Co-administration of chicken IL-2 alleviates clinical signs and replication of the ILTV chicken embryo origin vaccine by pre-activating natural killer cells and cytotoxic T lymphocytes.

IMPORTANCE: Chickens immunized with the infectious laryngotracheitis chicken embryo origin (CEO) vaccine (Medivac, PT Medion Farma Jaya) experience adverse reactions, hindering its safety and effective use in poultry flocks. To improve the effect of the vaccine, we sought to find a strategy to alleviate the respiratory reactions associated with the vaccine. Here, we confirmed that co-administering the CEO vaccine with chIL-2 by oral delivery led to significant alleviation of the vaccine reactions in chickens after immunization. Furthermore, we found that the co-administration of chIL-2 with the CEO vaccine reduced the clinical signs of the CEO vaccine while enhancing natural killer cells and cytotoxic T lymphocyte response to decrease viral loads in their tissues, particularly in the trachea and conjunctiva. Importantly, we demonstrated that the chIL-2 treatment can ameliorate the replication of the CEO vaccine without compromising its effectiveness. This study provides new insights into further applications of chIL-2 and a promising strategy for alleviating the adverse reaction of vaccines.

Imprecision in vaccine adverse event reporting and a methodological analysis of reporting systems to improve pharmacovigilance and public health.

INTRODUCTION: This study documents imprecision in Japanese reports of adverse events following immunization (AEFI). In doing so, it presents methods to analyze this imprecision. METHODS: These methods include use of unique Japanese data on the validity of certain AEFIs. They also include ways to estimate AEFI rates, which allow comparison of AEFI data between countries. Using US AEFI data for comparison, we show how differences in AEFI reporting systems likely influence AEFI statistics. RESULTS: Although our comparisons of AEFI rates are not precise, many of the difference we detected between Japanese and US statistics make sense and reflect differences in the societal and medical perspectives on various vaccines or can be explained by differences in the reporting systems including reporting sources. For example, differences in societal and medical perspective probably underly the extraordinarily high Japanese rates of anaphylaxis and other AEs following HPV immunizations from 2010 to 2016 compared to US rates and to Japanese rates for other vaccines. High US rates of reported Guillain-Barré syndrome following influenza vaccination relative to Japanese rates and to rates for other US vaccines are consistent with data suggesting that the index of suspicion for such reactions could affect AEFI rates. The findings that over half of Japanese anaphylaxis reports for every vaccine are erroneous, and that close to half of "serious" Japanese AEFI cases probably are not serious may be due in part not only to explanations unique to Japan, but also to factors that apply to the USA and other countries. Differences in reporting systems account for a much higher rate of non-serious AEFI reports in the USA compared to Japan. Japanese marketing authorization holders are probably at least as assiduous and timely in their reporting of AEFIs as health care providers, though granular level differences are apparent in reporting by various sources. CONCLUSION: The methods we used to analyze the validity of Japanese statistics can be used to analyze the validity of AEFI reports from other countries and aid the harmonization of adverse event reporting systems. Eventually, similar reporting systems might be adapted for drugs and medical devices.

Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies.

The COVID-19 pandemic had a severe global impact. A range of campaigns and activities, including vaccines, are being implemented to counteract this pandemic. Using observational data, the goal of this scoping review is to identify adverse events connected with COVID-19 vaccinations. We conduct a scoping study and searched three databases from the start of the COVID-19 pandemic in 2020 through June 2022. Based on our criteria and searched keywords, the review included eleven papers in total, with the majority of the studies being conducted in developed countries. The study populations varied and included general community populations, healthcare professionals, military forces, and patients with systemic lupus and cancer. This study includes vaccines from Pfizer-BioNTech, Oxford-AstraZeneca, Sinopharm, and Moderna. The COVID-19 vaccine-related adverse events were classified into three types: local side effects, systemic side effects, and other side effects such as allergies. The adverse reactions to COVID-19 vaccines are mild to moderate in severity, with no significant influence or interference in individual daily activities and no unique patterns in cause of death among vaccine-related deaths. According to the findings of these investigations, the COVID-19 vaccine is safe to administer and induces protection. It is vital to convey accurate information to the public about vaccination side effects, potential adverse responses, and the safety level of the vaccines supplied. Multiple strategies must be implemented at the individual, organizational, and population levels to eliminate vaccine hesitance. Future studies could investigate the vaccine's effect on people of various ages and medical conditions.

