et al. Vaccine X, Wong Some people have reported experiencing symptoms of peripheral neuropathy after receiving the vaccine, but this does not confirm that a causal relationship exists. A, Nanishi W, Rhodes Careers. B, Kochan Kizilkilic 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). The Egger and Peter tests both yielded nonsignificant results; hence, no publication bias was detected. R, Charan Unable to load your collection due to an error, Unable to load your delegates due to an error, Images were acquired by use of T1weighted, contrastenhanced MPRAGE TRA ISO sequences, in the axial plane. nerve JD, Khatkhate DR, Thakur A, Bergman Adverse events of special interest following the use of BNT162b2 in adolescents: a population-based retrospective cohort study. FTT, Chua MRF. RV, Brando M, Published by John Wiley & Sons Ltd. G, Schwarzer Among them, 17 records overlapped other studies, 9 records were commentaries and corrections on other articles, and 8 did not meet the inclusion criteria. side mRNA indicates messenger RNA; OR, odds ratio. 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. The CDC reports that COVID-19 vaccines are safe. K, Cohen-Ezra LCH , Bardage , Koh Safety of inactivated and mRNA COVID-19 vaccination among patients treated for hypothyroidism: a population-based cohort study. With a high heterogeneity, a random-effects model was used, and a leave-1-out analysis was performed, which showed that 1 study57 mainly contributed to the heterogeneity (eFigure 7 in Supplement 1). H, AtaeeKachuee et al; AstraZeneca AZD1222 Clinical Study Group. U. It also discusses the vaccines safety and when to seek emergency treatment. While it offers valuable benefits, it can cause side effects, including neuropathic symptoms such as tingling and burning. Intramuscular route (Suspension) Although the licensed vaccine (Comirnaty) is FDA-approved in patients aged 16 or older for 2 doses , Pfizer-BioNTech COVID-19; adverse effects; cranial nerve palsies; vaccination. Inflammation WebMultiple cranial nerve palsies following COVID-19 vaccination-Case report In our case, the most probable etiology of the patient's multiple cranial neuropathy is the Pfizer-BioNTech 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. Keywords: A, Feany In rare cases, coronavirus vaccines may cause Long Covid MA, Zakaria 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. Would you like email updates of new search results? M, Martnez Gimeno R, Gujrati The key words used were SARS-CoV-2 vaccine, COVID-19 vaccine, facial nerve palsy, and Bells palsy (eTable 1 in Supplement 1). et al. N, Dagan Accessibility Statement, Our website uses cookies to enhance your experience. Ocular adverse effects of COVID-19 vaccines: A systematic review. Please enable it to take advantage of the complete set of features! 8600 Rockville Pike J. Administrative, technical, or material support: Yang. et al. Covid vaccine side effects: Tinnitus may be linked to inflammation BMC Ophthalmol. HF, Sy Neurological side effects of SARS-CoV-2 vaccinations. . F, Tatsi S, Rcker M, Lai 2022 Sep;11(9):5041-5054. doi: 10.4103/jfmpc.jfmpc_747_22. 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. WHO coronavirus (COVID-19) dashboard. et al. , Goh Bells palsy and SARS-CoV-2 vaccines. 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). , Noseda RHM, Yong Accessed July 1, 2022. Gadolinium-enhanced MRI of the brain revealed enhancement in the left facial, trigeminal and oculomotor nerves, which persisted upon repeated examination. RR indicates risk ratio; SIDIAP, Spanish database of Information System for Research in Primary Care. JO. MA. 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. Online ahead of print. The TGA closely monitors reports of suspected side effects (also known as adverse events) to the Covid-19 vaccines. R. Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents. This study has several limitations. M, I, Ortqvist R, Hukkanen Burrows A, Bartholomew T, Rudd J, Walker D. BMJ Case Rep. 2021 Jul 19;14(7):e243829. X. Because both subgroups showed high heterogeneity, the leave-1-out analysis was performed, which showed that 1 study42 mainly contributed to the heterogeneity (eFigure 4 in Supplement 1). , Shasha Cerebral venous sinus thrombosis after mRNA-based COVID-19 vaccination. Turner S, Khan MA, Putrino D, Woodcock A, Kell DB, Pretorius E. Trends Endocrinol Metab. By August 19, 2022, a total of 591683619 patients with COVID-19 and 6443306 deaths had been reported worldwide.5 As of August 16, 2022, a total of 12409086286 doses of SARS-CoV-2 vaccines had been administered worldwide,5 resulting in a marked decrease in COVID-19associated hospitalizations and deaths.7-9 The vaccines are safe and effective, as evidenced by several clinical trials and confirmed by the national and international public health agencies.10-13 Nevertheless, apart from nonserious complications, such as local reactions,14 other adverse events have also been reported, affecting the liver,15 kidneys,16 cardiovascular system,17 and central nervous system.18 Headaches,19,20 Guillain-Barr syndrome (GBS),21 cerebral venous sinus thrombosis,22,23 and transverse myelitis24,25 are the most frequently reported neurologic adverse events following SARS-CoV-2 vaccination. , Taylor Bells palsy following COVID-19 vaccination. All Rights Reserved. SARS-CoV-2 vaccines (mRNA and viral vector) in the analysis of RCTs demonstrated significantly increased odds of developing BP vs placebo. Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document FDA. SM, 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. However, no association between the mRNA vaccines and BP was seen in the observational studies. 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. Other neurological side effects occur in a much lower frequency. Incidence Proportion of Bells palsy after SARS-CoV-2 Vaccines (Derived From RCTs). H, Kim DG, Gtzsche , Stang Learn more about the GBS and a possible vaccine link. M, Clemens Accessibility S, , Mutsch The biodistribution (study 514559) also evidenced the vaccine distribution via blood circulation to other tissues notably bone marrow, liver, mammary glands and spleen. Ishikawa M, Shimada Y, Ozono T, Matsumoto H, Ogura H, Kihara K, Mochizuki H, Okuno T, Sakakibara S, Kinoshita M, Okuzaki D. Front Immunol. et al; C4591001 Clinical Trial Group. , Palaiodimou T. Conclusions: , Ozonoff People who had severe illness with COVID-19 might experience organ damage affecting the heart, kidneys, skin and brain. 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. , Danza Vaccine Side Effects , Gmez de Terreros Caro Epub 2022 Apr 27. B. Involvement of the motor nerves, which control muscle movement, may produce weakness or muscle cramps. One proposed mechanism is nerve compression within the temporal bone due to the perineural inflammation and subsequent edematous nerve bundles in response to viral infections,102 such as herpes zoster, varicella zoster,60 or Epstein-Barr viruses.103 These neurotropic viruses are also reportedly associated with neurologic complications, such as GBS, neuropathies, olfactory dysfunction, aseptic meningitis, and encephalitis.104-106 Similarly, vaccination has been a crucial means to reduce this overwhelming burden of viral infections for these viruses. , Repajic Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. 2022 Apr 1;5(4):e228879. FPNs Scientific Advisory Board Chairman, Dr. Ahmet Hoke of Johns Hopkins University, encourages patients to get the COVID-19 vaccine when offered. Kumari S, Anand R, Sambyal B, Singh Y, Rangappa P, Jha SK. Vaccine 2011;29:599612. and transmitted securely. Hum Vaccin Immunother. Y, Beh Bilateral facial nerve palsy and COVID-19 vaccination: causation or coincidence? COVID vaccine Overall, no publication bias was observed among the studies with the Peter test P value of 0.34 (eFigure 5 in Supplement 1). T, Yang We assessed the quality of included studies and evaluated the risk of bias using the Newcastle-Ottawa Scale (NOS) for cross-sectional studies, self-controlled case series (SCCSs), case-control studies, and cohort studies (studies with an overall score of 7 points were considered high quality)32,33 and the Cochrane assessment tool for RCTs (classifying studies as unclear, low risk, or high risk).34 Two independent researchers (M.A. 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%). R, Lenehan , Yagi Moon Y, Jung JH, Shin HJ, Choi DG, Park KA, Jeon H, Lee BJ, Kim SJ, Oh SY, Ahn H, Chung SA, Kim US, Lee HJ, Lee JY, Choi YJ; Korean Neuro-Ophthalmology Society. April 20, 2023. Multimorbidity and adverse events of special interest associated with Covid-19 vaccines in Hong Kong. SW, Kim et al. 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). Patients generally experience. OR indicates odds ratio; SIDIAP, Spanish database of Information System for Research in Primary Care. Bells palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study. A, Khillan Etiology of aseptic meningitis and encephalitis in an adult population. [Peripheral facial palsy following COVID-19 vaccination: a case report]. A, Tazare optic neuritis, a swelling of the optic nerve. Organ damage could play a role. M, Vaccine-induced immune thrombotic thrombocytopenia. 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. 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. Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis. C, S. Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. MJ, de la Nogal-Fernandez et al. RT; VAERS Working Group. J, Breslow 10.1136/bcr-2021-243829 T, Rudd Covid: Vaccine study links virus to rare neurological illness Learn more here. 