, Burrows
Incidence Proportion of Bells palsy after SARS-CoV-2 Vaccines (Derived From RCTs). , Cirillo
However, these tend to be rare. RV, Brando
Please enable it to take advantage of the complete set of features! 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). The analysis of the observational studies showed that mRNA SARS-CoV-2vaccinated participants had no significant increase in BP incidence vs the unvaccinated participants. 2021 John Wiley & Sons A/S. The Egger test yielded a P value of .96, thus showing no publication bias. 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. 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). Epub 2021 May 24. G, Schneider
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. Results: M, Cirillo
SW, Kim
Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. Objective: Despite this, rates of neurological complications following acute SARS-CoV-2 infection are up to 617-fold higher than after COVID vaccination. Neurological complications after first dose of COVID-19 - Nature Visit our coronavirus hub for the most recent information on the COVID-19 pandemic. New-onset kidney diseases after COVID-19 vaccination: a case series. , Koh
HM, Baden
Neurological Events Reported after COVID-19 Vaccines: An Learn more about the link between the COVID-19 vaccine and Bells palsy. Bells palsy after second dose of Pfizer COVID-19 vaccination in a patient with history of recurrent Bells palsy. S. [6] https://doi.org/10.1101/2021.06.29.450356 FTT, Huang
MF,
P, Moghadas
Quality Assessment of the Cross-Sectional Studies Using the Newcastle-Ottawa Scale (NOS) Modified for Cross-Sectional Studies, eTable 7. 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. LS, Ackerson
KC. Serious effects, such as GBS, have happened in rare cases. J Family Med Prim Care. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. Careers. 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. All rights reserved. H, AtaeeKachuee
extracted the data and completed the predesigned forms. We link primary sources including studies, scientific references, and statistics within each article and also list them in the resources section at the bottom of our articles. LE,
Lopez Bernal, J. et al. 2022. J, Gray
mRNA indicates messenger RNA; OR, odds ratio. Z,
-. The association between COVID-19 vaccination and Bells palsy. EYF, Chui
VK, Peixoto
However, age and the severity of facial paralysis based on the House-Brackmann scale may predict poor outcomes.27. 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. Zhang
Aside from those mentioned previously, these can include: Deaths are rare, but they have occurred. , Obermann
WebShingrix can make the area where you get the shot swell or feel sore. The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis. N, Syriopoulou
Surveillance for adverse events after COVID-19 mRNA vaccination. nausea. This limitation hampered our ability to perform subgroup analyses based on parameters such as age, sex, vaccine dose, or vaccination-to-event time span. 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 Careers. Accessibility Statement, Our website uses cookies to enhance your experience. A. Adverse effects of the novel COVID-19 vaccinations are ever-evolving and receiving significant attention both in medical journals and the media.1 2 Unilateral facial nerve palsies were reported in the initial clinical trials of all three major vaccines approved for use in the UK.35 In the Pfizer-BioNTech mRNA phase 3 vaccine trial there were four Articles reporting BP incidence with SARS-CoV-2 vaccination were included. Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy N, Nayak
[3] https://www.fda.gov/media/150723/download Ann Neurol. P, Ghidossi
et al. Hum Vaccin Immunother. , Filippatos
COVID 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 F, Tatsi
K, Prasad
J, Basso
Safety of inactivated and mRNA COVID-19 vaccination among patients treated for hypothyroidism: a population-based cohort study. 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. Additionally, the vaccines met the strict safety standards of the FDA. Safety of COVID-19 vaccination and acute neurological events: a self-controlled case series in England using the OpenSAFELY platform. 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). Bells palsy following a single dose of mRNA SARS-CoV-2 vaccine: a case report. 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. BD, Holtzmuller
All rights reserved. Then blisters appear on your body or face, often in a strip on one side of your body. SA,
Y. Data Sources
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). A. M, Clemens
Jacobson
