SAC, Madhi PMC , Huang Surveillance for adverse events after COVID-19 mRNA vaccination. Main Outcomes and Measures Quantifying heterogeneity in a meta-analysis. O, Abu-Full X. A. Association of clinical and epidemiological characteristics with COVID-19 BNT162b2 mRNA vaccine short-term adverse reactions in healthcare workers. 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 New-Onset Amyotrophic Lateral Sclerosis in a Patient who Received the J&J/Janssen COVID-19 Vaccine. 10.1136/bcr-2021-243829 et al; ENSEMBLE Study Group. , Yalinda To compare the incidence of BP in SARS-CoV-2 vaccine recipients vs unvaccinated individuals or placebo recipients. No significant difference was found in BP among 22978880 first-dose recipients of the Pfizer/BioNTech vaccine compared with 22978880 first-dose recipients of the Oxford/AstraZeneca vaccine (OR, 0.97; 95% CI, 0.82-1.15; I2=0%). , Bardage The cerebrospinal fluid analysis showed no sign of inflammation, both initially and after 1 month from the start of the patient's symptoms. Summary of Studies Included in the Meta-analysis on Bell Palsy and SARS-CoV-2 Vaccination, Tiemstra The key words used were SARS-CoV-2 vaccine, COVID-19 vaccine, facial nerve palsy, and Bells palsy (eTable 1 in Supplement 1). JAMA Netw Open. Funnel Plot for RCTs: vaccinated vs saline placebo, eFigure 4. Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses. Some people have reported experiencing symptoms of peripheral neuropathy after receiving the vaccine, but this does not confirm that a causal relationship exists. , Higgins Acute abducens nerve palsy following COVID-19 vaccination. All in all, these limitations may have affected heterogeneity among studies, leading to potential confounders for analysis. The symptoms also include fatigue, severe headaches, nerve pain, blood pressure swings, and short-term memory problems. https://assets.publishing.service.gov.uk/government/uploads/system/uploa https://www.statnews.com/2020/09/09/astrazeneca-covid19-vaccine-trial-ho https://doi.org/10.1101/2021.06.29.450356, https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93537, https://casereports.bmj.com/content/bmjcr/14/4/e242956.full.pdf, https://onlinelibrary.wiley.com/doi/10.1111/ncn3.12537, Womens, childrens & adolescents health, Autoimmune damage to the nerves following Covid vaccines: EMA issued warning to patients and healthcare professionals. , Cirillo , Saltagi Conclusions and Relevance et al; COVE Study Group. Because of the high heterogeneity, a random-effects model was implemented, and a subgroup analysis was performed based on the study design (cohort or case-control study). Published online April 27, 2023. doi:10.1001/jamaoto.2023.0160. These complications may include encephalomyelitis, meningitis, GBS, or transverse myelitis.57. The observed-to-expected ratios for GBS, CVT and seizure following Janssen vaccination were 1.5-fold higher than background rates. T. 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. Lopez Bernal, J. et al. HM, Essink Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy: A Systematic Review and Meta-analysis. If I250%, representing substantial heterogeneity, the random-effects model was used; otherwise, the fixed-effects model was used. Symptoms of myocarditis or pericarditis include: Symptoms of thrombosis with thrombocytopenia syndrome include: Learn more about treating peripheral neuropathy. -, Woo EJ, MbaJonas A, Dimova RB, et al. L, Saatci Ocular adverse effects of COVID-19 vaccines: A systematic review. JP, Thompson The https:// ensures that you are connecting to the , Page Bookshelf B. (A) Gadolinium enhancement in the intracanalicular and labyrinthic segments of the left facial nerve (blue arrow). Background: 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. The key words 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. M, Yokota I, 2022 Sep;11(9):5041-5054. doi: 10.4103/jfmpc.jfmpc_747_22. (2022). et al. L, Stefanou et al. Please enable it to take advantage of the complete set of features! Vaccine Adverse Event Reporting System (VAERS) collected between January 1, 2021-June 14, 2021. Ann Neurol. Post COVID-19 vaccination-associated neurological complications. CI, Li Then blisters appear on your body or face, often in a strip on one side of your body. 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 HHS Vulnerability Disclosure, Help LS, Chen et al; ENSEMBLE Study Group. Case reports of acute transverse myelitis associated with mRNA vaccine for COVID-19. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). J, Gray , Klein Funnel Plot for Observational Studies on mRNA Vaccines: Vaccinated vs Unvaccinated, eFigure 6. FN, Alay PM, Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy: A Systematic Review and Meta-analysis. 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. [7] https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93537 2022 Nov 26;10(33):12289-12294. doi: 10.12998/wjcc.v10.i33.12289. 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 Vaccine 2011;29:599612. In some cases, the neuropathic symptoms can be serious. 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). Mirmosayyeb , Robins FPNs Scientific Advisory Board Chairman, Dr. Ahmet Hoke of Johns Hopkins University, encourages patients to get the COVID-19 vaccine when offered. The facial (cranial) nerves, on the contrary, are anatomically closer to the vaccine injection site in humans (deltoid muscle). , Liu (C) The contrast enhancement of the facial nerve persists upon repeated examination a month later (blue arrow). Facial nerve palsy after COVID-19 vaccinationa rare association or a coincidence. doi: 10.1001/jamanetworkopen.2022.8879. 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. 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DLL, Makmur XL, Xu 8600 Rockville Pike 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. However, the rate of neurological events after acute SARS-CoV-2 infection was up to 617-fold higher than after COVID vaccination. Epub 2023 Feb 28. Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. et al. Learn more about the GBS and a possible vaccine link. JM. T. TH. ICH, Bell Palsy Events in Groups of mRNA-Vaccinated Participants vs Unvaccinated Participants, With Data From Observational Studies, Figure 3. Minor to moderate side effects of Pfizer-BioNTech COVID-19 vaccine among Saudi residents: a retrospective cross-sectional study. Left Bells palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: a case report. X, Ravents Quality Assessment of the Cohorts Using the Newcastle-Ottawa Scale (NOS) Modified for Cohort Studies, eTable 5. 2022 May;52(3):511-525. Reports of serious neurological events following COVID vaccination are rare. Bells palsy following COVID-19 vaccination. LR, Essink (2022). JH. Bell palsy was significantly more common after SARS-CoV-2 infection (n=2822072) than after SARS-CoV-2 vaccinations (n=37912410) (relative risk, 3.23; 95% CI, 1.57-6.62; I2=95%). Neurological symptoms and neuroimaging alterations related with COVID-19 vaccine: cause or coincidence? E, Levy , Wan 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). , Koh Some people experience side effects such as tiredness, fever, and headaches after getting a COVID-19 vaccine, but these usually disappear within a few days. 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. We utilized publicly available data from the U.S. 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. 2013;2:38. F, Iskander Guillain-Barr syndrome following the first dose of Pfizer-BioNTech COVID-19 vaccine: case report and review of reported cases. Bells palsy after inactivated COVID-19 vaccination in a patient with history of recurrent Bells palsy: a case report. GAC, de Oliveira N, Doan , Yagi -, Burrows A, Bartholomew T, Rudd J, Walker D. Sequential contralateral facial nerve palsies following COVID19 vaccination first and second doses. RT; VAERS Working Group. Laser treatment can be beneficial for treating pain associated with neuropathy. KE, Goddard Emergency use authorization review memorandum for the Pfizer-BioNTech COVID-19 vaccine/BNT162b2. Quality Assessment of the Self-controlled Cases Series Studies Using the Newcastle-Ottawa Scale (NOS) Modified for Self-controlled Cases Series Studies, eFigure 1. Vaccine Adverse Event Reporting System Could Miss or Misinterpret Neurological Side Effects of COVID-19 Vaccinations. 2023 Jan 5;23(1):11. doi: 10.1186/s12886-022-02747-7. , Eom Online ahead of print. P, Moghadas GT, Chan Patients generally experience. 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? performed the risk of bias assessment, and conflicts were resolved via consensus. How to perform a meta-analysis with R: a practical tutorial. C. Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021. MA, Zakaria K, Association of facial paralysis with mRNA COVID-19 vaccines: a disproportionality analysis using the World Health Organization pharmacovigilance database. , Voysey 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. et al. Fifty studies were included, of which 17 entered the quantitative synthesis. Aims of the study: L. CSL, Ng Epub 2021 Nov 29. Of the excluded studies, 3 records91-93 were the reports of preliminary results of the major SARS-CoV-2 vaccine phase 3 clinical trials, of which the records reporting the final analyses were included instead. COVID-19 hospitalizations and deaths averted under an accelerated vaccination program in northeastern and southern regions of the USA. MHRA later also concluded that as a precautionary measure they will also be adding a warning for GBS in the product information [2]. N, Dagan ME, Hirsch This site needs JavaScript to work properly. Bell's Palsy and COVID-19 Vaccines: A Systematic Review and Meta-Analysis. H, Noor GBS, CVT and seizure may occur at higher than background rates following Janssen vaccination. Several mechanisms have been considered to explicate the underlying pathophysiology of BP. -. The Egger and Peter tests both yielded nonsignificant results; hence, no publication bias was detected. J, Varacallo The MHRA pharmacovigilance database reported ~187 cases of sciatica post-Covid vaccine AZ as of 28th July 2021. Vaccines for COVID-19. G, Orlandi JF, Granath N. R. Federal government websites often end in .gov or .mil. AJ, Jones 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. This site needs JavaScript to work properly. Accessibility Study 514559 showed that the Covid vaccine AZ was distributed to sciatic nerves in almost all animals and the distributed fractions did not clear throughout the study. , Walker et al. A, Bergman 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. Question , Fan PRISMA Flow Diagram of the Systematic Search, eFigure 2. M, Handunnetthi 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. You can learn more about how we ensure our content is accurate and current by reading our. , Sadoff Adverse reactions and safety profile of the mRNA COVID-19 vaccines among Asian military personnel. Accessibility -. Serious effects, such as GBS, have happened in rare cases. Ann Neurol. Results: MJ, de la Nogal-Fernandez C, 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. JAF, AAT, MFD, DGA, HG, AG, AHK, MS, JS, KT, EW, ASW, EB and coalition members have no relevant conflicts to report. T, Wu Bias in meta-analysis detected by a simple, graphical test. Learn more about the link between the COVID-19 vaccine and Bells palsy. Quality Assessment of the Randomized Controlled Trials Using the Cochrane Risk of Bias (ROB1) Tool, eFigure 3. Data Sources , Viechtbauer , Frontera SA, , Vilches Other neurological side effects occur in a much lower frequency. et al. T, Niimi Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. , Kennedy Eight observational studies39-46 reported adverse events, including BP, following the administration of the first and/or second dose of the SARS-CoV-2 mRNA vaccines. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. 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. Bells palsy following the Ad26.COV2.S COVID-19 vaccination. et al. SG. MA. Diagnosis of anosmia and hyposmia: a systematic review. GBS is rare. Facial paralysis following influenza vaccination: a disproportionality analysis using the Vaccine Adverse Event Reporting System Database. et al. , Sekiguchi 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). Because vaccination has been conducted globally, identifying the related short- and long-term adverse events is of great significance. -, Rosenblum HG, Hadler SC, Moulia D, et al. K-H, Hung 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. Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS. 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. 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. KR, Rushton 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. Other effects include: Many people who get the vaccine have muscle aches, headaches, or feel tired. et al. COVID-19; adverse effects; cranial nerve palsies; vaccination. M, Baharlouie 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. AA. MRF. RV, Brando Would you like email updates of new search results? 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 Certain neuropathic conditions, such as Guillain-Barr syndrome (GBS), have some associations with the vaccine. The CDC does not list brain aneurysms as a common side effect after COVID-19 vaccination in any age group. X. JL, Schultze I, Calvit mRNA indicates messenger RNA; OR, odds ratio. Is it possible to die from peripheral neuropathy? Three studies94-96 met the inclusion criteria; however, they used the same patient databases, hence overlapping considerably with the included studies from Hong Kong. , Wan All Rights Reserved. Our search also included review publications, editorials, letters to editors, and conference papers, as well as the references of all the studies included. Safety and efficacy of COVID-19 vaccines: a systematic review and meta-analysis of different vaccines at phase 3. O. 