Background: COVID-19 vaccine side effects have a fundamental role in public confidence in the vaccine and its uptake process. Thus far, the evidence on vaccine safety has exclusively been obtained from the manufacturer-sponsored studies; therefore, this study was designed to provide independent evidence on Pfizer–BioNTech COVID-19 vaccine side effects. Methods: A cross-sectional survey-based study was carried out between January and February 2021 to collect data on the side effects following the COVID-19 vaccine among healthcare workers in the Czech Republic. The study used a validated questionnaire with twenty-eight multiple-choice items covering the participants’ demographic data, medical anamneses, COVID-19-related anamneses, general, oral, and skin-related side effects. Results: Injection site pain (89.8%), fatigue (62.2%), headache (45.6%), muscle pain (37.1%), and chills (33.9%) were the most commonly reported side effects. All the general side effects were more prevalent among the ≤43-year-old group, and their duration was mainly one day (45.1%) or three days (35.8%) following the vaccine. Antihistamines were the most common drugs associated with side effects, thus requiring further investigation. The people with two doses were generally associated with a higher frequency of side effects. Conclusions: The distribution of side effects among Czech healthcare workers was highly consistent with the manufacturer’s data, especially in terms of their association with the younger age group and the second dose. The overall prevalence of some local and systemic side effects was higher than the manufacturer’s report. Further independent studies on vaccine safety are strongly required to strengthen public confidence in the vaccine.
The Joanna Briggs Institute methodology for the systematic review of text and opinion is unique, and continuously evolving and being further developed. Systematic reviews of text and opinion may be considered as legitimate sources of evidence, especially when there is an absence of other research designs.
Background: The critically ill patients suffering from coronavirus disease (COVID-19) and admitted to the intensive care units (ICUs) are susceptible to a wide array of complications that can be life-threatening or impose them to long-term complications. The COVID-19 oral mucocutaneous complications require multidisciplinary management and research for their pathophysiological course and epidemiological significance; therefore, the objective of this study was to evaluate the prevalence and characteristics of the critically ill COVID-19 patients with oral complications. Methods: We described the clinical and microbiological characteristics of the critically ill COVID-19 patients in our ICU department (Banska Bystrica, Slovakia). In addition, we reviewed the current body of evidence in Ovid MEDLINE®, Embase, Cochrane Library, and Google Scholar for the oral mucocutaneous complications of ICU patients with COVID-19. Results: Three out of nine critically ill patients (33.3%) in our ICU department presented with oral complications including haemorrhagic ulcers and necrotic ulcers affecting the lips and tongue. The microbiological assessment revealed the presence of opportunistic pathogens, confirming the possibility of co-infection. On reviewing the current literature, two hundred ten critically ill patients were reported to have oral complications due to their stay in the ICU setting. Perioral pressure ulcers were the most common complication, followed by oral candidiasis, herpetic and haemorrhagic ulcers, and acute onset macroglossia. The prolonged prone positioning and mechanical ventilation devices were the primary risk factors for those oral complications, in addition to the immunosuppressive drugs. Conclusions: The multidisciplinary approach is strongly advocated for monitoring and management of COVID-19 patients, thus implying that dermatology and oral healthcare specialists and nurses should be integrated within the ICU teams.
Background: COVID-19 vaccine hesitancy is a serious threat to mass vaccination strategies that need to be accelerated currently in order to achieve a substantial level of community immunity. Independent (non-sponsored) studies have a great potential to enhance public confidence in vaccines and accelerate their uptake process. Methods: A nationwide cross-sectional study for the side effects (SE) of CoronaVac was carried out in February 2021 among Turkish healthcare workers who were recently vaccinated. The questionnaire inquired about local and systemic SEs that occurred in the short-term, within four weeks, following vaccination. Results: A total of 780 healthcare workers were included in this study; 62.5% of them experienced at least one SE. Injection site pain (41.5%) was the most common local SE, while fatigue (23.6%), headache (18.7%), muscle pain (11.2%) and joint pain (5.9%) were the common systemic SEs. Female healthcare workers (67.9%) were significantly more affected by local and systemic SEs than male colleagues (51.4%). Younger age, previous infection, and compromised health status (chronic illnesses and regular medicines uptake) can be associated with an increased risk of CoronaVac SEs; Conclusions: The independent research shows a higher prevalence of CoronaVac SEs than what is reported by phase I–III clinical trials. In general, the results of this study confirm the overall safety of CoronaVac and suggest potential risk factors for its SEs. Gender-based differences and SEs distribution among age groups are worth further investigation.
