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 |
REPOSITORIES: biostudies-literature
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| S-EPMC8550908 | biostudies-literature
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| S-EPMC8244554 | biostudies-literature
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| S-EPMC8762504 | 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: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:Guillain-Barrè syndrome (GBS) is an acute immune-mediated neuropathy, possibly triggered by a recent infection or vaccination, and driven by an immune attack targeting the peripheral nervous system. GBS typically leads to ascending limb weakness, often with sensory and cranial nerve involvement 1-2 weeks after immune stimulation, but emergency and neurology physicians should be aware of its important clinical heterogeneity. In rare cases, bilateral facial nerve palsy can be the main clinical manifestation, as the case of the variant formerly known as bilateral facial weakness with paresthesias. An increasing number of case reports of GBS in patients receiving COVID-19 vaccination have been reported both during the pre-clinical phase and after large-scale authorities' approval. We report two cases of bifacial palsy with paresthesias, a rare variant of GBS, both occurring after the first dose of COVID-19 vaccine Vaxzevria™ (formerly COVID-19 vaccine AstraZeneca), showing a favorable outcome after high-dose immunoglobulin therapy, and discuss the literature of GBS post-COVID-19 vaccination.
| S-EPMC8973678 | 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:Introduction: The analysis of pharmacovigilance databases is crucial for the safety profiling of new and repurposed drugs, especially in the COVID-19 era. Traditional pharmacovigilance analyses-based on disproportionality approaches-cannot usually account for the complexity of spontaneous reports often with multiple concomitant drugs and events. We propose a network-based approach on co-reported events to help assessing disproportionalities and to effectively and timely identify disease-, comorbidity- and drug-related syndromes, especially in a rapidly changing low-resources environment such as that of COVID-19. Materials and Methods: Reports on medications administered for COVID-19 were extracted from the FDA Adverse Event Reporting System quarterly data (January-September 2020) and queried for disproportionalities (Reporting Odds Ratio corrected for multiple comparisons). A network (the Adversome) was estimated considering events as nodes and conditional co-reporting as links. Communities of significantly co-reported events were identified. All data and scripts employed are available in a public repository. Results: Among the 7,082 COVID-19 reports extracted, the seven most frequently suspected drugs (remdesivir, hydroxychloroquine, azithromycin, tocilizumab, lopinavir/ritonavir, sarilumab, and ethanol) have shown disproportionalities with 54 events. Of interest, myasthenia gravis with hydroxychloroquine, and cerebrovascular vein thrombosis with azithromycin. Automatic clustering identified 13 communities, including a methanol-related neurotoxicity associated with alcohol-based hand-sanitizers and a long QT/hepatotoxicity cluster associated with azithromycin, hydroxychloroquine and lopinavir-ritonavir interactions. Conclusion: Findings from the Adversome detect plausible new signals and iatrogenic syndromes. Our network approach complements traditional pharmacovigilance analyses, and may represent a more effective signal detection technique to guide clinical recommendations by regulators and specific follow-up confirmatory studies.
| S-EPMC8694570 | biostudies-literature
Project description:This study aimed to assess (i) COVID-19 transmission prior to and following spectator events and (ii) methodological approaches to capturing event-related transmission during the spectator return. Local authority population transmission rates were used to identify higher transmission areas, which were excluded from participant attendance following registration. Using observational online and SMS questionnaires, self-reported COVID-19 diagnoses (positive tests) and racing-related NHS Test and Trace contacts within 14 days of spectating were reported for two British Horseracing events and three Point to Point (PTP) grassroots races. There were 1,477 registrations for the British Horseracing events, and 1,678 registrations for PTP races. Responses were received from 464 attendees of British Horseracing events (31.4% response rate). Two attendees reported a COVID-19 diagnosis, and no attendees reported NHS Test and Trace contact. From PTP races, 862 attendees (51.3%) consented to receive the SMS survey, and responses were received from 495 attendees (57.4% response rate). Five attendees reported positive COVID-19 diagnoses, and two attendees reported being contacted by NHS Test and Trace, of which one was following a non-racing potential COVID-19 exposure. There was limited evidence of COVID-19 transmission at outdoor elite and grassroots level horseracing events during autumn 2020. A higher response rate was received with SMS surveys; however, there was a reluctancy to "opt in" to SMS methodology. This study describes different methodological approaches to monitoring COVID-19 transmission risk at events, which may have relevance for other sporting and event contexts during the current pandemic, and sustained attendances during periods with circulating transmissible diseases.
| S-EPMC8661870 | biostudies-literature
Project description:BackgroundVaccination is a key intervention to prevent COVID-19. Many vaccines are administered globally, yet there is not much evidence regarding their safety and adverse effects. Iran also faces this challenge, especially as data regarding the Sputnik V vaccine is sparse. Therefore, the aim of this study is to determine the adverse effects of the most commonly used vaccines in Iran.MethodsUsing a retrospective cohort study design, 6600 subjects aged 18 years or older who had received two doses of any of the three COVID-19 vaccines (Sinopharm, AstraZeneca, and Sputnik V) were selected using a random sampling method between March and August 2021. Subjects were asked about any adverse effects of the vaccines by trained interviewers via telephone interview. Vaccine-related adverse effects in individuals during the first 72 h and subsequently following both doses of the vaccines were determined. The demographic variables, type of administered vaccine, adverse effects, and history of the previous infection with COVID-19 were collected. Descriptive statistics (mean, standard deviation) and analytical statistics (Chi-squared and Wilcoxon tests) were performed at a 95% significance level using STATA software version 15 (STATA Corp, College Station, TX, USA).ResultsFrom 6600 participants, 4775 responded (response rate = 72.3%). Of the participants, 1460 (30.6%) received the AstraZeneca vaccine, 1564 (32.8%) received the Sinopharm vaccine and 1751 (36.7%) received the Sputnik V vaccine. 2653 participants (55.56%) reported adverse effects after the first dose and 1704 (35.7%) after the second dose. Sputnik V caused the most adverse effects with 1449 (82.7%) vaccine recipients reporting symptoms after the first or second dose, compared with 1030 (70.5%) for AstraZeneca and only 585 (37.4%) for the Sinopharm vaccine. The most common adverse effects after the first dose were fatigue (28.37%), chill/fever (26.86%), and skeletal pain (22.38%). These three adverse effects were the same for the second dose, although their prevalence was lower.ConclusionsIn this study, we demonstrate that the Sputnik V vaccine has the highest rate of adverse effects, followed by the AstraZeneca and Sinopharm vaccines. COVID-19 vaccines used in Iran are safe and there were no reports of serious adverse effects.
| S-EPMC9116064 | biostudies-literature