INTRODUCTION: Localised swelling at sites of filler injections has been reported in the Moderna mRNA-1273 coronavirus disease 2019 (COVID-19) vaccine trial. METHODS: We conducted a review of the existing data and literature on the potential pathophysiology for this adverse event and its potential management. RESULTS: Data from the Moderna and Pfizer COVID-19 vaccine Phase 3 trial and one case series were available. Three out of 30,400 subjects developed possible filler reaction in the Moderna trial. Two other cases were reported after emergency use authorisation. Reactions occurred at a mean of 1.4 days post-vaccination. Fillers were injected at a mean of 14.1 months before vaccination. Areas involved included lips, infraorbital areas and tear troughs. Treatment included observation, corticosteroids, antihistamine, hyaluronidase and 5-fluorouracil. CONCLUSION Rare, self-limiting adverse reactions to dermal fillers have been reported following COVID-19 vaccination. Clinicians should be aware of this clinical phenomenon and its management, as vaccination is carried out globally.
Humans ; 2019-nCoV Vaccine mRNA-1273/adverse effects* ; Cosmetic Techniques/adverse effects* ; COVID-19/prevention & control* ; COVID-19 Vaccines/administration & dosage* ; Dermal Fillers/administration & dosage* ; Edema/chemically induced* ; Injection Site Reaction/etiology*

During the coronavirus disease 2019 (COVID-19) pandemic, vaccines help control the spread of infection. To date, 47 vaccines have been approved, with another 227 candidates in various stages of development. In the short period of time since the beginning of their use, evidence has begun to emerge of complications following vaccination in the form of the development or exacerbation of a number of pathological conditions (Block et al., 2022; Haseeb et al., 2022). For example, a population-based study in France identified 1612 cases of myocarditis and 1613 cases of pericarditis requiring hospital treatment within five months of vaccination (le Vu et al., 2022).
Humans ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Vaccination/adverse effects* ; Vitiligo/etiology* ; Thymus Gland/physiopathology*

In Singapore, 9.03 million doses of the mRNA COVID-19 vaccines by Pfizer-BioNTech and Moderna have been administered, and 4.46 million people are fully vaccinated. An additional 87,000 people have been vaccinated with vaccines in World Health Organization's Emergency Use Listing. The aim of this review is to explore the reported cardiac adverse events associated with different types of COVID-19 vaccines. A total of 42 studies that reported cardiac side effects after COVID-19 vaccination were included in this study. Reported COVID-19 vaccine-associated cardiac adverse events were mainly myocarditis and pericarditis, most commonly seen in adolescent and young adult male individuals after mRNA vaccination. Reports of other events such as acute myocardial infarction, arrhythmia and stress cardiomyopathy were rare. Outcomes of post-vaccine myocarditis and pericarditis were good. Given the good vaccine efficacy and the high number of cases of infection, hospitalisation and death that could potentially be prevented, COVID-19 vaccine remains of overall benefit, based on the current available data.
Adolescent ; Humans ; Male ; Young Adult ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Myocarditis/etiology* ; Pericarditis ; RNA, Messenger ; Vaccination/adverse effects*