Hipertiroidismo por enfermedad de Graves posterior a vacuna contra SARS-CoV-2: reporte de 2 casos / Graves' disease hyperthyroidism following SARS-CoV-2 vaccination: a two cases report

Luego del inicio de las campañas de vacunación masiva contra la infección por COVID-19, se han publicado una serie de reportes que muestran la posible asociación entre la vacuna y alteraciones de la función tiroidea. Desde entonces, múltiples teorías han intentado explicar este hallazgo, en su mayoría de índole autoinmune. Dentro de estas destaca el síndrome autoinmune-autoinflamatorio secundario a adyuvantes (ASIA), que podría generar desórdenes tiroideos de novo o exacerbar los ya existentes. Presentamos dos casos de enfermedad de Graves Basedow posterior al uso de Coronavac. Ambas pacientes presentaron características similares a las descritas en la literatura y cumplen con los criterios de ASIA. No obstante, los beneficios de las vacunas superan los posibles riesgos asociados.

After the beginning of COVID-19 vaccination campaigns, a number of reports have shown the potential association between vaccines and thyroid disfunction. Since then several theories have tried to explain this finding, mostly autoinmmune. One of them is the autoimmune/inflammatory syndrome induced by adjuvants, that could trigger or exacerbate thyroid disease. We present two cases of Graves' disease post Coronavac vaccination. Both pacients share similar features than cases published previously and meet criteria for ASIA syndrome. Nevertheless, the benefts of vaccination largely outweigh any adverse events associated.

SARS-CoV-2 Infection and Vaccination Cutaneous Manifestations for the Inpatient Dermatologist.

Purpose of Review: The overall purpose of this review was to characterize and summarize cutaneous eruptions associated with coronavirus disease 2019 (COVID-19) as well as COVID-19 vaccination. Recent Findings: Cutaneous eruptions associated with COVID-19 infection have a reported frequency of 1-20%. Increased COVID-19 disease severity has been associated with morbilliform exanthems, urticaria, retiform purpura, and livedo racemosa. Papulovesicular eruptions were associated with a milder COVID-19 disease course. A range of dermatoses have also been reported with COVID-19 vaccination but have rarely prevented subsequent vaccination. Summary: Dermatologists should be aware of the associations between COVID-19 disease severity and cutaneous eruptions. Livedo racemosa and retiform purpura are particularly associated with increased disease severity and death. In the setting of COVID-19 vaccination, cutaneous eruptions can largely be managed symptomatically and very rarely do these reactions prevent subsequent vaccination.

Case report: subacute thyroiditis after receiving SARS-CoV-2 vaccine, maybe not only adjuvants.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induced the new coronavirus disease 2019 (COVID-19) pandemic worldwide. SARS-CoV-2 vaccines are designed to control the transmission of the disease. However, post-vaccination subacute thyroiditis (SAT) also appears with increase vaccination rate. Three cases of SAT after SARS-CoV-2 vaccines are described in this study. We have reported the patients' clinical symptoms, laboratory tests, and thyroid imaging. Tests for COVID-19 were all negative, and the patients did not report thyroid-related diseases, autoimmune diseases, or preceding upper respiratory system infections in their medical history. Three female patients showed neck pain on physical examination. The laboratory test results and imaging findings were consistent with the diagnostic criteria of SAT. The patients were carried out a standardized treatment according to their symptoms, and we closely followed up their response to the treatment. Clinicians must be aware of the possibility of SAT after receiving the vaccines and make timely therapy.

