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1.
JAMA Otolaryngol Head Neck Surg ; 149(6): 493-504, 2023 Jun 01.
Article in English | MEDLINE | ID: covidwho-2302203

ABSTRACT

Importance: 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. Objective: To compare the incidence of BP in SARS-CoV-2 vaccine recipients vs unvaccinated individuals or placebo recipients. Data Sources: 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. Study Selection: Articles reporting BP incidence with SARS-CoV-2 vaccination were included. Data Extraction and Synthesis: 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. The quality of the studies was evaluated by the Newcastle-Ottawa Scale. Main Outcomes and Measures: 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-2-infected vs SARS-CoV-2-vaccinated individuals. Results: Fifty studies were included, of which 17 entered the quantitative synthesis. Pooling 4 phase 3 randomized clinical trials showed significantly higher BP in recipients of SARS-CoV-2 vaccines (77 525 vaccine recipients vs 66 682 placebo recipients; odds ratio [OR], 3.00; 95% CI, 1.10-8.18; I2 = 0%). There was, however, no significant increase in BP after administration of the messenger RNA SARS-CoV-2 vaccine in pooling 8 observational studies (13 518 026 doses vs 13 510 701 unvaccinated; OR, 0.70; 95% CI, 0.42-1.16; I2 = 94%). No significant difference was found in BP among 22 978 880 first-dose recipients of the Pfizer/BioNTech vaccine compared with 22 978 880 first-dose recipients of the Oxford/AstraZeneca vaccine (OR, 0.97; 95% CI, 0.82-1.15; I2 = 0%). Bell palsy was significantly more common after SARS-CoV-2 infection (n = 2 822 072) than after SARS-CoV-2 vaccinations (n = 37 912 410) (relative risk, 3.23; 95% CI, 1.57-6.62; I2 = 95%). Conclusions and Relevance: This systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2-vaccinated vs placebo groups. The occurrence of BP did not differ significantly between recipients of the Pfizer/BioNTech vs Oxford/AstraZeneca vaccines. SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccination.


Subject(s)
Bell Palsy , COVID-19 Vaccines , COVID-19 , Humans , Bell Palsy/epidemiology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , SARS-CoV-2 , Vaccination
2.
Int J Infect Dis ; 111: 310-312, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-2113726

ABSTRACT

OBJECTIVES: Facial nerve palsy (or Bell's palsy) has occasionally been reported following the administration of coronavirus disease 2019 (COVID-19) mRNA vaccines (BNT162b2 and mRNA-1273). Our study investigated such cases using a large self-reporting database from the USA (Vaccine Adverse Event Reporting System [VAERS]). METHODS: A disproportionality analysis, adjusted for age and sex, was conducted for VAERS reports from individuals who were vaccinated at the age of 18 years or over, between January 2010 and April 2021. RESULTS: The analysis revealed that the adverse events following immunization (AEFI) of facial nerve palsy, after administration of COVID-19 mRNA vaccines, was significantly highly reported, both for BNT162b2 (reporting odds ratio [ROR] 1.84; 95% confidence interval [CI] 1.65-2.06) and mRNA-1273 (ROR 1.54; 95% CI 1.39-1.70). These levels were comparable to that following influenza vaccination reported before the COVID-19 pandemic (ROR 2.04; 95% CI 1.76-2.36). CONCLUSIONS: Our pharmacovigilance study results suggest that the incidence of facial nerve palsy as a non-serious AEFI may be lower than, or equivalent to, that for influenza vaccines. This information might be of value in the context of promoting worldwide vaccination, but needs to be validated in future observational studies.


Subject(s)
Bell Palsy , COVID-19 , Influenza Vaccines , Adolescent , Adult , Adverse Drug Reaction Reporting Systems , BNT162 Vaccine , Bell Palsy/epidemiology , COVID-19 Vaccines/adverse effects , Facial Nerve , Humans , Influenza Vaccines/adverse effects , Pandemics , Paralysis , RNA, Messenger/genetics , SARS-CoV-2 , Young Adult
3.
Vaccine ; 40(32): 4394-4402, 2022 07 30.
Article in English | MEDLINE | ID: covidwho-1946788

ABSTRACT

BACKGROUND: Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia. METHODS: Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period. RESULTS: There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21). CONCLUSION: This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.