Pregnant and lactating women (PLW) represent a particular population subset with increased susceptibility for COVID-19 morbidity and mortality, even though the evidence about the safety and efficacy of COVID-19 vaccines was delayed due to their initial exclusion from development trials. This unclear situation could have led to increased COVID-19 vaccine hesitancy levels among PLW; therefore, this study aimed to evaluate the attitudes of Czech PLW towards COVID-19 vaccines and the determinants of their attitudes. An analytical cross-sectional survey-based study was carried out in the University Hospital Brno (South Moravia, Czechia) between August and October 2021. The study utilised a self-administered questionnaire (SAQ) adapted from previous instruments used for the same purpose. The SAQ included closed-ended items covering demographic characteristics, clinical and obstetric characteristics, attitudes towards COVID-19 vaccination, and potential psychosocial predictors of vaccine acceptance. Out of the 362 included participants, 278 were pregnant (PW) and 84 were lactating women (LW). The overall COVID-19 vaccine acceptance (immediate and delayed) level was substantially high (70.2%), with a significant difference between PW (76.6%) and LW (48.8%). Out of the 70.2% who agreed to receive the vaccine, 3.6% indicated immediate acceptance, and 66.6% indicated delayed acceptance. Only 13.3% of the participants indicated their acceptance of their physician’s vaccination recommendation during pregnancy or while lactating, and 62.2% were against it. Our results agreed with the recent studies that revealed that PW tended to have a high level of COVID-19 vaccine acceptance, and they were also inclined to resist professional recommendations because they predominantly preferred to delay their vaccination. The pregnancy trimester, education level, employment status, and previous live births were significant determinants for COVID-19 vaccine acceptance. The most commonly preferred vaccine type was mRNA-based vaccines, followed by viral vector-based and inactivated virus vaccines. The first top priority of PLW was vaccine safety for their children, followed by vaccine safety for the PLW and vaccine effectiveness. Regarding psychosocial predictors, media/social media, trust in the government, the pharmaceutical industry, and healthcare professionals, partners, and a positive risk-benefit ratio were significant promoters for COVID-19 vaccine acceptance. Findings from this study suggest that promotional interventions targeting PLW should use web platforms and focus on vaccine safety evidence, the expected benefits of vaccines and potential harms of the infection.
Recent reports of thrombosis following AstraZeneca COVID-19 vaccine in young females (<55 years-old) led to temporary suspension and urgent investigation by the European Medicines Agency (EMA) that concluded that vaccine benefits still outweigh its side effects (SEs). Therefore, this study aims to provide early independent evidence on the vaccine SEs’ prevalence and their potential risk factors; a cross-sectional survey-based study was carried out between February and March 2021 in Germany and Czech Republic among healthcare workers who recently received the AstraZeneca COVID-19 vaccine. The study used a validated self-administered questionnaire composed of twenty-eight multiple-choice items covering demographic variables, medical anamneses, and local, systemic, oral, and skin related SEs of the vaccine. Out of the ninety-two included participants, 77.2% were females and 79.3% were from Germany. Their mean age was 35.37 ± 12.62 (19–64) years-old, 15.2% had chronic illnesses and 22.8% were receiving medical treatments. Overall, 94.6% of the participants reported at least one SE. The most common local SE was injection site pain (72.8%), and the most common systemic SEs were fatigue (73.9%), muscle pain (55.4%), chills (48.9%), feeling unwell (46.7%), nausea (45.7%), and headache (29.3%). The vast majority (91.9%) resolved within 1–3 days, and the below 35 years-old group was the least affected age group. The SEs’ frequency was insignificantly higher in females and previously infected participants; the vaccine safety for the elderly was supported by the early findings of this study. Chronic illnesses and medical treatments were not associated with an increased risk of SE incidence and frequency. No blood disorder SEs were reported in our sample. Further independent studies are highly required to evaluate the safety of the AstraZeneca vaccine and to explore whether gender or previous infection could be associated with the vaccine SEs.
The overarching aim of this study was to assess the predictors related to the willingness of Palestinian dental students to receive the COVID-19 vaccine when it becomes available. A cross-sectional study was conducted among a universal sample of dental students in the Palestinian territories. Willingness to get the COVID-19 vaccine was related to the following factors: Demographic characteristics, COVID-19-related experiences, beliefs and knowledge about the vaccine, attitudes toward vaccinations in general, and other factors outlined by the WHO SAGE Vaccination Hesitancy Questionnaire. Four hundred and seventeen students completed the questionnaire (response rate = 41.7%). In general, 57.8% (n = 241) were willing to take the COVID-19 vaccine when it became available to them, 27% (n = 114) were hesitant, and 14.9% (n = 62) were not willing to get vaccinated. The final regression model explained 46% of the variation in the willingness to receive the COVID-19 vaccine as follows: Attitudes towards new vaccines (β = 6.23, p < 0.001), believing in a favorable risk–benefit ratio (β = 5.64, p < 0.001), trust in the pharmaceutical industry (β = 5.92, p = 0.001), believing that natural immunity is better than being vaccinated (β = −4.24, p < 0.001), and having enough information about the vaccine (β = 4.12, p < 0.001). Adequate information about vaccines, their risk–benefit ratios, and natural and acquired immunity are important to build trust and favorable attitudes towards vaccines among future dentists.
Background: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. Methods: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses’ side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. Conclusions: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.
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