Project description:Metabolomics may help identify a particular metabolic signature “metabotype” in patients who are predisposed to developing AEFI such as a systemic reaction, or myocarditis that currently is difficult or impossible to identify prior to the development of the AEFI. This proposed pilot study looks at the metabolic profiles of a specific population of subjects who received the smallpox vaccine with or without other concomitantly administered vaccines to help determine if a unique metabotype can be identified in subjects who reported systemic reactions following immunization. In addition, this proposed study will look at the metabolic profile of several subjects with subclinical or clinically diagnosed myopericarditis to determine if these subjects have a unique metabotype. The ability to identify a unique metabotype would allow a clinician to potentially mitigate serious AEFI and ultimately improve the quality of immunization healthcare. If identified, these profiles might represent novel biomarkers of risk that can supplement existing clinical decision making for risk stratification or vaccine exemptions.
Project description:A good safety and immunogenicity profile was reported in Phase I and II clinical trials of inactivated SARS-CoV-2 vaccines. Here, we report two cases associated with vaccine-associated adverse events, including one patient with fever and another with anaphylactic shock resulting from inactivated SARS-CoV-2 vaccination. Cell sub-types and the importance of genetic characteristics were assessed using single-cell mRNA sequencing and machine learning. Overall, the patient with fever showed a significant increase in the numbers of cytotoxic CD8 T cells and MKI67high CD8 T cells. A potential concurrent infection with the Epstein-Barr virus enhanced interferon type I responses to vaccination against the virus. STAT1, E2F1, YBX1, and E2F7 played a key role in the transcription regulation of MKI67high CD8 T cells. In contrast, the patient with allergic shock displayed predominant increases in the numbers of S100A9high monocytes, activated CD4 T cells, and PPBPhigh megakaryocytes. The decision tree showed that LYZ and S100A8 in S100A9high monocytes contributed to the degranulation of neutrophils and activation of neutrophils involved in allergic shock. PPBP and PF4 were major contributors to platelet degranulation. These findings highlight the diversity of adverse reactions following inactivated SARS-CoV-2 vaccination and show the emerging role of cellular subtypes and central genes in vaccine-associated adverse reactions.
Project description:BackgroundLimited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.MethodsWe conducted an observational cross-sectional study to assess the potential adverse reactions to the Pfizer-BioNTech COVID-19 vaccine among a sample of healthcare workers (HCWs) in the city of Guayaquil, Ecuador, from March to May 2021.ResultsThe sample comprised 1291 patients, with a mean age of 39.3 years (SD, 13.5). In general, 79% (N = 1020) of participants presented an adverse effect of any type at first dose, while 75.1% (N = 969) did so at the second dose. Pain at the puncture site was the most common adverse effect overall after either the first (68.4%) and second (55.6%) dose. Regarding anaphylaxis, no participant developed the condition after the first dose, and only 0.2% (N = 2) developing it at the second dose. No fatalities were reported.ConclusionOur findings suggest that adverse reactions following COVID-19 vaccination with the Pfizer-BioNTech vaccine are relatively common, albeit often mild and self-limited. Consistent with the literature there were few cases of anaphylaxis, and no deaths that could be attributed to the inoculation with the vaccine. We hope our findings can help to reassure the public that benefits of vaccination highly outweigh the risks and contribute to the effort of reducing vaccine hesitancy among those who are concerned about the safety and potential side effects.
Project description:To protect against COVID-19, SARS-CoV-2 vaccines have been widely used. Besides anaphylaxis, some less severe adverse effects may occur at higher frequencies. It remains unclear whether present or past histories of allergic diseases exert effects on local and systemic reactions. We conducted a questionnaire survey among workers in our hospital. We analyzed the adverse effects occurring after the first and second doses of the Pfizer-BioNTech vaccine in 955 subjects. The presence or absence of local injection reactions and systemic reactions (headache, fatigability, fever, muscle pain, and joint pain) was questioned. The intensities of these reactions were graded on a scale of 0-4 (except fever) or 0-2 (fever). The allergic diseases that we focused on were bronchial asthma, atopic dermatitis, food allergy, pollinosis, and hand eczema. For the systemic reactions, fatigability after the first dose tended to be more severe in the bronchial asthma than in the non-allergic group. Headache, joint pain, and fever tended to be more severe in the food allergy than in the non-allergic group after the second dose. For the local skin reactions, atopic dermatitis subjects tended to show rather less severe local skin reactions after the second dose. The results contribute to the guidelines for the care of individuals with different allergy histories, so that they may safely receive their vaccine.