Subject(s)
COVID-19 Vaccines , COVID-19 , BNT162 Vaccine , Bell Palsy/chemically induced , Bell Palsy/epidemiology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Humans , Malaysia/epidemiology , Myocardial Infarction/chemically induced , Myocardial Infarction/epidemiology , Myocarditis/chemically induced , Myocarditis/epidemiology , Pericarditis/chemically induced , Pericarditis/epidemiology , Seizures/chemically induced , Stroke/chemically induced , Stroke/epidemiology , Thrombocytopenia/chemically induced , Thrombocytopenia/epidemiology , Vaccines, Inactivated , Venous Thromboembolism/chemically induced , Venous Thromboembolism/epidemiology
4.
Vaccine ; 40(32): 4479-4487, 2022 07 30.
Article in English | MEDLINE | ID: covidwho-1882615

ABSTRACT

INTRODUCTION: We investigated the potential association of COVID-19 vaccination with three acute neurological events: Guillain-Barré syndrome (GBS), transverse myelitis and Bell's palsy. METHODS: With the approval of NHS England we analysed primary care data from >17 million patients in England linked to emergency care, hospital admission and mortality records in the OpenSAFELY platform. Separately for each vaccine brand, we used a self-controlled case series design to estimate the incidence rate ratio for each outcome in the period following vaccination (4-42 days for GBS, 4-28 days for transverse myelitis and Bell's palsy) compared to a within-person baseline, using conditional Poisson regression. RESULTS: Among 7,783,441 ChAdOx1 vaccinees, there was an increased rate of GBS (N = 517; incidence rate ratio 2·85; 95% CI2·33-3·47) and Bell's palsy (N = 5,350; 1·39; 1·27-1·53) following a first dose of ChAdOx1 vaccine, corresponding to 11.0 additional cases of GBS and 17.9 cases of Bell's palsy per 1 million vaccinees if causal. For GBS this applied to the first, but not the second, dose. There was no clear evidence of an association of ChAdOx1 vaccination with transverse myelitis (N = 199; 1·51; 0·96-2·37). Among 5,729,152 BNT162b2 vaccinees, there was no evidence of any association with GBS (N = 283; 1·09; 0·75-1·57), transverse myelitis (N = 109; 1·62; 0·86-3·03) or Bell's palsy (N = 3,609; 0·89; 0·76-1·03). Among 255,446 mRNA-1273 vaccine recipients there was no evidence of an association with Bell's palsy (N = 78; 0·88, 0·32-2·42). CONCLUSIONS: COVID-19 vaccines save lives, but it is important to understand rare adverse events. We observed a short-term increased rate of Guillain-Barré syndrome and Bell's palsy after first dose of ChAdOx1 vaccine. The absolute risk, assuming a causal effect attributable to vaccination, was low.


Subject(s)
Bell Palsy , COVID-19 Vaccines , COVID-19 , Facial Paralysis , Guillain-Barre Syndrome , Myelitis, Transverse , 2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , Bell Palsy/chemically induced , Bell Palsy/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , England , Facial Paralysis/chemically induced , Facial Paralysis/epidemiology , Guillain-Barre Syndrome/chemically induced , Guillain-Barre Syndrome/epidemiology , Humans , Myelitis, Transverse/complications , Vaccination/adverse effects
5.
Eur J Neurol ; 29(8): 2526-2543, 2022 08.
Article in English | MEDLINE | ID: covidwho-1816547

