Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021.

On April 7, 2021, after 5 weeks' use of the Janssen COVID-19 vaccine under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA), CDC received reports of clusters of anxiety-related events after administration of Janssen COVID-19 vaccine from five mass vaccination sites, all in different states. To further investigate these cases, CDC interviewed vaccination site staff members to gather additional information about the reported events and vaccination site practices. Four of the five sites temporarily closed while an investigation took place. Overall, 64 anxiety-related events, including 17 reports of syncope (fainting), an anxiety-related event, among 8,624 Janssen COVID-19 vaccine recipients, were reported from these sites for vaccines administered during April 7-9. As a follow-up to these interviews, CDC analyzed reports of syncope shortly after receipt of Janssen COVID-19 vaccine to the Vaccine Adverse Event Reporting System (VAERS), the vaccine safety monitoring program managed by CDC and FDA. To compare the occurrence of these events with those reported after receipt of other vaccines, reports of syncopal events after influenza vaccine administered in the 2019-20 influenza season were also reviewed. Syncope after Janssen COVID-19 vaccination was reported to VAERS (8.2 episodes per 100,000 doses). By comparison, after influenza vaccination, the reporting rate of syncope was 0.05 episodes per 100,000 doses. Anxiety-related events can occur after any vaccination. It is important that vaccination providers are aware that anxiety-related adverse events might be reported more frequently after receipt of the Janssen COVID-19 vaccine than after influenza vaccination and observe all COVID-19 vaccine recipients for any adverse reactions for at least 15 minutes after vaccine administration.

Destination memory accuracy and confidence in younger and older adults.

Background/Study Context: Nascent research on destination memory-remembering to whom we tell particular information-suggested that older adults have deficits in destination memory and are more confident on inaccurate responses than younger adults. This study assessed the effects of age, attentional resources, and mental imagery on destination memory accuracy and confidence in younger and older adults. METHODS: Using computer format, participants told facts to pictures of famous people in one of four conditions (control, self-focus, refocus, imagery). RESULTS: Older adults had lower destination memory accuracy than younger adults, driven by a higher level of false alarms. Whereas younger adults were more confident in accurate answers, older adults were more confident in inaccurate answers. Accuracy across participants was lowest when attention was directed internally but significantly improved when mental imagery was used. Importantly, the age-related differences in false alarms and high-confidence inaccurate answers disappeared when imagery was used. CONCLUSION: Older adults are more likely than younger adults to commit destination memory errors and are less accurate in related confidence judgments. Furthermore, the use of associative memory strategies may help improve destination memory across age groups, improve the accuracy of confidence judgments in older adults, and decrease age-related destination memory impairment, particularly in young-old adults.

A phase I trial of the aurora kinase inhibitor, ENMD-2076, in patients with relapsed or refractory acute myeloid leukemia or chronic myelomonocytic leukemia.

ENMD-2076 is a novel, orally-active molecule that inhibits Aurora A kinase, as well as c-Kit, FLT3 and VEGFR2. A phase I study was conducted to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) and toxicities of ENMD-2076 in patients with acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). Patients received escalating doses of ENMD-2076 administered orally daily [225 mg (n = 7), 375 mg (n = 6), 325 mg (n = 9), or 275 mg (n = 5)]. Twenty-seven patients were treated (26 AML; 1 CMML-2). The most common non-hematological toxicities of any grade, regardless of association with drug, were fatigue, diarrhea, dysphonia, dyspnea, hypertension, constipation, and abdominal pain. Dose-limiting toxicities (DLTs) consisted of grade 3 fatigue, grade 3 typhilitis, grade 3 syncope and grade 3 QTc prolongation). Of the 16 evaluable patients, one patient achieved a complete remission with incomplete count recovery (CRi), three experienced a morphologic leukemia-free state (MLFS) with a major hematologic improvement in platelets (HI-P), and 5 other patients had a reduction in marrow blast percentage (i.e. 11-65 %). The RP2D in this patient population is 225 mg orally once daily.