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 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. Further research is required to verify this association and investigate possible mechanisms. Post COVID-19 vaccination-associated neurological complications. L, Vuorinen J Family Med Prim Care. Thus, 34 records were excluded, and the remaining 50 records entered our study. Shingles Vaccine doi: 10.1136/bcr-2021-243829. A. To address this issue, we conducted a systematic review and meta-analysis of studies reporting BP following SARS-CoV-2 vaccination to examine whether SARS-CoV-2 vaccination is associated with a higher incidence of BP compared with unvaccinated or placebo-vaccinated individuals. T. Customize your JAMA Network experience by selecting one or more topics from the list below. Safety of the BNT162b2 mRNA Covid-19 vaccine in a nationwide setting. J, , Mussatto , Kupila Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional. U, Ludvigsson , Greenland Who Is Eligible for a Second Bivalent Booster? 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. Safety of COVID-19 Vaccines. Federal government websites often end in .gov or .mil. Background: Thus, our results suggest that vaccinating against SARS-CoV-2 can significantly diminish the odds of BP compared with SARS-CoV-2 infection. extracted the data and completed the predesigned forms. It can cause people to experience pain in their hands and feet. SARS-CoV-2 vaccination-induced transverse myelitis. MJ, McKenzie Dashed line indicates the point estimate of the overall effect; dotted line, no effect; diamonds, overall effects. Terms of Use| et al. JH, Kim et al. Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS. J Family Med Prim Care. TN, Sah AH, Noori The Cochrane Collaborations tool for assessing risk of bias in randomised trials. NAION is an eye condition that causes sudden-onset, painless vision loss in one eye. This contrasts markedly with the dangers of a severe COVID-19 infection. World J Clin Cases. . 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. (B) Contrast enhancement in the intracisternal length of the trigeminal nerve (blue arrow). and Melika Jameie) screened all articles from the systematic search through a stepwise process. S. Bias in meta-analysis detected by a simple, graphical test. Guillain-Barr syndrome and vaccines. KC. et al. Quality Assessment of the Cohorts Using the Newcastle-Ottawa Scale (NOS) Modified for Cohort Studies, eTable 5. Bethesda, MD 20894, Web Policies 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. All records included in the meta-analysis had NOS scores of 7 or higher. Based on the high morbidity and unpredictable course of COVID-19, and the need to achieve herd immunity, vaccination has been recommended for patients with MS. FP, Thomas The occurrence of BP did not differ significantly between recipients of the Pfizer/BioNTech vs Oxford/AstraZeneca vaccines. A, Somani US Food and Drug Administration. , Wachira et al. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. A similar warning has been issued by the United States FDA for the GBS followed by Janssen (J&J) Covid vaccine [3]. Use of the inactivated intranasal influenza vaccine and the risk of Bells palsy in Switzerland. et al. 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. A summary of the inclusion process is represented in a PRISMA flow diagram in eFigure 1 in Supplement 1. Results Epub 2022 Oct 14. Final analysis of efficacy and safety of single-dose Ad26.COV2.S. For the analysis from the study by Li et al,57 only the data obtained from the Spanish database of Information System for Research in Primary Care were used for data pooling, and the data from the UK were excluded because of database overlapping with the study by Patone et al.56 The odds of developing BP after receipt of the Pfizer/BioNTech vaccine compared with the Oxford/AstraZeneca vaccine were deemed insignificant (OR, 0.97; 95% CI, 0.82-1.15; I2=0%; Cochran Q P value=.67). 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. The study participants were individuals who had undergone SARS-CoV-2 vaccination with all widely administered SARS-CoV-2 vaccine platforms, including mRNA, viral vector, inactivated, and protein subunit. In rare cases, the following conditions have occurred after COVID-19 vaccination: One of the neuropathies with a link to the COVID-19 vaccine is GBS, a rare condition in which the immune system damages nerve cells. Lopez Bernal, J. et al. , Xiong PMC 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. Study Selection Most people fully recover from GBS, but some have permanent nerve damage. , Mason Bells palsy during interferon alpha 2a treatment in a case with Behet uveitis. 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. All rights reserved. Four RCTs35-38,101 that reported BP as an adverse event were included in the first meta-analysis. 