BACKGROUND: Vaccination has been shown effective in controlling the global coronavirus disease 2019 (COVID-19) pandemic and reducing severe cases. This study was to assess the flare and change in disease activity after COVID-19 vaccination in patients with stable rheumatoid arthritis (RA). METHODS: A prospective cohort of RA patients in remission or with low disease activity was divided into a vaccination group and a non-vaccination group based on their COVID-19 vaccination status. Each of them was examined every 3 to 6 months. In the vaccination group, disease activity was compared before and after vaccination. The rates of flare defined as disease activity scores based on 28-joint count (DAS28) >3.2 with ΔDAS28 ≥0.6 were compared between vaccination and non-vaccination groups. RESULTS: A total of 202 eligible RA patients were enrolled. Of these, 98 patients received no vaccine shot (non-vaccination group), and 104 patients received two doses of vaccine (vaccination group). The median time interval from pre-vaccination visit to the first immunization and from the second dose of vaccine to post-vaccination visit was 67 days and 83 days, respectively. The disease activity scores at pre-vaccination and post-vaccination visits in the vaccination group patients were similar. At enrollment, gender, RA disease course, seropositivity, and disease activity were comparable across the two groups. Flare was observed in five (4.8%) of the vaccination group patients and nine (9.2%) of the non-vaccination group patients at post-vaccination assessment ( P  = 0.221). In terms of safety, 29 (27.9%) patients experienced adverse events (AEs) after vaccination. No serious AEs occurred. CONCLUSIONS COVID-19 vaccinations had no significant effect on disease activity or risk of flare in RA patients in remission or with low disease activity. Patients with stable RA should be encouraged to receive the COVID-19 vaccination.
Humans ; Arthritis, Rheumatoid ; Cohort Studies ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; East Asian People ; Prospective Studies ; Vaccination/adverse effects*

Humans ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Myocarditis ; SARS-CoV-2 ; Thrombosis/etiology* ; Vaccination

Ongoing global pandemic of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has promoted the unprecedented rapid development and large-scale rolling out of different platform-based COVID-19 vaccines worldwide. How to effectively respond to the expected scale increasing adverse events after vaccination campaign of COVID-19 vaccines is a common problem faced by the world. A lot of countries and regions around the world have arranged in advance at different levels, optimizing the original vaccine safety monitoring system from the perspectives of strengthening the foundation and capabilities, promoting internal and external cooperation, upgrading methods, as well as improving transparency and public communication, which has ensured the good and efficient operation of the system and can provide reference for the construction of relevant fields in China.
Humans ; COVID-19/prevention & control* ; COVID-19 Vaccines ; Pandemics/prevention & control* ; SARS-CoV-2 ; Viral Vaccines/adverse effects*

BACKGROUND: Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent. This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules. METHODS: Multiple databases with relevant studies were searched with an end date of October 31, 2021, and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31, 2022. Randomized controlled trials (RCTs) that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed. Primary outcomes included neutralizing antibodies against the original strain and serious adverse events (SAEs). A network meta-analysis (NMA) was conducted using a random-effects model. RESULTS: In all, 11 RCTs were included in the systematic review, and nine were ultimately included in the NMA. Among participants who received two doses of CoronaVac, another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit (SU); a dose of BNT162b2 induced the highest geometric mean ratio (GMR) of 15.24, 95% confidence interval [CI]: 9.53-24.39. Following one dose of BNT162b2 vaccination, a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone (GMR = 1.32; 95% CI: 1.06-1.64), NVX-CoV2373 (GMR = 1.60; 95% CI: 1.16-2.21), or ChAdOx1 (GMR = 1.80; 95% CI: 1.25-2.59). Following one dose of ChAdOx1, a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1 (GMR = 11.09; 95% CI: 8.36-14.71) or NVX-CoV2373 (GMR = 2.87; 95% CI: 1.08-3.91). No significant difference in the risk for SAEs was found in any comparisons. CONCLUSIONS: Relative to vaccination with two doses of CoronaVac, a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines. For primary vaccination, schedules including mRNA vaccines induce a greater immune response. However, the comparatively higher risk for local and systemic adverse events introduced by mRNA vaccines should be noted. REGISTRATION PROSPERO; https://www.crd.york.ac.uk/PROSPERO/ ; No. CRD42021278149.
Adult ; Humans ; BNT162 Vaccine ; 2019-nCoV Vaccine mRNA-1273 ; Network Meta-Analysis ; Immunization Schedule ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Viral Vaccines ; mRNA Vaccines ; Antibodies, Neutralizing ; Antibodies, Viral

