Adverse Effects of the COVID-19 Vaccine Reported by Lecturers and Staff of Kabul University of Medical Sciences, Kabul, Afghanistan.
TL;DR: In this article, the adverse reactions reported by the participants were mild to moderate in severity, and for a short duration, and the severity of most adverse reactions was mild-to moderate.
Abstract: Purpose To evaluate the occurrence, extent, and severity of adverse reactions associated with the vaccine of COVID-19 (ChAdOx1 nCoV-19 vaccine or AstraZeneca) among Kabul University of Medical Sciences staff. Patients and methods A retrospective observational, interview-based study was conducted from 4 to 20 April, 2021, to evaluate the adverse reactions associated with the vaccine of COVID-19 (ChAdOx1 nCoV-19 vaccine or AstraZeneca) among the staff and lecturers of the Kabul University of Medical Sciences, Kabul, Afghanistan. Participants were interviewed following the administration of the first dose of the AstraZeneca vaccines. They were asked to report any adverse reactions that occurred within 8-10 days after vaccination. The frequency, duration, severity, and outcome of the reactions were recorded. Association of the adverse reactions was analysed with the ages of participants and previous infection with SARS CoV-2. Results The most common adverse reactions reported by the participants were muscle pain (68.3%), local pain (58.8%) at the site of injection (68.3%), fever (66.3%) and fatigue (66.3%). Almost half of the respondents reported chills, joint pain and headache after receiving the first shot of the vaccine. The frequency of adverse reactions was higher in participants aged 40 years or less, and in those previously infected with SARS CoV-2. The severity of most adverse reactions was mild to moderate. No serious case or death was reported. Conclusion The adverse reactions reported by the participants were mild to moderate in severity, and for a short duration. The findings of this study help us to address the vaccine hesitancy caused by worries about severe adverse effects associated with the COVID-19 vaccine.
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TL;DR: Despite the higher prevalence of post-vaccination side effects among adenoviral vector vaccines recipients, both vaccines groups were equally effective in preventing symptomatic infections, and no life-threatening side effects were reported in either vaccine group.
Abstract: Healthcare workers were prioritized in vaccination campaigns globally because they are exposed to the highest risk of contamination by SARS-CoV-2. This study evaluated the self-reported post-vaccination side effects of inactivated (BBIBP-CorV and CoronaVac) and adenoviral vector-based (AZD1222, Gam-COVID-Vac and Ad26.COV2.S) vaccines among Algerian healthcare workers using a validated questionnaire. The final analysis included 721 healthcare workers, with a predominance of females (59.1%) and younger individuals 20–30 years old (39.4%). Less than half (49.1%) of the respondents reported at least one local side effect, while 53.8% reported at least one systemic side effect. These side effects were more prevalent among viral vector vaccinees than inactivated virus vaccinees. The most common local side effects were injection site pain (39%) and arm pain (25.4%), while fatigue (34.4%), fever (28.4%), headache (24.8%) and myalgia (22.7%) were the most prevalent systemic side effects. The side effects appeared earlier among inactivated virus vaccines recipients and generally lasted for 2 to 3 days for the two vaccinated groups. The risk factors associated with a higher prevalence of side effects included female gender, allergic individuals, individuals with regular medication, those who contracted the COVID-19 disease and those who received two doses for both inactivated and viral-based vaccines groups. Despite the higher prevalence of post-vaccination side effects among adenoviral vector vaccines recipients, both vaccines groups were equally effective in preventing symptomatic infections, and no life-threatening side effects were reported in either vaccine group.
23 citations
TL;DR: ChAdOx1 nCoV-19 Coronavirus vaccine (recombinant) is proven to be safe based on the findings as the majority of AEFIs observed were of minor grade only, but the vaccine beneficiaries should be strictly observed for a minimum of 30 minutes at the vaccination site to look for any serious AEFI.
