scholarly journals Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia

2021 ◽  
Vol 14 (9) ◽  
pp. 873
Author(s):  
Abanoub Riad ◽  
Barbora Hocková ◽  
Lucia Kantorová ◽  
Rastislav Slávik ◽  
Lucia Spurná ◽  
...  

mRNA-based COVID-19 vaccines such as BNT162b2 have recently been a target of anti-vaccination campaigns due to their novelty in the healthcare industry; nevertheless, these vaccines have exhibited excellent results in terms of efficacy and safety. As a consequence, they acquired the first approvals from drug regulators and were deployed at a large scale among priority groups, including healthcare workers. This phase IV study was designed as a nationwide cross-sectional survey to evaluate the post-vaccination side effects among healthcare workers in Slovakia. The study used a validated self-administered questionnaire that inquired about participants’ demographic information, medical anamneses, COVID-19-related anamnesis, and local, systemic, oral, and skin-related side effects following receiving the BNT162b2 vaccine. A total of 522 participants were included in this study, of whom 77% were females, 55.7% were aged between 31 and 54 years, and 41.6% were from Banska Bystrica. Most of the participants (91.6%) reported at least one side effect. Injection site pain (85.2%) was the most common local side effect, while fatigue (54.2%), headache (34.3%), muscle pain (28.4%), and chills (26.4%) were the most common systemic side effects. The reported side effects were of a mild nature (99.6%) that did not require medical attention and a short duration, as most of them (90.4%) were resolved within three days. Females and young adults were more likely to report post-vaccination side effects; such a finding is also consistent with what was previously reported by other phase IV studies worldwide. The role of chronic illnesses and medical treatments in post-vaccination side effect incidence and intensity requires further robust investigation among large population groups.

Biology ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 752
Author(s):  
Miloslav Klugar ◽  
Abanoub Riad ◽  
Mohamed Mekhemar ◽  
Jonas Conrad ◽  
Mayte Buchbender ◽  
...  

Background: the increasing number of COVID-19 vaccines available to the public may trigger hesitancy or selectivity towards vaccination. This study aimed to evaluate the post-vaccination side effects of the different vaccines approved in Germany; Methods: a cross-sectional survey-based study was carried out using an online questionnaire validated and tested for a priori reliability. The questionnaire inquired about demographic data, medical and COVID-19-related anamneses, and local, systemic, oral, and skin-related side effects following COVID-19 vaccination; Results: out of the 599 participating healthcare workers, 72.3% were females, and 79.1% received mRNA-based vaccines, while 20.9% received a viral vector-based vaccine. 88.1% of the participants reported at least one side effect. Injection site pain (75.6%) was the most common local side effect, and headache/fatigue (53.6%), muscle pain (33.2%), malaise (25%), chills (23%), and joint pain (21.2%) were the most common systemic side effects. The vast majority (84.9%) of side effects resolved within 1–3 days post-vaccination; Conclusions: the mRNA-based vaccines were associated with a higher prevalence of local side effects (78.3% vs. 70.4%; Sig. = 0.064), while the viral vector-based vaccine was associated with a higher prevalence of systemic side effects (87.2% vs. 61%; Sig. < 0.001). Females and the younger age group were associated with an increased risk of side effects either after mRNA-based or viral vector-based vaccines. The gender- and age-based differences warrant further rigorous investigation and standardized methodology.


Author(s):  
Bernadine O’Donovan ◽  
Ruth M. Rodgers ◽  
Anthony R. Cox ◽  
Janet Krska