Access to disease treatment among patients presenting to the emergency department with asthma or hypertension.

BACKGROUND: Asthma and hypertension are common among Emergency Department (ED) patients. Primary care providers are integral in managing these conditions, yet these patients are often in the ED. OBJECTIVE: To determine access to care among ED patients with asthma or hypertension and the association with sociodemographic factors and disease acuity. METHODS: This was a prospective, cross-sectional study of ED patients at an urban county hospital conducted between June 4 and August 31, 2008. Consenting patients were surveyed, and peak flow or blood pressure measured as appropriate. Access to disease treatment was defined as self-reported access to a primary care provider or current prescription for asthma or hypertension, or both. Descriptive statistics and multinomial logistic regression were used to analyze data. RESULTS: There were 2303 patients enrolled; 283 had asthma, 543 had hypertension, and 187 had both. Seventy-one patients (25.1%) with asthma, 151 patients (27.8%) with hypertension, and 19 patients (10.2%) with both had poor access to disease treatment. Seeking ED medical attention was related to having poor access to treatment for patients with both asthma and hypertension. Females with asthma had poor access to treatment. In hypertension patients, good access to treatment was associated with excellent/good health status, housing status, and decreasing age. Poor access to treatment was associated with increasing blood pressure. CONCLUSIONS: Poor access to disease treatment and aspects of socioeconomic status were associated with seeking care in the ED. Changes in access to treatment may affect the number of patients seeking ED care, but not the severity of the presenting illness.

CHILDREN'S MOVEMENT SKILLS WHEN PLAYING ACTIVE VIDEO GAMES.

Active video games (AVGs) may be useful for movement skill practice. This study examined children's skill execution while playing Xbox Kinect™ and during movement skill assessment. Nineteen children (10 boys, 9 girls; M age=7.9 yr., SD=1.4) had their skills assessed before AVG play and then were observed once a week for 6 wk. while playing AVGs for 50 min. While AVG play showed evidence of correct skill performance (at least 30-50% of the time when playing table tennis, tennis, and baseball), nearly all skills were more correctly performed during skill assessment (generally more than 50% of the time). This study may help researchers to better understand the role AVGs could play in enhancing real life movement skills.

Hammersmith Infant Neurological Examination Subscores Are Predictive of Cerebral Palsy.

BACKGROUND: The Hammersmith Infant Neurological Examination (HINE) is a standardized assessment that identifies early signs of cerebral palsy (CP). In practice, the clinician performs this assessment in its entirety, yielding a global score. This study aimed to investigate the individual HINE subscores and "asymmetries" as predictive indicators of CP. METHODS: In this retrospective nested case-control study, a pediatric neurologist performed the HINE on a cohort of three- to four-month-old former neonatal intensive care unit infants. The infants' neurodevelopmental outcomes were determined by chart review when they were aged two to three years. We performed univariate and multivariable logistic regression analyses to yield the accuracy of the global HINE score, HINE subscores, and "asymmetries" in classifying infants with and without CP. RESULTS: Of the 108 infants on whom HINE was performed, 50 were either discharged due to normal developmental progress or were lost to follow-up. Of the remaining 58 subjects, 17 had CP and 41 did not. Receiver operator characteristic (ROC) curves of univariate models yielded the following area under the curve (AUC) scores: global HINE score (AUC = 0.75), "reflexes and reactions" (AUC = 0.80), "cranial nerve function" (AUC = 0.76), "asymmetries" (AUC = 0.75), and "movements" (AUC = 0.71). The ROC for our multivariable model (AUC = 0.91) surpassed the global HINE score's predictive value for CP. CONCLUSIONS: The weighted combination of HINE subscores and "asymmetries" outperforms the global HINE score in predicting CP. These findings suggest the need for revisiting HINE, but further validation with a larger dataset is required.

CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description.

The U.S. Centers for Disease Control and Prevention (CDC) developed and implemented the CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) to monitor vaccine safety. Potential participants who received a COVID-19 vaccine in pregnancy or up to 30 days prior to their pregnancy-associated last menstrual period were eligible to participate in the registry, which monitored health outcomes of participants and their infants through phone interviews and review of available medical records. Data for select outcomes, including birth defects, were reviewed by clinicians. In certain cases, medical records were used to confirm and add detail to participant-reported health conditions. This paper serves as a description of CDC C19VPR protocol. We describe the development and implementation for each data collection aspect of the registry (i.e., participant phone interviews, clinical review, and medical record abstraction), data management, and strengths and limitations. We also describe the demographics and vaccinations received among eligible and enrolled participants. There were 123,609 potential participants 18-54 years of age identified from January 2021 through mid-June 2021; 23,339 were eligible and enrolled into the registry. Among these, 85.3 % consented to medical record review for themselves and/or their infants. Participants were majority non-Hispanic White (79.1 %), residents of urban areas (93.3 %), and 48.3 % were between 30 and 34 years of age. Most participants completed the primary series of vaccination by the end of pregnancy (89.7 %). Many participants were healthcare personnel (44.8 %), possibly due to the phased roll-out of the vaccination program. The registry continues to provide important information about the safety of COVID-19 vaccination among pregnant people, a population with higher risk of poor outcomes from COVID-19 who were not included in pre-authorization clinical trials. Lessons learned from the registry may guide development and implementation of future vaccine safety monitoring efforts for pregnant people and their infants.

The role of supportive messages and distracting thoughts on everyday problem-solving performance.

UNLABELLED: BACKGROUND/STUDY CONTEXT: An increasing number of studies have examined factors related to everyday problem-solving performance across adulthood. The current study examined the role of experimentally provided supportive messages intended to provide practical or emotional support on everyday problem-solving performance. Other factors such as participant age and distracting thoughts experienced during task completion were also investigated. METHODS: Everyday problem-solving performance, verbal ability performance, inductive reasoning performance, and self-reports of distracting thoughts were obtained from 54 middle-aged and 48 older adults. Participants were also exposed to practically supportive messages, emotionally supportive messages, or no supportive messages prior to completing the everyday problem-solving task. RESULTS: Exposure to emotionally supportive messages increased task performance and lowered levels of distracting thoughts. Distracting thoughts mediated the relation between exposure to emotionally supportive messages and everyday problem-solving performance. Distracting thoughts also mediated the relation between age and everyday problem-solving performance. CONCLUSION: Study findings indicate that emotionally supportive messages may increase everyday problem-solving performance by decreasing the amount of distracting thoughts experienced by participants. This finding suggests that consistent administration of emotionally supportive messages could result in more optimal everyday problem-solving performance among middle-aged and older adults.

Supine lying center of pressure movement characteristics as a predictor of normal developmental stages in early infancy.

BACKGROUND: Absent or abnormal fidgety movements in young infants are associated with subsequent diagnoses of developmental disorders such as cerebral palsy. The General Movement Assessment (GMA) is a qualitative clinical tool to visually identify infants with absent or abnormal fidgety movements associated with developmental stage, yet no quantitative measures exist to detect fidgety activity. OBJECTIVE: To determine whether a correlation exists between quantitative Center of Pressure (CoP) measurements during supine lying and age. METHODS: Twenty-four healthy full-term infants participated in the Institutional Review Board-approved study. Participants were placed supine in view of a GoPro camera on an AMTI force plate for two minutes. Spontaneous movements were evaluated by three trained raters using the GMA. Traditional CoP parameters (range, total path length, mean velocity, and mean acceleration of resultant CoP) were assessed, and complexity of each of the resultant CoP variables (location, velocity, and acceleration) was calculated by sample entropy. Linear regression with Pearson correlation was performed to assess the correlations between the CoP parameters and adjusted age. RESULTS: Nineteen infants were deemed fidgety per the GMA and were included in further analyses. All Sample entropy measures and range of resultant CoP had significant correlations with adjusted age (p< 0.05). Sample entropy of resultant CoP decreased with increasing age while range of resultant CoP increased with increasing age. CONCLUSION: The results suggest that complexity of CoP and range of CoP are good predictors of age in typical developing infants during the fidgety period. Therefore, an approach using these parameters should be explored further as a quantifiable tool to identify infants at risk for neurodevelopmental impairment.