Abstract: Background In January 2020, the Government of India based on the recommendation of the Drugs Controller General of India (DCGI) and National Technical Advisory Group on Immunization (NTAGI) started the rollout of the COVID-19 vaccine in the country. Two vaccines, ChAdOx1 nCoV-19 coronavirus vaccine (recombinant), i.e., COVISHIELD produced by Serum Institute of India and COVAXIN developed indigenously by Bharat Biotech, were given emergency use authorisation (EUA) by the DCGI. Methods In this cohort study, we assessed the incidence, pattern and severity of adverse events following immunization (AEFI) observed among the healthcare workers of a large tertiary care institute in eastern U.P., India vaccinated with ChAdOx1 nCoV-19 Coronavirus vaccine (recombinant) within 30 minutes of vaccination by direct observation. Results Out of the total 836 healthcare workers who were vaccinated with the first dose of the vaccine, around 10% experienced any AEFI within the directly observed period. The most common AEFI was pain/tenderness at the injection site experienced by 59.3% of those who experienced any AEFI followed by headache/dizziness (35.3%), itching/rashes at the injection site (8.1%), nausea/vomiting (5.8%) and fever/chills (4.7%). The majority (95.3%) of the AEFIs observed were of minor severity with no serious AEFIs observed as per the WHO severity classification. Conclusion ChAdOx1 nCoV-19 Coronavirus vaccine (recombinant) is proven to be safe based on our findings as the majority of AEFIs observed were of minor grade only. However, the vaccine beneficiaries should be strictly observed for a minimum of 30 minutes at the vaccination site to look for any serious AEFI with arrangements to manage the same.
8 citations
TL;DR: The reported reactions are relatively high but expected and no adverse events have been reported that are not listed in the official Summary of Product Characteristics.
Abstract: As a member state of the European Union, where vaccines against COVID-19 are available and affordable, Bulgaria reports the lowest immunization coverage and the most pronounced vaccine distrust. The present study aimed to assess the self-reported adverse reactions following COVID-19 vaccination as a possible tool to increase the trust in vaccines. A cross-sectional survey-based study, covering 761 vaccinated respondents, was conducted in Plovdiv (469 with an mRNA vaccine and 292 with an adenoviral vector vaccine). Descriptive statistics parametric and non-parametric methods were applied. Statistical significance was set at p<0.05. The median age of the respondents was 42 years, females (72.5%). At least one adverse reaction was reported in 89.9% of those immunized with mRNA vaccine and 93.8% in the adenoviral vector vaccine group (p>0.05). They were mild to moderate and resolved within several days. The levels of local reactions were comparable: 91.7% in those who received mRNA and 89.7% in those who received an adenoviral vector vaccine (p = 0.366). The most common types of systemic reactions were fatigue, headache, and muscle pains. An association was found between the systemic reactions and the type of vaccine administered: 59.7% in mRNA recipients and 89.4% in adenoviral vector vaccinees (p<0.001). None of the registered systemic reactions required medical attention. There were 3 reports of generalized urticaria after an mRNA and 2 after an adenoviral vector vaccine. The reported reactions are relatively high but expected and no adverse events have been reported that are not listed in the official Summary of Product Characteristics.
3 citations
TL;DR: There is a significant age and gender difference in adverse effects following the first dose of the AstraZeneca COVID-19 vaccine, and adverse reactions were higher among people with comorbidity in the age group of 50–60 years.
Abstract: Objective: The pandemic of coronavirus disease 2019 (COVID-19) is a major threat to community health, and vaccinations are a safe and effective way to reduce disease loads around the world. This study aimed to assess the age and gender disparity in adverse effects following the first dose of the AstraZeneca COVID-19 vaccine among the vaccinated population in Eastern Ethiopia. Methods: A community-based cross-sectional study design was conducted among 832 randomly selected individuals from December 1st to 20th, 2021, in eastern Ethiopia. Data were collected by face-to-face interviews using a pretested structured questionnaire. Data were analyzed using the SPSS V26. Descriptive summary statistics were done. A chi-square test statistic was computed to assess the difference in adverse effects between age groups and both genders. Result: Out of 832 study participants who had taken the first dose of AstraZeneca vaccine, 96.3% of them felt at least one adverse effect. The magnitude of adverse reactions was higher among male participants. The reported adverse reactions were significantly higher in the age group of 50–60 years with comorbidity than those of <50 and >60 years of age. Conclusion: Overall, there is a significant age and gender difference in adverse effects following the first dose of the AstraZeneca COVID-19 vaccine. In addition, adverse reactions were higher among people with comorbidity in the age group of 50–60 years. The Harari Regional Health Bureau should provide training for frontline healthcare workers on early recognition and response to adverse effects of the COVID-19 vaccine. In addition, information and education should be provided to the community as a whole regarding recognition and the appropriate measures to be taken.
