Last data update: Apr 29, 2024. (Total: 46658 publications since 2009)
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Coronavirus disease 2019 infections among emergency health care personnel: Impact on delivery of United States emergency medical care, 2020
Weber KD , Mower W , Krishnadasan A , Mohr NM , Montoy JC , Rodriguez RM , Giordano PA , Eyck PT , Harland KK , Wallace K , McDonald LC , Kutty PK , Hesse EM , Talan DA . Ann Emerg Med 2024 STUDY OBJECTIVE: In the early months of the coronavirus disease 2019 (COVID-19) pandemic and before vaccine availability, there were concerns that infected emergency department (ED) health care personnel could present a threat to the delivery of emergency medical care. We examined how the pandemic affected staffing levels and whether COVID-19 positive staff were potentially infectious at work in a cohort of US ED health care personnel in 2020. METHODS: The COVID-19 Evaluation of Risks in Emergency Departments (Project COVERED) project was a multicenter prospective cohort study of US ED health care personnel conducted from May to December 2020. During surveillance, health care personnel completed weekly electronic surveys and underwent periodic serology and nasal reverse transcription polymerase chain reaction testing for SARS-CoV-2, and investigators captured weekly data on health care facility COVID-19 prevalence and health care personnel staffing. Surveys asked about symptoms, potential exposures, work attendance, personal protective equipment use, and behaviors. RESULTS: We enrolled 1,673 health care personnel who completed 29,825 person weeks of surveillance. Eighty-nine (5.3%) health care personnel documented 90 (0.3%; 95% confidence interval [CI] 0.2% to 0.4%) person weeks of missed work related to documented or concerns for COVID-19 infection. Health care personnel experienced symptoms of COVID-19 during 1,256 (4.2%) person weeks and worked at least one shift whereas symptomatic during 1,042 (83.0%) of these periods. Seventy-five (4.5%) participants tested positive for SARS-CoV-2 during the surveillance period, including 43 (57.3%) who indicated they never experienced symptoms; 74 (98.7%; 95% CI 90.7% to 99.9%) infected health care personnel worked at least one shift during the initial period of infection, and 71 (94.7%) continued working until laboratory confirmation of their infection. Physician staffing was not associated with the facility or community COVID-19 levels within any time frame studied (Kendall tau's 0.02, 0.056, and 0.081 for no shift, one-week time shift, and 2-week time shift, respectively). CONCLUSIONS: During the first wave of the pandemic, COVID-19 infections in ED health care personnel were infrequent, and the time lost from the workforce was minimal. Health care personnel frequently reported for work while infected with SARS-CoV-2 before laboratory confirmation. The ED staffing levels were poorly correlated with facility and community COVID-19 burden. |
CDC guidelines for the prevention and treatment of anthrax, 2023
Bower WA , Yu Y , Person MK , Parker CM , Kennedy JL , Sue D , Hesse EM , Cook R , Bradley J , Bulitta JB , Karchmer AW , Ward RM , Cato SG , Stephens KC , Hendricks KA . MMWR Recomm Rep 2023 72 (6) 1-47 THIS REPORT UPDATES PREVIOUS CDC GUIDELINES AND RECOMMENDATIONS ON PREFERRED PREVENTION AND TREATMENT REGIMENS REGARDING NATURALLY OCCURRING ANTHRAX. ALSO PROVIDED ARE A WIDE RANGE OF ALTERNATIVE REGIMENS TO FIRST-LINE ANTIMICROBIAL DRUGS FOR USE IF PATIENTS HAVE CONTRAINDICATIONS OR INTOLERANCES OR AFTER A WIDE-AREA AEROSOL RELEASE OF: Bacillus anthracis spores if resources become limited or a multidrug-resistant B. anthracis strain is used (Hendricks KA, Wright ME, Shadomy SV, et al.; Workgroup on Anthrax Clinical Guidelines. Centers for Disease Control and Prevention expert panel meetings on prevention and treatment of anthrax in adults. Emerg Infect Dis 2014;20:e130687; Meaney-Delman D, Rasmussen SA, Beigi RH, et al. Prophylaxis and treatment of anthrax in pregnant women. Obstet Gynecol 2013;122:885-900; Bradley JS, Peacock G, Krug SE, et al. Pediatric anthrax clinical management. Pediatrics 2014;133:e1411-36). Specifically, this report updates antimicrobial drug and antitoxin use for both postexposure prophylaxis (PEP) and treatment from these previous guidelines best practices and is based on systematic reviews of the literature regarding 1) in vitro antimicrobial drug activity against B. anthracis; 2) in vivo antimicrobial drug efficacy for PEP and treatment; 3) in vivo and human antitoxin efficacy for PEP, treatment, or both; and 4) human survival after antimicrobial drug PEP and treatment of localized anthrax, systemic anthrax, and anthrax meningitis. CHANGES FROM PREVIOUS CDC GUIDELINES AND RECOMMENDATIONS INCLUDE AN EXPANDED LIST OF ALTERNATIVE ANTIMICROBIAL DRUGS TO USE WHEN FIRST-LINE ANTIMICROBIAL DRUGS ARE CONTRAINDICATED OR NOT TOLERATED OR AFTER A BIOTERRORISM EVENT WHEN FIRST-LINE ANTIMICROBIAL DRUGS ARE DEPLETED OR INEFFECTIVE AGAINST A GENETICALLY ENGINEERED RESISTANT: B. anthracis strain. In addition, these