Therefore, the benefits outweigh the risks for most people, according to the review authors. Learn more here. Coronavirus (COVID-19) update: July 13, 2021. Individuals have also reported side effects at the injection site, including arm pain, SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccination. For data selection, the records obtained from different search databases were first transferred to EndNote software, version X9 (Clarivate Plc). The TGA closely monitors reports of suspected side effects (also known as adverse events) to the Covid-19 vaccines. 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. Safety and efficacy of COVID-19 vaccines: a systematic review and meta-analysis of different vaccines at phase 3. L, Khouri
[10] https://casereports.bmj.com/content/bmjcr/14/4/e242956.full.pdf 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. Involvement of the autonomic nerves, which control involuntary body processes, may lead to: pericarditis and myocarditis, which are inflammation of the outer lining of the heart and inflammation of the heart muscle, respectively, thrombocytopenia syndrome, a condition that causes blood clots to form, a feeling that the heart is pounding, beating fast, or fluttering. 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. Learn more here. C, Dessypris
Conclusions and Relevance
KE, Goddard
BMJ Case Rep. 2023 Jan 30;16(1):e253302. T. J,
Estimators of the Mantel-Haenszel variance consistent in both sparse data and large-strata limiting models. A, Tazare
, Liu
This article is protected by copyright. T, Niimi
The number of reports of serious peripheral neuropathies is very small compared with the number of people who have received the vaccines. The site is secure. 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. Three studies94-96 met the inclusion criteria; however, they used the same patient databases, hence overlapping considerably with the included studies from Hong Kong. The site is secure. Front Pharmacol. L, Luo
D,
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. An overall 643 records were identified through our systematic search method. 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. A. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. EU reviews reports of rare nerve disorder after AstraZeneca's Bells palsy after Sputnik V COVID-19 (Gam-COVID-Vac) vaccination. Bell palsy is the sudden onset of facial paralysis or paresis due to facial nerve inflammation in the absence of central nervous system disease and after excluding the other causes of acute peripheral palsy.2 The management includes early treatment with oral corticosteroids and eye care to prevent corneal injury.26 The benefits of antiviral therapy have remained unproven.26 Most cases of BP resolve after a few months. MNT is the registered trade mark of Healthline Media. Interpretation: G, Carrafiello
SA, Althaqafi
V, Michos
Warner
et al; C4591001 Clinical Trial Group. How to perform a meta-analysis with R: a practical tutorial. The quality of the studies was evaluated by the Newcastle-Ottawa Scale. et al. COVID , Kaulen
, Shibli
Several mechanisms have been considered to explicate the underlying pathophysiology of BP. 10.1136/bcr-2021-243829 C, Sun
, Castaldo
SARS-CoV-2 vaccines (mRNA and viral vector) in the analysis of RCTs demonstrated significantly increased odds of developing BP vs placebo. 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, Critical revision of the manuscript for important intellectual content: Rafati, Pasebani, Melika Jameie, Yang, Mana Jameie, Sakhaei, Rahimlou, Kheradmand. K. DR, Thakur
B,
Online ahead of print. Peripheral neuropathy has a link to the COVID vaccine. 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. CC, Sokol
(B) Contrast enhancement in the intracisternal length of the trigeminal nerve (blue arrow). Further research is required to verify this association and investigate possible mechanisms. Y, Baker
Mirmosayyeb
COVID Vaccine Side Effects Disclaimer. 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). VP. Neurological side effects of SARS Bells palsy following COVID-19 vaccination: a case report. All free text symptoms that were reported within 42 days of vaccine administration were manually reviewed and grouped into 36 individual neurological diagnostic categories. HHS Vulnerability Disclosure, Help Publication bias was assessed visually with funnel plots, and asymmetry was statistically tested using the Egger test as well as the Peter test (a method of choice for binary outcomes).52,53 A 2-tailed P<.05 was considered statistically significant. , Sadoff
, Page
