cranial nerve palsies with small angle exotropia following COVID-19 mRNA vaccination in an adolescent: A case report. Note that the rates of headache, fatigue, dizziness and syncope exceed the yaxis scale for the Janssen vaccine and event rates are listed above these bars. Federal government websites often end in .gov or .mil. et al. Drs Rafati and Pasebani contributed equally to this work. Left Bells palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: a case report. MMWR Morb Mortal Wkly Rep. 2021 Aug 13;70(32):1094-1099. doi: 10.15585/mmwr.mm7032e4. Findings Sixty days later, she had received two doses of the Pfizer COVID-19 vaccine, the first dose on April 10, 2021, and the second dose 21 days later, without any systemic side effects. Drafting of the manuscript: Rafati, Pasebani, Melika Jameie, Yang, Mana Jameie, Ilkhani, Amanollahi, Sakhaei, Kheradmand. The Cochrane Collaborations tool for assessing risk of bias in randomised trials. This article discusses the connection between peripheral neuropathy and the COVID-19 vaccine, including the symptoms, possible causes, and treatment. However, complications can affect a person's life expectancy. Nerve damage, including peripheral neuropathy Fatigue and post-exertional malaise Cognitive impairment/altered mental state Muscle, joint, and chest pain Objective To evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination.. Design, Setting, and Participants The COVID-19 Citizen Science Study, an online cohort study, YJ, Results Etiology of aseptic meningitis and encephalitis in an adult population. To compare the incidence of BP in SARS-CoV-2 vaccine recipients vs unvaccinated individuals or placebo recipients. 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. 2023 American Medical Association. M, P, Ghidossi Addressing the publication bias, the funnel plots are provided in eFigure 3 in Supplement 1. 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. 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. CW, Chuang JM. , Hwang Hospital-based observational study of neurological disorders in patients recently vaccinated with COVID-19 mRNA vaccines. et al; C4591001 Clinical Trial Group. , McMurry , Sadoff Thus, our results suggest that vaccinating against SARS-CoV-2 can significantly diminish the odds of BP compared with SARS-CoV-2 infection. TH. G, Carrafiello Overall, in all 4 trials, BP incidence was significantly higher in the vaccine group (77525 recipients) vs placebo (66682 recipients) (OR, 3.00; 95% CI, 1.10-8.18; I2=0%; Cochran Q P value=0.84). Fatigue has been reported by roughly et al. First, all records were screened using the title and abstracts. Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy: A Systematic Review and Meta-analysis. N, Fayad (2021). Ocular adverse effects of COVID-19 vaccines: A systematic review. Bells palsy following COVID-19 vaccination with high CSF antibody response. Since April 2021, some people have developed myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after receiving the Pfizer-BioNTech or Moderna coronavirus vaccines in the United States, according to the U.S. et al. The Egger and Peter tests both yielded nonsignificant results; hence, no publication bias was detected. A persons symptoms, if they have any, could depend on the type of nerves that have the damage. NA, Harakeh CO, da Cruz WebShingrix can make the area where you get the shot swell or feel sore. JD, Khatkhate Importance Little is known about the factors associated with COVID-19 vaccine adverse effects in a real-world population.. The study was exempt from ethical approval by the local institutional ethics committee because we used previously published data. The etiology of Bells palsy: a review. SARS-CoV-2 infection and hospitalization among adults aged 18 years, by vaccination status, before and during SARS-CoV-2 B.1.1.529 (Omicron) variant predominanceLos Angeles County, California, November 7, 2021-January 8, 2022. A, Bergman Quality Assessment of the Cohorts Using the Newcastle-Ottawa Scale (NOS) Modified for Cohort Studies, eTable 5. C, Dessypris BK, FTT, Huang -, Rosenblum HG, Hadler SC, Moulia D, et al. et al. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). EWW, Accessibility Statement, Our website uses cookies to enhance your experience. et al. Would you like email updates of new search results? 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 Use or keep moving your arm. 