updated guidelines include new recommendations regarding special considerations for the diagnosis and treatment of anthrax meningitis, including comorbid, social, and clinical predictors of anthrax meningitis. The previously published CDC guidelines and recommendations described potentially beneficial critical care measures and clinical assessment tools and procedures for persons with anthrax, which have not changed and are not addressed in this update. In addition, no changes were made to the Advisory Committee on Immunization Practices recommendations for use of anthrax vaccine (Bower WA, Schiffer J, Atmar RL, et al. Use of anthrax vaccine in the United States: recommendations of the Advisory Committee on Immunization Practices, 2019. MMWR Recomm Rep 2019;68[No. RR-4]:1-14). The updated guidelines in this report can be used by health care providers to prevent and treat anthrax and guide emergency preparedness officials and planners as they develop and update plans for a wide-area aerosol release of B. anthracis. |
COVID-19 vaccine safety first year findings in adolescents
Hesse EM , Hause A , Myers T , Su JR , Marquez P , Zhang B , Cortese MM , Thames-Allen A , Curtis CR , Maloney SA , Thompson D , Nair N , Alimchandani M , Niu M , Gee J , Shay DK , Shimabukuro TT . Pediatrics 2023 151 (5) BACKGROUND AND OBJECTIVES: The Food and Drug Administration expanded Emergency Use Authorization for use of Pfizer-BioNTech (BNT-162b2) coronavirus disease 2019 vaccine to include people ages 12 years and older on May 10, 2021. We describe adverse events observed during the first full year of the US coronavirus disease 2019 vaccination program for adolescents ages 12 to 17 years. METHODS: We conducted descriptive analyses using data from 2 complementary US vaccine safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health impacts, and the Vaccine Adverse Event Reporting System (VAERS), the national spontaneous reporting system. We reviewed reports and calculated adverse event reporting rates using vaccine administration data. RESULTS: Among 172 032 adolescents ages 12 to 17 years enrolled in v-safe, most reported reactions following BNT-162b2 were mild to moderate, most frequently reported on the day after vaccination, and more common after dose 2. VAERS received 20 240 adverse event reports; 91.5% were nonserious. Among adverse events of interest, we verified 40 cases of multisystem inflammation syndrome in children (1.2 cases per million vaccinations), 34 (85%) of which had evidence of prior severe acute respiratory syndrome coronavirus 2 infection; and 570 cases of myocarditis (17.7 cases per million vaccinations), most of whom (77%) reported symptom resolution at the time of report. CONCLUSIONS: During the first year BNT-162b2 was administered to adolescents ages 12 to 17 years, most reported adverse events were mild and appeared self-limited. Rates of myocarditis were lower than earlier reports. No new serious safety concerns were identified. |
Antitoxin use in the prevention and treatment of anthrax disease: A systematic review
Hesse EM , Godfred-Cato S , Bower WA . Clin Infect Dis 2022 75 S432-s440 BACKGROUND: Bacillus anthracis is a high-priority threat agent because of its widespread availability, easy dissemination, and ability to cause substantial morbidity and mortality. Although timely and appropriate antimicrobial therapy can reduce morbidity and mortality, the role of adjunctive therapies continues to be explored. METHODS: We searched 11 databases for articles that report use of anthrax antitoxins in treatment or prevention of systemic anthrax disease published through July 2019. We identified other data sources through reference search and communication with experts. We included English-language studies on antitoxin products with approval by the US Food and Drug Administration (FDA) for anthrax in humans, nonhuman primates, and rabbits. Two researchers independently reviewed studies for inclusion and abstracted relevant data. RESULTS: We abstracted data from 12 publications and 2 case reports. All 3 FDA-approved anthrax antitoxins demonstrated significant improvement in survival as monotherapy over placebo in rabbits and nonhuman primates. No study found significant improvement in survival with combination antitoxin and antimicrobial therapy compared to antimicrobial monotherapy. Case reports and case series described 25 patients with systemic anthrax disease treated with antitoxins; 17 survived. Animal studies that used antitoxin monotherapy as postexposure prophylaxis (PEP) demonstrated significant improvement in survival over placebo, with greatest improvements coming with early administration. CONCLUSIONS: Limited human and animal evidence indicates that adjunctive antitoxin treatment may improve survival from systemic anthrax infection. Antitoxins may also provide an alternative therapy to antimicrobials for treatment or PEP during an intentional anthrax incident that could involve a multidrug-resistant B. anthracis strain. |
Emergency department personnel patient care-related COVID-19 risk.