ABSTRACT

BACKGROUND AND PURPOSE: With the progression of coronavirus infectious disease 2019 (COVID-19), various neurological manifestations have been noticed in infected patients, and Bell's Palsy (BP) is one of the peripheral neuropathies among those. BP has been associated with various other viral agents. Its evidence in patients with COVID-19 signifies the possibility of association between BP and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This research was undertaken to evaluate the number of published cases of BP as the only major neurological manifestation in patients with COVID-19 from March 2020 to December 2021 and to investigate the association of SARS-CoV-2 and BP. METHODS: A systematic review of the published English literature was performed using an electronic search in the PubMed/Medline, Scopus, Research Gate, Research Square, and Google Scholar databases, using keywords such as "COVID-19" OR/AND "SARS-CoV-2" OR/AND "Bell's palsy" OR/AND "facial nerve palsy" OR/AND "neurological" OR/AND "manifestation". RESULTS: The search strategy revealed 32 relevant publications with a total of 46 patients. BP was the initial manifestation in 37% of cases, and in 63% of cases it developed after COVID-19 symptoms; 71.7% of cases showed complete recovery, and 21.7% showed only partial relief from BP. CONCLUSIONS: Although the number of documented cases in this research is low, evidence of BP as the only major neurological manifestation in patients with COVID-19 signifies an important clinical finding and the possibility of another viral etiology of BP. More evidence is needed to establish the exact correlation between these two entities.


Subject(s)
Bell Palsy , COVID-19 , Communicable Diseases , Facial Paralysis , Peripheral Nervous System Diseases , Bell Palsy/diagnosis , Bell Palsy/epidemiology , Bell Palsy/etiology , COVID-19/complications , Communicable Diseases/complications , Humans , Peripheral Nervous System Diseases/complications , SARS-CoV-2
6.
Vaccine ; 40(24): 3305-3312, 2022 05 26.
Article in English | MEDLINE | ID: covidwho-1805293

ABSTRACT

BACKGROUND: Background incidence rates are critical in pharmacovigilance to facilitate identification of vaccine safety signals. We estimated background incidence rates of 11 adverse events of special interest related to COVID-19 vaccines in Ontario, Canada. METHODS: We conducted a population-based retrospective observational study using linked health administrative databases for hospitalizations and emergency department visits among Ontario residents. We estimated incidence rates of Bell's palsy, idiopathic thrombocytopenia, febrile convulsions, acute disseminated encephalomyelitis, myocarditis, pericarditis, Kawasaki disease, Guillain-Barré syndrome, transverse myelitis, acute myocardial infarction, and anaphylaxis during five pre-pandemic years (2015-2019) and 2020. RESULTS: The average annual population was 14 million across all age groups with 51% female. The pre-pandemic mean annual rates per 100,000 population during 2015-2019 were 191 for acute myocardial infarction, 43.9 for idiopathic thrombocytopenia, 28.8 for anaphylaxis, 27.8 for Bell's palsy, 25.0 for febrile convulsions, 22.8 for acute disseminated encephalomyelitis, 11.3 for myocarditis/pericarditis, 8.7 for pericarditis, 2.9 for myocarditis, 2.0 for Kawasaki disease, 1.9 for Guillain-Barré syndrome, and 1.7 for transverse myelitis. Females had higher rates of acute disseminated encephalomyelitis, transverse myelitis and anaphylaxis while males had higher rates of myocarditis, pericarditis, and Guillain-Barré syndrome. Bell's palsy, acute disseminated encephalomyelitis, and Guillain-Barré syndrome increased with age. The mean rates of myocarditis and/or pericarditis increased with age up to 79 years; males had higher rates than females: from 12 to 59 years for myocarditis and ≥12 years for pericarditis. Febrile convulsions and Kawasaki disease were predominantly childhood diseases and generally decreased with age. CONCLUSIONS: Our estimated background rates will permit estimating numbers of expected events for these conditions and facilitate detection of potential safety signals following COVID-19 vaccination.


Subject(s)
COVID-19 Vaccines , COVID-19 , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Bell Palsy/chemically induced , Bell Palsy/epidemiology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Encephalomyelitis, Acute Disseminated/chemically induced , Encephalomyelitis, Acute Disseminated/epidemiology , Female , Guillain-Barre Syndrome/chemically induced , Guillain-Barre Syndrome/epidemiology , Humans , Incidence , Male , Mucocutaneous Lymph Node Syndrome/chemically induced , Mucocutaneous Lymph Node Syndrome/epidemiology , Myelitis, Transverse/chemically induced , Myelitis, Transverse/epidemiology , Myocardial Infarction/chemically induced , Myocardial Infarction/epidemiology , Myocarditis/chemically induced , Myocarditis/epidemiology , Ontario/epidemiology , Pericarditis/chemically induced , Pericarditis/epidemiology , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Retrospective Studies , Seizures, Febrile/chemically induced , Seizures, Febrile/epidemiology
7.
BMJ ; 376: e068373, 2022 03 16.
Article in English | MEDLINE | ID: covidwho-1745759

