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Biologics have expanded the armamentarium for psoriasis, but there has been a growing concern about the risk of lymphoma in patients under tumour necrosis factor (TNF)-α inhibitor and methotrexate. Besides, the mRNA-based coronavirus disease 2019 (COVID-19) vaccination was known to stimulate the proliferation of T-follicular helper cells. We report a case of a patient with psoriasis under adalimumab developing nodal T-follicular helper cell lymphoma, angioimmunoblastic-type following the mRNA-1273 COVID-19 vaccine. We suspect that adalimumab, methotrexate, Epstein-Barr virus (EBV) reactivation, previous reactive lymphoid hyperplasia and psoriasis per se predispose our patient to a lymphoma-prone condition, and the two doses of the mRNA vaccine act as the last straw.

Measuring T cell response can add information about antivirus immunity provided by antibody test results. The study evaluates the impact of a third mRNA COVID-19 vaccine dose on T cell response and antibody production in kidney transplant recipients (25 KTRs) versus healthy controls (26 Hc). Results show a significant rise in S-activated CD4+CD154+IFNγ+TNFα+ double producer cells in both KTRs (p=0.025) and Hc (p=0.009) as well as increased spike antibody response in KTRs (p=0.00019) and Hc (p=3.10-8) third-month post-third dose. Moreover, the study revealed a drop in seronegative KTRs (nonresponders) from 9/25 (36%) pre-third dose to 2/25 (7%) at 3 months post-third dose while 5/9 (56%) of non-responders post-second dose showed specific T cell responses. Notably, the third dose significantly improved seroconversion rates in both KTRs and Hc, although Hc individuals exhibited higher antibody levels. [ABSTRACT FROM AUTHOR]

Preexisting cardiovascular disease (CVD) is a pivotal risk factor for severe coronavirus disease 2019 (COVID-19). We investigated the longitudinal (over 1 year and 9 months) humoral and cellular responses to primary series and booster doses of mRNA COVID-19 vaccines in patients with CVD. Twenty-six patients with CVD who received monovalent mRNA COVID-19 vaccines were enrolled in this study. Peripheral blood samples were serially drawn nine times from each patient. IgG against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike receptor-binding domain (RBD) was measured using an enzyme-linked immunosorbent assay. The numbers of interferon-γ-releasing cells in response to SARS-CoV-2 peptides were measured using an enzyme-linked immunospot assay. The RBD-IgG titers increased 2 weeks after the primary series and booster vaccination and waned 6 months after vaccination. The S1-specific T cell responses in patients aged < 75 years were favorable before and after booster doses; however, the Omicron BA.1-specific T cell responses were poor. These results suggest that regular vaccination is useful to maintain long-term antibody levels and has implications for booster dose strategies in patients with CVD. Additional booster doses, including Omicron variant-adapted mRNA vaccines, may be recommended for patients with CVD, regardless of age. [ABSTRACT FROM AUTHOR]

This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against >15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history.

• In Norway, 12–17-year-olds had greater COVID-19 vaccine uptake than younger children of age 5–11 years. • About one every eight children aged 5–11 years with high risk for severe COVID-19 was unvaccinated. • Parental COVID-19 vaccination status, especially in the mother, was major determinant of COVID-19 vaccine uptake in children and adolescents. • Prior SARS-CoV-2 infection, being born premature and having moderate or high risk of severe COVID-19 were important determinants of vaccine uptake. Factors related with COVID-19 vaccine uptake in children and adolescents in Norway remain unclear, despite this being useful knowledge for future pandemic preparedness. This study aimed to comprehensively examine individual and familial factors associated with vaccine uptake in children and adolescents in Norway. We utilized nationwide registry-data from various health registries and Statistics Norway, encompassing all children and adolescents living in Norway during the pandemic, until 31-Dec-2022. Vaccine uptake is defined as receiving at least one dose of COVID-19 vaccine. We employed a forward stepwise logistic regression model and a random forest machine-learning algorithm to explore the relationship between vaccine uptake and socio-cultural, demographic, and health-related factors. We included 423,548 5–11-year-olds, 269,830 12–15-year-olds, and 120,854 16–17-year-olds. Vaccine uptake in these three groups was respectively 2.6 %, 73.3 %, and 87.3 %. Factors associated with vaccine uptake varied by age group. In youngest children, immigrant background (Odds-ratio (OR) = 1.58, 95 % confidence interval (CI) (1.14–2.19)), born extremely preterm (OR = 2.38, 95 % CI (1.60–3.54)), having risk of severe COVID-19 (OR = 5.40, 95 % CI (4.69–6.23) and maternal COVID-19 vaccination (OR = 6.34, 95 % CI (5.35–7.53)) were positively associated with vaccine uptake. The latter two factors were also strongly, positively associated with vaccine uptake in 12–15-year-olds, while previous SARS-CoV-2 infection was negatively associated (OR = 0.12, 95 % CI (0.11–0.14). Similar findings were observed in 16–17-year-olds. COVID-19 vaccine uptake differed markedly by age group, and major associated factors included socio-demographics and parental COVID-19 vaccination status, prior SARS-CoV-2 infection, but also being born premature and having moderate or high risk of severe COVID-19. [ABSTRACT FROM AUTHOR]

Background Improved coronavirus disease 2019 (COVID-19) prevention is needed for immunocompromised individuals. Methods A prospective study was performed of health care workers (HCW) and immunocompromised participants with baseline serology following 2 mRNA vaccine doses and who were retested after dose 3 (D3); multivariable regression was used to identify predictors of serological responses. IFN-γ/TNF-α T-cell responses were assessed in a subset. Results In total, 536 participants were included: 492 immunocompromised (206 solid organ transplant [SOT], 128 autoimmune, 80 hematologic malignancy [HM], 48 solid tumor, 25 HIV), and 44 HCW. D3 significantly increased spike IgG levels among all, but SOT and HM participants had the lowest median antibody levels post-D3 (increase from 0.09 to 0.83 and 0.27 to 1.92, respectively), versus HCW and persons with HIV, autoimmune conditions, and solid tumors (increases from 4.44 to 19.79, 2.9 to 15.75, 3.82 to 16.32, and 4.1 to 25.54, respectively). Seropositivity post-D3 was lowest for SOT (49.0%) and HM (57.8%), versus others (>90%). Neutralization post-D3 was lowest among SOT and HM. Predictors of lower antibody levels included low baseline levels and shorter intervals between vaccines. T-cell responses against spike increased significantly among HCW and nonsignificantly among immunocompromised individuals. Conclusions D3 significantly improves serological but not T-cell responses among immunocompromised individuals. SOT and HM patients have suboptimal responses to D3. [ABSTRACT FROM AUTHOR]

Background: Although there are some data regarding the COVID-19 vaccine and in in vitro fertilization (IVF) treatments, its potential impact in terms of serum immunoglobulin G (IgG) levels has not been evaluated prospectively. This study aimed to assess the effect of COVID-19 vaccine and IgG levels on IVF outcomes. Methods: This observational, cohort study was conducted at a referral IVF unit. Couples undergoing IVF treatment during the COVID-19 vaccination period were recruited from March–April 2021. The study compared 38 women who had received the Pfizer mRNA COVID-19 vaccination to 10 women who had not and were not infected by the virus. We also compared pre- and post-vaccination IVF treatments for 24 women. The relation between serologic titers and IVF treatment outcomes was also assessed. Results: No significant difference was found between the vaccinated and unvaccinated/uninfected groups regarding the main outcome measures. However, there was a trend toward a higher pregnancy rate for the unvaccinated group (57% vs. 23%, p = 0.078) but no difference in delivery rate (p = 0.236), gestational week (p = 0.537) or birth rate (p = 0.671). Conclusion: We cautiously state that the COVID-19 mRNA vaccine does not affect fertility outcomes, including fertilization, pregnancy and delivery rates, obstetric outcomes, and semen parameters, regardless of measured IgG levels. [ABSTRACT FROM AUTHOR]

Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing damage. Soon after the launch of global COVID-19 vaccination campaigns, the World Health Organization released a signal detection about SSNHL cases following administration of various COVID-19 vaccines. Post-marketing studies have been conducted in different countries using either pharmacovigilance or medico-administrative databases to investigate SSNHL as a potential adverse effect of COVID-19 vaccines. Here, we examine the advantages and limitations of each type of post-marketing study available. While pharmacoepidemiological studies highlight the potential association between drug exposure and the event, pharmacovigilance approaches enable causality assessment. The latter objective can only be achieved if an expert evaluation is provided using internationally validated diagnostic criteria. For a rare adverse event such as SSNHL, case information and quantification of hearing loss are mandatory for assessing seriousness, severity, delay onset, differential diagnoses, corrective treatment, recovery, as well as functional sequelae. Appropriate methodology should be adopted depending on whether the target objective is to assess a global or individual risk. [ABSTRACT FROM AUTHOR]

mRNA COVID-19 vaccines have been reported as protecting against COVID-19 and reducing its severity, and we have recognized post-vaccination symptoms recently. This research investigates the clinical trajectories of ocular disorders in a 51-year-old female who received a second dose of the BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine. Exhibiting fever and blurred vision within 24 h post-vaccination, with progressive blurry vision over two months, she underwent in-depth ophthalmologic examinations, revealing intraocular cellular infiltration in anterior chamber, vitreous opacity, and frosted branch angiitis in both eyes. Comprehensive evaluations, including systemic workups as well as ocular and blood specimen analyses, excluded autoimmune and infectious etiologies, consolidating the diagnosis of vaccine-induced ocular inflammation. Despite adherence to prevailing therapeutic protocols, her condition showed no significant improvement over 18 months, pointing to a possible long post-COVID vaccination syndrome. Such persistent sequelae underscore the need for detailed studies to discern the interactions between vaccine-induced immune responses and the development of post-vaccination sequelae. Continual documentation of patients with long post-COVID vaccination syndrome is now essential to better understand the vaccine's immunological effects, aiding in improving global vaccination strategies. [ABSTRACT FROM AUTHOR]

Background: Existing data regarding the link between COVID‐19 vaccine and myasthenia gravis (MG) are scarce. We aimed to assess the association between Pfizer‐BioNTech vaccine with both new‐onset MG and MG exacerbation. Methods: For the first aim, we conducted a nested case–control study in a cohort of 3,052,467 adults, without a diagnosis of MG, from the largest healthcare provider in Israel. Subjects were followed from January 1, 2021 until June 30, 2022 for the occurrence of MG. Ten randomly selected controls were matched to each case of new‐onset MG on age and sex. For the second aim, a nested case–control study was conducted in a cohort of 1446 MG patients. Four randomly selected MG patients (controls) were matched to each case of MG exacerbation. Exposure to COVID‐19 vaccine in the prior 4 weeks was assessed in cases and controls. Results: Overall, 332 patients had new‐onset MG and were matched with 3320 controls. Multivariable conditional logistic regression models showed that the odds ratio (OR) for new‐onset MG, associated with COVID‐19 vaccine, was 1.14 (95% CI 0.73–1.78). The results were consistent in sensitivity analysis that used more stringent criteria to define MG. Overall, 62 patients with MG exacerbation were matched to 248 MG controls. The multivariable OR for MG exacerbation, associated with COVID‐19 vaccine, was 1.35 (95% CI 0.37–4.89). All results were similar when the prior exposure to COVID‐19 vaccine was extended to 8 weeks. Conclusion: This study suggests that Pfizer‐BioNTech vaccine is not associated with increased risk of new‐onset nor exacerbation of MG. [ABSTRACT FROM AUTHOR]

Preexisting cardiovascular disease (CVD) is a pivotal risk factor for severe coronavirus disease 2019 (COVID-19). We investigated the longitudinal (over 1 year and 9 months) humoral and cellular responses to primary series and booster doses of mRNA COVID-19 vaccines in patients with CVD. Twenty-six patients with CVD who received monovalent mRNA COVID-19 vaccines were enrolled in this study. Peripheral blood samples were serially drawn nine times from each patient. IgG against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike receptor-binding domain (RBD) was measured using an enzyme-linked immunosorbent assay. The numbers of interferon-γ-releasing cells in response to SARS-CoV-2 peptides were measured using an enzyme-linked immunospot assay. The RBD-IgG titers increased 2 weeks after the primary series and booster vaccination and waned 6 months after vaccination. The S1-specific T cell responses in patients aged < 75 years were favorable before and after booster doses; however, the Omicron BA.1-specific T cell responses were poor. These results suggest that regular vaccination is useful to maintain long-term antibody levels and has implications for booster dose strategies in patients with CVD. Additional booster doses, including Omicron variant-adapted mRNA vaccines, may be recommended for patients with CVD, regardless of age.

Background There is growing consensus that coronavirus disease 2019 booster vaccines may be coadministered with other age-appropriate vaccines. Adding to the limited available data supporting coadministration, especially with adjuvanted vaccines, could enhance vaccine coverage in adults. Methods In this phase 3, randomized, open-label study, eligible adults aged ≥50 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and a first dose of recombinant zoster vaccine (RZV1) 2 weeks apart (Seq group) or concomitantly (Coad group). The second RZV dose (RZV2) was administered 2 months post-RZV1 in both groups. Primary objectives were noninferiority of anti–glycoprotein E (gE) and anti–spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives. Results In total, 273 participants were randomized to the Seq group and 272 to the Coad group. Protocol-specified noninferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI],.89–1.13) for anti-gE antibodies 1 month post-RZV2, and 1.09 (95% CI,.90–1.32) for anti–spike antibodies 1 month post–mRNA-1273 booster. No clinically relevant differences were observed in overall frequency, intensity, or duration of adverse events between the 2 study groups. Most solicited adverse events were mild/moderate in intensity, each with median duration ≤2.5 days. Administration site pain and myalgia were the most frequently reported in both groups. Conclusions Coadministration of mRNA-1273 booster vaccine with RZV in adults aged ≥50 years was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines administered sequentially. Clinical Trials Registration.  NCT05047770. [ABSTRACT FROM AUTHOR]

The severe acute respiratory syndrome coronavirus-2 pandemic significantly affected clinical practice, also in pediatric oncology units. Cancer patients needed to be treated with an adequate dose density despite the SARS-CoV-2 infection, balancing risks of developing severe COVID-19 disease. Although the pandemic spread worldwide, the prevalence of affected children was low. The percentage of children with severe illness was approximately 1–6%. Pediatric cancer patients represent a prototype of a previously healthy immune system that is hampered by the tumor itself and treatments, such as chemotherapy and steroids. Through a review of the literature, we reported the immunological basis of the response to SARS-CoV-2 infection, the existing antiviral treatments used in pediatric cancer patients, and the importance of vaccination. In conclusion, we reported the real-life experience of our pediatric oncology unit during the pandemic period. Starting from the data available in literature, and our experience, showing the rarity of severe COVID-19 disease in pediatric patients with solid tumors, we recommend carefully tailoring all the oncological treatments (chemotherapy/targeted therapy/stem cell transplantation/radiotherapy). The aim is the preservation of the treatment's timing, balanced with an evaluation of possible severe COVID-19 disease. [ABSTRACT FROM AUTHOR]

Abstract Background As messenger RNA (mRNA)-based vaccines for coronavirus disease 2019 (COVID-19) have been administered to millions of individuals worldwide, cases of de novo and relapsing glomerulonephritis after mRNA COVID-19 vaccination are increasing in the literature. While most previous publications reported glomerulonephritis after the first or second dose of an mRNA vaccine, few reports of glomerulonephritis occurring after the third dose of an mRNA vaccine currently exist. Case presentation We report a case of rapidly progressive glomerulonephritis in a patient following the third dose of an mRNA COVID-19 vaccine. A 77-year-old Japanese man with a history of hypertension and atrial fibrillation was referred to our hospital for evaluation of anorexia, pruritus, and lower extremity edema. One year before referral, he received two mRNA vaccines (BNT162b2) for COVID-19. Three months before the visit, he received a third mRNA vaccine (mRNA-1273) for COVID-19. On admission, the patient presented severe renal failure with a serum creatinine level of 16.29 mg/dL, which had increased from 1.67 mg/dL one month earlier, prompting us to initiate hemodialysis. Urinalysis showed nephrotic-range proteinuria and hematuria. Renal biopsy revealed mild mesangial proliferation and expansion, a lobular appearance, and double contours of the glomerular basement membrane. Renal tubules had severe atrophy. Immunofluorescence microscopy showed strong mesangial staining for IgA, IgM, and C3c. Electron microscopy exhibited mesangial and subendothelial electron-dense deposits, leading to a diagnosis of IgA nephropathy with membranoproliferative glomerulonephritis-like changes. The kidney function remained unchanged after steroid therapy. Conclusions Although the link between renal lesions and mRNA vaccines remains unclear, a robust immune response induced by mRNA vaccines may play a role in the pathogenesis of glomerulonephritis. Further studies of the immunological effects of mRNA vaccines on the kidney are warranted.

