Adverse event reporting and Bell's palsy risk after COVID-19 vaccination.
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ABSTRACT:
SUBMITTER: Chang KC
PROVIDER: S-EPMC8550908 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: Not available
| S-EPMC8550921 | biostudies-literature
Project description:The COVID-19 pandemic necessitated an urgent global response in vaccine deployment, achieving over 70.6% global vaccination coverage with at least one dose. This study focuses on Taiwan's vaccine administration and adverse event reporting, set against a global backdrop. Using data from Taiwan's Vaccine Adverse Event Reporting System (VAERS) and global vaccination data, this study investigates vaccine safety and the public health implications of vaccination strategies from local and global perspectives. Taiwan's proactive approach, resulting in high vaccination rates, provides a case study for the monitoring and management of vaccine-related adverse events. This study offers insights into the safety profiles of various COVID-19 vaccines and further explores the implications of adverse event reporting rates for vaccine policy and public health strategies. The comparative analysis reveals that, while vaccination has been effective in controlling the virus's spread, safety monitoring remains critical for maintaining public trust. It underscores the necessity of enhanced surveillance and the importance of transparent and tailored risk communication to support informed public health decisions. The findings aim to contribute to the global dialogue on vaccine safety, equitable distribution, evidence-based policy-making, and development of mitigation measures with consideration of local demographics in the ongoing fight against COVID-19.
| S-EPMC11209125 | biostudies-literature
Project description: Not available
| S-EPMC8244554 | biostudies-literature
Project description:What is known and objectiveEvidence on whether the coronavirus disease 2019 (COVID-19) vaccination could cause hearing-related adverse events is still conflicting. This study aims to access the association between COVID-19 vaccine and hearing disorder.MethodsThe Vaccine Adverse Event Reporting System (VAERS) was queried between January 2020 to November 2021. The disproportionality pattern for hearing impairment of COVID-19 vaccine was accessed by calculating the reporting odds ratio (ROR) and proportional reporting ratio (PRR). A further subgroup analysis based on the type of COVID-19 vaccine and the doses administered was performed. In addition, the disproportionalities for hearing dysfunction between COVID-19 and influenza vaccines were compared.Results and discussionA total of 14,956 reports of hearing-related adverse events were identified with COVID-19 vaccination and 151 with influenza vaccine during the analytic period in VAERS. The incidence of hearing disorder following COVID-19 vaccination was 6.66 per 100,000. The results of disproportionality analysis revealed that the adverse events of hearing impairment, after administration of COVID-19 vaccine, was significantly highly reported (ROR 2.38, 95% confidence interval [CI] 2.20-2.56; PRR: 2.35, χ2 537.58), for both mRNA (ROR 2.37, 95% CI 2.20-2.55; PRR 2.34, χ2 529.75) and virus vector vaccines (ROR 2.50, 95% CI 2.28-2.73; PRR 2.56, χ2 418.57). While the disproportional level for hearing dysfunction was quite lower in influenza vaccine (ROR 0.36, 95% CI 0.30-0.42; PRR 0.36, χ2 172.24).What is new and conclusionThis study identified increased risk for hearing disorder following administration of both mRNA and virus vector COVID-19 vaccines compared to influenza vaccination in real-world settings.
| S-EPMC9539140 | biostudies-literature
Project description:BackgroundObservable symptoms of Bell's palsy following vaccinations may arouse concern over the safety profiles of novel COVID-19 vaccines in the general public. However, there are only a few studies on Bell's palsy following mRNA COVID-19 vaccination with inconclusive findings. This study aimed to update the previous analysis on the risk of Bell's palsy following mRNA (BNT162b2) COVID-19 vaccination.MethodsThis study included cases aged ≥16-years-old with a new diagnosis of Bell's palsy within 28 days after BNT162b2 vaccinations from the population-based electronic health records in Hong Kong, using a nested case-control and self-controlled case series (SCCS) analyses were employed. The association between Bell's palsy and BNT162b2 was evaluated using conditional logistic and Poisson regression in nested case-control and SCCS analysis, respectively.ResultsA total of 54 individuals were newly diagnosed with Bell's palsy after BNT162b2 vaccinations. The incidence of Bell's palsy was 1.58 (95% CI:1.19-2.07) per 100,000 doses administered. The nested case-control analysis showed significant association between BNT162b2 vaccinations and Bell's palsy (Adjusted OR: 1.543, 95%CI:1.123 - 2.121), with up to 1.112 excess events per 100,000 people receiving two doses of BNT162b2. An increased risk of Bell's palsy was observed during the first 14 days after the second dose of BNT162b2 in both nested case-control (Adjusted OR: 2.325, 95%CI:1.414 - 3.821) and SCCS analysis (Adjusted IRR=2.44, 95%CI:1.32-4.50).ConclusionThere is an overall increased risk of Bell's palsy following BNT162b2 vaccination, particularly within the first 14 days after the second dose, but the absolute risk was very low.
