A vaccine against the novel coronavirus disease (COVID-19) was needed to prevent unprecedented mortality and morbidity around the world 8, 9, 10. Emergency use authorization of the WHO-prequalified vaccine was determined by local governments based on initial data on safety and efficacy3. The safety profile of these vaccines requires continued monitoring to assess health effects and confirm trust and acceptance among the public 11,12,13,14. To our knowledge, this is the first comprehensive study on the safety profile of a COVID-19 vaccine in the Bangladeshi population. Our study found six main aspects of COVID-19 vaccine side effects. First, the majority of participants experienced local and systemic side effects after vaccination. These side effects were mostly reported (70-85%) within 48 hours after vaccination. These findings were similar to initial clinical trials and observational studies, but differed in duration and intensity in this study7,8,15,16,17,18. Local effects were common (70-85%), including pain at the injection site, hand pain, heaviness in the injected hand, redness, back pain, muscle pain, and swelling (70-85%), whereas systemic effects were Fever, headache, and myalgia were common (80%). %). Longitudinal studies have already reported the long-term effects of COVID-19 vaccines in different populations. Following this statement, COVID-19 vaccines have also been found to be associated with long-term side effects more than 6 months after vaccination 17 , 18 , 19 , 20 21, 22. Skin allergies, urticaria, and psoriasis were reported in 60% to 70% of vaccinees after 6 months, a finding that is unique to this population compared to other studies. These symptoms require detailed investigation and clinical trials to determine their relationship to vaccination.
Second, there was a decrease in the number of vaccinated people from the first dose to the second dose, and from the second to the third dose. Approximately 25.7% and 48.9% of recipients had a decrease from the first to the second and the first to the third dose, respectively, followed by 31.8% from the second to the third dose. This finding is fully supported by national and international data on vaccination1,6,11,12,13,14. Previous studies also support that concerns about the safety profile may influence acceptance of COVID-19 vaccines in resource-limited settings and developed countries 11, 12. 13, 14. We also found a relatively high proportion of breakthrough cases (15-25%) after vaccination among the study population. In order to increase acceptance and trust in vaccines and prevent further health damage from COVID-19, effective and safe vaccines that have undergone appropriate testing must be widely available. This statement is supported by previous studies12,13. Third, we found that all vaccines were significantly associated with a variety of side effects in recipients. After the first dose, injection site pain, swelling, redness, heaviness of the injected hand, fever, headache, muscle pain, chills, shortness of breath, vomiting, nausea, anosmia, and diarrhea were significantly associated (p-value <0.05). ) A combination of Oxford-AstraZeneca and Sinopharm's BIBP vaccines. These local and systemic effects were also found to be significantly associated with the Moderna, Pfizer-BioNTech, Oxford-AstraZeneca, Sinopharm BIBP, and Sinovac vaccines after the second and third vaccinations. . Health effects six months after vaccination, such as psoriasis and hives, were seen at higher rates among participants and were significantly associated with these vaccines. This is a relatively new report among vaccinated people in Bangladesh. Additionally, there are no long-term reports of inflammatory skin conditions associated with vaccination from Bangladesh. Several increases in psoriasis and urticaria cases following COVID-19 vaccination have been previously reported in the United States, Belgium, Vietnam, China, and Taiwan. Our findings are in good agreement with those of previous studies22-24,26-29.
Fourth, we found that the blood clots in our participants were only associated with the Oxford-AstraZeneca vaccine. The incidence of thrombosis in people receiving the Oxford-AstraZeneca homolog ranged from 3.5% to 5.7%. This statement is in good agreement with previous findings obtained in numerous studies worldwide30,31,32,33,34,35. However, some studies that reported a low incidence of blood clots after taking Pfizer-BioNTech and Moderna found that only Oxford-AstraZeneca was associated with thrombosis. In neighboring India, numerous reports of thrombosis and thrombocytopenia following vaccination with the Oxford-AstraZeneca vaccine have been recorded36. This is one of the first reports of thrombosis due to COVID-19 vaccination in Bangladesh. Fifth, we also reported comprehensive results after homologous and heterologous administration of the COVID-19 vaccine. Similar doses of Oxford and AstraZeneca were found to have higher rates of side effects than Sinopharm BIBP. But the uneven second dose with Moderna had the highest rate of local and systemic effects, followed by Pfizer-BioNTech and Oxford-AstraZeneca. This finding is also relatively new in the Bangladeshi population and is similar to previous findings in other countries8,9,37,38,39,40,41. Similarly, at the third dose of the heterogeneous mixture, Moderna had the highest rate of side effects and Sinopharm BIBP had the lowest rate of effects. Sixth, we determined risk factors for adverse outcomes in participants. We found that COVID-19 vaccinations have the highest rates of various side effects. Among the vaccines, Oxford-AstraZeneca (OR 4.24, 95% CI 3.99-4.68) and Moderna (OR 4.29, 95% CI 3.87-4.58) had the highest odds of side effects, followed by other vaccines. Host demographics, including gender, habits such as smoking habits, and pre-existing health conditions such as COPD, asthma, diabetes, and autoimmune diseases, were associated with a higher likelihood of side effects. These findings are fully consistent with previous findings7,8,10,17,31,41,42,43,44. COVID-19 vaccinations and the use of the Moderna, Oxford-AstraZeneca and Pfizer-BioNTech vaccines were significantly more likely to cause long-term, serious side effects.
This study has some limitations. These include self-reported data from participants, the number of people receiving the Moderna and Pfizer-BioNTech vaccines could be even higher, and the lack of detailed histopathology data. In the future, including data from histopathological analysis may enable more accurate predictions related to COVID-19 vaccination. Although we designed the study in a prospective manner to reduce recall bias, mild recall bias may exist due to the small number of participants.
