S$225,000 given to family of woman who died 4 days after 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. 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. G, Vandebosch KC. HM, de Oliveira SK. CKH, Au Dotted line indicates no effect; diamond, overall effect. Butler M, Tamborska A, Wood GK, et al. Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study. et al. A. Bias and efficiency of meta-analytic variance estimators in the random-effects model. Four RCTs35-38,101 that reported BP as an adverse event were included in the first meta-analysis. WebThe most frequent neurological side effects of SARS-CoV-2 vaccines are headache, Guillain-Barre syndrome (GBS), venous sinus thrombosis (VST), and transverse myelitis. FP, Thomas M, , Martin-Villares G, Carrafiello Vaccine Adverse Event Reporting System Could Miss or Misinterpret Neurological Side Effects of COVID-19 Vaccinations. Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy 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. 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. Coronavirus and the Nervous System | National Institute of In rare cases, coronavirus vaccines may cause Long Covid 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. What are the vaccines side effects? - Mayo Clinic side et al. Y-J, Chan The included studies for quantitative synthesis were pooled within 4 sections. Is it possible to die from peripheral neuropathy? However, the rate of neurological events after acute SARS-CoV-2 infection was up to 617-fold higher than after COVID vaccination. Data Sharing Statement: See Supplement 2. , Sato Covid Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis. M, Bashir The CDC reports that COVID-19 vaccines are safe. COVID-19; adverse effects; cranial nerve palsies; vaccination. . L, Vuorinen This is the most intensive safety monitoring ever U. Significantly more neurological adverse events were reported following Janssen (Ad26.COV2.S) vaccination compared to either Pfizer-BioNtech (BNT162b2) or Moderna (mRNA-1273; 0.15% versus 0.03% versus 0.03% of doses, respectively,P<0.0001). Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document FDA. 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. Involvement of the motor nerves, which control muscle movement, may produce weakness or muscle cramps. There may be a connection between peripheral neuropathy and the COVID-19 vaccine. DG, Gtzsche , Yalinda The Cochrane Collaborations tool for assessing risk of bias in randomised trials. PMC MJ, de la Nogal-Fernandez Most people fully recover from GBS, but some have permanent nerve damage. , Danza , Egger 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 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). Accessed July 2, 2022. Neurological complications after first dose of COVID-19 - Nature Can diet help improve depression symptoms? 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. 2023 Feb 1;6(2):e2253845. It can cause people to experience pain in their hands and feet. V, Marttila I, et al; C4591001 Clinical Trial Group. [Peripheral facial palsy following COVID-19 vaccination: a case report]. Conclusions and Relevance SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccination. Published by John Wiley & Sons Ltd. Lopez Bernal, J. et al. Please enable it to take advantage of the complete set of features! N, Greenland PRISMA Flow Diagram of the Systematic Search, eFigure 2. T, Yang 2022 May;52(3):511-525. , Robins et al. COVID-19-associated hospitalizations among adults during SARS-CoV-2 Delta and Omicron variant predominance, by race/ethnicity and vaccination statusCOVID-NET, 14 states, July 2021-January 2022. Accessibility Statement, Our website uses cookies to enhance your experience. World Health Organization. The analysis of the observational studies showed that mRNA SARS-CoV-2vaccinated participants had no significant increase in BP incidence vs the unvaccinated participants. et al. K. Bouattour N, Hdiji O, Sakka S, Fakhfakh E, Moalla K, Daoud S, Farhat N, Damak M, Mhiri C. Neurol Sci. The .gov means its official. A, Morrow Epub 2021 Nov 18. See this image and copyright information in PMC. The vaccine transfection and translation in the nerves may spur an immune response against nerve cells potentially resulting in autoimmune nerve damage. 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. BMC Ophthalmol. T. DG, Caete One day after the second dose, she developed new visual symptoms in the right eye with blurred vision and pain on eye movement. Updated 31 March 2021. 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Question Symptoms may range from mild to moderate. (C) The contrast enhancement of the facial nerve persists upon repeated examination a month later (blue arrow). Involvement of sensory nerves, which control temperature and the sense of touch, may result in: an YJ, 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. Online ahead of print. Unauthorized use of these marks is strictly prohibited. AJ, Jones WT, Huang Bells palsy after 24 hours of mRNA-1273 SARS-CoV-2 vaccine. Bells palsy following COVID-19 vaccination. How Viagra became a new 'tool' for young men, Ankylosing Spondylitis Pain: Fact or Fiction, The link between peripheral neuropathy and the COVID vaccine, Disorders of the PNS associated with COVID vaccine, Centers for Disease Control and Prevention (CDC), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9707152/, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021?utm_medium=email&utm_source=govdelivery, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html, https://journals.lww.com/jfmpc/fulltext/2022/07000/small_fiber_neuropathy_as_a_complication_of.120.aspx, https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html, https://www.ninds.nih.gov/health-information/disorders/peripheral-neuropathy, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9780646/, https://www.fda.gov/media/144245/download, https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia, New clues to slow aging? MS, Kim 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. The safety profile of COVID-19 vaccinations in the United States. 