OBJECTIVES: This study aimed to observe the clinical and immune response characteristics of vaccinated persons infected with the delta variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Yangzhou, China. METHODS: We extracted the medical data of 129 patients with delta-variant infection who were admitted to Northern Jiangsu People's Hospital (Yangzhou, China) between August and September, 2021. The patients were grouped according to the number of vaccine doses received into an unvaccinated group: a one-dose group and a two-dose group. The vaccine used was SARS-CoV-2-inactivated vaccine developed by Sinovac. We retrospectively analyzed the patients' epidemiological, clinical, laboratory, and imaging data. RESULTS: Almost all patients with delta-variant infection in Yangzhou were elderly, and patients with severe/critical illness were over 70 years of age. The rates of severe/critical illness (P=0.006), fever (P=0.025), and dyspnea (P=0.045) were lower in the two-dose group than in the unvaccinated group. Compared to the unvaccinated group, the two-dose group showed significantly higher lymphocyte counts and significantly lower levels of C-reactive protein (CRP), interleukin-6 (IL-6), and D-dimer during hospitalization and a significantly higher positive rate of immunoglobulin G (IgG) antibodies at admission (all P<0.05). The cumulative probabilities of hospital discharge and negative virus conversion were also higher in the two-dose group than in the unvaccinated group (P<0.05). CONCLUSIONS Two doses of the SARS-CoV-2-inactivated vaccine were highly effective at limiting symptomatic disease and reducing immune response, while a single dose did not seem to be effective.
Aged ; Aged, 80 and over ; Humans ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Critical Illness ; Immunity ; Retrospective Studies ; SARS-CoV-2 ; Vaccines, Inactivated/adverse effects* ; Viral Vaccines/adverse effects*

Coronavirus disease 2019 (COVID-19) is an acute respiratory infectious disease caused by 2019-nCoV. Due to the physiological change in pregnancy, pregnant women are susceptible to COVID-19 and are at increased risk for adverse pregnancy outcomes, especially in the context of spread of novel variants. At present, less evidences have been obtained from randomized controlled trials on the effectiveness and safety of COVID-19 vaccine use in pregnant women, and the recommendations of COVID-19 vaccination for pregnant women vary with countries, posing challenge to the prevention and control of COVID-19 in pregnant women. This paper summarizes the progress in major research of 2019-nCoV infection in pregnancy conducted both at home and abroad, describes the harm of COVID-19 in pregnancy to pregnant women, fetuses and infants and introduces the effectiveness and safety of COVID-19 vaccination in pregnancy revealed by real world studies in order to provide reference for the related research and development of COVID-19 prevention and control strategies in pregnant women.
COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Female ; Humans ; Infant ; Pregnancy ; Pregnancy Complications, Infectious/prevention & control* ; Pregnancy Outcome ; SARS-CoV-2 ; Vaccination

Objective: To evaluate the methodology of the published systematic reviews and Meta-analyses (SR/MA) on efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines. Methods: We conducted a retrieval for literatures published as of December 10, 2021 in English databases (Medline, Embase, Cochrane Library, Web of science) and Chinese databases (CNKI, Wanfang data, VIP, Sinomed). Two reviewers independently screened literatures and extracted data. The methodology of included SR/MA papers was assessed by A MeaSurement Tool to Assess systematic Review-2 (AMSTAR-2) tool in 16 items. Results: A total 22 SR/MA papers were included, in which 3 (13.6%) had low quality and 19 (86.4%) had very low quality. The main problems of these SR/MA included having no definite PICO (Participants, intervention, control and outcome), providing no preliminary research protocol, no list of excluded studies and justify the exclusions, making no evaluation and explanation or discussion of the risk of bias of original studies, no adequate evaluation of publication bias and discuss its likely impact on the results, etc. Conclusion: SR/MA for the efficacy and safety of COVID-19 vaccines had varied methodological deficiencies, further improvements are needed.
COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Humans ; Meta-Analysis as Topic ; Systematic Reviews as Topic