Abstract is missing (Short communication)

The aim of this research was to investigate the possible association between smoking habits and the incidence of adverse effects (AEs) after mRNA COVID-19 vaccine. A longitudinal observational study was conducted on a sample of Italian healthcare workers. Healthcare workers who were administered the mRNA COVID-19 vaccine (either BNT162b2 or mRNA-1273) were evaluated for the occurrence of AEs after three vaccine doses. Multivariate Poisson regression analyses were fitted to predict AE risk according to smoking characteristics – such as number of tobacco cigarettes smoked per day, smoking time, and use of electronic cigarette (e-cig). Of 320 total participants, 72 (22.5%) smoked cigarettes, and 50 (15.6%) used e-cig, 49 of which being dual users. Tobacco smoking significantly increased the risks of muscle and joint pain during the primary COVID-19 vaccination cycle and of chills during the whole vaccination series. The number of cigarettes smoked per day and vaping variously predicted AE onset during the whole cycle, with a tendency to respectively reduce and increase their risks. Duration of smoking did not affect any AE, except for headache after the booster dose. Most results remained significant after Bonferroni adjustment of significance level. Our pilot study indicated a possible effect of smoking habits on AE onset. Our research offers evidence that helps understanding possible predictors of the interindividual variability in COVID-19 vaccine response, serving as a reference for further studies on the effect of smoking on vaccine safety and effectiveness. [ABSTRACT FROM AUTHOR]

Abstract Background Since the campaign of vaccination against COVID‐19 was started, a wide variety of cutaneous adverse effects after vaccination has been documented worldwide. Varicella zoster virus (VZV) reactivation was reportedly the most frequent cutaneous reaction in men after administration of mRNA COVID‐19 vaccines, especially BNT162b2. Aims A patient, who had persistent skin lesions after BNT162b2 vaccination for such a long duration over 3 months, was investigated for VZV virus and any involvement of vaccine‐derived spike protein. Materials & Methods Immunohistochemistry for detection of VZV virus and the spike protein encoded by mRNA COVID‐19 vaccine. PCR analysis for VZV virus. Results The diagnosis of VZV infection was made for these lesions using PCR analyses and immunohistochemistry. Strikingly, the vaccine‐encoded spike protein of the COVID‐19 virus was expressed in the vesicular keratinocytes and endothelial cells in the dermis. Discussion mRNA COVID‐19 vaccination might induce persistent VZV reactivation through perturbing the immune system, although it remained elusive whether the expressed spike protein played a pathogenic role. Conclusion We presented a case of persistent VZV infection following mRNA COVID‐19 vaccination and the presence of spike protein in the affected skin. Further vigilance of the vaccine side effect and investigation for the role of SP is warranted.

Abstract Background The Pfizer BioNTech COVID-19 vaccine was the first to receive emergency authorization and approval from the FDA. Therefore, it is preferred by most recipients; however, many people are concerned about the vaccine’s side effects. At the time of the study, December 2021, Palestine lacked a national reporting system for monitoring adverse vaccine effects. Therefore, this study investigates the post-vaccine adverse events following the Pfizer/BioNTech COVID-19 Vaccine administration in Palestine and identifies the occurrence, extent, and severity among university staff, employees, and students at Birzeit University. Method A questionnaire-based retrospective cross-sectional study was conducted using a university website (Ritaj), social media platforms (e.g., Facebook and Telegram), and in-person interviews. The Chi-square, Fisher’s exact, and McNemar’s tests were used to investigate significant relationships. Data were analyzed using SPSS version 22. Results In total, 1137 participants completed the questionnaire, 33.2% were males, and the mean age was 21.163 years. All participants received at least one dose of the Pfizer-BioNTech COVID-19 vaccine. Approximately one-third of participants reported no adverse effects after receiving the first, second, or third doses (34%, 33.6%, and 32.5%, respectively). The most commonly reported adverse events were fever, chills, headache, fatigue, pain and swelling at the injection site, muscle pain, and joint pain. Allergic reactions were reported by 12.7% of the participants; furthermore, participants with a history of allergy or anaphylaxis before vaccination had a significantly higher tendency for post-vaccination allergic reactions. Eight participants reported rare side effects, including 7 (0.6%) cases of thrombocytopenia and one (0.1%) case of myocarditis. Males aged less than 20 years and smokers were significantly less likely to complain of adverse events. The number of reported side effects was significantly higher after the second vaccine dose than after the first dose. Finally, participants infected with COVID-19 before vaccination was significantly associated with side effects such as fever, chills, shortness of breath, and persistent cough. Conclusion In this study, the most common post- BNT162b2 Vaccination reported self-limiting side effects similar to those reported by Pfizer/BioNTech Company. However, higher rates of allergic reactions were reported in this sample. Rare side effects, such as thrombocytopenia and myocarditis, were reported by 8 participants. COVID vaccines have been developed at an accelerated pace, and vaccine safety is a top priority; therefore, standard monitoring through a national adverse event reporting system is necessary for safety assurance. Continuous monitoring and long-term studies are required to ensure vaccine safety.

Background: As messenger RNA (mRNA)-based vaccines for coronavirus disease 2019 (COVID-19) have been administered to millions of individuals worldwide, cases of de novo and relapsing glomerulonephritis after mRNA COVID-19 vaccination are increasing in the literature. While most previous publications reported glomerulonephritis after the first or second dose of an mRNA vaccine, few reports of glomerulonephritis occurring after the third dose of an mRNA vaccine currently exist. Case presentation: We report a case of rapidly progressive glomerulonephritis in a patient following the third dose of an mRNA COVID-19 vaccine. A 77-year-old Japanese man with a history of hypertension and atrial fibrillation was referred to our hospital for evaluation of anorexia, pruritus, and lower extremity edema. One year before referral, he received two mRNA vaccines (BNT162b2) for COVID-19. Three months before the visit, he received a third mRNA vaccine (mRNA-1273) for COVID-19. On admission, the patient presented severe renal failure with a serum creatinine level of 16.29 mg/dL, which had increased from 1.67 mg/dL one month earlier, prompting us to initiate hemodialysis. Urinalysis showed nephrotic-range proteinuria and hematuria. Renal biopsy revealed mild mesangial proliferation and expansion, a lobular appearance, and double contours of the glomerular basement membrane. Renal tubules had severe atrophy. Immunofluorescence microscopy showed strong mesangial staining for IgA, IgM, and C3c. Electron microscopy exhibited mesangial and subendothelial electron-dense deposits, leading to a diagnosis of IgA nephropathy with membranoproliferative glomerulonephritis-like changes. The kidney function remained unchanged after steroid therapy. Conclusions: Although the link between renal lesions and mRNA vaccines remains unclear, a robust immune response induced by mRNA vaccines may play a role in the pathogenesis of glomerulonephritis. Further studies of the immunological effects of mRNA vaccines on the kidney are warranted. [ABSTRACT FROM AUTHOR]