Abstract Aim: To determine the use and perceived value of different information sources that patients may use to support identification of medicine side effects; to explore associations between coping styles and use of information sources. Background: Side effects from medicines can have considerable negative impact on peoples’ daily lives. As a result of an ageing UK population and attendant multi-morbidity, an increasing number of medicines are being prescribed for patients, leading to increased risk of unintended side effects. Methods: A cross-sectional survey of patients who use medicine, recruited from community pharmacies. The survey sought views on attributes of various information sources, their predicted and actual use, incorporating a shortened Side Effects Coping Questionnaire (SECope) scale and the abbreviated Miller Behavioural Style Scale (MBSS). Findings: Of 935 questionnaires distributed, 230 (25.0%) were returned, 61.3% from females; 44.7% were retired and 84.6% used at least one medicine regularly. 69.6% had experienced a side effect, resulting in 57.5% of these stopping the medicine. Patient information leaflets (PILs) and GPs were both predicted and actually most widely used sources, despite GPs being judged as relatively less accessible and PILs less trustworthy, particularly by regular medicine users. Pharmacists, considered both easy to access and trustworthy, were used by few in practice, while the internet was considered easy to access, but less trustworthy and was also little used. SECope sub-scales for non-adherence and information seeking showed positive associations with stopping a medicine and seeking information from a health professional. More high monitors than low monitors stopped a medicine themselves, but there were no differences in use of information sources. Information seeking following a side effect is a common strategy, potentially predicted by the SECope, but not the MBSS. Limited GP accessibility could contribute to high internet use. Further research could determine how the trustworthiness of PILs can be improved.


2021 ◽  
Vol 14 (10) ◽  
pp. 1049
Author(s):  
Abanoub Riad ◽  
Andrea Pokorná ◽  
Jitka Klugarová ◽  
Natália Antalová ◽  
Lucia Kantorová ◽  
...  

Young adults had been widely perceived as a low-risk group for COVID-19 severity; therefore, they were deprioritised within the mass vaccination strategies as their prognosis of COVID-19 infection is relatively more favourable than older age groups. On the other hand, vaccination of this demographic group is indispensable to achieve herd immunity. A cross-sectional survey-based study was used to evaluate the side effects of mRNA-based COVID-19 vaccines among university students in the Czech Republic. The validated questionnaire was delivered in a digital form, and it consisted of demographic data; COVID-19 vaccine-related anamnesis; and local, systemic, orofacial, and skin-related side effects’ prevalence, onset, and duration. Out of the 539 included participants, 70.1% were females and 45.8% were <23 years old. The vast majority (95.2%) reported at least one side effect. The most common side effect was injection site pain (91.8%), followed by fatigue (62.5%), headache (36.4%), and muscle pain (34.9%). The majority of local side effects occurred after both doses (74.4%), while most systemic side effects occurred after the second dose only (56.2%). Most local (94.2%) and systemic (93.3%) side effects resolved within three days after vaccination. Females participants’ adjusted odds ratio (AOR) showed they were 2.566 (CI 95%: 1.103–5.970) times more likely to experience post-vaccination side effects, and the participants who received two doses reported an increased AOR of 1.896 (0.708–5.077) for experiencing side effects. The results of this study imply that mRNA-based COVID-19 vaccines are highly probably safe for young adults, and further studies are required to investigate the role of medical anamnesis, prior COVID-19 infection, and gender in side effects incidence.


Vaccines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 766
Author(s):  
Gabriella Di Giuseppe ◽  
Concetta P. Pelullo ◽  
Andrea Paolantonio ◽  
Giorgia Della Polla ◽  
Maria Pavia

This cross-sectional survey was designed to evaluate hospital healthcare workers’ (HCWs) willingness to receive the influenza vaccination during the COVID-19 pandemic and to identify the related determinants, since it is plausible that the two epidemics will coexist in future winters. Overall, 68% out of 490 participants expressed their willingness to receive influenza vaccination in the 2020/21 season, with 95% of those ever and 45.8% of those never vaccinated in the previous six influenza seasons. Belief that influenza vaccine is useful in distinguishing influenza symptoms from those of COVID-19 and that the influenza vaccine is useful to prevent influenza in hospital settings, willingness to receive COVID-19 vaccination, having no concern about influenza vaccine side effects, concern about the possibility to transmit influenza to hospitalized patients, and influenza vaccination in previous years were all predictors of willingness to receive influenza vaccination. In the context of the COVID-19 pandemic, a relevant increase in the willingness to undergo influenza vaccination was reported. Therefore, interventions focused primarily on enabling factors are needed to promote the adherence to influenza vaccination in future seasons among HCWs.


