Evaluation of Adverse Effects after the Second Dose of BNT162b2 Mrna Vaccination for COVID-19: A Survey-based Analysis among Italian Healthcare Workers DOI Open Access
Gianluigi Ferrazza,

Alessandro Nucera,

Susanna Longo

и другие.

The Open Public Health Journal, Год журнала: 2023, Номер 16(1)

Опубликована: Окт. 23, 2023

Backgrounds and Aims: Since the start of SARS-CoV-2 pandemic, healthcare workers have been at elevated risk contracting COVID-19. Although COVID-19 vaccines contributed to eradication of, or substantial decreases in, incidence lethal diseases, major determinant vaccine hesitancy is a fear associated adverse effects. Here, we performed survey assessing reactogenicity safety BNT162b2 in real-world setting. Methods: Data were collected from March 1 June 14, 2021. A total 206 hospital employees undergoing mRNA vaccination completed survey. These received questionnaire collect common uncommon effects developing 2–6 days after second dose Pfizer-BioNTech vaccine. Results: After dose, female sex was found be with higher vaccine-related severe systemic than male (odds ratio [OR] 3.116, 95% CI 2.365–7.113). We also observed that anti-SARS-CoV-2 receptor-binding domain titer, determined on day when administered, significantly participants those without such (OR 1.017, 1.001–1.034). Conclusion: Our study suggested healthy had three-fold Further research warranted determine whether high RBD titer time might indicate disproportionate inflammatory reaction leading findings contribute decrease disappearance hesitancy.

Язык: Английский

Self‐Reported Delayed Adverse Events and Flare Following COVID‐19 Vaccination Among Patients With Autoimmune Rheumatic Disease (AIRD) in Malaysia: Results From the COVAD‐2 Study DOI Open Access
Syahrul Sazliyana Shaharir, Azmawati Mohammed Nawi,

Theepa Nesam Mariamutu

и другие.

International Journal of Rheumatic Diseases, Год журнала: 2025, Номер 28(1)

Опубликована: Янв. 1, 2025

ABSTRACT Objectives To determine the prevalence of self‐reported delayed adverse events (DAEs), major AEs, and flares following COVID‐19 vaccinations among patients with autoimmune rheumatic diseases (AIRDs) in Malaysia. Methodology An electronically validated survey from vaccination (COVAD) study group was distributed July 2021 to healthy controls (HCs). The collected data on DAEs (any AE that persisted or occurred after 7 days vaccination), any early (MAEs), vaccination. Generalized estimating equation (GEE) models were performed factors associated repeated DAEs, MAEs, flares. Results A total 556 vaccines administered 204 subjects (150 AIRDs 54 HCs), 72.1% completing 3 doses. In multivariate GEE analysis, there a greater frequency minor versus HCs (OR 5.65, p = 0.052). occurrence MAEs higher (4.9% vs. 1.3%, 0.052), but it no longer significant model. group, BNT162b2 vaccine increased risk for (OR4.68, 0.02) while multimorbidity showed 8.25, 0.007). rate flare 10.6% analysis revealed systemic lupus erythematosus (SLE) (OR0.31, 0.03) hydroxychloroquine (HCQ) 0.16, < 0.001) protective against flare. Conclusion rates comparable other reported studies. Different types vaccines, underlying AIRDs, treatments may influence symptoms AEs postvaccination COVID‐19.

Язык: Английский

Процитировано

1

Pediatric Systemic Lupus Erythematous in COVID-19 Era DOI Creative Commons

Ancuța Lupu,

Ingrith Miron, Cristina Gavrilovici

и другие.

Viruses, Год журнала: 2023, Номер 15(2), С. 272 - 272

Опубликована: Янв. 18, 2023

Pediatric systemic lupus erythematosus is a chronic autoimmune disorder with highly variable course and prognosis. It results in functional abnormalities the immune system due to intrinsic factors use of immunosuppressive therapies associated underlying comorbidities seem increase risk severe COVID-19 poor outcomes disease pediatric (SLE) patients. The aim this review obtain better understanding existing link between new viral infection lupus. We have analyzed characteristics newly diagnosed cases SLE following which been reported literature describe impact that has on patients already suffering SLE.