3 citations
TL;DR: In this article , a validated questionnaire was distributed as a Google form to rheumatologists across the country via social networking sites from late December 2021 till early January 2022, which included questions regarding participants' socio-demographic details, COVID-19 infection and vaccination details with special emphasis on AEs.
Abstract: The study aimed to explore the experience of coronavirus disease-2019 (COVID-19) infection and vaccine adverse events (AEs) among rheumatologists. A validated questionnaire was distributed as a Google form to rheumatologists across the country via social networking sites from late December 2021 till early January 2022. The questionnaire included questions regarding participants' socio-demographic details, COVID-19 infection and vaccination details with special emphasis on AEs. Out of 246 responses, 228 were valid. 200 (81.3%) responders had received the vaccine. The mean age of the 228 participants was 37.9 ± 8.5 years, 196 were females and 32 males (F:M 6.1:1) from 18 governorates across the country. Comorbidities were present in 54 subjects (27%). There was a history of highly suspicious or confirmed COVID-19 infection in 66.7% that were all managed at home. The COVID-19 vaccine was received by 200 and a booster dose of 18.5%. Obesity and musculoskeletal involvement co-morbidities were present only in those with AEs (9.1% and 5.5% respectively). AEs were present in 82%; 66.7% had injection-site tenderness, 50% fatigue, 35.5% fever, 15% chills, 42.5% myalgia, 14.5% arthralgia, 8% low back pain, headache 31%, dizziness 10%, sleepliness 16% and 15% developed post-vaccine. There were no differences according to the geolocation regarding the occurrence of COVID-19 infection (p = 0.19) or AEs post-vaccine (p = 0.58). The adverse events were mostly mild to moderate and tolerable which makes this work in agreement with other studies that support the broad safety of the vaccine in favor of the global benefit from mass vaccination.
2 citations
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TL;DR: Hospitalised COVID-19 patients are frequently elderly subjects with co-morbidities receiving polypharmacy, all of which are known risk factors for d
Abstract: Background: Hospitalised COVID-19 patients are frequently elderly subjects with co-morbidities receiving polypharmacy, all of which are known risk factors for d
14,343 citations
University of Oxford1, Federal University of São Paulo2, University of the Witwatersrand3, Stellenbosch University4, Liverpool School of Tropical Medicine5, University of Sheffield6, University of London7, Newcastle upon Tyne Hospitals NHS Foundation Trust8, University Hospital Southampton NHS Foundation Trust9, University Hospitals Bristol NHS Foundation Trust10, Guy's and St Thomas' NHS Foundation Trust11, University Hospitals Birmingham NHS Foundation Trust12, St George's, University of London13, AstraZeneca14, North Bristol NHS Trust15, University College Hospital16, University of Hull17, Escola Bahiana de Medicina e Saúde Pública18, Federal University of Rio Grande do Norte19, Northwest University (China)20, Universidade Federal de Santa Maria21, Glasgow Dental Hospital and School22, Boston Children's Hospital23, Universidade Federal do Rio Grande do Sul24, Western General Hospital25, University of Glasgow26, Cambridge University Hospitals NHS Foundation Trust27, University of Cambridge28, Nottingham University Hospitals NHS Trust29, Aneurin Bevan University Health Board30
TL;DR: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.
3,741 citations
TL;DR: In this article, the authors examined the proportion and probability of self-reported systemic and local side-effects within 8 days of vaccination in individuals using the COVID Symptom Study app who received one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 nCoV-19 vaccine.