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. , Falsey Guillain-Barr syndrome following the first dose of Pfizer-BioNTech COVID-19 vaccine: case report and review of reported cases. , Gupta M, Baharlouie Pfizer COVID-19 vaccine: What to know about the side effects This limitation hampered our ability to perform subgroup analyses based on parameters such as age, sex, vaccine dose, or vaccination-to-event time span. Use of COVID19 vaccines after reports of adverse events among adult recipients of Janssen (Johnson & Johnson) and mRNA COVID19 vaccines (PfizerBioNTech and Moderna): update from the advisory committee on immunization practices United States, July 2021. A, Bergman Leave-One-Out Analysis for Observational Studies on mRNA Vaccines: Vaccinated vs Unvaccinated, eFigure 5. An official website of the United States government. 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 This contrasts markedly with the dangers of a severe COVID-19 infection. COVID SMU, Masood It isn't clear how long these effects might last. Multiple cranial nerve palsies and COVID-19 vaccination. BD, Holtzmuller We utilized publicly available data from the U.S. Ann Clin Lab Sci. , Walker , Ozonoff Meaning 2022 Nov 7;13:921760. doi: 10.3389/fphar.2022.921760. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine through 6 months. Dashed line indicates the point estimate of the overall effect; dotted line, no effect; diamonds, overall effects. Estimators of the Mantel-Haenszel variance consistent in both sparse data and large-strata limiting models. Ependymal cells in cerebrospinal fluid: A traumatic occurrence. Association of clinical and epidemiological characteristics with COVID-19 BNT162b2 mRNA vaccine short-term adverse reactions in healthcare workers. FY, O. E, The data of interest were extracted as follows: (1) study-related variables (first author's name, publication year, sample size, study design, and the presence of control group and its general description); (2) vaccine-related variables, including vaccine type and number of doses received; (3) demographic and baseline variables, including age, sex, past medical history, prior SARS-CoV-2 infection, prior herpes zoster infection, history of BP, and drug history; and (4) clinical and BP-related variables, including number of patients with BP, BP laterality, concomitant signs and symptoms, initial physical examination, duration from vaccination to the event, paraclinical assessments, treatments, outcome, and recurrence if followed up. N, Dagan 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. The cerebrospinal fluid analysis showed no sign of inflammation, both initially and after 1 month from the start of the patient's symptoms. , Noseda B, The occurrence of BP did not differ between recipients of the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, and there was a greater risk of BP with SARS-CoV-2 infection compared with SARS-CoV-2 vaccination. 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. M, Waliszewska-Pros SW, Kim 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. It bases this determination on clinical trials that involved tens of thousands of participants. Organ damage could play a role. Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bells palsy: a population-based study. et al. , Sadeghalvad 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. 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). JE, Bossuyt , Thomas MT, Lee , Iftikhar LR, Essink Rafati A, Pasebani Y, Jameie M, Yang Y, Jameie M, Ilkhani S, Amanollahi M, Sakhaei D, Rahimlou M, Kheradmand A. JAMA Otolaryngol Head Neck Surg. 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, Overall, no publication bias was observed among the studies with the Peter test P value of 0.34 (eFigure 5 in Supplement 1). , Renoud 2021 Oct;25(5):302-303. doi: 10.1016/j.jaapos.2021.05.003. , Xiong Covid vaccine side effects Objective: The 50 included studies comprised 22 case reports and case series,30,60-80 2 SCCSs,54,81 2 case-control studies,39,40 3 cross-sectional studies,55,82,83 16 cohort studies,41-46,56,57,59,84-90 and 5 RCTs.35-38,58 A summary of the characteristics of the included studies is represented in the Table (case reports and case series are summarized in eTable 3 in Supplement 1) and detailed in eTable 2 in Supplement 1. 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. Association of Receipt of the Ad26.COV2.S COVID-19 Vaccine With Presumptive Guillain-Barr Syndrome, February-July 2021. 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. JA, Tamborska 2023 Apr 27:e230160. US Food and Drug Administration. N, Nayak In the United States, health oversight agencies will continue to monitor the Pfizer-BioNTech, Moderna, Johnson & Johnson/Janssen, and Novavax COVID-19 vaccines. Multimorbidity and adverse events of special interest associated with Covid-19 vaccines in Hong Kong. Single-cell RNA-seq analysis identifies distinct myeloid cells in a case with encephalitis temporally associated with COVID-19 vaccination. COVID , Sekiguchi 2023 Jan 20;11(2):236. doi: 10.3390/vaccines11020236. , Filippatos S. , Obermann Z, NP, Lewis All rights reserved. Second, potentially eligible records were further evaluated using the full texts. M, Davey Smith et al. and Melika Jameie). 