Язык: Английский

Процитировано

15

Systemic lupus erythematosus following COVID-19 vaccination. A systematic review of case reports and case series DOI
Nelson Luis Cahuapaza-Gutierrez

Lupus, Год журнала: 2024, Номер 33(4), С. 375 - 386

Опубликована: Фев. 5, 2024

Objective Vaccination against SARS-CoV-2 reduced morbidity and mortality rates due to COVID-19 worldwide. However, several adverse effects have been documented of great interest such as Systemic Lupus Erythematosus (SLE). The aim the present study was perform a systematic review case reports series describing development SLE following vaccination. Methods Case report studies were included. Systematic reviews, narratives, letters editor, correspondence, etc. excluded. A selective bibliographic search performed in PubMed, Scopus, EMBASE databases. In addition, Web Science platform consulted. Joanna Brigs Institute (JBI) tool used assess risk bias quality studies. Statistical Package for Social Sciences (SPSS) 23.0 formal analysis descriptive data. Results 12 met eligibility criteria reported total 16 patients. mean age 42.4 ± 18.69 years. slight predominance post-vaccination observed females (females ( n = 9) males 7). higher association found with Pfizer-BioNTech-162b2 vaccine (75%), followed by Sinopharm (12.5%), Moderna (6.25%). AstraZeneca (6.25%) vaccines. Most cases associated first dose (56.25%), second (37.5%) only one third dose. number days elapsed from administration appearance clinical manifestations between 1 30 days. Mainly there involvement musculoskeletal cutaneous system. All patients responded well treatment good evolution no death. Conclusion Cases vaccination are infrequent. monitoring is recommended persons receiving vaccine, mainly those vaccine.

Язык: Английский

Процитировано

6

Risk of flare or relapse in patients with immune-mediated diseases following SARS-CoV-2 vaccination: a systematic review and meta-analysis DOI Creative Commons
Mahya Shabani, Parnian Shobeiri,

Shadi Nouri

и другие.

European journal of medical research, Год журнала: 2024, Номер 29(1)

Опубликована: Янв. 17, 2024

Patients with autoimmune and immune-mediated diseases (AI-IMD) are at greater risk of COVID-19 infection; therefore, they should be prioritized in vaccination programs. However, there concerns regarding the safety vaccines terms disease relapse, flare, or exacerbation. In this study, we aimed to provide a more precise reliable vision using systematic review meta-analysis. PubMed-MEDLINE, Embase, Web Science were searched for original articles reporting relapse/flare adult patients AI-IMD between June 1, 2020 September 25, 2022. Subgroup analysis sensitivity conducted investigate sources heterogeneity. Statistical was performed R software. A total 134 observations various AI-IMDs across 74 studies assessed rate exacerbation patients. Accordingly, crude overall prevalence 6.28% (95% CI [4.78%; 7.95%], I2 = 97.6%), changing from (I2 97.6%) 6.24% 65.1%) after removing outliers. administering mRNA, vector-based, inactive showed 8.13% ([5.6%; 11.03%], 98.1%), 0.32% ([0.0%; 4.03%], 93.5%), 3.07% ([1.09%; 5.9%], 96.2%) exacerbation, respectively (p-value 0.0086). category, nephrologic (26.66%) hematologic (14.12%) disorders had highest dermatologic (4.81%) neurologic (2.62%) exhibited have lowest < 0.0001). The flare/relapse/exacerbation is found minimal, especially vector-based vaccines. Vaccination against recommended population.

Язык: Английский

Процитировано

5

Immunogenicity and safety of BNT162b2 vaccination in adolescents with systemic lupus erythematosus DOI
Nuntawan Piyaphanee, Sirirat Charuvanij,

Sutheera Thepveera

и другие.

Lupus, Год журнала: 2024, Номер 33(5), С. 450 - 461

Опубликована: Фев. 9, 2024

Objectives We evaluated the immunogenicity and safety of BNT162b2 vaccination in adolescents with systemic lupus erythematosus (adoSLE) receiving either high- or low-dose immunosuppressant (High-IS Low-IS). Methods Patients aged 12–18 years diagnosed SLE were enrolled. High-IS was defined as >7.5 mg/day prednisolone other immunosuppressant, while Low-IS only ≤7.5 no immunosuppressant. Two doses given 4 weeks apart, followed by a booster (third) dose at 4–6 months later. Anti-spike receptor binding domain (anti-RBD) IgG against Wuhan, neutralising antibody (NT) Wuhan Omicron variants, cellular immune response IFN-γ-ELISpot assay following vaccination. Adverse events (AEs) flare monitored. Results A total 73 participants enrolled, 40 33 group, respectively. At 2nd dose, overall anti-RBD seropositivity 97.3%, difference between groups ( p = .498). AdoSLE on had lower < .001), NT .022) than those Low-IS. 3rd induced significantly higher responses after .001) both established seroconversion persistent levels group. SELENA-SLEDAI scores within 12 2-dose before (3.1 vs 2.5; .036); however, occurrence disease index not different compared to vaccination, consistent across groups. Non-severe AEs occurred similarly Conclusion SARS-CoV-2 vaccine Vaccination can increase activity requires close monitoring for flare.