Utilization of social media communities for caregiver information support in stroke recovery: An analysis of content and interactions.

BACKGROUND: Caregivers often use the internet to access information related to stroke care to improve preparedness, thereby reducing uncertainty and enhancing the quality of care. METHOD: Social media communities used by caregivers of people affected by stroke were identified using popular keywords searched for using Google. Communities were filtered based on their ability to provide support to caregivers. Data from the included communities were extracted and analysed to determine the content and level of interaction. RESULTS: There was a significant rise in the use of social media by caregivers of people affected by stroke. The most popular social media communities were charitable and governmental organizations with the highest user interaction-this was for topics related to stroke prevention, signs and symptoms, and caregiver self-care delivered through video-based resources. CONCLUSION: Findings show the ability of social media to support stroke caregiver needs and practices that should be considered to increase their interaction and support.

Inhibition of Cell Proliferation and MAP Kinase and Akt Pathways in Oral Squamous cell Carcinoma by Genistein and Biochanin A.

High morbidity and mortality associated with oral squamous cell carcinoma (OSCC) are largely attributable to late stage diagnosis. Despite significant advances in therapeutic strategies, the five-year survival rate for oral cancer remains at about 50%. A chemopreventive approach may be an effective alternative or adjunct to current therapies. Previous studies have shown anti-tumor effects of isoflavones in several cancers, including oral cancer. However, their mechanisms of action are still unclear. We hypothesized that isoflavones inhibit multiple signaling pathways implicated in oral carcinogenesis. To address our hypothesis, we investigated the effects of three isoflavone derivatives, genistein, biochanin A and daidzein, on SCC15 and SCC25 squamous cell carcinoma cell lines. In cell proliferation experiments, we found that genistein and biochanin A inhibited SCC15 and SCC25 cell growth with an IC50 of 50 µM. We also investigated the effect of isoflavones on ERK and Akt pathways. Our results, from western blot analysis, suggest that both genistein and biochanin A induced decreases in phosphorylation of ERK and Akt at treatment concentrations of 20, 50 and 100 µM. Taken together, our results clearly demonstrate a differential regulation of signaling pathways by various isoflavones in OSCC cell lines. Thus, tumor progression models can be utilized to study the preventive and therapeutic roles of isoflavones in oral cancer cell lines.

Aspirin Use among Adults with Cardiovascular Disease in the United States: Implications for an Intervention Approach.

Cardiovascular disease (CVD) is a major underlying cause of death, with high economic burden in most countries, including the United States. Lifestyle modifications and the use of antiplatelet therapy, such as aspirin, can contribute significantly to secondary prevention of CVD in adults. This study examined the prevalence and associated factors of aspirin use for the secondary prevention of angina pectoris, myocardial infarction (MI), and cerebrovascular disease (stroke) in a sample of American adults. The 2015 Behavioral Risk Factor Surveillance System (BRFSS) dataset was analyzed for this cross-sectional study. Almost 16% of the study population (N = 441,456) had angina, MI, or stroke. Weighted percentages of respondents with angina, MI, and stroke were 4%, 4.3%, and 3%, respectively. Overall, weighted prevalence of daily (or every other day) aspirin use was about 65%, 71%, and 57% among respondents with angina, MI, and stroke, respectively. Factors that were significantly associated with aspirin use included male sex, more than high school education, high blood pressure, diabetes, and less than excellent general health. There were existing differences among individuals with CVD based on diagnosis, demographic and socioeconomic status in the use of aspirin for secondary prevention. Resources for promoting aspirin use should be directed toward groups with lower utilization.