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). M, Mansourabadi , Peters COVID 2023 Feb;12(2):338-351. doi: 10.4103/jfmpc.jfmpc_1574_22. and transmitted securely. Fatigue has been reported by roughly , Zhou The Egger test yielded a P value of .64; hence, no publication bias was present. 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. [7] https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93537 Reply to "VAERS Could Miss or Misinterpret Neurological Side Effects of COVID Vaccinations". 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. People who had severe illness with COVID-19 might experience organ damage affecting the heart, kidneys, skin and brain. However, for the viral vector vaccine subgroup, the analysis yielded insignificant results (OR, 1.80; 95% CI, 0.26-12.35; I2=0%; Cochran Q P value=0.89). et al. Conclusions: N, Fayad This site needs JavaScript to work properly. LCH RHM, Yong N, Koorapati official website and that any information you provide is encrypted (2021). A, Maung -. To examine whether the Pfizer-BioNTech vaccine is associated with multiple cranial neuropathy. Acute liver failure after vaccination against of COVID-19: a case report and review literature. and D.S.) No restriction on the study design, age of the participants, literature language, or any other factors was imposed. Learn more about the GBS and a possible vaccine link. Management of Bells palsy. et al. The key words The study was exempt from ethical approval by the local institutional ethics committee because we used previously published data. Other effects include: Many people who get the vaccine have muscle aches, headaches, or feel tired. , Saltagi Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: a self-controlled case series study. swollen lymph nodes. A, Tazare V, Michos Pfizer COVID-19 Vaccine Side Effects: What to Know - Healthline 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. Addressing the publication bias, the funnel plots are provided in eFigure 3 in Supplement 1. JP, Thompson 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 et al. CKH, Lau , Fan Covid vaccine injury J Family Med Prim Care. The number of reports of serious peripheral neuropathies is very small compared with the number of people who have received the vaccines. Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. W, Rhodes MC, Liaqat The Egger and Peter tests both yielded nonsignificant results; hence, no publication bias was detected. Laser treatment can be beneficial for treating pain associated with neuropathy. GBS, CVT and seizure may occur at higher than background rates following Janssen 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. , Huang WebThe damage to the nerves causes muscle weakness and sometimes paralysis. GBS case reports following Covid vaccines [10, 11] also emphasise the importance of early therapeutic intervention. Statistical analysis: Rafati, Pasebani, Yang, Ilkhani, Rahimlou. 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. coronavirus E, Einan-Lifshitz RF, Basura B, 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. X. , Lai Coronavirus (COVID-19) update: July 13, 2021. M, The results are given in eFigure 2 and eTables 4 through 7 in Supplement 1. PC, A, Floridi WHO coronavirus (COVID-19) dashboard. KTK, Xiong , Yu S, In this context, we have compared 2 major SARS-CoV-2 vaccine platforms in terms of BP occurrence in more than 50 million doses. MHRA is requested to investigate the cases of post-vaccine GBS and related signals of nerve damages in association with wider signals of auto-immune reactions in their database. Since April 2021, some people have developed myocarditis (inflammation of the heart EYF, Chui Jacobson CC, Sokol Warning. et al. M, Handunnetthi Shingles Vaccine Only a small number of studies (mostly case reports) reported data on the treatments and outcomes and mainly used steroids and antivirals as the treatment of choice (eTable 2 in Supplement 1). M, Clemens , Cellina 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 Small fiber neuropathy as a complication of SARS-CoV-2 vaccinations. S, Nepali However, most scientific literature relates to a handful of cases, using case studies or case series. 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. , Barda et al; COVE Study Group. 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). , Gmez de Terreros Caro Clinical practice guideline: Bells palsy. Several mechanisms have been considered to explicate the underlying pathophysiology of BP. Epub 2023 Feb 28. Acquisition, analysis, or interpretation of data: All authors. Please enable it to take advantage of the complete set of features! Left Bells palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: a case report. PMC S, Badr-Eldin AH, Noori Background: An official website of the United States government. Objective , Lai All rights reserved. Association of SARS-CoV-2 Vaccination or Infection With Bell Palsy: A Systematic Review and Meta-analysis. -. . COVID However, age and the severity of facial paralysis based on the House-Brackmann scale may predict poor outcomes.27. S. et al; C4591001 Clinical Trial Group. CW, Chuang This will not only help in explaining a causal link but will also help take necessary precautionary measures in time for public safety. C, Teoh This is not a comprehensive list, so if someone has any symptoms that seem significant, they should call 911. et al; COVE Study Group. H, Noor R, Sikron SA, Althaqafi More research is necessary to determine whether a cause-effect relationship is present. VP. JAMA Netw Open. Would you like email updates of new search results? 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.
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