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. Considerations for causality assessment of neurological and neuropsychiatric complications of SARSCoV2 vaccines: from cerebral venous sinus thrombosis to functional neurological disorder. 2023 Jan 20;11(2):236. doi: 10.3390/vaccines11020236. 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). LS, Chen Association of clinical and epidemiological characteristics with COVID-19 BNT162b2 mRNA vaccine short-term adverse reactions in healthcare workers. N, Nayak , Lim Bells palsy following COVID-19 vaccination. No restriction on the study design, age of the participants, literature language, or any other factors was imposed. Accessed March 2, 2023. Articles reporting BP incidence with SARS-CoV-2 vaccination were included. Data Sharing Statement: See Supplement 2. C, Oliva et al. This heterogeneity could be attributable to different inclusion criteria or sampling methods. Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of et al; European Headache Federation School of Advanced Studies (EHF-SAS). This article is protected by copyright. The Egger test yielded a P value of .64; hence, no publication bias was present. 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. Of the pooled studies, only Tamaki et al55 reported a precalculated RR (eFigure 8 in Supplement 1). Y, Khurana M, Koutsokera Is it possible to die from peripheral neuropathy? Yan MM, Zhao H, Li ZR, Chow JW, Zhang Q, Qi YP, Wu SS, Zhong MK, Qiu XY. 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. H, Kim FN, Alay swollen lymph nodes. While it offers valuable benefits, it can cause side effects, including neuropathic symptoms such as tingling and burning. , Ozonoff RT; VAERS Working Group. Kharoubi 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). , Gonzlez-Enrquez S, Rcker The most commonly reported symptoms of post- COVID-19 syndrome include: Fatigue Symptoms that get worse after physical or mental effort Fever Lung (respiratory) symptoms, including difficulty breathing or shortness of breath and cough Other possible symptoms include: A summary of the inclusion process is represented in a PRISMA flow diagram in eFigure 1 in Supplement 1. About 1 in 4 J Neurol Neurosurg Psychiatry 2021;92:11441151. , Mason Available at: Sejvar JJ, Kohl KS, Gidudu J, et al. Recently, vaccine distribution to the vasculature and interaction with circulatory platelets have been proposed as a likely mechanism for thrombosis with thrombocytopenia syndrome (TTS) [6]. All Rights Reserved. Rare Side Effects of COVID Vaccines Myocarditis and the COVID-19 Vaccines. The occurrence of BP did not differ significantly between recipients of the Pfizer/BioNTech vs Oxford/AstraZeneca vaccines. Individuals have also reported side effects at the injection site, including arm pain, , Martin-Villares GBS, CVT and seizure may occur at higher than background rates following Janssen vaccination. , Nishizawa Objective It can cause people to experience pain in their hands and feet. , Tahir et al. I. , Tan 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. 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. Organ damage could play a role. , Polack People who had severe illness with COVID-19 might experience organ damage affecting the heart, kidneys, skin and brain. A, Bartholomew , Saltagi et al. In line with this finding, prior studies56,57 also found that the risk of neurologic adverse events from SARS-CoV-2 infection is markedly higher than from the SARS-CoV-2 vaccines. C. M, Baharlouie N, Syriopoulou 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. Surveillance for adverse events after COVID-19 mRNA vaccination. 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. D. VWS, M, Zamani The results are given in eFigure 2 and eTables 4 through 7 in Supplement 1. [7] https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93537 The analysis of the observational studies showed that mRNA SARS-CoV-2vaccinated participants had no significant increase in BP incidence vs the unvaccinated participants. Myocarditis and pericarditis after COVID-19 vaccination are rare. Gadolinium-enhanced MRI of the brain revealed enhancement in the left facial, trigeminal and oculomotor nerves, which persisted upon repeated examination. Neurological symptoms and neuroimaging alterations related with COVID-19 vaccine: cause or coincidence? B. Of these, 180 were removed because they were duplicate records. 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. Epub 2021 Nov 18. 