Adverse event reporting and Bell's palsy risk after COVID-19 vaccination.
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ABSTRACT:
SUBMITTER: Khouri C
PROVIDER: S-EPMC8550921 | biostudies-literature | 2021 Nov
REPOSITORIES: biostudies-literature
Publications
Adverse event reporting and Bell's palsy risk after COVID-19 vaccination.
Khouri Charles C Roustit Matthieu M Cracowski Jean-Luc JL
The Lancet. Infectious diseases 20211101 11
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Project description: Not available
| S-EPMC8550908 | 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:PurposeTo assess the risk of vaccine-associated uveitis (VAU) after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination and evaluate uveitis onset interval and clinical presentations in the patients.DesignA retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention Vaccine Adverse Event Reporting System.ParticipantsPatients diagnosed with VAU after administration of BNT162b2 (Pfizer-BioNTech, Pfizer Inc/BioNTech SE), mRNA-1273 (Moderna, Moderna Therapeutics Inc), and Ad26.COV2.S (Janssen, Janssen Pharmaceuticals) vaccine worldwide.MethodsA descriptive analysis of the demographics, clinical history, and presentation was performed. We evaluated the correlation among the 3 vaccines and continuous and categorical variables. A post hoc analysis was performed between uveitis onset interval after vaccination and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset postvaccination was performed.Main outcome measuresThe estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.ResultsA total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n = 853, 77.97%). The mean age of patients with VAU was 46.24 ± 16.93 years, and 68.65% (n = 751) were women. Most cases were reported after the first dose (n = 452, 41.32%) and within the first week (n = 591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22 ± 42.74 days) compared with BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (P < 0.0001). The post hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared with the mRNA 1273 vaccine (P < 0.0001). The 30-day risk analysis showed a significant difference among the 3 vaccines (P < 0.0001).ConclusionsThe low crude reporting rate and observed to expected ratio suggest a low safety concern for VAU. This study provides insights into a possible temporal association between reported VAU events and SARS-CoV-2 vaccines; however, further investigations are required to delineate the associated immunological mechanisms.
| S-EPMC9428109 | 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: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:The COVID-19 pandemic is being battled via the largest vaccination campaign in history, with more than eight billion doses administered thus far. Therefore, discussions about potentially adverse reactions, and broader safety concerns, are critical. The U.S. Vaccination Adverse Event Reporting System (VAERS) has recorded vaccination side effects for over 30 years. About 580,000 events have been filed for COVID-19 thus far, primarily for the Johnson & Johnson (New Jersey, USA), Pfizer/BioNTech (Mainz, Germany), and Moderna (Cambridge, USA) vaccines. Using available databases, we evaluated these three vaccines in terms of the occurrence of four generally-noticed adverse reactions-namely, cerebral venous sinus thrombosis, Guillain-Barré syndrome (a severe paralytic neuropathy), myocarditis, and pericarditis. Our statistical analysis also included a calculation of odds ratios (ORs) based on total vaccination numbers, accounting for incidence rates in the general population. ORs for a number of adverse events and patient groups were (largely) increased, most notably for the occurrence of cerebral venous sinus thrombosis after vaccination with the Johnson & Johnson vaccine. The overall population OR of 10 increases to 12.5 when limited to women, and further yet (to 14.4) among women below age 50 yrs. In addition, elevated risks were found (i) for Guillain-Barré syndrome (OR of 11.6) and (ii) for myocarditis/pericarditis (ORs of 5.3/4.1, respectively) among young men (<25 yrs) vaccinated with the Pfizer/BioNTech vaccine. Any conclusions from such a retrospective, real-world data analysis must be drawn cautiously, and should be confirmed by prospective double-blinded clinical trials. In addition, we emphasize that the adverse events reported here are not specific side effects of COVID vaccines, and the significant, well-established benefits of COVID-19 vaccination outweigh the potential complications surveyed here.
| S-EPMC8950485 | 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:IntroductionOnce the COVID-19 pandemic was declared, the world was waiting for the clue that would be able to cut down the progression of the disease. Vaccines play a crucial role in reducing the disease and saving many people worldwide. However, there are several side effects of these vaccines, like pain, fatigue, fever, and neurological defects like Bell's palsy. In this systematic review, we presented evidence about the occurrence of Bell's palsy followed by COVID-19 vaccination.MethodsWe searched PubMed, SCOPUS, EBSCO, and Web of Science (WOS) from inception till October 2022. The quality assessment was conducted using the Joanna Briggs Institute, National Institute of Health, and Newcastle-Ottawa. The analysis was conducted on SPSS.ResultsThirty-five records were involved in our study. The results of our cases revealed that most of the patients (62.8%) experienced unilateral facial paralysis. Also, the majority of the cases were reported after the first dose, and most cases were after Pfizer, AstraZeneca, and Sputnik V vaccines, respectively. The patients who were treated with corticosteroids, IVIG, and anti-viral drugs, showed marked recovery afterward.ConclusionThe rate ratio of Bell's palsy after COVID-19 vaccination was 25.3 per 1,000,000. The ratio was higher after the first dose compared to the second dose and was higher among those who took Oxford/AstraZeneca vaccine compared to other vaccines. However, this condition was reported in a small number of cases among a large number of vaccinated people worldwide. It is important to note that the benefits of getting vaccinated far outweigh any potential risks.
| S-EPMC9961047 | biostudies-literature