Mohr NM , Krishnadasan A , Harland KK , Ten Eyck P , Mower WR , Schrading WA , Montoy JCC , McDonald LC , Kutty PK , Hesse E , Santibanez S , Weissman DN , Slev P , Talan DA . PLoS One 2022 17 (7) e0271597 OBJECTIVES: Emergency department (ED) health care personnel (HCP) are at risk of exposure to SARS-CoV-2. The objective of this study was to determine the attributable risk of SARS-CoV-2 infection from providing ED care, describe personal protective equipment use, and identify modifiable ED risk factors. We hypothesized that providing ED patient care increases the probability of acquiring SARS-CoV-2 infection. METHODS: We conducted a multicenter prospective cohort study of 1,673 ED physicians, advanced practice providers (APPs), nurses, and nonclinical staff at 20 U.S. centers over 20 weeks (May to December 2020; before vaccine availability) to detect a four-percentage point increased SARS-CoV-2 incidence among HCP related to direct patient care. Participants provided monthly nasal and serology specimens and weekly exposure and procedure information. We used multivariable regression and recursive partitioning to identify risk factors. RESULTS: Over 29,825 person-weeks, 75 participants (4.5%) acquired SARS-CoV-2 infection (31 were asymptomatic). Physicians/APPs (aOR 1.07; 95% CI 0.56-2.03) did not have higher risk of becoming infected compared to nonclinical staff, but nurses had a marginally increased risk (aOR 1.91; 95% CI 0.99-3.68). Over 99% of participants used CDC-recommended personal protective equipment (PPE), but PPE lapses occurred in 22.1% of person-weeks and 32.1% of SARS-CoV-2-infected patient intubations. The following factors were associated with infection: household SARS-CoV-2 exposure; hospital and community SARS-CoV-2 burden; community exposure; and mask non-use in public. SARS-CoV-2 intubation was not associated with infection (attributable risk fraction 13.8%; 95% CI -2.0-38.2%), and nor were PPE lapses. CONCLUSIONS: Among unvaccinated U.S. ED HCP during the height of the pandemic, the risk of SARS-CoV-2 infection was similar in nonclinical staff and HCP engaged in direct patient care. Many identified risk factors were related to community exposures. |
Mycobacterium porcinum Skin and Soft Tissue Infections After Vaccinations - Indiana, Kentucky, and Ohio, September 2018-February 2019
Blau EF , Flinchum A , Gaub KL , Hartnett KP , Curran M , Allen VK , Napier A , Hesse EM , Hause AM , Cathey R , Feaster C , Mohr M , de Fijter S , Mitchell S , Moulton-Meissner HA , Benowitz I , Spicer KB , Thoroughman DA . MMWR Morb Mortal Wkly Rep 2021 70 (42) 1472-1477 During December 2018-February 2019, a multistate investigation identified 101 patients with vaccination-associated adverse events among an estimated 940 persons in Kentucky, Indiana, and Ohio who had received influenza; hepatitis A; pneumococcal; or tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines at the workplace during September 11-November 28, 2018. These vaccines had been administered by staff members of a third-party health care company contracted by 24 businesses. Company A provided multiple vaccine types during workplace vaccination events across 54 locations in these adjoining states. Injection-site wound isolates from patients yielded Mycobacterium porcinum, a nontuberculous mycobacteria (NTM) species in the Mycobacterium fortuitum group; subtyping using pulsed-field gel electrophoresis of all 28 available isolates identified two closely related clusters. Site visits to company A and interviews with staff members identified inadequate hand hygiene, improper vaccine storage and handling, lack of appropriate medical record documentation, and lack of reporting to the Vaccine Adverse Event Reporting System (VAERS). Vaccination-associated adverse events can be prevented by training health care workers responsible for handling or administering vaccines in safe vaccine handling, administration, and storage practices, timely reporting of any suspected vaccination-associated adverse events to VAERS, and notifying public health authorities of any adverse event clusters. |
Demographic, clinical, and epidemiologic characteristics of persons under investigation for Coronavirus Disease 2019-United States, January 17-February 29, 2020.