ABSTRACT

OBJECTIVE: To study the association between covid-19 vaccines, SARS-CoV-2 infection, and risk of immune mediated neurological events. DESIGN: Population based historical rate comparison study and self-controlled case series analysis. SETTING: Primary care records from the United Kingdom, and primary care records from Spain linked to hospital data. PARTICIPANTS: 8 330 497 people who received at least one dose of covid-19 vaccines ChAdOx1 nCoV-19, BNT162b2, mRNA-1273, or Ad.26.COV2.S between the rollout of the vaccination campaigns and end of data availability (UK: 9 May 2021; Spain: 30 June 2021). The study sample also comprised a cohort of 735 870 unvaccinated individuals with a first positive reverse transcription polymerase chain reaction test result for SARS-CoV-2 from 1 September 2020, and 14 330 080 participants from the general population. MAIN OUTCOME MEASURES: Outcomes were incidence of Bell's palsy, encephalomyelitis, Guillain-Barré syndrome, and transverse myelitis. Incidence rates were estimated in the 21 days after the first vaccine dose, 90 days after a positive test result for SARS-CoV-2, and between 2017 and 2019 for background rates in the general population cohort. Indirectly standardised incidence ratios were estimated. Adjusted incidence rate ratios were estimated from the self-controlled case series. RESULTS: The study included 4 376 535 people who received ChAdOx1 nCoV-19, 3 588 318 who received BNT162b2, 244 913 who received mRNA-1273, and 120 731 who received Ad26.CoV.2; 735 870 people with SARS-CoV-2 infection; and 14 330 080 people from the general population. Overall, post-vaccine rates were consistent with expected (background) rates for Bell's palsy, encephalomyelitis, and Guillain-Barré syndrome. Self-controlled case series was conducted only for Bell's palsy, given limited statistical power, but with no safety signal seen for those vaccinated. Rates were, however, higher than expected after SARS-CoV-2 infection. For example, in the data from the UK, the standardised incidence ratio for Bell's palsy was 1.33 (1.02 to 1.74), for encephalomyelitis was 6.89 (3.82 to 12.44), and for Guillain-Barré syndrome was 3.53 (1.83 to 6.77). Transverse myelitis was rare (<5 events in all vaccinated cohorts) and could not be analysed. CONCLUSIONS: No safety signal was observed between covid-19 vaccines and the immune mediated neurological events of Bell's palsy, encephalomyelitis, Guillain-Barré syndrome, and transverse myelitis. An increased risk of Bell's palsy, encephalomyelitis, and Guillain-Barré syndrome was, however, observed for people with SARS-CoV-2 infection.


Subject(s)
Bell Palsy/epidemiology , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Encephalomyelitis/epidemiology , Guillain-Barre Syndrome/epidemiology , Myelitis, Transverse/epidemiology , SARS-CoV-2/immunology , Adult , Aged , Female , Humans , Incidence , Male , Middle Aged , Routinely Collected Health Data , Spain , United Kingdom , Vaccination/adverse effects
8.
Acta Otolaryngol ; 142(2): 220-223, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1655776

ABSTRACT

BACKGROUND: The aetiology of idiopathic facial nerve palsy (Bell's palsy, BP) and sudden sensorineural hearing loss (SSNHL) are not known. It has been proposed that common respiratory tract viruses play a part in the pathophysiology of these diseases. OBJECTIVES: The incidence of many infectious diseases decreased during the lockdown of the society that took place during the COVID-19 pandemic. We investigated a possible change in the incidence of BP and SSNHL during the lock-down. MATERIAL AND METHODS: We searched the patient records for all BP and SSNHL cases between 1 Jan 2017 - 31 Aug 2020 at the hospital district of Helsinki and Uusimaa that covers a population of about 1.2 million. RESULTS: The mean monthly incidence on BP decreased during the COVID-19 pandemic lock-down. No change in the SSNHL incidence was discovered. CONCLUSIONS AND SIGNIFICANCE: There is reason to speculate that one aetiologic reason for BP are transmittable respiratory tract pathogens.