Acquired hemophilia A after vaccination against SARS-CoV-2 with the mRNA-1273 (Moderna) vaccine.

Acquired hemophilia A is a rare bleeding diathesis most typically seen in systemic rheumatic disease, solid and hematologic malignancies, and pregnancy. We present a case of this condition that occurred immediately after vaccination against SARS-CoV-2 with the mRNA-1273 (Moderna) vaccine.

Erythema Multiforme Following Hepatitis A and Pneumococcal Vaccinations.

Erythema multiforme (EM) is a rare cell-mediated immune response characterized by target or iris patches or plaques that present symmetrically on the extremities. This condition may be associated with pruritus but is usually self-limited and spontaneously resolves within 5 weeks of onset; prodromal symptoms are rare. Several known cases have been linked to vaccination, but many vaccines used in pediatric care have been reported as causative agents of EM. This case study offers an association of EM following administration of the hepatitis A and pneumococcal vaccines.

New-onset Graves' disease following SARS-CoV-2 vaccination: a case report.

A 22-year-old male with a history of ulcerative colitis and nephrotic syndrome treated with immunomodulatory agents including vedolizumab and mycophenolic acid developed hyperthyroidism 2 weeks following the first administration of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 vaccine). Graves' disease (GD) was diagnosed based on the elevated thyrotropin-receptor antibody, thyroid scintigraphy and ultrasound. To this day, four cases of new-onset GD following SARS-CoV-2 vaccine were reported in patients with no previous history of thyroid disease. Two cases of recurrence of GD following SARS-CoV-2 vaccine were also reported. Although the underlying mechanisms of vaccine-induced autoimmunity remain to be clarified, there is a rationale for the association between SARS-CoV-2 vaccination and the development of Th1-mediated diseases, at least in predisposed individuals. The BNT162b2 vaccine could be a trigger for GD in some patients. However, the benefit/risk ratio remains by far in favour of SARS-CoV-2 vaccination considering the potentially higher risk of severe infection in these patients.

Higher Antibody Concentrations in U.S. Health Care Workers Associated with Greater Reactogenicity Post-Vaccination.

Multiple factors may be associated with immune responses to SARS-CoV-2 vaccines. Factors potentially related to magnitude and durability of response include age, time, and vaccine reactogenicity. This study analyzed SARS-CoV-2 IgG spike antibody responses following the second dose of vaccine in healthcare workers (HCWs). Data were collected from participants enrolled in a longitudinal SARS-CoV-2 serology study over a 12-month period. Participants completed a survey documenting symptoms post-vaccination. Serum specimens were tested for SARS-CoV-2 IgG antibodies using the Abbott Architect AdvisdeDx SARS-CoV-2 IgGII assay. Antibody levels were compared against time from second vaccine dose, and symptoms following vaccination. Altogether, 335 women (86.6%) and 52 men (13.4%) participated. Median age was 37 years (IQR 30-43). Overall median antibody level was 2150.80 [1246.12, 3556.98] AU/mL (IQR). Age was not associated with antibody concentration (p-value = 0.10). Higher antibody responses (2253 AU/mL vs. 1506 AU/mL; p = 0.008) were found in HCWs with one or more symptoms after the second dose of the vaccine (n = 311). Antibody responses persisted throughout the study period post-vaccination; statistically significant decreases in antibody responses were observed over time (p < 0.001). Higher antibody response was associated with reactogenicity post-vaccine. Age and sex were not associated with higher antibody responses.

Adverse events following COVID-19 vaccination in South Korea between February 28 and August 21, 2021: A nationwide observational study.

