Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS).

Background: On June 8, 2021, a new 20-valent pneumococcal conjugate vaccine (PCV20, PREVNAR 20, Pfizer, Inc.) was licensed for use in adults aged ≥ 18 years by the US Food and Drug Administration (FDA).

Objective: To describe reports to the Vaccine Adverse Event Reporting System (VAERS) after administration of the 20-valent pneumococcal conjugate vaccine in adults.

Reporting rates for VAERS death reports following COVID-19 vaccination, December 14, 2020-November 17, 2021.

Purpose: Despite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS). We aimed to provide information and context about reports of death to VAERS following COVID-19 vaccination.

ICD-10 anaphylaxis algorithm and the estimate of vaccine-attributable anaphylaxis incidence in Medicare.

Background: Anaphylaxis is a rare, serious allergic reaction. Its identification in large healthcare databases can help better characterize this risk.

Objective: To create an ICD-10 anaphylaxis algorithm, estimate its positive predictive values (PPVs) in a post-vaccination risk window, and estimate vaccination-attributable anaphylaxis rates in the Medicare Fee For Service (FFS) population.

Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS).

Background: The objective of this study is to assess cases of thrombocytopenia, including immune thrombocytopenia (ITP), reported to the Vaccine Adverse Event Reporting System (VAERS) following vaccination with mRNA COVID-19 vaccines.

Methods: This case-series study analyzed VAERS reports of thrombocytopenia after vaccination with Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine.

Results: Fifteen cases of thrombocytopenia were identified among 18,841,309 doses of Pfizer-BioNTech COVID-19 Vaccine and 13 cases among 16,260,102 doses of Moderna COVID-19 Vaccine.

Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018.

Background: Myopericarditis after vaccination has been sporadically reported in the medical literature. Here, we present a thorough descriptive analysis of reports to a national passive vaccine safety surveillance system (VAERS) of myopericarditis after vaccines licensed for use in the United States.

Methods: We identified U.

Demonstration of reciprocal diurnal variation in human serum T3 and rT3 concentration demonstrated by mass spectrometric analysis and establishment of thyroid hormone reference intervals.

Background: There has been a wide range of reference intervals proposed in previous literature for thyroid hormones due to large between-assay variability of immunoassays, as well as lack of correction for collection time. We provided the diurnal reference intervals for five thyroid hormones, namely total thyroxine (TT4), total triiodothyronine (TT3), free thyroxine (FT4), free triiodothyronine (FT3), and reverse T3 (rT3), measured in serum samples of healthy participants using a liquid chromatography/tandem mass spectrometry (LC-MS/MS) method.

Methods: Couplet serum samples (a.

Culturally tailored tobacco control: Aboriginal community perspectives in Sydney, Australia.

Introduction: A community-based project was developed to support quit attempts and denormalise smoking in Aboriginal communities. This qualitative study evaluates the effectiveness of project strategies, messages and the partnership process, and explores impacts observed by Aboriginal community members, complementing findings from a quantitative evaluation.

Methods: The study comprised five focus groups (40 participants) and 14 in-depth interviews (with 15 community members).

Inadequate Reporting of Analytical Characteristics of Biomarkers Used in Clinical Research: A Threat to Interpretation and Replication of Study Findings.

Background: Analytical characteristics of methods to measure biomarkers determine how well the methods measure what they claim to measure. Transparent reporting of analytical characteristics allows readers to assess the validity and generalizability of clinical studies in which biomarkers are used. Our aims were to assess the reporting of analytical characteristics of biomarkers used in clinical research and to evaluate the extent of reported characterization procedures for assay precision.

Adaptive NK cells in people exposed to correlate with protection from malaria.

How antibodies naturally acquired during infection provide clinical immunity to blood-stage malaria is unclear. We studied the function of natural killer (NK) cells in people living in a malaria-endemic region of Mali. Multi-parameter flow cytometry revealed a high proportion of adaptive NK cells, which are defined by the loss of transcription factor PLZF and Fc receptor γ-chain.

Evaluating an Aboriginal tobacco social marketing project in Sydney, Australia.

Introduction: A partnership between three Aboriginal Community Controlled Organisations and a mainstream health service was formed to develop, implement and evaluate a comprehensive and culturally appropriate social marketing project which aimed to encourage smokers to quit smoking. The project also supported quit attempts and promoted denormalisation of smoking.