Project description:PurposeTo assess the risk of vaccine-associated uveitis (VAU) following SARS-CoV-2 vaccination and evaluate uveitis onset interval and clinical presentations in the patients.DesignA retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS).ParticipantsPatients diagnosed with VAU following administration of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Janssen) vaccine, worldwide.MethodsA descriptive analysis of the demographics, clinical history and presentation was performed. We evaluated the correlation between the three vaccines and continuous and categorical variables. A post-hoc analysis was performed between uveitis onset-interval after vaccination, and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset post-vaccination was performed.Main outcome measuresThe estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.ResultsA total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU for the cases reports from the United States was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n=853, 77.97%). The mean age of patients with VAU was 46.24±16.93 years, and 68.65% (n=751) were women. Most cases were reported after the first dose (n=452, 41.32%) and within the first week (n=591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22± 42.74 days) compared to BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (p<0.0001). The post-hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared to the mRNA 1273 vaccine (p<0.0001) and the first dose compared to the second dose (p=0.0021). The 30-day risk analysis showed a significant difference between the three vaccines (p<0.0001).ConclusionsThe low crude reporting rate and observed-expected ratio suggests a low safety concern for VAU. This study provides insights into possible temporal association between reported VAU events and SARS-CoV-2 vaccines, however further investigations are required to delineate the associated immunological mechanisms.
Project description:A growing number of cutaneous adverse reactions have been reported following the administration of a COVID-19 vaccine. We describe a series of twenty patients who developed a variety of cutaneous conditions within two weeks of receiving the Pfizer/ BioNTech BNT162b2 vaccine.
Project description:Objective: We investigated whether there were sex differences in adverse reactions to an inactivated SARS-CoV-2 vaccine among medical staff in China. Methods: From 24 February to 7 March 2021 an online cross-sectional survey was conducted with a self-administered COVID-19 vaccine questionnaire among medical staff in Taizhou, China. In total, 1397 interviewees (1,107 women and 290 men) participated in the survey. Results: In our study, 178 (16.1%) women and 23 (7.9%) men reported adverse reactions following their first vaccination, and 169 (15.3%) women and 35 (12.1%) men reported adverse reactions following their second vaccination. After adjusting for confounding factors, adverse reactions to other vaccines, worry about adverse reactions, knowledge of the inactivated vaccine being used in the hospital, taking the vaccine for one's family proactively and receiving an influenza vaccination were significantly related to adverse reactions to both injections in women. In contrast, in men, concerns about adverse reactions independently increased the risk of adverse reactions following either vaccination, and a history of adverse reactions to other vaccines also increased the risk of adverse reactions to both injections. Conclusions: Sex differences in the frequency of reported adverse reactions to an inactivated SARS-CoV-2 vaccine and potential factors were demonstrated in a sample of medical staff.
Project description:Concerns about vaccine safety are an important reason for vaccine hesitancy, however, limited information is available on whether common adverse reactions following vaccination affect the immune response. Data from three clinical trials of recombinant vaccines were used in this post hoc analysis to assess the correlation between inflammation-related solicited adverse reactions (ISARs, including local pain, redness, swelling or induration and systematic fever) and immune responses after vaccination. In the phase III trial of the bivalent HPV-16/18 vaccine (Cecolin®), the geometric mean concentrations (GMCs) for IgG anti-HPV-16 and -18 (P<0.001) were significantly higher in participants with any ISAR following vaccination than in those without an ISAR. Local pain, induration, swelling and systemic fever were significantly correlated with higher GMCs for IgG anti-HPV-16 and/or anti-HPV-18, respectively. Furthermore, the analyses of the immunogenicity bridging study of Cecolin® and the phase III trial of a hepatitis E vaccine yielded similar results. Based on these results, we built a scoring model to quantify the inflammation reactions and found that the high score of ISAR indicates the strong vaccine-induced antibody level. In conclusion, this study suggests inflammation-related adverse reactions following vaccination potentially indicate a stronger immune response.
Project description:Although valuable and effective in decreasing disease burden, influenza vaccination has low rates of efficacy, especially in those at most risk. Studies have shown that acute exercise can improve vaccine responses, most consistently with weaker antigens. Here we examined the effect of resistance exercise on the acute and longer-term responses to influenza vaccination among healthy older adults. Forty-six participants (47.8% male, mean 73.4 ± 6.6 years) were randomised to perform one 45-min moderate-intensity resistance exercise session or sit quietly prior to the receipt of influenza vaccination. Acute exercise reduced vaccine reactions but had no effect on either antibody responses or development of influenza-like symptoms during six months of follow-up. Psychosocial and behavioural characteristics were examined for potential associations with the responses to vaccination. Participants (n = 36) vaccinated in the previous year had higher baseline antibody titres but not follow-up titres nor more frequent experience of influenza-like symptoms over 6 months compared to those unvaccinated in the previous year. These findings provide further support for the ability of acute exercise to reduce vaccine reactions and suggest risk factors for vaccine responses for future exploration. Highlights • Acute exercise reduced influenza vaccine reactions in older adults.• Acute exercise did not change antibody titres.• Psychosocial and behavioural factors had limited association with responses.