OBJECTIVES: To investigate the clinical characteristics of adverse events (AEs) after COVID-19 vaccination in patients in South Korea. DESIGN: Data from the Korean Disease Control and Prevention Agency on AEs from 4 COVID-19 vaccines, including AZD1222, BNT162b2, JNJ-78436735, and mRNA-1273, from February 26, 2021, to August 21, 2021, were assessed. The epidemiological characteristics, clinical symptoms, severity, complications, and mortality were descriptively analyzed. RESULTS: Overall, 36.3 million individuals who completed the COVID-19 vaccination doses during the study period were included, and 153,183 AEs were reported. Most AEs occurred after the first dose (80.6%) and within a day (63.2%) after vaccination. Of the AEs, 95.5% were nonsevere cases; however, 4.5% were severe. Most mild AEs showed a similar frequency across all age groups, but major severe AEs and mortality events increased with age. CONCLUSIONS: Although there were differences in the frequency of occurrence, various adverse reactions were confirmed in using all 4 COVID-19 vaccines, even with the BNT162b2 (Pfizer-BioNTech) vaccine. Caution is needed, and further research should be continuously conducted.

Silent thyroiditis following vaccination against COVID-19: report of two cases.

PURPOSE: It is well established that thyroiditis and other thyroid disorders can be induced by COVID-19 infection, but there is limited information about the autoimmune/inflammatory syndrome induced by adjuvants (ASIA) after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. We report two cases of thyrotoxicosis following SARS-CoV-2 vaccine. METHODS AND RESULTS: Two young health care peoples (wife and husband) received a first dose of SARS-CoV-2 vaccine, and few weeks later developed clinical manifestations of thyroid hyperactivity, with increased thyroid hormone levels on thyroid function tests, suppressed thyroid-stimulating hormone and negative antithyroid antibodies, despite being healthy before vaccination. They were diagnosed at the 4th week after first dose of SARS-Cov-2 vaccine as silent thyroiditis and followed without treatment, since their symptoms were not severe. At the 6th week, the patients became wholly asymptomatic and their thyroid function returned to normal. CONCLUSIONS: Thyrotoxicosis can occur after SARS-CoV-2 vaccination probably related to silent thyroiditis.

The skin as a critical window in unveiling the pathophysiologic principles of COVID-19.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the etiologic agent of coronavirus disease 2019 (COVID-19), is a single-stranded RNA virus whose sequence is known. COVID-19 is associated with a heterogeneous clinical phenotype ranging from asymptomatic to fatal disease. It appears that access to nasopharyngeal respiratory epithelia expressing angiotensin-converting enzyme (ACE) 2, the receptor for SARS-CoV-2, is followed by viral replication in the pulmonary alveolar septal capillary bed. We have demonstrated in earlier studies that incomplete viral particles, termed pseudovirions, dock to deep subcutaneous and other vascular beds, potentially contributing to the prothrombotic state and systemic complement activation that characterizes severe and critical COVID-19. A variety of skin eruptions have been described in the setting of SARS-CoV-2 infection and more recently, after COVID-19 vaccination. The vaccines deliver a laboratory-synthesized mRNA that encodes a protein that is identical to the spike glycoprotein of SARS-CoV-2, allowing the production of immunogenic spike glycoprotein that will then elicit T cell and B cell adaptive immune responses. In this contribution, we review an array of cutaneous manifestations of COVID-19 that provide an opportunity to study critical pathophysiologic mechanisms that underlie all clinical facets of COVID-19, ranging from asymptomatic/mild to severe and critical COVID-19. We classify cutaneous COVID-19 according to underlying pathophysiologic principles. In this regard we propose three main pathways: (1) complement mediated thrombotic vascular injury syndromes deploying the alternative and mannan binding lectin pathways and resulting in the elaboration of cytokines like interleukin 6 from endothelium in the setting of severe and critical COVID-19 and (2) the robust T cell and type I interferon-driven inflammatory and (3) humoral-driven immune complex mediated vasculitic cutaneous reactions observed with mild and moderate COVID-19. Presented are novel data on cutaneous vaccine reactions that manifest a clinical and morphologic parallel with similar eruptions observed in patients with mild and moderate COVID-19 and in some cases represent systemic eczematoid hypersensitivity reactions to a putative vaccine-based antigen versus unmasking subclinical hypersensitivity due to immune enhancing effects of the vaccine. Finally, we demonstrate for the first time the localization of human synthesized spike glycoprotein after the COVID-19 vaccine to the cutaneous and subcutaneous vasculature confirming the ability of SARS-CoV-2 spike glycoprotein to bind endothelium in the absence of intact virus.