Methods: The project was evaluated through baseline (n = 427) and follow-up (n = 611) surveys carried out face-to-face with Aboriginal and/or Torres Strait Islander participants 18 years and older recruited through convenience sampling at community events and venues during 2010-2011 and 2015.

Assessment of thyroid function in intensive care unit patients by liquid chromatography tandem mass spectrometry methods.

Objectives: Patients with non-thyroidal illness syndrome have many abnormalities in thyroid hormone tests. Such patients have medical comorbidities associated with low serum proteins and are on multiple medications that interfere with thyroid hormone measurement by immunoassay platforms. It is unknown if these thyroid hormone measurements reflect physiologic conditions or if they are artifacts of testing methodology.

DIAGNOSIS OF ENDOCRINE DISEASE: How reliable are free thyroid and total T3 hormone assays?

Hypothyroidism is a very common disorder worldwide, for which the usual treatment is monotherapy with levothyroxine (L-T). However, a number of patients treated with L-T continue to report symptoms of hypothyroidism despite seemingly normal levels of thyroid-stimulating hormone (TSH), free-T (FT) and free-T (FT) measured by immunoassay. This review summarizes the limitations of the immunoassays commonly used to measure thyroid hormone levels and emphasizes the advantages of the role of liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Algorithmic Approach With Clinical Pathology Consultation Improves Access to Specialty Care for Patients With Systemic Lupus Erythematosus.

Objectives: Harris Health System (HHS) is a safety net system providing health care to the underserved of Harris County, Texas. There was a 6-month waiting period for a rheumatologist consult for patients with suspected systemic lupus erythematosus (SLE). The objective of the intervention was to improve access to specialty care.

Pathology Consultation on Patients With a Large Rh Immune Globulin Dose Requirement.

Objectives: To review the differential diagnosis and laboratory issues for women with a large calculated dose of Rh immune globulin (RhIG).

Methods: A case-based approach is used to review the differential diagnosis of patients with a large calculated dose of RhIG, RhIG dosing for women with baseline elevations in hemoglobin F, the formulations of RhIG, and issues for the transfusion medicine service with the release of large doses of RhIG.

Results: A large fetomaternal bleed after delivery requiring multiple doses of RhIG is rare.

Sirt1-Positive Lymphocytes in Acute Cellular Cardiac Allograft Rejection: Contributor to Pathogenesis and a Therapeutic Target.

Cardiac allograft rejection remains a problem, despite advances with immunosuppressants. Understanding the mechanisms behind rejection is essential for developing targeted therapies. The goal of this investigation is to explore Sirtuin 1 (Sirt1) as a therapeutic target for cardiac allograft rejection.

Bioinformatics Analysis to Determine Prognostic Mutations of 72 de novo Acute Myeloid Leukemia Cases from the Cancer Genome Atlas (TCGA) with 23 Most Common Mutations and no Abnormal Cytogenetics.

Objectives: Up to 40% of acute myeloid leukemia (AML) patients have normal cytogenetics (CN-AML) but they may have gene mutations. An important issue in the treatment of CN-AML is how gene mutation patterns may help with patient management. The Cancer Genome Atlas (TCGA) database has data from 200 cases of de novo AML including cytogenetics, gene mutations, and survival duration (prognosis).

Utility of VerifyNow for Point-of-Care Identification of an Aspirin Effect Prior to Emergency Cardiac Surgery.

Background: Patients with cardiovascular disease are frequently on aspirin, which may place them at risk for bleeding during surgical procedures. The utility of the VerifyNow test to rapidly identify an aspirin effect and predict bleeding risk prior to cardiac surgery was explored.

Methods: A retrospective study was performed of patients on a clinical pathology consultation service that provides laboratory and transfusion support for patients undergoing major cardiac surgery.

Smoking among Aboriginal adults in Sydney, Australia.

Issue addressed Tobacco consumption contributes to health disparities among Aboriginal Australians who experience a greater burden of smoking-related death and diseases. This paper reports findings from a baseline survey on factors associated with smoking, cessation behaviours and attitudes towards smoke-free homes among the Aboriginal population in inner and south-western Sydney. Methods A baseline survey was conducted in inner and south-western Sydney from October 2010 to July 2011.

Therapeutic plasma exchange as a therapeutic modality for the treatment of IVIG complications.

Intravenous immunoglobulin (IVIG) is used for the treatment of a number of inflammatory conditions. Hemolysis due to passive transfer of blood group antibodies is a well recognized complication of IVIG therapy. Therapy is largely supportive and consists of blood product support and hemodialysis.