McGovern OL , Stenger M , Oliver SE , Anderson TC , Isenhour C , Mauldin MR , Williams N , Griggs E , Bogere T , Edens C , Curns AT , Lively JY , Zhou Y , Xu S , Diaz MH , Waller JL , Clarke KR , Evans ME , Hesse EM , Morris SB , McClung RP , Cooley LA , Logan N , Boyd AT , Taylor AW , Bajema KL , Lindstrom S , Elkins CA , Jones C , Hall AJ , Graitcer S , Oster AM , Fry AM , Fischer M , Conklin L , Gokhale RH . PLoS One 2021 16 (4) e0249901 BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), evolved rapidly in the United States. This report describes the demographic, clinical, and epidemiologic characteristics of 544 U.S. persons under investigation (PUI) for COVID-19 with complete SARS-CoV-2 testing in the beginning stages of the pandemic from January 17 through February 29, 2020. METHODS: In this surveillance cohort, the U.S. Centers for Disease Control and Prevention (CDC) provided consultation to public health and healthcare professionals to identify PUI for SARS-CoV-2 testing by quantitative real-time reverse-transcription PCR. Demographic, clinical, and epidemiologic characteristics of PUI were reported by public health and healthcare professionals during consultation with on-call CDC clinicians and subsequent submission of a CDC PUI Report Form. Characteristics of laboratory-negative and laboratory-positive persons were summarized as proportions for the period of January 17-February 29, and characteristics of all PUI were compared before and after February 12 using prevalence ratios. RESULTS: A total of 36 PUI tested positive for SARS-CoV-2 and were classified as confirmed cases. Confirmed cases and PUI testing negative for SARS-CoV-2 had similar demographic, clinical, and epidemiologic characteristics. Consistent with changes in PUI evaluation criteria, 88% (13/15) of confirmed cases detected before February 12, 2020, reported travel from China. After February 12, 57% (12/21) of confirmed cases reported no known travel- or contact-related exposures. CONCLUSIONS: These findings can inform preparedness for future pandemics, including capacity for rapid expansion of novel diagnostic tests to accommodate broad surveillance strategies to assess community transmission, including potential contributions from asymptomatic and presymptomatic infections. |
Diagnosed and Undiagnosed COVID-19 in US Emergency Department Health Care Personnel: A Cross-sectional Analysis.
Mohr NM , Harland KK , Krishnadasan A , Eyck PT , Mower WR , Willey J , Chisolm-Straker M , Lim SC , McDonald LC , Kutty PK , Hesse E , Santibanez S , Talan DA . Ann Emerg Med 2020 78 (1) 27-34 STUDY OBJECTIVE: We determine the percentage of diagnosed and undiagnosed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among a sample of US emergency department (ED) health care personnel before July 2020. METHODS: This was a cross-sectional analysis of ED health care personnel in 20 geographically diverse university-affiliated EDs from May 13, to July 8, 2020, including case counts of prior laboratory-confirmed coronavirus disease 2019 (COVID-19) diagnoses among all ED health care personnel, and then point-in-time serology (with confirmatory testing) and reverse transcriptase-polymerase chain reaction testing in a sample of volunteers without a previous COVID-19 diagnosis. Health care staff were categorized as clinical (physicians, advanced practice providers, and nurses) and nonclinical (clerks, social workers, and case managers). Previously undiagnosed infection was based on positive SARS-CoV-2 serology or reverse transcriptase-polymerase chain reaction result among health care personnel without prior diagnosis. RESULTS: Diagnosed COVID-19 occurred in 2.8% of health care personnel (193/6,788), and the prevalence was similar for nonclinical and clinical staff (3.8% versus 2.7%; odds ratio 1.5; 95% confidence interval 0.7 to 3.2). Among 1,606 health care personnel without previously diagnosed COVID-19, 29 (1.8%) had evidence of current or past SARS-CoV-2 infection. Most (62%; 18/29) who were seropositive did not think they had been infected, 76% (19/25) recalled COVID-19-compatible symptoms, and 89% (17/19) continued to work while symptomatic. Accounting for both diagnosed and undiagnosed infections, 4.6% (95% confidence interval 2.8% to 7.5%) of ED health care personnel were estimated to have been infected with SARS-CoV-2, with 38% of those infections undiagnosed. CONCLUSION: In late spring and early summer 2020, the estimated prevalence of severe acute respiratory syndrome coronavirus 2 infection was 4.6%, and greater than one third of infections were undiagnosed. Undiagnosed SARS-CoV-2 infection may pose substantial risk for transmission to other staff and patients. |
Myopericarditis Associated With Smallpox Vaccination Among US Army Personnel - Fort Hood, Texas, 2018
Mandra AM , Superior MJ , Guagliardo SAJ , Hesse E , Pacha LA , Stidham RA , Colbeck DC , Hrncir DE , Hall N , Petersen BW , Rao AK . Disaster Med Public Health Prep 2021 16 (3) 1-7 OBJECTIVE: In March 2018, the US Department of Defense (DOD) added the smallpox vaccination, using ACAM2000, to its routine immunizations, increasing the number of persons receiving the vaccine. The following month, Fort Hood reported a cluster of 5 myopericarditis cases. The Centers for Disease Control and Prevention and the DOD launched an investigation. METHODS: The investigation consisted of a review of medical records, establishment of case definitions, causality assessment, patient interviews, and active surveillance. A 2-sided exact rate ratio test was used to compare myopericarditis incidence rates. RESULTS: This investigation identified 4 cases of probable myopericarditis and 1 case of suspected myopericarditis. No alternative etiology was identified as a cause. No additional cases were identified. There was no statistically significant difference in incidence rates between the observed cluster (5.23 per 1000 vaccinated individuals, 95% CI: 1.7-12.2) and the ACAM2000 clinical trial outcomes for symptomatic persons, which was 2.29 per 1000 vaccinated individuals (95% CI: 0.3-8.3). CONCLUSIONS: Vaccination with ACAM2000 is the presumptive cause of this cluster. Caution should be exercised before considering vaccination campaigns for smallpox given the clinical morbidity and costs incurred by a case of myopericarditis. Risk of myopericarditis should be carefully weighed with risk of exposure to smallpox. |
Clinical and Laboratory Findings in Patients with Potential SARS-CoV-2 Reinfection, May-July 2020.