Subject(s)
Bell Palsy , COVID-19 , Hearing Loss, Sensorineural , Bell Palsy/epidemiology , Bell Palsy/etiology , COVID-19/epidemiology , Communicable Disease Control , Hearing Loss, Sensorineural/complications , Hearing Loss, Sensorineural/etiology , Humans , Incidence , Pandemics , Physical Distancing
9.
Lancet Infect Dis ; 22(1): 64-72, 2022 01.
Article in English | MEDLINE | ID: covidwho-1599084

ABSTRACT

BACKGROUND: Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk of Bell's palsy after BNT162b2 and CoronaVac vaccination. METHODS: In this case series and nested case-control study done in Hong Kong, we assessed the risk of Bell's palsy within 42 days following vaccination with BNT162b2 (Fosun-BioNTech [equivalent to Pfizer-BioNTech]) or CoronaVac (from Sinovac Biotech, Hong Kong) using data from voluntary surveillance reporting with the Hospital Authority, the COVID-19 Vaccine Adverse Event Online Reporting system for all health-care professionals, and the Hospital Authority's territory-wide electronic health records from the Clinical Data Analysis and Reporting System. We described reported cases of Bell's palsy among vaccine recipients (aged 18-110 years for CoronaVac and aged 16-110 years for BNT162b2). We compared the estimated age-standardised incidence of clinically confirmed cases among individuals who had received the CoronaVac or BNT162b2 vaccination (up to 42 days before presentation) with the background incidence in the population. A nested case-control study was also done using conditional logistic regression to estimate the odds ratio (OR) for risk of Bell's palsy and vaccination. Cases and controls were matched (1:4) by age, sex, admission setting, and admission date. FINDINGS: Between February 23 and May 4, 2021, 451 939 individuals received the first dose of CoronaVac and 537 205 individuals received the first dose of BNT162b2. 28 clinically confirmed cases of Bell's palsy were reported following CoronaVac and 16 cases were reported following BNT162b2. The age-standardised incidence of clinically confirmed Bell's palsy was 66·9 cases per 100 000 person-years (95% CI 37·2 to 96·6) following CoronaVac vaccination and 42·8 per 100 000 person-years (19·4 to 66·1) for BNT162b2 vaccination. The age-standardised difference for the incidence compared with the background population was 41·5 (95% CI 11·7 to 71·4) for CoronaVac and 17·0 (-6·6 to 40·6) for BNT162b2, equivalent to an additional 4·8 cases per 100 000 people vaccinated for CoronaVac and 2·0 cases per 100 000 people vaccinated for BNT162b2. In the nested case-control analysis, 298 cases were matched to 1181 controls, and the adjusted ORs were 2·385 (95% CI 1·415 to 4·022) for CoronaVac and 1·755 (0·886 to 3·477) for BNT162b2. INTERPRETATION: Our findings suggest an overall increased risk of Bell's palsy after CoronaVac vaccination. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event. Additional studies are needed in other regions to confirm our findings. FUNDING: The Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, China. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.


Subject(s)
BNT162 Vaccine/adverse effects , Bell Palsy/etiology , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Vaccination/adverse effects , Vaccines, Inactivated/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Bell Palsy/epidemiology , Case-Control Studies , Female , Health Personnel , Humans , Incidence , Male , Middle Aged , Population , Young Adult
12.
Nat Med ; 27(12): 2144-2153, 2021 12.
Article in English | MEDLINE | ID: covidwho-1483142