| S-EPMC9278169 | biostudies-literature
Project description:BackgroundAn excess risk of Bell's palsy has been suggested after mRNA vaccines. We examined the association between the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy.MethodsUsing the database of the largest healthcare provider in Israel, we retrieved data from different periods in 2018-2021. Observed cases of Bell's palsy occurring within 21-days after the first vaccine dose and within 30-days after the second vaccine dose were compared to the expected cases, based on the experience of the population in 2019. Standardized incidence ratios (SIRs) and attributable risks (ARs) were computed.FindingsOverall, 132 cases of Bell's palsy were reported in 2,594,990 vaccinees with the first dose, and 152 cases in 2,434,674 vaccinees after the second dose. The age and sex weighted SIRs were 1.36(95% CI, 1.14-1.61) and 1.16(0.99-1.36) after the first and second vaccine dose, respectively. SIRs tended to be higher in older age groups after the first and second vaccine doses. The estimates were more pronounced in older females after the first vaccine dose; SIR=1.71(1.10-2.54) at age 45-64, and 2.51(1.65-3.68) at age ≥65 years. The highest AR was 4.46 per 100,000 vaccinees detected in females aged ≥65 years. In patients with previous history of Bell's palsy, only 4 cases of Bell's palsy were reported in 7,567 vaccinees and 10 cases in 7,045 vaccinees after the first and the second dose, respectively. The age and sex weighted SIRs were 1.15(0.36-2.76) and 2.15(1.09-3.83) after the first and second vaccine dose, respectively.InterpretationThis study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of Bell's palsy. The small estimated attributable risks suggest that the impact on public health is relatively minor. The benefits of vaccinations explicitly outweigh the possible link to Bell's palsy that has high recovery rate if timely treated with corticosteroids.FundingNo external funding was available for this study.
| S-EPMC8566165 | biostudies-literature
Project description: Not available
| S-EPMC8762504 | biostudies-literature
Project description:Previous studies have shown controversial results on the risk of Bell's palsy after influenza vaccination. Since the antigenic components of influenza vaccine can vary from season to season, continuous safety monitoring is required. The aim of the present study was to determine whether there was an increased risk of Bell's palsy in the elderly after influenza vaccination between the 2015/2016 and 2017/2018 flu seasons. This study included the elderly who received influenza vaccinations for three flu seasons using a large-linked database of vaccination registration data from the Korea Disease Control and Prevention Agency and the National Health Insurance Service claims data. We used a self-controlled risk interval design with a risk interval of 1 to 42 days and a control interval of 57 to 98 days postvaccination and calculated the incidence rate ratio. To ensure the robustness of the results, sensitivity analyses were also carried out with different risk and control intervals. Of 4,653,440 elderly people who received the influenza vaccine, there was no statistically significant increase in the risk of Bell's palsy (IRR: 0.99, 95% CI: 0.92-1.07). Similar results were found in analysis results for each season and the results of the sensitivity analyses excluding the 2017/2018 season. In conclusion, we found no evidence of an increased risk of Bell's palsy after influenza vaccination. The results of our study provide reassurance about the safety of the influenza vaccine NIP program. However, it is necessary to continuously monitor the risk of Bell's palsy during future flu seasons.
| S-EPMC8310133 | biostudies-literature
Project description:IntroductionVero Cell, AstraZeneca, Janssen, mRNA-1273 (Moderna), and Pfizer COVID-19 vaccines have been authorized for emergency use in Nepal. These vacines have been linked to some adverse effects, including fever, myalgia, and headache. Furthermore Bell's Palsy a rare adverse effect was also reported to be associated with the use of mRNA-1273 (Moderna) vaccine in some patients.Case presentationIn this case report we present a 17-year-old female who acquired Bell's Palsy following the administration of mRNA-1273 (Moderna) COVID-19 vaccination.DiscussionThe possible etiology of BP that has been suggested is infection by reactivated viruses, such as the varicella-zoster virus (VZV), herpes simplex virus type 1 (HSV-1), human herpesvirus 6, and the Usutu virus, [1] the most accepted hypothesis is the one with reactivation of latent Herpes Simplex Virus type 1 in the geniculate ganglia of the facial nerves, an autoimmune mechanism through the mimicry of host molecules by the antigens of the vaccines.ConclusionThough the extent of association between the mRNA vaccination and the development of Bell's Palsy has yet to be confirmed, this example highlights the need to closely monitor side effects and repercussions after receiving a new vaccine.
| S-EPMC9151463 | biostudies-literature
Project description:BackgroundEvidence on mortality risks associated with MS-immunotherapies during the SARS-CoV2 pandemic derived thus far mainly from single country experiences.ObjectiveIn this analysis, we aim to determine the frequency of COVID-19 associated fatality reports of patients receiving an MS-immunotherapy as reported to the international Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from February 2020 to March 2021.MethodsIn all, 1071 cases for this cross-sectional analysis were retrieved from FAERS and a multivariable logistic regression was performed. We adjusted for sex, age, region, month of report to FDA, immunotherapy-class and additionally for healthcare-system and pandemic-related metrics.ResultAnti-CD20 therapies (60%) followed by sphingosine-1 phosphate modulators (12%) and dimethylfumarat (10%) were reported most frequently. In 50% of the cases, MS-phenotype is not reported, relapsing MS in 35% and progressive MS in 15%. Besides older age (odds ratio [OR]: 1.1; 95% confidence interval [CI]: 1.07-1.13; p < 0.01), anti-CD20 therapies were significantly associated with a higher risk of death (OR: 4.1; 95% CI: 1.17-14.46; p = 0.03), whereas female sex was associated with a reduced mortality risk (OR: 0.4, 95% CI: 0.22-0.72; p < 0.01).ConclusionUsing international open access data and a multidisciplinary approach for risk prediction, we identified an increased mortality risk associated with anti-CD20 therapies, which is in line with national and multi-national cohort studies.
| S-EPMC9551667 | biostudies-literature