et al. Some people have reported experiencing symptoms of peripheral neuropathy after receiving the vaccine, but this does not confirm that a causal relationship exists. Pfizer-BioNTech COVID-19 Vaccine Reactions & Adverse Events Below are examples of potential symptoms: The authors of a 2023 review speculated on factors that may underlie a link between the COVID-19 vaccine and peripheral neuropathies. Instead, the virus mRNA in the vaccines might interact with the immune cellular membranes and elicit an innate immune response,107 which in turn may trigger BP, similar to the cases reported with interferon treatment.115,116. Symptoms of myocarditis or pericarditis include: Symptoms of thrombosis with thrombocytopenia syndrome include: Learn more about treating peripheral neuropathy. The CDC does not list brain aneurysms as a common side effect after COVID-19 vaccination in any age group. Multimorbidity and adverse events of special interest associated with Covid-19 vaccines in Hong Kong. Immunogenicity and adverse effects of the 2-dose BNT162b2 messenger RNA vaccine among liver transplantation recipients. Acute liver failure after vaccination against of COVID-19: a case report and review literature. -, Rosenblum HG, Hadler SC, Moulia D, et al. 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. Published online April 27, 2023. doi:10.1001/jamaoto.2023.0160. N, Fayad
S,
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. Abstracts of Presentations at the Association of Clinical Scientists 143. The key words The fourth section pooled the risk ratio (RR) of BP in SARS-CoV-2infected patients vs SARS-CoV-2 vaccine recipients. , Poudel
J Korean Med Sci. , Falsey
et al. In rare cases, serious side effects occur. Summary of Studies Included in the Meta-analysis on Bell Palsy and SARS-CoV-2 Vaccination, Tiemstra
N,
, Sato
Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. N,
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. BY, Cen
ICH,
COVID-19 hospitalizations and deaths averted under an accelerated vaccination program in northeastern and southern regions of the USA. Y, Hoshina
Vaccine MRF. Vaccines for COVID-19. Baugh
Bilateral facial nerve palsy and COVID-19 vaccination: causation or coincidence? , Lai
GBS case reports following Covid vaccines [10, 11] also emphasise the importance of early therapeutic intervention. S, Kaur
Dentists: Unexplained Pain, Tooth Loss and Bone Problems May Be FOIA After removing duplicate records, 2 independent researchers (Y.P. M, Baharlouie
P. While it offers valuable benefits, it can cause side effects, including neuropathic symptoms such as tingling and burning. Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D. The CARE guidelines: consensusbased clinical case reporting guideline development. Other causes were excluded by laboratory tests. Drs Rafati and Pasebani contributed equally to this work. S,
, Viechtbauer
Covid vaccine side effects , Xiong
Can diet help improve depression symptoms? A, Feany
, Sadeghalvad
JP, Altman
Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. 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. S, Nepali
Fda . EWW,
HF, Sy
Federal government websites often end in .gov or .mil. et al. , Polack
et al. R, Lenehan
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, M, Minder
SG. Summary of the Studies Characteristics (Case Reports and Case Series), eTable 4. Butler M, Tamborska A, Wood GK, et al. The authors declare they have no conflicts of interests. 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). OR indicates odds ratio. 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. Case reports of acute transverse myelitis associated with mRNA vaccine for COVID-19. An official website of the United States government. This systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2vaccinated vs placebo groups. R, Sikron
. Covid vaccine side effects With SARS-CoV-2 infection, however, the reported BP incidence is significantly higher at 32.3 to 82 per 100000 patients.55,57 These results overall suggest that the BP incidence after SARS-CoV-2 vaccines is comparable with the overall incidence in the general population, whereas it clearly exceeds that with SARS-CoV-2 infection. official website and that any information you provide is encrypted (D) The contrast enhancement of the trigeminal nerve persists upon repeated examination a month later (blue arrow). Conflict of Interest Disclosures: None reported. K-H, Hung
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. 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 Scientists 'Confirm' the Pfizer Vaccine Causes Neurological Damage It isn't clear how long these effects might last. Abara WE, Gee J, Marquez P, Woo J, Myers TR, DeSantis A, Baumblatt JAG, Woo EJ, Thompson D, Nair N, Su JR, Shimabukuro TT, Shay DK. HM, de Oliveira
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.