Lee JT , Hesse EM , Paulin HN , Datta D , Katz LS , Talwar A , Chang G , Galang RR , Harcourt JL , Tamin A , Thornburg NJ , Wong KK , Stevens V , Kim K , Tong S , Zhou B , Queen K , Drobeniuc J , Folster JM , Sexton DJ , Ramachandran S , Browne H , Iskander J , Mitruka K . Clin Infect Dis 2021 73 (12) 2217-2225 BACKGROUND: We investigated patients with potential SARS-CoV-2 reinfection in the United States during May-July 2020. METHODS: We conducted case finding for patients with potential SARS-CoV-2 reinfection through the Emerging Infections Network. Cases reported were screened for laboratory and clinical findings of potential reinfection followed by requests for medical records and laboratory specimens. Available medical records were abstracted to characterize patient demographics, comorbidities, clinical course, and laboratory test results. Submitted specimens underwent further testing, including RT-PCR, viral culture, whole genome sequencing, subgenomic RNA PCR, and testing for anti-SARS-CoV-2 total antibody. RESULTS: Among 73 potential reinfection patients with available records, 30 patients had recurrent COVID-19 symptoms explained by alternative diagnoses with concurrent SARS-CoV-2 positive RT-PCR, 24 patients remained asymptomatic after recovery but had recurrent or persistent RT-PCR, and 19 patients had recurrent COVID-19 symptoms with concurrent SARS-CoV-2 positive RT-PCR but no alternative diagnoses. These 19 patients had symptom recurrence a median of 57 days after initial symptom onset (interquartile range: 47 - 76). Six of these patients had paired specimens available for further testing, but none had laboratory findings confirming reinfections. Testing of an additional three patients with recurrent symptoms and alternative diagnoses also did not confirm reinfection. CONCLUSIONS: We did not confirm SARS-CoV-2 reinfection within 90 days of the initial infection based on the clinical and laboratory characteristics of cases in this investigation. Our findings support current CDC guidance around quarantine and testing for patients who have recovered from COVID-19. |
Association Between CMS Quality Ratings and COVID-19 Outbreaks in Nursing Homes - West Virginia, March 17-June 11, 2020.
Bui DP , See I , Hesse EM , Varela K , Harvey RR , August EM , Winquist A , Mullins S , McBee S , Thomasson E , Atkins A . MMWR Morb Mortal Wkly Rep 2020 69 (37) 1300-1304 Nursing homes are high-risk settings for outbreaks of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1,2). During the COVID-19 pandemic, U.S. health departments worked to improve infection prevention and control (IPC) practices in nursing homes to prevent outbreaks and limit the spread of COVID-19 in affected facilities; however, limited resources have hampered health departments' ability to rapidly provide IPC support to all nursing homes within their jurisdictions. Since 2008, the Centers for Medicare & Medicaid Services (CMS) has published health inspection results and quality ratings based on their Five-Star Quality Rating System for all CMS-certified nursing homes (3); these ratings might be associated with facility-level risk factors for COVID-19 outbreaks. On April 17, 2020, West Virginia became the first state to mandate and conduct COVID-19 testing for all nursing home residents and staff members to identify and reduce transmission of SARS-CoV-2 in these settings (4). West Virginia's census of nursing home outbreaks was used to examine associations between CMS star ratings and COVID-19 outbreaks. Outbreaks, defined as two or more cases within 14 days (with at least one resident case), were identified in 14 (11%) of 123 nursing homes. Compared with 1-star-rated (lowest rated) nursing homes, the odds of a COVID-19 outbreak were 87% lower among 2- to 3-star-rated facilities (adjusted odds ratio [aOR] = 0.13, 95% confidence interval [CI] = 0.03-0.54) and 94% lower among 4- to 5-star-rated facilities (aOR = 0.06, 95% CI = 0.006-0.39). Health departments could use star ratings to help identify priority nursing homes in their jurisdictions to inform the allocation of IPC resources. Efforts to mitigate outbreaks in high-risk nursing homes are necessary to reduce overall COVID-19 mortality and associated disparities. Moreover, such efforts should incorporate activities to improve the overall quality of life and care of nursing home residents and staff members and address the social and health inequities that have been recognized as a prominent feature of the COVID-19 pandemic in the United States (5). |
Risk for subdeltoid bursitis after influenza vaccination: A population-based cohort study