Presently, evidence-based research studies on the efficacy and safety of mRNA COVID-19 vaccines are limited. The objective of this study is to conduct a systematic review and meta-analysis of Randomized Controlled Trials (RCTs) to learn about the efficacy of mRNA COVID-19 vaccines and the side effects associated with them. We used five databases to conduct an electronic search of material published between 2020 and June 2021. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) declaration was used to create and report on a procedure for a systematic review and meta-analysis. The systematic review comprised eleven RCTs, and nine RCTs were included for meta-analysis. To assess bias risk, the Cochrane collaboration tool was employed. In a total of 70604 cases, the overall effectiveness of the mRNA vaccines was determined to be 94.6% (95% CI 0.04-0.08). The administration of mRNA-based vaccine was associated with a greater number of side effects, such as, injection site pain, fever, swelling, fatigue, headache, chills, by yielding a summary OR of 4.35 (95% CI 2.05-9.24), 8.50 (95% CI 3.03-23.86), 3.66 (95% CI 1.12-12.01), 1.15 (95% CI 0.049-2.72), 1.49 (95% CI 0.90-2.46), 5.72 (95% CI 5.24-6.24) respectively. In all investigations, the mRNA-based COVID-19 vaccines caused mild to moderate local and systemic adverse effects following the first and second doses of immunization. mRNA vaccines were shown to have an overall effectiveness of 94.6%. The findings demonstrate the overall safety and effectiveness of all currently available mRNA-based COVID 19 vaccines, giving unambiguous data-driven evidence to support the continuing worldwide public health endeavor to immunize the whole population. [ABSTRACT FROM AUTHOR]

The present study aimed to estimate the anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents in Europe. We retrieved data on 371 anaphylaxis cases following mRNA COVID-19 vaccination in children ≤ 17 years old notified to EudraVigilance as of October 8, 2022. Overall, 27,120,512 doses of BNT162b2 vaccine and 1,400,300 doses of mRNA-1273 vaccine have been delivered to children during the study period. The overall mean anaphylaxis rate was 12.81 [95% confidence interval (CI): 11.49–14.12] per 106 mRNA vaccine doses [12.14 (95% CI: 6.37–17.91) per 106 doses for mRNA-1273 and 12.84 (95% CI: 11.49–14.19) per 106 doses for BNT162b2]. Children 12–17 years old accounted for 317 anaphylaxis cases, followed by 48 cases in children 3–11 years old, and 6 cases in children 0–2 years old. Children 10–17 years old had a mean anaphylaxis rate of 13.52 (95% CI: 12.03–15.00) cases per 106 mRNA vaccine doses and children 5–9 years old had a mean anaphylaxis rate of 9.51 (95% CI: 6.82–12.20) cases per 106 mRNA vaccine doses. There were two fatalities, both in the 12–17 years age group. The fatal anaphylaxis rate was 0.07 cases per 106 mRNA vaccine doses. Anaphylaxis is a rare adverse event after receiving an mRNA COVID-19 vaccine in children. Continuous surveillance of serious adverse events is needed to guide vaccination policies as we move towards SARS-CoV-2 endemicity. Larger real-world studies on COVID-19 vaccination in children, using clinical case confirmation, are imperative. [ABSTRACT FROM AUTHOR]

The coronavirus disease 2019 (COVID-19) pandemic is a universal emergency public health issue. A large proportion of the world's population has had several spike antigen exposures to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and/or COVID-19 vaccinations in a relatively short-term period. Although sporadic hematopoietic adverse events after COVID-19 vaccine inoculation were reported, there is currently no sufficient evidence correlating anti-spike protein immune responses and hematopoietic adverse events of vaccinations. We reported the first case of Ph-positive B-cell acute lymphoblastic leukemia (ALL) occurring after a bivalent mRNA COVID-19 vaccine inoculation. The otherwise healthy 43-year-old female patient had a total of six spike antigen exposures in the past 1.5 years. Informative pre-vaccine tests and bone marrow study results were provided. Although the causal relationship between bivalent vaccinations and the subsequent development of Ph–positive B-cell ALL cannot be determined in the case report, we propose that anti-spike protein immune responses could be a trigger for leukemia. Clinicians must investigate the hematopoietic adverse events closely after COVID-19 vaccinations. Further pre-clinical studies to investigate the safety of bivalent mRNA COVID-19 vaccine are required. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has significantly impacted global health, and the widespread immunization of adults against SARS-CoV-2 has played a pivotal role in altering the course of the disease. While COVID-19 vaccine adverse events are generally uncommon and mild, the recent vaccination of the pediatric population has emphasized the need for vigilance and reporting of potential side effects. In this case report, we present a 6-year-old boy who developed Henoch-Schönlein purpura following the administration of the first dose of Pfizer-BioNTech BNT16B2b2 mRNA COVID-19 vaccine, making it the earliest reported case of such an adverse event. Our report highlights the importance of continued monitoring and reporting of adverse events in pediatric patients receiving the COVID-19 vaccine, as well as the need for prompt diagnosis and management of potential vaccine-related complications.

Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing damage. Soon after the launch of global COVID-19 vaccination campaigns, the World Health Organization released a signal detection about SSNHL cases following administration of various COVID-19 vaccines. Post-marketing studies have been conducted in different countries using either pharmacovigilance or medico-administrative databases to investigate SSNHL as a potential adverse effect of COVID-19 vaccines. Here, we examine the advantages and limitations of each type of post-marketing study available. While pharmacoepidemiological studies highlight the potential association between drug exposure and the event, pharmacovigilance approaches enable causality assessment. The latter objective can only be achieved if an expert evaluation is provided using internationally validated diagnostic criteria. For a rare adverse event such as SSNHL, case information and quantification of hearing loss are mandatory for assessing seriousness, severity, delay onset, differential diagnoses, corrective treatment, recovery, as well as functional sequelae. Appropriate methodology should be adopted depending on whether the target objective is to assess a global or individual risk.

mRNA COVID-19 vaccines have been reported as protecting against COVID-19 and reducing its severity, and we have recognized post-vaccination symptoms recently. This research investigates the clinical trajectories of ocular disorders in a 51-year-old female who received a second dose of the BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine. Exhibiting fever and blurred vision within 24 h post-vaccination, with progressive blurry vision over two months, she underwent in-depth ophthalmologic examinations, revealing intraocular cellular infiltration in anterior chamber, vitreous opacity, and frosted branch angiitis in both eyes. Comprehensive evaluations, including systemic workups as well as ocular and blood specimen analyses, excluded autoimmune and infectious etiologies, consolidating the diagnosis of vaccine-induced ocular inflammation. Despite adherence to prevailing therapeutic protocols, her condition showed no significant improvement over 18 months, pointing to a possible long post-COVID vaccination syndrome. Such persistent sequelae underscore the need for detailed studies to discern the interactions between vaccine-induced immune responses and the development of post-vaccination sequelae. Continual documentation of patients with long post-COVID vaccination syndrome is now essential to better understand the vaccine’s immunological effects, aiding in improving global vaccination strategies.

Abstract Background Research on the COVID-19 vaccination in patients with underlying rheumatic disorders in pediatric age is lacking. We studied possible adverse events of the mRNA BNT162b2 vaccine against SARS-CoV-2 (Pfizer-BioNTech) in children and adolescents with juvenile idiopathic arthritis (JIA), and also if there is a risk of flaring of the underlying JIA. We reported 36 JIA patients aged 5–18 years old received 2 doses of the COVID-19 vaccine (72 doses). Patients were followed before and after vaccination, and any related adverse event was recorded. JIA disease activity was assessed using Juvenile Arthritis Disease Activity Score-10 (JADAS-10) before and after vaccination. Results Among 72 doses of the vaccine received, local adverse events (AEs) were reported by majority of the patients (66.7%); most commonly reported local AE was pain at the site of injection. Systemic AEs were revealed by (65.3%), most commonly reported systemic AEs were tiredness, myalgia, and headache. Almost all the reported AE were mild to moderate and resolved within 1–2 days and were also more frequently noted after the second dose. No flaring of the underlying primary rheumatic disease after vaccination. No one of the study group revealed serious adverse events. Conclusions This is one of the early studies reporting that mRNA COVID-19 vaccine seems to be safe in children and adolescents with JIA. Almost all the reported adverse events were mild to moderate and transient. Also, no serious adverse events or flaring of the primary disease were reported.