Язык: Английский

Процитировано

5

Vaccination and the risk of systemic lupus erythematosus: a meta-analysis of observational studies DOI Creative Commons
Meijiao Wang,

Huanpeng Gu,

Yingqi Zhai

и другие.

Arthritis Research & Therapy, Год журнала: 2024, Номер 26(1)

Опубликована: Март 3, 2024

Abstract Objective This meta-analysis aims to explore the potential link between vaccines and systemic lupus erythematosus (SLE). Methods We systematically searched PubMed, Cochrane Library, Embase for observational studies from inception September 3, 2023, using medical subject headings (MeSH) keywords. Study quality was assessed NOS scale. Statistical analyses were conducted STATA software (version 14.0). Publication bias evaluated funnel plots Egger’s regression. Results The incorporated 17 studies, encompassing 45,067,349 individuals with follow-up periods ranging 0.5 2 years. pooled analysis revealed no significant association vaccinations an increased risk of SLE [OR = 1.14, 95% CI (0.86–1.52), I 78.1%, P 0.348]. Subgroup indicated that HBV vaccination significantly associated elevated =2.11, (1.11-4.00), 63.3%, 0.02], HPV slightly 1.43, (0.88–2.31), 72.4%, 0.148], influenza showed 0.96, (0.82–1.12), 0.0%, 0.559], COVID-19 vaccine marginally a decreased 0.44, (0.18–1.21), 91.3%, 0.118]. Conclusions study suggests are not linked SLE. Our results provide valuable insights, alleviating concerns about post-vaccination supporting further development efforts.

Язык: Английский

Процитировано

4

Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study DOI Creative Commons

R Naveen,

Elena Nikiphorou, Mrudula Joshi

и другие.

Lara D. Veeken, Год журнала: 2022, Номер 62(7), С. 2453 - 2463

Опубликована: Ноя. 21, 2022

Abstract Objective To determine COVID-19 vaccine-related adverse events (AEs) in the seven-day post-vaccination period patients with SLE vs autoimmune rheumatic diseases (AIRDs), non-rheumatic (nrAIDs), and healthy controls (HC). Methods Data were captured through Vaccination Autoimmune Diseases (COVAD) questionnaire (March–December 2021). Multivariable regression models accounted for age, gender, ethnicity, vaccine type background treatment. Results Among 9462 complete respondents, 583 (6.2%) (mean age: 40.1 years; 94.5% females; 40.5% Asian; 42.9% Pfizer-recipients). Minor AEs reported by 83.0% of patients, major 2.6%, hospitalization 0.2%. AE frequencies similar between active inactive SLE. Rashes more frequent HC (OR; 95% CI: 1.2; 1.0, 1.5), chills less AIRDs (0.6; 0.4, 0.8) nrAIDs (0.5; 0.3, 0.8), fatigue 0.9). Pfizer-recipients higher overall (2.2; 1.1, 4.2) injection site pain (2.9; 1.6, 5.0) than recipients other vaccines, Oxford/AstraZeneca-recipients body ache, fever, (OR: 2.5, 3.0), Moderna-recipients chills, rashes 2.6, 4.3). Hospitalization across types. treatment groups, although antimalarial users non-users Conclusion While vaccination-related four-fifths those mostly minor comparable to individuals, providing reassurance regarding vaccination safety

Язык: Английский

Процитировано

15

Risk of disease flares after SARS-CoV-2 mRNA vaccination in patients with systemic lupus erythematosus DOI Creative Commons
Jun Kikuchi, Yasushi Kondo,

Shuichiro Kojima

и другие.