ABSTRACT

Emerging reports of rare neurological complications associated with COVID-19 infection and vaccinations are leading to regulatory, clinical and public health concerns. We undertook a self-controlled case series study to investigate hospital admissions from neurological complications in the 28 days after a first dose of ChAdOx1nCoV-19 (n = 20,417,752) or BNT162b2 (n = 12,134,782), and after a SARS-CoV-2-positive test (n = 2,005,280). There was an increased risk of Guillain-Barré syndrome (incidence rate ratio (IRR), 2.90; 95% confidence interval (CI): 2.15-3.92 at 15-21 days after vaccination) and Bell's palsy (IRR, 1.29; 95% CI: 1.08-1.56 at 15-21 days) with ChAdOx1nCoV-19. There was an increased risk of hemorrhagic stroke (IRR, 1.38; 95% CI: 1.12-1.71 at 15-21 days) with BNT162b2. An independent Scottish cohort provided further support for the association between ChAdOx1nCoV and Guillain-Barré syndrome (IRR, 2.32; 95% CI: 1.08-5.02 at 1-28 days). There was a substantially higher risk of all neurological outcomes in the 28 days after a positive SARS-CoV-2 test including Guillain-Barré syndrome (IRR, 5.25; 95% CI: 3.00-9.18). Overall, we estimated 38 excess cases of Guillain-Barré syndrome per 10 million people receiving ChAdOx1nCoV-19 and 145 excess cases per 10 million people after a positive SARS-CoV-2 test. In summary, although we find an increased risk of neurological complications in those who received COVID-19 vaccines, the risk of these complications is greater following a positive SARS-CoV-2 test.


Subject(s)
BNT162 Vaccine/adverse effects , Bell Palsy/epidemiology , COVID-19/pathology , ChAdOx1 nCoV-19/adverse effects , Guillain-Barre Syndrome/epidemiology , Hemorrhagic Stroke/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , BNT162 Vaccine/immunology , Bell Palsy/virology , COVID-19/diagnosis , COVID-19/immunology , ChAdOx1 nCoV-19/immunology , England/epidemiology , Female , Guillain-Barre Syndrome/virology , Hemorrhagic Stroke/virology , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Nervous System Diseases/epidemiology , Nervous System Diseases/virology , SARS-CoV-2/immunology , Scotland/epidemiology , Young Adult
14.
PLoS One ; 16(8): e0256379, 2021.
Article in English | MEDLINE | ID: covidwho-1374149

ABSTRACT

INTRODUCTION: The COVID-19 pandemic caused by SARS-CoV-2 has now affected tens of millions of people globally. It is the hope that vaccines against SARS-CoV-2 will deliver a comprehensive solution to this global pandemic; however, this will require extensive national vaccination programs. Ultimately, clinical conditions and even sudden unexplained death will occur around the time of vaccination, thus a distinction needs to be made between events that are causally related to the vaccine or temporally related to vaccination. This study aimed to estimate the background occurrence of 43 clinical conditions in the Japanese population. METHODS: A retrospective cohort study was conducted from 2013 to 2019 using data from two large healthcare claims databases (MDV and JMDC) in Japan. The estimated number of new cases and incidence were calculated based on the actual number of new cases identified in the databases. The PubMed and Ichushi-web databases, as well as grey literature such as guidelines and government statistics, were also searched to identify any publications related to incidence of these conditions in Japan. RESULTS AND CONCLUSION: The estimates of the number of total cases and incidence were similar for the MDV and JMDC databases for some diseases. In addition, some estimates were similar to those in the scientific literature. For example, from the MDV and JMDC databases, estimates of incidence of confirmed Bell's palsy in 2019 were 41.7 and 47.9 cases per 100,000 population per year, respectively. These estimates were of the same order from the scientific publication. Determining whether clinical conditions occurring around the time of vaccination are causally or only temporally related to vaccination will be critical for public health decision makers as well as for the general public. Comparison of background occurrence at the population level may provide some additional objective evidence for the evaluation of temporality or causality.