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 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). Bell Palsy Events in Groups of Pfizer/BioNTech Recipients vs Oxford/AstraZeneca Recipients, With Data From Observational Studies, Figure 4. Drs Rafati and Pasebani contributed equally to this work. Three of the 5 RCTs had a low risk of bias,35-37 and 2 were unclear38,58 in the criterion D5: detection bias of the Cochrane assessment tool but were low risk in the rest of the criteria. Statistical analysis: Rafati, Pasebani, Yang, Ilkhani, Rahimlou. et al. The COVID-19 vaccine is an important tool that reduces illness and death from SARS-CoV-2, the virus responsible for the infection. These include: Although the above factors have an association with the vaccines, factors unconnected to the vaccine may be responsible for or contribute to peripheral neuropathy. , Baden Epub 2022 Apr 27. It bases this determination on clinical trials that involved tens of thousands of participants. M, Koutsokera 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 biodistribution (study 514559) also evidenced the vaccine distribution via blood circulation to other tissues notably bone marrow, liver, mammary glands and spleen. N, Pfizer and BioNTech said MK, Taneja Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bells palsy: a population-based study. , Shemer et al; AstraZeneca AZD1222 Clinical Study Group. doi: 10.1136/bcr-2021-243829. 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. A, Dubinsky-Pertzov 2021 John Wiley & Sons A/S. N, Koorapati Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis. 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. Another condition of the PNS that may have associations with the COVID-19 vaccine is small fiber neuropathy. Of these, 180 were removed because they were duplicate records. Therefore, further research using larger-scale studies is necessary to determine the link between COVID-19 vaccines and peripheral neuropathy. The incidence of BP in those who received the Pfizer/BioNTech or Oxford/AstraZeneca vaccines did not differ significantly. 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). In this context, we have compared 2 major SARS-CoV-2 vaccine platforms in terms of BP occurrence in more than 50 million doses. Neurological autoimmune diseases following vaccinations against SARS-CoV-2: a case series. In rare cases, serious side effects occur. The patient received high doses of corticosteroids, with improvement of symptoms. , Balduzzi Organ damage could play a role. 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. I, Ortqvist retinopathy, which is damage to the retina. 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]. Adverse events of special interest and mortality following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines in Hong Kong: a retrospective study. Safety of inactivated and mRNA COVID-19 vaccination among patients treated for hypothyroidism: a population-based cohort study. , Sohrabi The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis. The records that did not meet the preestablished eligibility criteria were excluded. FOIA Fda . . E, OR indicates odds ratio; SIDIAP, Spanish database of Information System for Research in Primary Care. Additionally, the vaccines met the strict safety standards of the FDA. MF, 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. Nerve damage, including peripheral neuropathy Fatigue and post-exertional malaise Cognitive impairment/altered mental state Muscle, joint, and chest pain The novel COVID-19 vaccines have side effects that require efficient and close monitoring. Bell Palsy Events in Groups of Pfizer/BioNTech Recipients vs Oxford/AstraZeneca Recipients, With Data From Observational Studies View LargeDownload Dashed line indicates the point estimate of the overall effect; dotted line, Visit our coronavirus hub for the most recent information on the COVID-19 pandemic. 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. 2023 Healthline Media UK Ltd, Brighton, UK. Further research is required to verify this association and investigate possible mechanisms. 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. J, Basso BY, Cen 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.