Respiratory health, allergies, and the farm environment: design, methods and enrollment in the observational Wisconsin Infant Study Cohort (WISC): a research proposal.

Epidemiologic and cross-sectional studies suggest that early life farming and animal exposures are associated with major health benefits, influencing immune development and modifying the subsequent risk of allergic diseases, including asthma. The Wisconsin Infant Study Cohort (WISC) study was established in central Wisconsin to test the hypothesis that early life animal farm exposures are associated with distinct innate immune cell maturation trajectories, decreased allergen sensitization and reduced respiratory viral illness burden during the first 2 years of life. Beginning in 2013, a total of 240 families have been enrolled, 16,522 biospecimens have been collected, and 4098 questionnaires have been administered and entered into a secure database. Study endpoints include nasal respiratory virus identification and respiratory illness burden score, allergic sensitization, expression of allergic disease, and anti-viral immune response maturation and profiles. The WISC study prospective design, broad biospecimen collections, and unique US rural community will provide insights into the role of environmental exposures on early life immune maturation profiles associated with protection from allergic sensitization and significant respiratory viral disease burden. The WISC study findings will ultimately inform development of new strategies to promote resistance to severe respiratory viral illnesses and design primary prevention approaches for allergic diseases for all infants.

Polypharmacy and Off-label Drug Use in Dentistry: knowledge, attitudes and practices of California dental hygienists.

Purpose: This study examined the knowledge, attitudes, and practices of dental hygienists, licensed in the state of California, regarding polypharmacy and off-label drug use for purposes in dentistry.Methods: A cross-sectional design was used to assess the knowledge, attitudes, and practices (KAP) related to off-label drug use and polypharmacy via an online survey tool. The study sample included licensed dental hygienists, who were members of the Long Beach and Tri-County Dental Hygienists' Associations located in Southern California (n=360). Descriptive statistics were used to assess the participant characteristics. ANOVA was used to assess differences in knowledge, attitudes and practices when compared to three key variables: highest academic/professional degree, experience and license type.Results: One hundred seven electronic surveys (n=107) were returned for a 34% response rate. Over half of respondents (53%) held an associates' degree for their license, most (72%) worked in a general dentistry setting and 46% had practiced 15 years or less. Regarding knowledge of polypharmacy and off-label drug use, the results demonstrated very low knowledge, with 25% of the respondents unable to answer any of the knowledge questions correctly. No significant differences in practices related to off-label drugs or polypharmacy were found based on type of licensure, highest degree achieved, or years of experience. However, participants holding a baccalaureate degree or higher were significantly more confident (p=.011) in discussing polypharmacy with patients and colleagues.Conclusion: Participants showed a general low-level of knowledge related to polypharmacy and off-label drug use in dentistry regardless of their level of education, years of experience, or type of dental hygiene licensure; indicating a need for increased pharmacology content in both entry-level dental hygiene programs and continuing education courses.

Selenium, Mercury, and Their Molar Ratio in Sportfish from Drinking Water Reservoirs.