Two Cases of Graves' Disease Following SARS-CoV-2 Vaccination: An Autoimmune/Inflammatory Syndrome Induced by Adjuvants.

Background: The autoimmune/inflammatory syndrome induced by adjuvants (ASIA) comprises four entities, including the postvaccination phenomenon, which appears after being exposed to adjuvants in vaccines that increase the immune response. There is limited information about autoimmune endocrine diseases and ASIA after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. Patient's Findings: Two female health care workers received a SARS-CoV-2 vaccine, and three days later developed clinical manifestations of thyroid hyperactivity, with increased thyroid hormone levels on thyroid function tests, suppressed thyroid-stimulating hormone, and elevated antithyroid antibodies. Summary: Vaccines have been shown to trigger an immune response that leads to a broad spectrum of autoimmune diseases, including autoimmune thyroid disease. Our patients met the diagnostic criteria for ASIA; they were exposed to an adjuvant (vaccine), and they developed clinical manifestations of thyroid hyperfunction within a few days, with the appearance of antithyroid antibodies, despite being healthy before vaccination. Conclusion: Graves' disease can occur after SARS-CoV-2 vaccination.

Adverse Reactions to Vaccination: From Anaphylaxis to Autoimmunity.

Vaccines are important for providing protection from infectious diseases. Vaccination initiates a process that stimulates development of a robust and long-lived immune response to the disease agents in the vaccine. Side effects are sometimes associated with vaccination. These vary from development of acute hypersensitivity responses to vaccine components to local tissue reactions that are annoying but not significantly detrimental to the patient. The pathogenesis of these responses and the consequent clinical outcomes are discussed. Overstimulation of the immune response and the potential relationship to autoimmunity is evaluated in relation to genetic predisposition.

Adverse reactions in a population of Sydney pet rabbits vaccinated against rabbit calicivirus.

OBJECTIVE: To determine the general clinical presentation and incidence of adverse reactions to Cylap® RCD vaccinations, of a nature serious enough for veterinary attention, in a Sydney population of pet rabbits. DESIGN: A retrospective survey using hospital databases. METHODS: Nine veterinary hospitals in Sydney participated in a database search for the number of rabbits vaccinated within a 2-year period. The hospitals involved had an identified interest in rabbit medicine and included general, specialist and teaching hospitals. Details of the rabbit, vaccination event and any possible reaction were collected and analysed. RESULTS: Of 933 events recorded in 705 rabbits, 17 (1.8%) adverse reactions were observed. Of the adverse events, local injection site reactions (alopecia, abrasions and scabbing) were most common. Other reactions, including systemic signs of gastrointestinal tract stasis, lethargy and forelimb lameness, were also documented. Overall, rabbits presented for vaccination were mostly male (57.7%) and desexed (71.3%), with an average age of 28.1 months (median 19.0, range 1.4-149.8 months) and an average weight at first vaccination of 2.12 kg (median 2.08 kg, range 0.18-5.6 kg). A significant association between increasing age and decreased incidence of adverse events was demonstrated (P value, 0.038). CONCLUSIONS: The benefits of vaccination against RCV outweigh the risks of an adverse reaction occurring. Data from this study show that adverse reactions occur infrequently, are generally mild and self-resolving, and decrease in incidence with increasing age. These results are similar to previous field research on wild rabbit colonies and reports from government and industry.