Hesse EM , Navarro RA , Daley MF , Getahun D , Henninger ML , Jackson LA , Nordin J , Olson SC , Zerbo O , Zheng C , Duffy J . Ann Intern Med 2020 173 (4) 253-261 BACKGROUND: Subdeltoid bursitis has been reported as an adverse event after intramuscular vaccination in the deltoid muscle. Most published case reports involved influenza vaccine. OBJECTIVE: To estimate the risk for subdeltoid bursitis after influenza vaccination. DESIGN: Retrospective cohort study. SETTING: The Vaccine Safety Datalink, which contains health encounter data for 10.2 million members of 7 U.S. health care organizations. PATIENTS: Persons who received an inactivated influenza vaccine during the 2016-2017 influenza season. MEASUREMENTS: Potential incident cases were identified by searching administrative data for persons with a shoulder bursitis diagnostic code within 180 days after receiving an injectable influenza vaccine in the same arm. The date of reported bursitis symptom onset was abstracted from the medical record. A self-controlled risk interval analysis was used to calculate the incidence rate ratio of bursitis in a risk interval of 0 to 2 days after vaccination versus a control interval of 30 to 60 days, which represents the background rate. The attributable risk was also estimated. RESULTS: The cohort included 2 943 493 vaccinated persons. Sixteen cases of symptom onset in the risk interval and 51 cases of symptom onset in the control interval were identified. The median age of persons in the risk interval was 57.5 years (range, 24 to 98 years), and 69% were women. The incidence rate ratio was 3.24 (95% CI, 1.85 to 5.68). The attributable risk was 7.78 (CI, 2.19 to 13.38) additional cases of bursitis per 1 million persons vaccinated. LIMITATION: The results may not be generalizable to vaccinations done in other types of health care settings. CONCLUSION: Although an increased risk for bursitis after vaccination was present, the absolute risk was small. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention. |
Association between vaccine exemption policy change in California and adverse event reporting
Hause AM , Hesse EM , Ng C , Marquez P , McNeil MM , Omer SB . Pediatr Infect Dis J 2020 39 (5) 369-373 BACKGROUND: California Senate Bill 277 (SB277) eliminated non-medical immunization exemptions. Since its introduction on February 19, 2015, the rate of medical exemptions in the state has increased. Filing a report to Vaccine Adverse Event Reporting System (VAERS) may be perceived as helpful in applying for a medical exemption. Our objective was to describe trends in reporting to VAERS from California coincident with introduction of SB277. METHODS: This was a retrospective study of Californian children <18 years for whom a VAERS report was submitted between June 1, 2011 and July 31, 2018. VAERS is a national, passive, vaccine safety surveillance program co-managed by Centers for Disease Control and Prevention and FDA. The main outcomes were the proportion of VAERS reports submitted by parents (vs. other reporter types), time from immunization to VAERS report (reporting time), and adverse event type. We also performed spatial analysis, mapping reports pre- and post-mandate by county. RESULTS: We identified 6703 VAERS reports from California during the study period. The proportion of reports received from parents increased after implementation of SB277, from 14% to 23%. The median reporting time by parents increased from 9 days in 2013-2014 to 31 days in 2016-2017. After the introduction of SB277, we observed an increase in reports describing behavioral and developmental symptoms among reports submitted >6 months after immunization. CONCLUSIONS: These recent changes in reporting patterns coincident with the introduction of SB277 may indicate that more parents are using VAERS to assist in applying for a medical exemption for their child. |
Shoulder injury related to vaccine administration (SIRVA): Petitioner claims to the National Vaccine Injury Compensation Program, 2010-2016
Hesse EM , Atanasoff S , Hibbs BF , Adegoke OJ , Ng C , Marquez P , Osborn M , Su JR , Moro PL , Shimabukuro T , Nair N . Vaccine 2019 38 (5) 1076-1083 BACKGROUND: Since 2010, petitioner claims of shoulder injury related to vaccine administration (SIRVA) to the National Vaccine Injury Compensation Program (VICP) have been increasing. OBJECTIVE: To conduct a scientific review of clinical characteristics of SIRVA petitions to the VICP. METHODS: We queried the VICP's Injury Compensation System database for medical reports of alleged SIRVA and SIRVA-like injuries. Medical reports are summaries of petitioner claims and supporting documentation along with a VICP clinician reviewer diagnosis and assessment of criteria for concession. We conducted a descriptive analysis of SIRVA petitioner claims recommended by the VICP for concession as SIRVA injuries. RESULTS: We identified 476 petitioner claims recommended for concession. Claims per year increased from two in 2011, the first full year in the analytic period, to 227 in 2016. Median age was 51 years, 82.8% were women, and median body mass index was 25.1 (range 17.0-48.9). Four hundred cases (84.0%) involved influenza vaccine. Pharmacy or store (n = 168; 35.3%) was the most common place of vaccination followed by doctor's office (n = 147; 30.9%). Fewer than half of cases reported a suspected administration error; 172 (36.1%) reported 'injection too high' on the arm. Shoulder pain, rotator cuff problems, and bursitis were common initial diagnoses. Most (80.0%) cases received physical or occupational therapy, 60.1% had at least one steroid injection, and 32.6% had surgery. Most (71.9%) healthcare providers who gave opinions on causality considered the injury was caused by vaccination. A minority (24.3%) of cases indicated that symptoms had resolved by the last visit available in medical records. CONCLUSIONS: Most conceded claims for SIRVA were in women and involved influenza vaccines. Injection too high on the arm could be a factor due to the risk of injecting into underlying non-muscular tissues. Healthcare providers should be aware of proper injection technique and anatomical landmarks when administering vaccines. |