2020 ◽  
Author(s):  
Silky Dhamija ◽  
Yayati Joshi ◽  
Amar Nandhakumar

Abstract Background Various modalities are under study for prevention and treatment of novel coronavirus. One such modality is use of Hydroxychloroquine/Choloroquine. The objective of survey was to understand the awareness and impact of HCQ/CQ prophylaxis among the health care workers (HCWs) including surgeons and anaesthetists.Methods A web-based, cross-sectional survey was conducted for HCWs globally. Participation was voluntary and confidentiality was maintained by making participants' information anonymous. The questionnaire consisted of 28 items. Data were tabulated in excel, and descriptive statistics were performed. Results Survey was taken by 344 HCWs from all over the world. 98% participants heard about the use of HCQ/CQ prophylaxis against COVID 19 infection. 301 HCWs knew about the side effects of HCQ/CQ. 54 1% participants agree there is not adequate research done. 122 participants took HCQ/CQ prophylaxis. Out of 29 5% participants who received the medicine from hospital under hospital protocol, 66 7% were given medication without baseline investigations and 30 5% HCWs were not even briefed about the drug and its side effects by the hospitals. 36 2% participants developed side effects. 8 7% HCWs were tested for COVID19 out of 344 participants.Conclusion The drug taken by HCWs was without adequate evidence, prior investigations, supervision and follow-up. Most of the participants self prescribed the drug. No separate guidelines were stated for people who had co-morbid conditions. Hospitals neither conducted baseline investigations and nor briefed HCWs about HCQ/CQ. These are some serious concerns we are looking into as who will be answerable in case of adverse events.


Vaccines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1156
Author(s):  
Mohamed Hassan Elnaem ◽  
Nor Hidayah Mohd Taufek ◽  
Norny Syafinaz Ab Rahman ◽  
Nor Ilyani Mohd Nazar ◽  
Che Suraya Zin ◽  
...  

This study aimed to investigate the attitudes, perceptions, and experiences of side effects with the COVID-19 vaccines in Malaysia among participants in the National Vaccination Program. A cross-sectional survey was conducted among a sample of vaccine-eligible and vaccinated individuals in Malaysia between May and July 2021. A total of 428 respondents completed the survey. A vast majority (98.6%) of the respondents had registered to be vaccinated. Twenty participants (4.7%) expressed concerns about either registering or receiving the COVID-19 vaccination, mainly due to their uncertainty of vaccine safety. Approximately 77.5% received their vaccinations. Of them, 76.8% had experienced vaccine-related side effects. About 40% of the side effects occurred more with the second dose, particularly those who received the Pfizer-BioNTech vaccine (p < 0.001). Pain at the injection site (61.1%) and tiredness (48.8%) were the most reported side effects. Compared to those aged ≥60 years, all age groups were more likely to exhibit vaccine-related side effects; meanwhile, males (OR: 0.51, 95% CI: 0.27–0.93) were less likely to experience side effects than females. Those who received the Sinovac vaccine were at lower risk of experiencing side effects (OR: 0.08, 95% CI: 0.03–0.22) and were more likely to report fewer side effects than Pfizer-BioNTech (p = 0.012) and Oxford-AstraZeneca groups (p= 0.001). The overall attitudes toward the COVID-19 vaccination program were positive. Several differences in the experiences of vaccine-related side effects, in terms of prevalence and numbers, were attributed to age, gender, and received vaccine type.


Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 556
Author(s):  
Ma’mon M. Hatmal ◽  
Mohammad A. I. Al-Hatamleh ◽  
Amin N. Olaimat ◽  
Malik Hatmal ◽  
Dina M. Alhaj-Qasem ◽  
...  