Background: Since the campaign of vaccination against COVID‐19 was started, a wide variety of cutaneous adverse effects after vaccination has been documented worldwide. Varicella zoster virus (VZV) reactivation was reportedly the most frequent cutaneous reaction in men after administration of mRNA COVID‐19 vaccines, especially BNT162b2. Aims: A patient, who had persistent skin lesions after BNT162b2 vaccination for such a long duration over 3 months, was investigated for VZV virus and any involvement of vaccine‐derived spike protein. Materials & Methods: Immunohistochemistry for detection of VZV virus and the spike protein encoded by mRNA COVID‐19 vaccine. PCR analysis for VZV virus. Results: The diagnosis of VZV infection was made for these lesions using PCR analyses and immunohistochemistry. Strikingly, the vaccine‐encoded spike protein of the COVID‐19 virus was expressed in the vesicular keratinocytes and endothelial cells in the dermis. Discussion: mRNA COVID‐19 vaccination might induce persistent VZV reactivation through perturbing the immune system, although it remained elusive whether the expressed spike protein played a pathogenic role. Conclusion: We presented a case of persistent VZV infection following mRNA COVID‐19 vaccination and the presence of spike protein in the affected skin. Further vigilance of the vaccine side effect and investigation for the role of SP is warranted. [ABSTRACT FROM AUTHOR]

The successful deployment of safe and effective vaccines against coronavirus disease 2019 (COVID-19) has been crucial in reducing the global disease burden. Owing to the need for vaccination series over time, continuous observational studies are needed to estimate the COVID-19 vaccine response in real-world conditions. In particular, the detection, assessment, and understanding of adverse effects following immunization (AEFI) with a COVID-19 vaccine are crucial to better address vaccination strategies. Therefore, this study aimed to investigate the risk of repeated AEFI post-administration of a booster dose of mRNA COVID-19 vaccine in a sample of healthcare workers (HCWs) in an Italian teaching hospital. The data on any local and systemic AEFI were studied in multivariate Poisson regression analyses to model the association between the incidence of each postvaccination symptom and its prior reporting after the administration of the previous doses. Overall, compared with the primary vaccination series, the majority of post-third dose AEFI were less reported. The results from multivariable models showed that the likelihood of reporting an AEFI after the third dose was higher in those who experienced the same postvaccination symptom after the second dose (all AEFI except for itch at injection site) and, although not significant for all AEFI, after the first dose. Any associations with age, gender, smoking habits, previous SARS-CoV-2 infection and other characteristics, as well as the health impact of AEFI were also assessed. Taken together, the results from this research support reframe AEFI symptoms as signals of a robust postvaccination reaction as well as of common vaccine response, and they add important data to inform booster vaccination strategies in HCWs and, extensively, in the adult population. [ABSTRACT FROM AUTHOR]

Background: The Pfizer BioNTech COVID-19 vaccine was the first to receive emergency authorization and approval from the FDA. Therefore, it is preferred by most recipients; however, many people are concerned about the vaccine's side effects. At the time of the study, December 2021, Palestine lacked a national reporting system for monitoring adverse vaccine effects. Therefore, this study investigates the post-vaccine adverse events following the Pfizer/BioNTech COVID-19 Vaccine administration in Palestine and identifies the occurrence, extent, and severity among university staff, employees, and students at Birzeit University. Method: A questionnaire-based retrospective cross-sectional study was conducted using a university website (Ritaj), social media platforms (e.g., Facebook and Telegram), and in-person interviews. The Chi-square, Fisher's exact, and McNemar's tests were used to investigate significant relationships. Data were analyzed using SPSS version 22. Results: In total, 1137 participants completed the questionnaire, 33.2% were males, and the mean age was 21.163 years. All participants received at least one dose of the Pfizer-BioNTech COVID-19 vaccine. Approximately one-third of participants reported no adverse effects after receiving the first, second, or third doses (34%, 33.6%, and 32.5%, respectively). The most commonly reported adverse events were fever, chills, headache, fatigue, pain and swelling at the injection site, muscle pain, and joint pain. Allergic reactions were reported by 12.7% of the participants; furthermore, participants with a history of allergy or anaphylaxis before vaccination had a significantly higher tendency for post-vaccination allergic reactions. Eight participants reported rare side effects, including 7 (0.6%) cases of thrombocytopenia and one (0.1%) case of myocarditis. Males aged less than 20 years and smokers were significantly less likely to complain of adverse events. The number of reported side effects was significantly higher after the second vaccine dose than after the first dose. Finally, participants infected with COVID-19 before vaccination was significantly associated with side effects such as fever, chills, shortness of breath, and persistent cough. Conclusion: In this study, the most common post- BNT162b2 Vaccination reported self-limiting side effects similar to those reported by Pfizer/BioNTech Company. However, higher rates of allergic reactions were reported in this sample. Rare side effects, such as thrombocytopenia and myocarditis, were reported by 8 participants. COVID vaccines have been developed at an accelerated pace, and vaccine safety is a top priority; therefore, standard monitoring through a national adverse event reporting system is necessary for safety assurance. Continuous monitoring and long-term studies are required to ensure vaccine safety. [ABSTRACT FROM AUTHOR]

For persons with immediate allergic reactions to mRNA COVID‐19 vaccines, skin testing (ST) to the vaccine/excipients (polyethylene glycol[PEG] and polysorbate 80 [PS]) has been recommended, but has unknown accuracy. To assess vaccine/excipient ST accuracy in predicting all‐severity immediate allergic reactions upon re‐vaccination, systematic review was performed searching Medline, EMBASE, Web of Science, and the WHO global coronavirus database (inception‐Oct 4, 2021) for studies addressing immediate (≤4 h post‐vaccination) all‐severity allergic reactions to 2nd mRNA COVID‐19 vaccination in persons with 1st dose immediate allergic reactions. Cases evaluating delayed reactions, change of vaccine platform, or revaccination without vaccine/excipient ST were excluded. Meta‐analysis of diagnostic testing accuracy was performed using Bayesian methods. The GRADE approach evaluated certainty of the evidence, and QUADAS‐2 assessed risk of bias. Among 20 studies of mRNA COVID‐19 first dose vaccine reactions, 317 individuals underwent 578 ST to any one or combination of vaccine, PEG, or PS, and were re‐vaccinated with the same vaccine. Test sensitivity for either mRNA vaccine was 0.2 (95%CrI 0.01–0.52) and specificity 0.97 (95%CrI 0.9–1). PEG test sensitivity was 0.02 (95%CrI 0.00–0.07) and specificity 0.99 (95%CrI 0.96–1). PS test sensitivity was 0.03 (95%CrI 0.00–0.0.11) and specificity 0.97 (95%CrI 0.91–1). Combined for use of any of the 3 testing agents, sensitivity was 0.03 (95%CrI 0.00–0.08) and specificity was 0.98 (95%CrI 0.95–1.00). Certainty of evidence was moderate. ST has low sensitivity but high specificity in predicting all‐severity repeat immediate allergic reactions to the same agent, among persons with 1st dose immediate allergic reactions to mRNA COVID‐19 vaccines. mRNA COVID‐19 vaccine or excipient ST has limited risk assessment utility. [ABSTRACT FROM AUTHOR]

Numerous studies have reported myocarditis resulting from messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccination. However, to date, there have been no reports highlighting the safety of mRNA COVID-19 vaccines in children and adults with a prior history of myocarditis, which was the intent of this study. Children and adults cared for at the Cleveland Clinic were identified through the electronic health records, who had a history of myocarditis before the COVID-19 pandemic and had subsequently received at least 2 doses of the mRNA COVID-19 vaccines (n = 34). Only 1 patient in this series had recurrence of myocarditis confirmed by cardiac magnetic resonance imaging after receiving the second dose. He was a White man who had his first episode of myocarditis at age 20 and was 27 years of age at the time of recurrence. He was hospitalized for 2 days with no need for cardiac support or reported arrhythmias and was stable at outpatient follow-up. In patients with an old history of non–COVID-19 myocarditis, the risk of recurrent myocarditis after receipt of mRNA COVID-19 vaccination is low, and when it occurs it seems to be self-limiting. Our study will be valuable to clinicians while discussing the risk–benefit ratio of vaccinations in patients with a prior history of myocarditis. [ABSTRACT FROM AUTHOR]