Calibration of the cloud and aerosol spectrometer for coal dust composition and morphology
Barone TL , Hesse E , Seaman CE , Baran AJ , Beck TW , Harris ML , Jaques PA , Lee T , Mischler SE . Adv Powder Technol 2019 30 (9) 1805-1814 The cloud and aerosol spectrometer (CAS) was calibrated to enable CAS sizing of coal dust for studies on flammable dust control. Coal dust sizes were determined by light-scattering theories for irregular particles that account for particle composition and morphology in computing coal dust diameters. Coal dust size computations were compared with test dust that was generated by cyclone separation and air-jet sieving and characterized by aerodynamic particle sizer (APS) and computer-controlled scanning electron microscopy (CCSEM) measurements. For test dust in the range of 0.5–32 μm, coal dust size distributions were consistent with cyclone-separated and sieve-segregated sizes. For the 3–20 μm size range, the coal dust size distribution had a mass median diameter that was 14% larger than that of the APS. This difference was reasonable considering that the basic calibration for glass spheres had 13% uncertainty. For the 20–32 μm and 32–45 μm test dusts, mass median diameters differed from CCSEM measurements by only 4% and 5%, respectively. Overall, the results suggest agreement between test dust sizes and computations for coal dust. Alternatively, using conventional Mie theory computations for spheres, coal dust mass median diameters were 35% and 40% larger than APS and CCSEM measurements, respectively. |
Notes from the field: Administration of expired injectable influenza vaccines reported to the Vaccine Adverse Event Reporting System - United States, July 2018-March 2019
Hesse EM , Hibbs BF , Cano MV . MMWR Morb Mortal Wkly Rep 2019 68 (23) 529-530 Influenza vaccination is recommended annually for persons aged ≥6 months for the prevention and control of influenza (1). Every year, injectable inactivated influenza vaccine (IIV) has a standard expiration date of June 30 for the upcoming influenza season (i.e., July 1–June 30 of the following year). Vaccination with an expired influenza vaccine might not protect against influenza infection because different influenza virus strains can be included in the vaccine each year; in addition, protection against viruses included in the vaccine could wane if vaccine potency decreases over time. During July 11, 2018–March 29, 2019 in the United States, the Vaccine Adverse Event Reporting System (VAERS) received 125 reports of 192 patients receiving expired IIV during the 2018–19 influenza season (2), during which time 169.1 million doses of seasonal influenza vaccine were distributed (3). Dates of vaccination were documented for 102 patients and ranged from July 2, 2018, to January 16, 2019. The number of expired vaccine doses administered increased in September and decreased after October, coinciding with dates when influenza vaccine is typically given (Figure). Ages were available for 103 vaccine recipients. Seventy-three recipients (70.1%) were identified as being in high-risk age groups for influenza; eight were aged <5 years, and 65 were aged >50 years (1). An additional six reports specified that the patient had been pregnant at time of vaccination; pregnancy outcomes were not reported. Adverse events after the administration of an expired IIV were rarely reported (four of 125 reports; 3.2%). None were serious, and adverse events were consistent with adverse events for seasonal IIV. |
Postlicensure safety surveillance of recombinant Zoster vaccine (Shingrix) - United States, October 2017-June 2018
Hesse EM , Shimabukuro TT , Su JR , Hibbs BF , Dooling KL , Goud R , Lewis P , Ng CS , Cano MV . MMWR Morb Mortal Wkly Rep 2019 68 (4) 91-94 Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged >/=50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged >/=60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), injection site pain (985; 22.5%), and injection site erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials. |
Collaborative biomedicine in the age of big data: the case of cancer.
Shaikh Abdul R, Butte Atul J, Schully Sheri D, Dalton William S, Khoury Muin J, Hesse Bradford W. J. Med. Internet Res. 2014 16(4) e101 . J. Med. Internet Res. 2014 16(4) e101 Shaikh Abdul R, Butte Atul J, Schully Sheri D, Dalton William S, Khoury Muin J, Hesse Bradford W. J. Med. Internet Res. 2014 16(4) e101 |
Implications of Internet availability of genomic information for public health practice.