Background: Since the coronavirus disease 2019 (COVID-19) was declared a pandemic, there was no doubt that vaccination is the ideal protocol to tackle it. Within a year, a few COVID-19 vaccines have been developed and authorized. This unparalleled initiative in developing vaccines created many uncertainties looming around the efficacy and safety of these vaccines. This study aimed to assess the side effects and perceptions following COVID-19 vaccination in Jordan. Methods: A cross-sectional study was conducted by distributing an online survey targeted toward Jordan inhabitants who received any COVID-19 vaccines. Data were statistically analyzed and certain machine learning (ML) tools, including multilayer perceptron (MLP), eXtreme gradient boosting (XGBoost), random forest (RF), and K-star were used to predict the severity of side effects. Results: A total of 2213 participants were involved in the study after receiving Sinopharm, AstraZeneca, Pfizer-BioNTech, and other vaccines (38.2%, 31%, 27.3%, and 3.5%, respectively). Generally, most of the post-vaccination side effects were common and non-life-threatening (e.g., fatigue, chills, dizziness, fever, headache, joint pain, and myalgia). Only 10% of participants suffered from severe side effects; while 39% and 21% of participants had moderate and mild side effects, respectively. Despite the substantial variations between these vaccines in the presence and severity of side effects, the statistical analysis indicated that these vaccines might provide the same protection against COVID-19 infection. Finally, around 52.9% of participants suffered before vaccination from vaccine hesitancy and anxiety; while after vaccination, 95.5% of participants have advised others to get vaccinated, 80% felt more reassured, and 67% believed that COVID-19 vaccines are safe in the long term. Furthermore, based on the type of vaccine, demographic data, and side effects, the RF, XGBoost, and MLP gave both high accuracies (0.80, 0.79, and 0.70, respectively) and Cohen’s kappa values (0.71, 0.70, and 0.56, respectively). Conclusions: The present study confirmed that the authorized COVID-19 vaccines are safe and getting vaccinated makes people more reassured. Most of the post-vaccination side effects are mild to moderate, which are signs that body’s immune system is building protection. ML can also be used to predict the severity of side effects based on the input data; predicted severe cases may require more medical attention or even hospitalization.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
A Rosso ◽  
A Massimi ◽  
V Baccolini ◽  
E Pitini ◽  
C Marzuillo ◽  
...  

Abstract Background Further to the increase in measles cases reported in Italy since 2016, MMR vaccination became mandatory in 2017, leading to an increase in vaccination coverage in the Country. To guarantee sustained coverage, factors influencing the intention to vaccinate in the population should be better understood. Methods We conducted a cross-sectional survey to assess knowledge and attitudes on pediatric vaccinations and intention to vaccinate among pregnant women attending Antenatal Classes in Rome, through distribution of a self-administered questionnaire, which included a specific section on MMR vaccination. Multiple logistic regression analysis was performed to analyze the determinants of the intention to vaccinate with MMR. Results A total of 458 pregnant women attending CANs in 36 family health centers and two hospitals answered the survey. Intention to vaccinate with MMR was associated with having received information from a healthcare professional (OR 1.92, 95%CI 1.01-3.63), the perceived importance of vaccines to protect against measles (OR 4.68, 95%CI 2.48- 9.54) and rubella (OR 5.97, 95%CI 2.98-11.95), not believing in news about the risks of MMR vaccine (OR 2.75, 95%CI 1.38-5.50), and the sense of guilt in case the child should contract the disease (OR 2.56, 95%CI 1.16-5.62). Factors negatively associated with the intention to vaccinate were the use of alternative medicine (OR 0.34, 95%CI 0.16- 0.76), believing that MMR vaccine can have serious side effects (OR 0.37, 95%CI 0.00-0.29) and guilt in case of serious side effects (OR 0.40, 95%CI 0.21-0.76). Conclusions Fear of MMR side effects is a relevant driver of the intention to vaccinate, coupled with the perceived importance to vaccinate to protect against measles and rubella. Also the source of information plays an important role in shaping ideas on vaccines. Information and communication strategies should be promoted to increase trust in vaccines, with a direct involvement of healthcare workers. Key messages Fear of MMR side effects and perceived benefits of the vaccine influence the intention to vaccinate. Information and communication strategies to increase vaccination appectance involving healthcare workers are needed.


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