Mercury (Hg) bioaccumulates in aquatic ecosystems and may pose a risk to humans who consume fish. Selenium (Se) has the ability to reduce Hg toxicity, but the current guidance for human consumption of fish is based on Hg concentration alone. The purpose of the present study was to examine the relationship between Se and Hg in freshwater sportfish, for which there is a paucity of existing data. We collected three species of fish from different trophic positions from two drinking water reservoirs in central North Carolina, USA, to assess Hg and Se concentrations in relation to fish total length and to compare two measures of the protective ability of Se, the Se:Hg molar ratio and Se health benefit value (HBVSe), to current guidance for Hg. According to the Se:Hg molar ratio, all of the low trophic position fish sampled and the middle trophic position fish sampled from one of the reservoirs were safe for consumption. The same number of fish were considered safe using the HBVSe. More fish were deemed unsafe when using the Se:Hg molar ratio and HBVSe than were considered unsafe when using the U.S. Environmental Protection Agency (USEPA) Hg threshold. These findings suggest that the measures of Se protection may be unnecessarily conservative or that the USEPA Hg threshold may not be sufficiently protective of human health, especially the health of sensitive populations like pregnant or nursing mothers and young children. Future examination of the Se:Hg molar ratio and HBVSe from a variety of fish tissue samples would help refine the accuracy of these measures so that they may be appropriately utilized in ecological and human health risk assessment.

Thiophilic interaction chromatography (TIC) of amyloid-beta protein precursor.

Neuritic plaques, one of the diagnostic characteristics of an AD, contain extracellular deposits of amyloid-beta (Abeta) derived from amyloid-beta protein precursor (AbetaPP). The objective of this study was to extract AbetaPP out of HEK293 cells and to purify it. Two procedures were chosen for purification of AbetaPP: Thiophilic Interaction Chromatography (TIC) and molecular sieving. Using Superdex 75, Superose 12, and Fractogel gel matrices, AbetaPP was isolated on HPLC. The chromatograms illustrate the purification of AbetaPP. Our method describes a new and elegant way for the extraction and purification of AbetaPP from HEK293 cell lines using thiophilic interaction chromatography (TIC).

Comparing mechanical fetal response during descent, crowning, and restitution among deliveries with and without shoulder dystocia.

OBJECTIVE: Previous computer simulations of shoulder dystocia (SD) explored the effect of SD itself on the mechanical response of the fetus. Our objective was to perform a mechanical simulation study to explore the variations in fetal response during routine, unilateral SD (USD), and bilateral SD (BSD) deliveries. STUDY DESIGN: Using a biofidelic birthing simulator, we performed 30 experiments mimicking passage of the fetus through the pelvis. For routine deliveries, we engaged the fetal head and allowed it to progress through cardinal movements using typical uterine contraction forces. Deliveries stopped when the head restituted externally to left occiput anterior (LOA) position. The identical procedure was repeated for USD deliveries, except we obstructed the anterior shoulder on the symphysis pubis; for BSD, the posterior shoulder was also impacted on the sacral promontory. For each delivery we continuously measured head rotation, brachial plexus (BP) stretch and neck extension, selecting peak values for analysis. Maximum rotation, BP stretch, and extension were compared among groups using analysis of variance, with P < .05 considered significant. RESULTS: Among routine, USD, and BSD deliveries, mean peak BP stretch varied between 10% and 21%, rotation varied between 70 degrees and 77 degrees, and extension varied between 6% and 18%. Greatest stretch occurred in the posterior BP during descent in non-SD deliveries, whereas anterior BP stretch, rotation, and extension were similar among the 3 types of deliveries. CONCLUSION: Quantifiable mechanical response occurs in routine and SD deliveries. Posterior BP stretch is significantly longer for routine deliveries than either USD or BSD deliveries. By itself, shoulder dystocia does not pose additional risk of brachial plexus stretch over routine deliveries.

After shoulder dystocia: managing the subsequent pregnancy and delivery.

Among risk factors for shoulder dystocia, a prior history of delivery complicated by shoulder dystocia is the single greatest risk factor for shoulder dystocia occurrence, with odds ratios 7 to 10 times that of the general population. Recurrence rates have been reported to be as high as 16%. Whereas prevention of shoulder dystocia in the general population is neither feasible nor cost-effective, intervention efforts directed at the particular subgroup of women with a prior history of shoulder dystocia can concentrate on potentially modifiable risk factors and individualized management strategies that can minimize recurrence and the associated significant morbidities and mortality.