Hesse BW , Arora NK , Khoury MJ . Public Health Genomics 2012 15 201-8 Tensions in the field have emerged over how best to communicate to the public about genomic discoveries in an era of direct-to-consumer (DTC) DNA testing services available through the Internet. Concerns over what the psychological and behavioral response might be to a nuanced, multiplex risk message have spurred some to offer caution in communicating to the public about personalized risk until the necessary research has been completed on how to communicate effectively. The popularization of DTC testing services, along with a spreading Internet culture on transparency for personal data, may make 'waiting to communicate' a moot point. To steer communication efforts in the midst of increasing access to personal genomic information, a self-regulation framework is presented. The framework emphasizes the importance of presenting a coherent message in all communiques about public health genomics. Coherence should be based on an evidence-based model of how the public processes information about health conditions and an emphasis on risk-to-action links. Recommendations from the President's Council of Advisors for Science and Technology are reviewed as a way of identifying targets of opportunity for structured communications both within the healthcare system and in the broader external ecosystem of publicly available health information technologies. |
Restricted enzooticity of hepatitis E virus genotypes 1 to 4 in the United States.
Dong C , Meng J , Dai X , Liang JH , Feagins AR , Meng XJ , Belfiore NM , Bradford C , Corn JL , Cray C , Glass GE , Gordon ML , Hesse RA , Montgomery DL , Nicholson WL , Pilny AA , Ramamoorthy S , Shaver DD , Drobeniuc J , Purdy MA , Fields HA , Kamili S , Teo CG . J Clin Microbiol 2011 49 (12) 4164-72 Hepatitis E is recognized as a zoonosis, and swine are known reservoirs, but how broadly enzootic its causative agent, hepatitis E virus (HEV), is remains controversial. To determine the prevalence of HEV infection in animals, a serological assay with capability to detect anti-HEV-antibody across a wide variety of animal species was devised. Recombinant antigens comprising truncated capsid proteins generated from HEV-subgenomic constructs that represent all four viral genotypes were used to capture anti-HEV in the test sample and as an analyte reporter. To facilitate development and validation of the assay, serum samples were assembled from blood donors (n = 372), acute hepatitis E patients (n = 94), five laboratory animals (rhesus monkey, pig, New Zealand rabbit, Wistar rat, and BALB/c mouse) immunized with HEV antigens, and four pigs experimentally infected with HEV. The assay was then applied to 4,936 sera collected from 35 genera of animals that were wild, feral, domesticated, or otherwise held captive in the United States. Test positivity was determined in 457 samples (9.3%). These originated from: bison (3/65, 4.6%), cattle (174/1,156, 15%), dogs (2/212, 0.9%), Norway rats (2/318, 0.6%), farmed swine (267/648, 41.2%), and feral swine (9/306, 2.9%). Only the porcine samples yielded the highest reactivities. HEV RNA was amplified from one farmed pig and two feral pigs and characterized by nucleotide sequencing to belong to genotype 3. HEV infected farmed swine primarily, and the role of other animals as reservoirs of its zoonotic spread appears to be limited. |
Swine influenza virus A (H3N2) infection in human, Kansas, USA, 2009
Cox CM , Neises D , Garten RJ , Bryant B , Hesse RA , Anderson GA , Trevino-Garrison I , Shu B , Lindstrom S , Klimov AI , Finelli L . Emerg Infect Dis 2011 17 (6) 1143-4 Triple-reassortant swine influenza viruses (SIVs), which contain genes from human, swine, and avian influenza A viruses, have been enzootic among swine herds in the United States since the late 1990s. Although uncommon, occasional transmission of triple-reassortant SIVs from swine to humans has occurred. Before April 2009, only limited, nonsustained human-to-human transmission of SIVs had been reported. Although an animal source for pandemic (H1N1) 2009 virus has yet to be identified, the pandemic strain resulted from the reassortment of 2 different lineages of SIV. |
Report of an NIAID workshop on dengue animal models
Cassetti MC , Durbin A , Harris E , Rico-Hesse R , Roehrig J , Rothman A , Whitehead S , Natarajan R , Laughlin C . Vaccine 2010 28 (26) 4229-34 Dengue is a mosquito-borne viral disease of humans that has re-emerged in many parts of the world and has become an important international public health threat. Dengue incidence and geographical spread has dramatically increased in the last few decades and is now affecting most tropical and sub-tropical regions of the world. Despite extensive research efforts for several decades, no vaccines or therapeutics are currently available to prevent and treat dengue infections. One of the main obstacles to the development of countermeasures has been the lack of good animal models that recapitulate dengue pathogenesis in humans and reliably predict the safety and efficacy of countermeasures against dengue. In September 2008, the National Institute of Allergy and Infectious Diseases (NIAID) held a workshop to consider the current state-of-the-art developments in animal models for dengue and discuss strategies to accelerate progress in this field. This report summarizes the main discussions and recommendations that resulted from the meeting. |
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