Abstract: Summary Background The Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccines have shown excellent safety and efficacy in phase 3 trials. We aimed to investigate the safety and effectiveness of these vaccines in a UK community setting. Methods In this prospective observational study, we examined the proportion and probability of self-reported systemic and local side-effects within 8 days of vaccination in individuals using the COVID Symptom Study app who received one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 nCoV-19 vaccine. We also compared infection rates in a subset of vaccinated individuals subsequently tested for SARS-CoV-2 with PCR or lateral flow tests with infection rates in unvaccinated controls. All analyses were adjusted by age (≤55 years vs >55 years), sex, health-care worker status (binary variable), obesity (BMI Findings Between Dec 8, and March 10, 2021, 627 383 individuals reported being vaccinated with 655 590 doses: 282 103 received one dose of BNT162b2, of whom 28 207 received a second dose, and 345 280 received one dose of ChAdOx1 nCoV-19. Systemic side-effects were reported by 13·5% (38 155 of 282 103) of individuals after the first dose of BNT162b2, by 22·0% (6216 of 28 207) after the second dose of BNT162b2, and by 33·7% (116 473 of 345 280) after the first dose of ChAdOx1 nCoV-19. Local side-effects were reported by 71·9% (150 023 of 208 767) of individuals after the first dose of BNT162b2, by 68·5% (9025 of 13 179) after the second dose of BNT162b2, and by 58·7% (104 282 of 177 655) after the first dose of ChAdOx1 nCoV-19. Systemic side-effects were more common (1·6 times after the first dose of ChAdOx1 nCoV-19 and 2·9 times after the first dose of BNT162b2) among individuals with previous SARS-CoV-2 infection than among those without known past infection. Local effects were similarly higher in individuals previously infected than in those without known past infection (1·4 times after the first dose of ChAdOx1 nCoV-19 and 1·2 times after the first dose of BNT162b2). 3106 of 103 622 vaccinated individuals and 50 340 of 464 356 unvaccinated controls tested positive for SARS-CoV-2 infection. Significant reductions in infection risk were seen starting at 12 days after the first dose, reaching 60% (95% CI 49–68) for ChAdOx1 nCoV-19 and 69% (66–72) for BNT162b2 at 21–44 days and 72% (63–79) for BNT162b2 after 45–59 days. Interpretation Systemic and local side-effects after BNT162b2 and ChAdOx1 nCoV-19 vaccination occur at frequencies lower than reported in phase 3 trials. Both vaccines decrease the risk of SARS-CoV-2 infection after 12 days. Funding ZOE Global, National Institute for Health Research, Chronic Disease Research Foundation, National Institutes of Health, UK Medical Research Council, Wellcome Trust, UK Research and Innovation, American Gastroenterological Association.
670 citations
22 Feb 2021
TL;DR: The SARS-CoV-2 virus is an RNA virus that belongs to the Coronaviridae family and causes COVID-19 disease, which caused more than 1,866,000 deaths as discussed by the authors.
Abstract: The new SARS-CoV-2 virus is an RNA virus that belongs to the Coronaviridae family and causes COVID-19 disease. The newly sequenced virus appears to originate in China and rapidly spread throughout the world, becoming a pandemic that, until January 5th, 2021, has caused more than 1,866,000 deaths. Hence, laboratories worldwide are developing an effective vaccine against this disease, which will be essential to reduce morbidity and mortality. Currently, there more than 64 vaccine candidates, most of them aiming to induce neutralizing antibodies against the spike protein (S). These antibodies will prevent uptake through the human ACE-2 receptor, thereby limiting viral entrance. Different vaccine platforms are being used for vaccine development, each one presenting several advantages and disadvantages. Thus far, thirteen vaccine candidates are being tested in Phase 3 clinical trials; therefore, it is closer to receiving approval or authorization for large-scale immunizations.
421 citations
TL;DR: In this article, the authors conducted a cross-sectional study to assess the attitude of healthcare workers toward COVID-19 vaccination and found that 36% of respondents were willing to take the vaccine as soon as it became available while 56% were not sure or would wait to review more data.
351 citations