Suspected allergic reactions after mRNA COVID-19 vaccination withheld multiple individuals from getting fully vaccinated during the pandemic. We vaccinated adults who had experienced possible allergic symptoms after their first intramuscular dose of a COVID-19 mRNA vaccine with a 1/5th fractional intradermal test dose of the mRNA-1273 (Moderna) COVID-19 vaccine. No anaphylactic reactions were observed after intradermal vaccination (n = 56). Serum anti-S1 IgG concentrations were measured using a bead-based multiplex assay four weeks after vaccinations. Antibody concentrations were compared with a previously collected nationwide cohort that had received two intramuscular doses of mRNA-1273. Antibody responses in all subjects tested (n = 47) were comparable to standard of care intramuscular dosing. Fractional intradermal dosing of mRNA COVID-19 vaccines may provide a pragmatic solution that is safe, time efficient compared to skin prick testing, dose sparing and immunogenic in individuals with suspected vaccine allergy. [ABSTRACT FROM AUTHOR]

Abstract Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare disease and has occasionally been described after vaccination, especially against viral agents. We present a case of a patient who presents with the classic pentad of TTP a few days after receiving the first dose of the mRNA Pfizer COVID‐19 vaccine. To our knowledge, this is the second report of a de novo TTP following mRNA Pfizer COVID‐19 vaccination.

The effect of a third vaccine dose (3D) of homologous mRNA vaccine on blood levels of SARS-CoV-2-receptor binding domain (RBD)-total antibodies was assessed in 40 hemodialysis patients (HD) and 21 kidney transplant recipients (KTR) at a median of 46 days after 3D. Anti-RBD antibodies were detected in 39/40 HD and 19/21 KTR. Overall, 3D boosted anti-RBD antibody levels (median: 58-fold increase). Neutralizing antibodies (NtAb) against the Wuhan-Hu-1, Delta, and Omicron variants were detected in 14, 13, and 11 out of 14 HD patients, and in 5, 5, and 4 out of 8 KTR patients, respectively. The median fold increase in NtAb titers in HD patients was 77, 28, and 5 and 56, 37, and 9 in KTR patients for each respective variant. SARS-CoV-2-S S-IFN-γ-producing CD8+ and CD4+ T-cell responses were detected in the majority of HD (35 and 36/37, respectively) and all KTR (16/16) patients at 3D. Overall, the administration of 3D boosted T-cell levels in both population groups. In conclusion, a homologous mRNA COVID-19 vaccine 3D exerts a booster effect on anti-RBD antibodies, NtAb binding to Wuhan-Hu-1, Delta, and Omicron variants, and SARS-CoV-2-S-IFN-γ-producing T cells in both HD and KTR patients. The magnitude of the effect was more marked in HD than KTR patients. [ABSTRACT FROM AUTHOR]

In recent years, during the ravages of COVID-19, a variety of vaccines have been developed and are now on the market. However, although these new vaccines have undergone various trials, there are still many unknown side effects. We report a case of a 30-year-old woman who presented with general weakness, sore throat, generalized skin rashes, symmetrical arthralgia, and persistent fever of up to 40 °C with onset 16 days after receiving the Moderna COVID-19 vaccine. Adult-onset Still's disease (AOSD) was diagnosed according to Yamaguchi's criteria after excluding the feasibility of infectious diseases, autoimmune diseases, and malignancies. In particular, her responses to glucocorticoids and naproxen were significant and inversely proportional to her use of empirical antibiotics in the initial stage of treatment. We studied some similar cases of AOSD, which also considered the adverse effects of COVID-19 vaccination and suggested the immunogenicity and possibility of inflammatory responses related to COVID-19 vaccination. [ABSTRACT FROM AUTHOR]

Background: We assessed the added benefit and waning effectiveness of a third COVID-19 vaccine dose (original formula) for preventing COVID-19-related outcomes., Methods: We used Medicare claims data to conduct a retrospective cohort study in U.S. community-dwelling Medicare Fee-for-Service beneficiaries aged ≥65 years during the BA.1/BA.2 Omicron period (December 19, 2021 - March 26, 2022). We estimated relative vaccine effectiveness (RVE) of 3 versus 2 doses of mRNA COVID-19 vaccines using marginal structural Cox regression models., Results: Among 8,135,020 eligible beneficiaries, 73.3% were 3-dose vaccinated by March 26, 2022. At 14-60 days since vaccination, a third dose provided significant added benefit against COVID-19-related hospitalization for Moderna (RVE: 77.2%; 95% confidence interval (CI): 76.0%, 78.4%) and Pfizer-BioNTech (RVE: 72.5%; 95% CI: 70.8%, 74.0%). Added benefit was lower >120 days. For those with prior medically attended COVID-19 diagnoses, Pfizer-BioNTech provided an added benefit for 120 days, while Moderna provided some added benefit >120 days. Added benefit for either vaccine was higher against death compared to less severe outcomes, which still decreased >120 days., Conclusions: A third dose COVID-19 vaccine provided significant added benefit against COVID-19-related hospitalization and death, even for beneficiaries with prior medically attended COVID-19 diagnoses. This added benefit decreased after 4 months., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2024.)

Background: Behcet's disease (BD) is an inflammatory disorder known for various symptoms, including oral and genital ulcers and ocular inflammation. Panuveitis, a severe eye condition, is rare as the first sign of BD., Case Summary: We present an unusual case of a 30-year-old man who developed panuveitis after receiving the mRNA-based coronavirus disease 2019 (COVID-19) vaccine (Moderna). Laboratory tests ruled out infections, but he had a positive HLA-B51 result and a history of genital ulcer and oral ulcers, leading to a BD diagnosis. Treatment with corticosteroids improved his condition. Interestingly, he had another episode of panuveitis after the second mRNA vaccine dose, which also responded to corticosteroids., Conclusion: This case highlights the rare onset of BD following mRNA COVID-19 vaccination, suggesting a potential link between these vaccines and BD's eye symptoms, emphasizing the importance of quick treatment in similar cases., Competing Interests: Conflict-of-interest statement: All authors declare that there are no conflicts of interest for this paper., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Systems vaccinology approaches have introduced novel tools for the evaluation of the safety profile of novel vaccine antigens by developing biomarkers of vaccine reactogenicity associated with potential adverse events. The use of such approaches may prove extremely advantageous in the context of a global pandemic where accelerated approval of new vaccine formulations for all ages is essential for the containment of the epidemic. The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has had devastating effects on global health, but the emergency authorization of mRNA vaccines significantly reduced SARS-CoV-2–associated morbidity and mortality. Despite their favorable safety profile in adult populations, recent reports have raised concerns about an association of the mRNA-based vaccines with acute myocarditis, predominantly among male adolescents and young adults following the second vaccine dose. Here, we review data on myocarditis epidemiology following SARS-CoV-2 mRNA vaccination and describe potential mechanisms involved that may explain the sex- and age-related differences, focusing on mRNA immune reactivity. The case of vaccine-associated myocarditis highlights the need to incorporate precision vaccinology approaches for the development of safe and effective vaccines for everyone. [ABSTRACT FROM AUTHOR]

This longitudinal observational study investigated the risk of breakthrough SARS-CoV-2 infection up to 6 months after a booster dose of an mRNA COVID-19 vaccine in infection-naïve vs. previously infected healthcare workers (HCWs), and whether this difference varied over time. A Cox proportional hazard regression model with Aalen's additive analysis was fitted to examine the association between the risk of infections and predictor variables. Overall, we observed an incidence rate of 2.5 cases per 1000 person-days (95% confidence interval [CI] 2.0–3.0), which dropped at 0.8 per 1000 person-days (95% CI 0.3–2.0) in recipients with prior SARS-CoV-2 infection. The fitted analysis indicated an adjusted hazard ratio of 0.32 (95% CI 0.13–0.80; p-value = 0.01) for those with hybrid immunity with a slope that became steeply negative roughly starting from day 90. No difference was seen according to participants' smoking habits. Characteristics of infected HCWs were also described. Our study quantifies the time-varying effects of vaccine-induced and hybrid immunity after the booster dose (during the Omicron variant predominance in Italy) and observed that the protection waned more rapidly in infection-naïve recipients starting from the third month. The results add important evidence that can be used to inform COVID-19 vaccination strategies. [ABSTRACT FROM AUTHOR]