Immunological Medicine, Год журнала: 2024, Номер 47(2), С. 76 - 84

Опубликована: Янв. 8, 2024

This study aims to elucidate the effectiveness and safety of SARS-CoV-2 mRNA vaccination in patients with systemic lupus erythematosus (SLE). We enrolled uninfected SLE who received two vaccine doses (BNT162b2 or mRNA-1273) historical unvaccinated patients. Neutralizing antibodies, adverse reactions, disease flares were evaluated 4 weeks after second vaccination. Ninety each group. Among vaccinated patients, Disease Activity Index (SLEDAI), prednisolone before 2, 5 mg/d, respectively. After vaccination, 19 (21.1%) had no neutralizing antibodies. Adverse reactions occurred 88.9% within 3 d. Negative antibodies associated anemia mycophenolate mofetil administration. SLEDAI increased modestly but significantly 13 (14.4%) experiencing (4.4%) severe (nephritis three vasculitis one). The flare rate was higher than controls. mean duration between 35 d, at least 8 days Multivariable analysis showed that high anti-dsDNA flares. type, antibody titer, reaction frequency did not affect Therefore, residual activity increases risk.

Язык: Английский

Процитировано

3

Gross Hematuria after the COVID-19 mRNA Vaccination: Nationwide Multicenter Prospective Cohort Study in Japan DOI Creative Commons
Ryousuke Aoki, Yoshihito Nihei, Keiichi Matsuzaki

и другие.

Kidney360, Год журнала: 2024, Номер 5(9), С. 1322 - 1332

Опубликована: Июль 8, 2024

Key Points Little is known about the clinicopathological characteristics and renal outcomes in patients with gross hematuria (GH) after vaccination. To fill a knowledge gap regarding vaccination GH, we conducted nationwide multicenter prospective cohort study. GH more likely to occur IgA nephropathy, female bias, but without progressive exacerbation of function. Background In past 3 years, cases for coronavirus disease 2019 nephropathy (IgAN) have been frequently reported worldwide. However, postevent prognosis these patients, their clinical backgrounds, underlying mechanisms remain unknown. Therefore, study Japan. Methods We analyzed laboratory findings at time first presentation hospital 6 months histopathological kidney biopsy specimens. Moreover, changes pathological biomarkers IgAN such as galactose-deficient IgA1 (Gd-IgA1) its immune complexes were also evaluated. Results During period, 127 newly presenting enrolled, clear bias (73.2%). was observed second or subsequent vaccinations most (92.9%). Of 37 undergoing before vaccination, 36 had diagnosed IgAN/IgA vasculitis (IgAV). remaining 90 69 70 who underwent ( n =67)/IgAV =2). Their histopathology did not show high incidence acute lesions endocapillary hypercellularity crescentic lesions. Most showed temporary increase proteinuria, no sustained worsening Among measured, serum Gd-IgA1 comparable throughout observation period; however, only urinary increased GH. Conclusions found that IgAN/IgAV, Although further investigation needed causal relationship between this provides many insights into molecular

Язык: Английский

Процитировано

3

Safety Profile of SARS-CoV-2 Vaccination in Patients with Lupus Nephritis: A Retrospective Study DOI Open Access
Dimitra Petrou, Smaragdi Marinaki,

Pelagia Kriki

и другие.

Journal of Clinical Medicine, Год журнала: 2025, Номер 14(2), С. 406 - 406

Опубликована: Янв. 10, 2025

Objectives: Vaccination against SARS-CoV-2 has been vital in alleviating the spread of recent pandemic. We aimed to estimate frequency and type adverse events related vaccine patients with lupus nephritis (LN), assess its impact, if any, on risk subsequent reactivation nephritis. Methods: This was a retrospective, multicenter study which included biopsy-proven LN, who had received at least one dose. Patients ended up end-stage kidney disease (ESKD) prior vaccination or were diagnosed LN after excluded. Adverse events, systemic local, COVID-19 outcomes (full recovery, death, long COVID-19), outcome (remission, refractory disease, relapse, ESKD death), demographics, laboratory measurements, immunosuppressive regimens recorded. Results: Sixty-seven included. The median age 33 (20-46) years. Induction therapy for administered 92.5% 74.6% maintenance therapy. Of these, 94.02% remission vaccination. BNT162b2 mRNA 97.01% cases, mild symptoms 28.35% (myalgias 17.91%, headache 13.43%, arthralgias fever 10.44%) local effects 35.82% (pain 25.37%, swelling 13.43%). Overall, among upon vaccination, two (3.17%) experienced relapse within 5.75 (±0.25) months, while 75% those active achieved 21 (±2) months. Conclusions: appears safe without serious occurring, there is no significant impact clinical course disease.

Язык: Английский

Процитировано

0