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. July 2, 2022. , Lai Messenger RNA coronavirus disease 2019 (COVID-19) vaccination with BNT162b2 increased risk of Bells palsy: a nested case-control and self-controlled case series study. I, Ortqvist N, Doan Ependymal cells in cerebrospinal fluid: A traumatic occurrence. Learn more about the link between the COVID-19 vaccine and Bells palsy. et al. 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. Y, Beh In the first section, 4 studies35-38 corresponding to the phase 3 RCTs of the major SARS-CoV-2 vaccines (ie, Pfizer/BioNTech, Moderna, Janssen, and Oxford/AstraZeneca) were evaluated. et al. Learn more about the GBS and a possible vaccine link. Claim: A scientific study "confirmed" that the Pfizer vaccine causes neurological damage. , Gmez de Terreros Caro A, April 9, 2021. P, Koo Bells palsy after second dose of Moderna covid-19 vaccine: coincidence or causation? IF-N. , Thomas M, Anglin Albakri K, Khaity A, Atwan H, Saleh O, Al-Hajali M, Cadri S, Diab RA, Albazee E, Negida A. Question , Kamath A, Somani and Melika Jameie) screened all articles from the systematic search through a stepwise process. Acute abducens nerve palsy following COVID-19 vaccination. Clipboard, Search History, and several other advanced features are temporarily unavailable. DR, Thakur C. S. retinopathy, which is damage to the retina. , Assiri Considering that the overall BP incidence is approximately 15 to 30 per 100000 annually in the general population,1 our analysis of RCTs suggests a similar BP incidence of 18 per 100000 among SARS-CoV-2 vaccine recipients (eFigure 9 in Supplement 1). S, Ish , Patone , Gupta Y, Tsaraf N, Shaygannejad Management of Bells palsy. WT, Huang et al. RF, Basura et al. Dotted line indicates no effect; diamond, overall effect. However, these tend to be rare. et al. Disclaimer. L, Chui Long COVID: pathophysiological factors and abnormalities of coagulation. 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. 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. 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. , Huang M, Waliszewska-Pros S, The key words Guillain-Barre Syndrome (GBS), and cerebral venous thrombosis (CVT) occurred in fewer than 1 per 1,000,000 doses. JH. I, V, Marttila CSL, MRF. RV, Brando J, Chan 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. In our case, the most probable etiology of the patient's multiple cranial neuropathy is the Pfizer-BioNTech vaccine, which highlights the need for prolonged surveillance of COVID-19 vaccine neurological complications. 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. N, Taneja -. JAMA 2021;326:16061613. et al. Nath is convinced they are extremely rare. Long Covid, in contrast, affects anywhere from about 5% Learn more here. sharing sensitive information, make sure youre on a federal [9] https://assets.publishing.service.gov.uk/government/uploads/system/uploa Accessibility TB, Cash , Hls government site. JH, Kim MHRA later also concluded that as a precautionary measure they will also be adding a warning for GBS in the product information [2]. What are the signs and symptoms of neuropathy? L, Saatci All data and statistics are based on publicly available data at the time of publication. The .gov means its official. 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. SM, The safety of COVID-19 mRNA vaccines: a review. , Greenland HHS Vulnerability Disclosure, Help , Balduzzi et al. CKH, Lau Because RCTs and major observational studies did not report treatment outcomes and recurrence, we were not able to draw a meaningful conclusion on whether there were any differences in the treatment outcome for BP with the SARS-CoV-2 vaccine, with SARS-CoV-2 infection, or in spontaneous cases. You can learn more about how we ensure our content is accurate and current by reading our. The quality of the studies was evaluated by the Newcastle-Ottawa Scale. J, Bells palsy following COVID-19 vaccination: a case report. Quality Assessment of the Case Controls Using the Newcastle-Ottawa Scale (NOS) Modified for Case-Control Studies, eTable 6. N. JAMA Otolaryngol Head Neck Surg. Several mechanisms have been considered to explicate the underlying pathophysiology of BP. PT, Zisman , Egger JF, Granath K, Mano Woo EJ, Mba-Jonas A, Dimova RB, Alimchandani M, Zinderman CE, Nair N. JAMA. , Finsterer The https:// ensures that you are connecting to the G, Orlandi 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. KE, Goddard Safety of COVID-19 vaccination and acute neurological events: a self-controlled case series in England using the OpenSAFELY platform.
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