We report the case of a 59-year-old man with squamous cell carcinoma (SCC) of the right mandibular gingiva, who presented with bilateral cervical lymphadenopathy (CLA) after mRNA coronavirus disease 2019 (COVID-19) vaccination. The patient was diagnosed. Imaging studies performed prior to surgery revealed bilateral CLA and axillary lymphadenopathy (LA) ipsilateral to the vaccination site. Fine-needle aspiration (FNA) biopsy of the left CLA revealed reactive lymph nodes. The patient underwent surgical intervention for the malignant tumor, and the specimen was sent for histopathologic evaluation. The biopsy-proven cancer stage was pT3N0Mx. Positron emission tomography (PET-CT), performed six months after surgery, showed persistent bilateral CLA. However, FNA of the left axillary LA once again showed no evidence of metastasis or recurrence. Since the treatment plan may change based on the type of LA, it is important to figure out whether an mRNA vaccine has been administered to patients with head and neck cancer. [ABSTRACT FROM AUTHOR]

Myocarditis comprises many clinical presentations ranging from asymptomatic to sudden cardiac death. The history, physical examination, cardiac biomarkers, inflammatory markers, and electrocardiogram are usually helpful in the initial assessment of suspected acute myocarditis. Echocardiography is the primary tool to detect ventricular wall motion abnormalities, pericardial effusion, valvular regurgitation, and impaired function. The advancement of cardiac magnetic resonance (CMR) imaging has been helpful in clinical practice for diagnosing myocarditis. A recent Scientific Statement by the American Heart Association suggested CMR as a confirmatory test to diagnose acute myocarditis in children. However, standard CMR parametric mapping parameters for diagnosing myocarditis are unavailable in pediatric patients for consistency and reliability in the interpretation. The present review highlights the unmet clinical needs for standard CMR parametric criteria for diagnosing acute and chronic myocarditis in children and differentiating dilated chronic myocarditis phenotype from idiopathic dilated cardiomyopathy. Of particular relevance to today's practice, we also assess the potential and limitations of CMR to diagnose acute myocarditis in children exposed to severe acute respiratory syndrome coronavirus-2 infections. The latter section will discuss the multi-inflammatory syndrome in children (MIS-C) and mRNA coronavirus disease 19 vaccine-associated myocarditis. [ABSTRACT FROM AUTHOR]

The association between maternal COVID-19 vaccination in pregnancy and factors such as high risk for severe COVID-19, pre-existing asthma, prior adverse reproductive history, or paternal COVID-19 vaccination during pregnancy, remains unclear. The aim of this study is two-fold: (i) to describe uptake of COVID-19 vaccine during pregnancy by maternal risk for severe COVID-19 and asthma, and (ii) to comprehensively examine individual and familial factors associated with vaccine uptake during pregnancy in Norway. Based on nation-wide registry-linkage data in Norway, we included 101,659 deliveries with gestational length ≥12 weeks, in 2021–2022. Our outcome measure was uptake of at least one dose of mRNA COVID-19 vaccine during pregnancy, using a narrow (first ever dose) and broad (any dose) definition. We fit univariate and multivariate modified Poisson regression models, clustered by county of residency and adjusted for calendar time, to estimate risk ratios (RR) with 95 % Confidence Intervals (CIs). Gestational uptake of any COVID-19 vaccine dose increased from <1 % before mid Aug-2021, to 38.8 % in the rest of 2021, and 48.9 % in 2022. Only 28.8 % and 33.9 % pregnant individuals with high risk for severe COVID-19 or asthma, respectively, received at least one COVID-19 vaccine dose. Paternal COVID-19 vaccination was strongly associated with greater vaccine uptake by pregnant individuals (adjusted RR: 7.2, 95 % CI: 6.8–7.5). Maternal SARS-CoV-2 infection pre-pregnancy (adjusted RR: 0.31, 95 % CI: 0.26, 0.37), familial and individual migrant status were associated with a considerable decreased likelihood of vaccine uptake in pregnancy. History of miscarriage or pregnancy with congenital anomaly were not associated with vaccine uptake. Despite rising COVID-19 vaccine rates in pregnancy, uptake remained low for high-risk individuals. Paternal vaccination, pre-pregnancy infection, migration status, and maternal citizenship were strongly associated with prenatal vaccine uptake. This knowledge can inform tailoring of future vaccination campaigns. [ABSTRACT FROM AUTHOR]

The coronavirus disease 2019 (COVID-19) pandemic is a universal emergency public health issue. A large proportion of the world’s population has had several spike antigen exposures to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and/or COVID-19 vaccinations in a relatively short-term period. Although sporadic hematopoietic adverse events after COVID-19 vaccine inoculation were reported, there is currently no sufficient evidence correlating anti-spike protein immune responses and hematopoietic adverse events of vaccinations. We reported the first case of Ph-positive B-cell acute lymphoblastic leukemia (ALL) occurring after a bivalent mRNA COVID-19 vaccine inoculation. The otherwise healthy 43-year-old female patient had a total of six spike antigen exposures in the past 1.5 years. Informative pre-vaccine tests and bone marrow study results were provided. Although the causal relationship between bivalent vaccinations and the subsequent development of Ph–positive B-cell ALL cannot be determined in the case report, we propose that anti-spike protein immune responses could be a trigger for leukemia. Clinicians must investigate the hematopoietic adverse events closely after COVID-19 vaccinations. Further pre-clinical studies to investigate the safety of bivalent mRNA COVID-19 vaccine are required.

Introduction: mRNA coronavirus disease 2019 (COVID-19) vaccination has been widely used to arrest the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Rarely, autoimmune events such as relapses in patients with multiple sclerosis (MS) have been reported after vaccination. However, the possible effects of vaccination in a patient already experiencing the symptoms of a relapse represent an unusual scenario that has not been described. Patients and Methods: This is a retrospective case series of four patients from three major tertiary referral centers that received mRNA COVID-19 vaccination after starting with symptoms of acute demyelination of the central nervous system due to non-recognized MS. A detailed description of each case, including MRI studies, serum light-neurofilament levels, and cerebrospinal fluid (CSF) cytokine profile, is provided. Case Description: All patients presented exacerbation of ongoing symptoms after vaccination (range 14–112 days first dose). All patients presented MRI features suggestive of highly active MS and fulfilled McDonald 2017 criteria at the time of presentation. All patients presented high serum light-neurofilament levels and oligoclonal G bands restricted to the CSF. Higher levels of interleukin-6 in the CSF were present in the more severe cases. Discussion: We describe exacerbation of relapses after mRNA COVID-19 vaccination. We hypothesize RNA sensors such as Toll-like receptor 7 may be activated and contribute to amplify the inflammatory response during a relapse. Conclusion: Patients should seek medical attention if experiencing acute neurological symptoms, especially before vaccination. Fast diagnostic procedures and prompt treatment should be performed in these patients. Pharmacovigilance and further study are warranted to confirm causality. [ABSTRACT FROM AUTHOR]

Although serious adverse events have remained uncommon, cases of myocarditis induced by messenger RNA (mRNA) COVID-19 vaccines have been reported. Here, we presented a rare but potentially fatal disorder, hemophagocytic lymphohistiocytosis, in a 14-year-old previously healthy adolescent after BNT162b2 mRNA vaccination. The initial evaluation showed splenomegaly, pancytopenia, hyperferritinemia, and hypofibrinogenemia. Further examination revealed positive blood EBV DNA, and other infectious pathogen surveys were all negative. Hemophagocytosis was observed in the bone marrow aspiration and biopsy. HLH was confirmed and intravenous immunoglobulin (IVIG) and methylprednisolone pulse therapy were given. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) was set up for cardiopulmonary support for 3 days due to profound hypotension. The patient was kept on oral prednisolone treatment for 28 days with the following gradual tapering. The hemogram and inflammatory biomarkers gradually returned to normal, and the patient was discharged. The fulminant presentation of HLH in our case could be the net result of both acute immunostimulation after COVID-19 vaccination and EBV infection. Our case suggests that the immune activation after COVID-19 vaccination is likely to interfere with the adequate immune response to certain infectious pathogens, resulting in a hyperinflammatory syndrome. [ABSTRACT FROM AUTHOR]

