Facial nerve palsy following the administration of COVID-19 mRNA vaccines: analysis of a self-reporting database.

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.

Change in long-term care service usage in Japan following the COVID-19 pandemic: A survey using a nationwide statistical summary in 2018-2021.

AIM: Social restrictions due to the coronavirus disease (COVID-19) pandemic forced many long-term care (LTC) service-users to refrain from using services. We aimed to evaluate the degree of change in the use of LTC services. METHODS: We retrospectively analyzed data from the publicly distributed nationwide statistics summarizing the monthly number of public LTC insurance users in Japan between April 2018 and March 2021. The degree of decline was quantified as a ratio, where the ratio of a certain month to the reference month was divided by the ratio in the previous year. RESULTS: The use of LTC services started to decline in March 2020 and reached its largest decline in May 2020. Thereafter, it recovered but insufficiently, even as of late 2020. The degree of decline was particularly large for services provided in facilities for community-dwelling elderly individuals [Ratio to the previous year = 0.717 (95% CI: 0.645-0.796) in short-stay services, and Ratio = 0.876 (95% CI: 0.802-0.957) in outpatient services], but was non-significant in other types of services, including those provided for elderly individuals living in nursing homes. CONCLUSIONS: Community-dwelling elderly individuals who had used outpatient or short-stay services were especially affected by the COVID-19 pandemic in 2020. This underlines the need for further investigation of the medium- or long-term influence of the decline in service usage on the mental and physical health of the LTC service-users and their caregivers. Geriatr Gerontol Int 2022; 22: 803-809.

Suicide Prevention Program with Cooperation from Senior Volunteers, Governments, and Schools: A Study of the Intervention Effects of "Educational Lessons Regarding SOS Output" Focusing on Junior High School Students.

As a suicide countermeasure for young people, implementing "SOS output education" that provides young people with opportunities and approaches to seeking support with community cooperation can be expected to reduce lifelong suicide risk. We implemented an "SOS output education" for junior high school students with cooperation from educators, government staff, and older people working as community volunteers. A total of 188 students were allocated to an intervention group and a waiting group. Outcome assessments were implemented at three points in time: before the program (Time 1), after the program (Time 2), and three months after the program (Time 3). Results showed that the number of people with worries increased in the intervention group compared with the waiting group between Time 1 and Time 2. There was also an increase in people with "reliable adults" between Time 1 and Time 3, and people with "adults who you can talk to at any time" increased between Time 2 and Time 3 in the intervention group. By implementing the SOS output education program with community cooperation, an increase was observed in the intervention group in terms of support-seeking awareness and the number of people with reliable adults and with adults who they can talk to at any time.

Need of care in interpreting Google Trends-based COVID-19 infodemiological study results: potential risk of false-positivity.

BACKGROUND: Google Trends (GT) is being used as an epidemiological tool to study coronavirus disease (COVID-19) by identifying keywords in search trends that are predictive for the COVID-19 epidemiological burden. However, many of the earlier GT-based studies include potential statistical fallacies by measuring the correlation between non-stationary time sequences without adjusting for multiple comparisons or the confounding of media coverage, leading to concerns about the increased risk of obtaining false-positive results. In this study, we aimed to apply statistically more favorable methods to validate the earlier GT-based COVID-19 study results. METHODS: We extracted the relative GT search volume for keywords associated with COVID-19 symptoms, and evaluated their Granger-causality to weekly COVID-19 positivity in eight English-speaking countries and Japan. In addition, the impact of media coverage on keywords with significant Granger-causality was further evaluated using Japanese regional data. RESULTS: Our Granger causality-based approach largely decreased (by up to approximately one-third) the number of keywords identified as having a significant temporal relationship with the COVID-19 trend when compared to those identified by Pearson or Spearman's rank correlation-based approach. "Sense of smell" and "loss of smell" were the most reliable GT keywords across all the evaluated countries; however, when adjusted with their media coverage, these keyword trends did not Granger-cause the COVID-19 positivity trends (in Japan). CONCLUSIONS: Our results suggest that some of the search keywords reported as candidate predictive measures in earlier GT-based COVID-19 studies may potentially be unreliable; therefore, caution is necessary when interpreting published GT-based study results.

The impact of COVID-19 pandemic on the utilization of ambulatory care for patients with chronic neurological diseases in Japan: Evaluation of an administrative claims database.

The COVID-19 pandemic has affected not only the emergency medical system, but also patients' regular ambulatory care, as such decrease in the number of patients visiting outpatient clinics decreased in 2020 than in 2019, or the ban lifting of subsequent visits by telephone for outpatient clinics since March 2020 in lieu of ambulatory care for chronic diseases. In this context, we investigate the impact of the COVID-19 pandemic on ambulatory care at Japanese outpatient clinics for patients with chronic neurological diseases during 2020. We collected data from the administrative claims database (DeSC database) covering more than 1 million individuals. Serial changes in the frequency of subsequent outpatient visits to clinics or hospitals (excluding large hospitals) for chronic ambulatory care of epilepsy, migraine, Parkinson's disease (PD), and Alzheimer's disease (AD) in 2020 were measured. As a result, since April 2020, the monthly outpatient visits for epilepsy, PD, and AD decreased slightly but significantly (approximately 0.90 in relative risk [RR]) but visits for migraine increased (RR = 1.15). Telephone visit was most frequently used in April-May, in less than 5% of monthly outpatient clinic visits for the examined neurological diseases. Outpatient visits for migraine treatment were more likely to be done by telephone than in case of other diseases (adjusted Odds ratio = 2.08). These results suggest that the impact of COVID-19 pandemic on regular ambulatory care for several chronic neurological diseases yielded different effect depending on the disease, in terms of the frequency or type of outpatient visits.

Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database.

In late March and early April 2020, the antimalarial drug, chloroquine, has been approved as an emergency treatment for the coronavirus disease 2019 (COVID-19) in the United States and in Europe. Although infrequent, neuropsychiatric symptoms have been reported in patients who received chloroquine for the treatment of malaria or autoimmune diseases. In this study, aiming to investigate these adverse events (AEs) using a large self-reporting database, we conducted a disproportionality analysis for the detection of neuropsychiatric AE signals associated with the use of chloroquine (or hydroxychloroquine), reported to FDA Adverse Event Reporting System (FAERS) database between the fourth quarter of 2012 and the fourth quarter of 2019. We included 2,389,474 AE cases, among which 520 cases developed neuropsychiatric AE following the use of chloroquine. Adjusted reporting odds ratio (ROR) for the development of each of the neuropsychiatric AEs following the use of chloroquine was calculated using a multilevel model: exposure to chloroquine was associated with a statistically significant high reporting of amnesia, delirium, hallucinations, depression, and loss of consciousness, (lower 95% confidence interval of the adjusted ROR > 1), although the degree of increase in their ROR was limited. There was no statistically significant high reporting of any other neuropsychiatric AE, including suicide, psychosis, confusion, and agitation. Current pharmacovigilance study results did not suggest any potential link between the use of chloroquine and an increased risk of suicide, psychosis, confusion, and agitation, which would be informative during the emergency use of chloroquine for the treatment of COVID-19.