Subject(s)
COVID-19/epidemiology , Immunization Programs , Bell Palsy/epidemiology , Bell Palsy/prevention & control , COVID-19/virology , Databases, Factual , Guillain-Barre Syndrome/epidemiology , Guillain-Barre Syndrome/prevention & control , Humans , Japan/epidemiology , Optic Neuritis/epidemiology , Optic Neuritis/prevention & control , Retrospective Studies , SARS-CoV-2/isolation & purification , Vaccination
15.
Am J Otolaryngol ; 42(5): 103129, 2021.
Article in English | MEDLINE | ID: covidwho-1293531

ABSTRACT

OBJECTIVES: The symptoms of COVID-19 at the time of presentation mainly include fever, cough, respiratory distress and myalgia. On the other hand, as neurological symptoms, disruption of taste and smell and cerebrovascular pathologies are well-known, whereas other neurological symptoms and signs are being newly recognized. Sudden-onset sensorineural hearing loss (SSNHL) and idiopathic acute facial paralysis (Bell's palsy) are otologic emergencies that are frequently encountered by otorhinolaryngology specialists. Although there are many articles describing SSNHL and Bell's palsy in the literature, the literature describing their relationship to COVID-19 is limited. In our study, we aimed to present the neuro-otologic relationship of SSNHL and Bell's palsy with COVID-19. MATERIAL AND METHODS: The pretreatment real-time oronasopharyngeal PCR tests, COVID-19 symptomatology and COVID-19 infection statuses of patients who presented to our clinic with isolated SSNHL and Bell's palsy between April 2020 and April 2021 were questioned, and the data of the patients were collected. Throughout their treatment, the patients were followed-up in terms of COVID-19 infection. This is a prospective study. Moreover, to observe the change in the incidence, the data of patients visiting between January 2019 and January 2020 were also collected. The data of the patients were statistically analyzed using SPSS. RESULTS: The study included a total of 177 patients. The SSNHL group consisted of 91 patients, and the Bell's palsy group consisted of 86 patients. Neither group showed a statistically significant difference in comparison to the year without the pandemic in terms of the patient numbers (incidence), sex, age, morbidity, response to treatment or social habits. There was a statistically significant difference in age only in the Bell's palsy group, but this difference was not medically significant. CONCLUSION: As a result of our study, we did not observe a relationship between COVID-19 and cases of SSNHL and Bell's palsy. It is recommended to apply standard otologic treatment to isolated SSNHL and Bell's palsy patients whose association with COVID-19 is not determined.


Subject(s)
Bell Palsy/epidemiology , COVID-19/complications , Facial Paralysis/epidemiology , Hearing Loss, Sensorineural/epidemiology , Hearing Loss, Sudden/epidemiology , Adult , Aged , Bell Palsy/diagnosis , Bell Palsy/virology , COVID-19/diagnosis , COVID-19/epidemiology , Facial Paralysis/diagnosis , Facial Paralysis/virology , Female , Hearing Loss, Sensorineural/diagnosis , Hearing Loss, Sensorineural/virology , Hearing Loss, Sudden/diagnosis , Hearing Loss, Sudden/virology , Humans , Incidence , Male , Middle Aged , Prospective Studies , Symptom Assessment , Turkey
17.
Fam Pract ; 39(1): 80-84, 2022 01 19.
Article in English | MEDLINE | ID: covidwho-1286563

ABSTRACT

BACKGROUND: Vaccinations are a cornerstone of preventative medicine in the USA. However, growing concerns regarding facial nerve palsy following vaccination exist. OBJECTIVE: This study aims to assess the occurrence of facial palsy as reported by the Vaccine Adverse Event Reporting System (VAERS) database. METHODS: A retrospective analysis of the VAERS database was performed for cases of 'Facial Palsy', 'Bell's Palsy', 'Facial Paralysis' and 'Ramsay Hunt Syndrome' between 2009 and 2018. Subgroup analysis was performed to determine gender, age, history of facial palsy, type of vaccine used, number of days until onset of symptoms and overall facial palsy rate. RESULTS: Nine hundred and forty-four entries met our inclusion criteria with 961 vaccine administrations resulting in facial paralysis. Facial palsy following vaccinations was evenly distributed across all age cohorts with two peaks between 60 and 74 years old and between 0 and 14 years old. Most patients were female (N = 526, 55.7%) without a reported history of facial palsy (N = 923, 97.8%). In 2009, reported incidence rate was 0.53%, as compared with 0.23% in 2018. The influenza vaccine had the greatest number of cases (N = 166, 17.3%), followed by the varicella (N = 87, 9.1%) and human papillomavirus vaccines (N = 47, 4.9%). CONCLUSIONS: With the SARS-CoV-2 pandemic and recent approvals of the vaccinations, there is growing concern of facial palsy following vaccination. Although it is a known adverse event following vaccination, the likelihood of facial palsy following vaccination is low, with only 0.26% of overall reported cases over a 10-year span.