Background: Although neurological adverse events have been reported after receiving coronavirus disease 2019 (COVID-19) vaccines, associations between COVID-19 vaccination and aneurysmal subarachnoid hemorrhage (SAH) have rarely been discussed. We report here the incidence and details of three patients who presented with intracranial aneurysm rupture shortly after receiving messenger ribonucleic acid (mRNA) COVID-19 vaccines. Case Description: We retrospectively reviewed the medical records of individuals who received a first and/ or second dose of mRNA COVID-19 vaccine between March 6, 2021, and June 14, 2021, in a rural district in Japan, and identified the occurrences of aneurysmal SAH within 3 days after mRNA vaccination. We assessed incidence rates (IRs) for aneurysmal SAH within 3 days after vaccination and spontaneous SAH for March 6–June 14, 2021, and for the March 6–June 14 intervals of a 5-year reference period of 2013–2017. We assessed the incidence rate ratio (IRR) of aneurysmal SAH within 3 days after vaccination and spontaneous SAH compared to the crude incidence in the reference period (2013–2017). Among 34,475 individuals vaccinated during the study period, three women presented with aneurysmal SAH (IR: 1058.7/100,000 person-years), compared with 83 SAHs during the reference period (IR: 20.7/100,000 persons-years). IRR was 0.026 (95% confidence interval [CI] 0.0087–0.12; P < 0.001). A total of 28 spontaneous SAHs were verified from the Iwate Stroke Registry database during the same period in 2021 (IR: 34.9/100,000 personyears), and comparison with the reference period showed an IRR of 0.78 (95%CI 0.53–1.18; P = 0.204). All three cases developed SAH within 3 days (range, 0–3 days) of the first or second dose of BNT162b2 mRNA COVID-19 vaccine by Pfizer/BioNTech. The median age at the time of SAH onset was 63.7 years (range, 44– 75 years). Observed locations of ruptured aneurysms in patients were the bifurcations of the middle cerebral artery, internal carotid-posterior communicating artery, and anterior communicating artery, respectively. Favorable outcomes (modified Rankin scale scores, 0–2) were obtained following microsurgical clipping or intra-aneurysm coiling. Conclusion: Although the advantages of COVID-19 vaccination appear to outweigh the risks, pharmacovigilance must be maintained to monitor potentially fatal adverse events and identify possible associations. [ABSTRACT FROM AUTHOR]

The pathogenesis of COVID-19 involves both humoral and cellular immunological responses, with cell-mediated immunity being discussed as the primary and most effective immune response to viral infection. It is supposed that COVID-19 vaccines also elicited effective cell immune response, and specifically IFNγ secreted by SARS-CoV-2-specific T-helper 1 and Tcytotoxic cells. Using an interferon-gamma release assay (IGRA) test, we aimed to monitor cellular post-vaccination immunity in healthy subjects vaccinated with BNT162b2 mRNA COVID-19 vaccine (Comirnaty). We tested 37 healthcare workers (mean age 54.3 years, range 28–72, 22 females, 15 males) following COVID-19 mRNA COVID-19 vaccine and 15 healthy unvaccinated native persons as control subjects using QuantiFERON SARS-CoV-2 RUO test, performed approximately 1 month after vaccination. We also measured virus-neutralizing antibodies. Thirty-one out of 37 tested subjects had significantly raised levels of SARS-CoV-2 specific IFNγ against SARS-CoV-2 Ag1 and Ag2 1 month following COVID-19 vaccination. In addition, we found a significant difference between the IFNγ levels in fully vaccinated subjects and the control group (p < 0.01).We also found a substantial correlation (r = 0.9; p < 0.01) between virus-neutralizing antibodies titers and IFNγ concentrations released by T cells. We believe that IGRA tests are an excellent tool to assess the development of a post-vaccination immune response when immunized against SARS-CoV-2. However, IGRA-based tests should be performed within a few weeks following vaccination. Therefore, we can speculate that the application of these tests to assess long-term immune response is debatable. [ABSTRACT FROM AUTHOR]

IntroductionmRNA coronavirus disease 2019 (COVID-19) vaccination has been widely used to arrest the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Rarely, autoimmune events such as relapses in patients with multiple sclerosis (MS) have been reported after vaccination. However, the possible effects of vaccination in a patient already experiencing the symptoms of a relapse represent an unusual scenario that has not been described.Patients and MethodsThis is a retrospective case series of four patients from three major tertiary referral centers that received mRNA COVID-19 vaccination after starting with symptoms of acute demyelination of the central nervous system due to non-recognized MS. A detailed description of each case, including MRI studies, serum light-neurofilament levels, and cerebrospinal fluid (CSF) cytokine profile, is provided.Case DescriptionAll patients presented exacerbation of ongoing symptoms after vaccination (range 14–112 days first dose). All patients presented MRI features suggestive of highly active MS and fulfilled McDonald 2017 criteria at the time of presentation. All patients presented high serum light-neurofilament levels and oligoclonal G bands restricted to the CSF. Higher levels of interleukin-6 in the CSF were present in the more severe cases.DiscussionWe describe exacerbation of relapses after mRNA COVID-19 vaccination. We hypothesize RNA sensors such as Toll-like receptor 7 may be activated and contribute to amplify the inflammatory response during a relapse.ConclusionPatients should seek medical attention if experiencing acute neurological symptoms, especially before vaccination. Fast diagnostic procedures and prompt treatment should be performed in these patients. Pharmacovigilance and further study are warranted to confirm causality.

BackgroundA few studies on vaccination in patients with rheumatic diseases, including arthritis, connective tissue diseases, vasculitis, and psoriatic arthropathy (PsA), demonstrated reduced production of neutralizing antibodies to SARS-CoV-2 Spike RBD (receptor-binding domain contained in the N-terminal of the S1 globular head region) when compared to the general population.ObjectiveThe aim of our study was to observe whether different therapies for PsA [methotrexate, anti-TNF antibodies, soluble TNF receptor (etanercept) or IL-17 inhibitors] have a different impact on SARS-CoV-2 vaccination in a homogeneous population of patients.MethodsWe enrolled 110 PsA patients in remission, assessed with Disease Activity in PSoriatic Arthritis (DAPSA). Of these: 63 were in treatment with anti-TNF-α therapy (26 etanercept, 15 certolizumab, 5 golimumab, 17 adalimumab); 37 with anti-IL17 secukinumab; 10 with methotrexate. All patients underwent vaccination for SARS-CoV-2 with mRNA BNT162b2 vaccine. Assessment of absolute and percentage lymphocyte subsets and anti-SARS-CoV-2 Spike RBD IgG antibody value 3 weeks after the second vaccine dose were performed. In addition, the serum antibody levels of 96 healthy healthcare workers (HCW) were analyzed.ResultsThe mean disease activity assessed with DAPSA score was 2.96 (SD = 0.60) with no significant differences between patients under different medications (p = 0.779). Median levels of neutralizing antibodies to SARS-CoV-2 Spike RBD were 928.00 binding antibody unit (BAU)/mL [IQR 329.25, 1632.0]; 1068.00 BAU/ml [IQR 475.00, 1632.00] in patients taking MTX, 846.00 BAU/ml [IQR 125.00, 1632.00] in patients taking etanercept, 908.00 BAU/mL [IQR 396.00, 1632.00] in patients taking anti-IL17 and 1148.00 BAU/ml [IQR 327.00, 1632.00] in patients taking TNF-α inhibitors, without statistically significant differences between these groups. Mean serum antibody level of HCW group was 1562.00 BAU/ml [IQR 975.00, 1632.00], being significantly higher than in the patient group (p = 0.000816). Absolute and percentage count of lymphocyte subsets were not statistically different between the subgroups under different treatments and when compared with HCW.ConclusionsAs for other rheumatic diseases on immunomodulatory treatment, our data showed a reduced humoral response in PsA patients compared to the control group. However, antibody response did not significantly differ between groups treated with different medications.