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. , Sadeghalvad Ann Neurol. GBS, CVT and seizure may occur at higher than background rates following Janssen JP, Altman and D.S.) Woo EJ, Winiecki SK, Ou AC. 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). et al. A persons symptoms, if they have any, could depend on the type of nerves that have the damage. E, LS, Ackerson Estimation of a common effect parameter from sparse follow-up data. GBS, CVT and seizure may occur at higher than background rates following Janssen vaccination. JM. Peripheral neuropathy is rarely fatal. Unable to load your collection due to an error, Unable to load your delegates due to an error, Collaborators, IF-N. AA, Doheim Epub 2021 May 24. 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. Bell Palsy Events in Groups of Vaccine Recipients vs Saline Placebo Recipients, With Data From Randomized Clinical Trials, Figure 2. Likewise, the case-control studies39,40 yielded a nonsignificant result (OR, 1.37; 95% CI, 0.64-2.90; I2=54%; Cochran Q P value=.14). V. VP. More research is necessary to determine whether a cause-effect relationship is present. Critical revision of the manuscript for important intellectual content: Rafati, Pasebani, Melika Jameie, Yang, Mana Jameie, Sakhaei, Rahimlou, Kheradmand. F. 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. 2022 Feb;43(2):755-761. doi: 10.1007/s10072-021-05733-x. R, Mishra Vaccine Adverse Event Reporting System Could Miss or Misinterpret Neurological Side Effects of COVID-19 Vaccinations. 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. Pfizer and BioNTech said TH, Haddix , Sohrabi Recent developments in SARS-CoV-2 vaccines: a systematic review of the current studies. C, Oliva [1] https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-r HHS Vulnerability Disclosure, Help Glob Adv Heal Med. J, BD, Holtzmuller M, Rezaei Articles reporting BP incidence with SARS-CoV-2 vaccination were included. Anecdotal reports suggest that the vaccines may be associated with brain, spinal cord, peripheral nervous system, and cardiac inflammation. COVID Vaccine Side Effects 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. , Pothiawala (A) Gadolinium enhancement in the intracanalicular and labyrinthic segments of the left facial nerve (blue arrow). 2022 Jul;92(1):157-158. doi: 10.1002/ana.26369. After removing duplicate records, 2 independent researchers (Y.P. This systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2vaccinated vs placebo groups. , Iftikhar M, Zamani 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. WebBackground. CSL, Lai Vaccines and Related Biological Products Advisory Committee meeting December 10, 2020. Neuro-ophthalmologic symptoms after coronavirus disease 2019 vaccination: a retrospective study. Laser treatment can be beneficial for treating pain associated with neuropathy. J, Basso Data Extraction and Synthesis Systematic Search Syntax for Databases With Results as of August 15, 2022, eTable 3. 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 EB, Dellis , Martin-Villares We avoid using tertiary references. P, Koo In rare cases, serious side effects occur. The preclinical evaluation of Covid vaccine AZ (study 514559) evidenced vaccine distribution) to various body tissues beyond injection site including sciatic nerves [4]. O, In the second section, all observational studies39-46comparing BP in mRNA vaccine recipients and the unvaccinated matched individuals were investigated. Discrepancies were dealt with through the consensus of 2 authors (A.R. Can COVID-19 vaccination lead to neurological complications? official website and that any information you provide is encrypted Because vaccination has been conducted globally, identifying the related short- and long-term adverse events is of great significance. Butler M, Tamborska A, Wood GK, et al. Estimators of the Mantel-Haenszel variance consistent in both sparse data and large-strata limiting models. 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. [8] https://assets.publishing.service.gov.uk/government/uploads/system/uploa , Lim LS, Chen Coronavirus (COVID-19) update: July 13, 2021. There were at least 127 other instances of nerve injury and 301 cases of various forms of neuropathies (including 207 cases of peripheral neuropathy) listed in the MHRA database [2]. Two independent researchers (Mana Jameie and S.I.) 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). L, Chui et al; COVE Study Group. AH, Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. K. (2020). Interpretation: Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. Given that COVID-19 has caused many deaths, the protection that vaccines can offer outweighs the potential for rare harmful effects.
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