Subject(s)
Bell Palsy , COVID-19 , Facial Paralysis , Influenza Vaccines , Bell Palsy/epidemiology , Bell Palsy/etiology , Child, Preschool , Facial Paralysis/epidemiology , Facial Paralysis/etiology , Female , Humans , Retrospective Studies , SARS-CoV-2 , Vaccination/adverse effects
18.
J Laryngol Otol ; 135(8): 668-670, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1225475

ABSTRACT

BACKGROUND: Bell's palsy is a lower motor neurone facial weakness of unknown aetiology, although reactivation of a virus within the facial nerve has been proposed. METHODS: A prospective study was conducted of Bell's palsy cases presenting to our paediatric ENT unit over a 19-week period, from February to June 2020. Patients were invited for severe acute respiratory syndrome coronavirus-2 antibody testing. A text-message questionnaire was sent to other ENT centres to determine their observational experience. RESULTS: During the study period, 17 children presented with Bell's palsy, compared with only 3 children in the same time period in the previous year (p < 0.0001). Five patients underwent severe acute respiratory syndrome coronavirus-2 antibody testing, the results of which were all negative. Four out of 15 centres questioned perceived an increased incidence in paediatric Bell's palsy. CONCLUSION: Clinicians are encouraged to be vigilant to the increase in paediatric Bell's palsy seen during the coronavirus disease 2019 pandemic, which may represent a post-viral sequela of coronavirus disease 2019.


Subject(s)
Bell Palsy/epidemiology , COVID-19/epidemiology , Bell Palsy/etiology , Bell Palsy/virology , COVID-19/complications , Child , Female , Humans , Incidence , Male , Prospective Studies , Surveys and Questionnaires , United Kingdom/epidemiology
20.
Am J Otolaryngol ; 42(5): 103032, 2021.
Article in English | MEDLINE | ID: covidwho-1171724

ABSTRACT

PURPOSE: Publications about increased number of peripheral facial paralysis in the COVID-19 pandemic emerged in the literature. However, these studies comprised of an estimate rather than a broad analysis of exact numbers. In this study, we planned to investigate whether the pandemic really resulted in an increase in facial paralysis cases admitted to the hospital by evaluating the cases who applied to our hospital due to facial paralysis in the COVID-19 pandemic year and in the previous 4 years. MATERIALS AND METHODS: Patients who applied to our hospital due to facial paralysis between March 2016-February 2017 (Group 1), between March 2017-February 2018 (Group 2), between March 2018-February 2019 (Group 3), between March 2019-February 2020 (Group 4), and between March 2020-February 2021 (Group 5) were investigated and detailed data were noted. RESULTS: 156, 164, 149, 172 and 157 patients were admitted to the hospital due to peripheral facial paralysis in Group 1, 2, 3, 4, and 5, respectively. Of these patients, 155, 164, 145, 169, and 153 were Bell's palsy, respectively. SARS-CoV-2 RT-PCR test was positive in only 2 of the 153 patients who were diagnosed in the year of the pandemic. CONCLUSIONS: This study showed that the number of peripheral facial paralysis detected during the COVID-19 pandemic was similar to previous years. Very few number of positive SARS-CoV-2 RT-PCR test results may have been found incidentally in Bell's palsy patients. Theses stating that SARS-CoV-2 causes peripheral facial paralysis should be supported by laboratory studies and postmortem research.


Subject(s)
Bell Palsy/epidemiology , COVID-19/complications , Facial Paralysis/epidemiology , Bell Palsy/diagnosis , Bell Palsy/virology , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Nucleic Acid Testing , Facial Paralysis/diagnosis , Facial Paralysis/virology , Hospitalization , Humans , Incidence , Real-Time Polymerase Chain Reaction , Retrospective Studies , Turkey
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