key: cord-0783579-nyy5lpfx authors: Shrestha, Yogendra; Venkataraman, Rajesh title: The prevalence of inverse health consequences of COVID-19 vaccines: a post-vaccination study date: 2022-03-24 journal: Vacunas DOI: 10.1016/j.vacun.2022.03.002 sha: 29f3d9a7f8ade4630088797ddd288138bf4f7b77 doc_id: 783579 cord_uid: nyy5lpfx BACKGROUND: COVID-19 vaccinations are intended to help produce neutralizing antibodies which target surface spike protein to combat the SARS-Cov-2 virus. Similarly, COVID-19 recovered patients exhibit high levels of SARS-CoV-2 neutralizing antibodies, which predominantly target the surface spike protein and are associated with the occurrence of health consequences in survivors. OBJECTIVE: The aim of the study is to explore the long-term health consequences of the COVID-19 vaccines. METHODOLOGY: A prospective, exploratory observational study conducted both online and offline using various questionnaires with all immunized individuals who had been inoculated for at least a month following their last COVID-19 vaccine either AZD1222® or BBV152® vaccines. RESULTS: We evaluated 258 individuals who had taken the COVID vaccine and found that females made up the majority (54.3%) and that the mean age was 24 years. Postvaccination long-term health issues were reported by 36.05% (93) of the participants, with 37.86% (53) of females and 33.9% (40) of males (p = 0.292) having symptoms. Myalgia was reported by 20.15% (52), fatigue was 13.95% (36), paresthesia was 1.16% (3), ageusia was 0.77% (2), sadness/irritability was 2.31% (6), and loss of concentration/excessive worry was 3.1% (8). CONCLUSIONS: Myalgia, fatigue, paresthesia, ageusia, coughs and colds, dyspnea, sadness/irritability, and lack of concentration/ excessive worry are health consequences related to the COVID-19 vaccination which follow a similar pattern of post-COVID syndrome. We considered the total number of students, lecturers, healthcare professionals, and other workers such as housekeepers, public relations officers, and hospital administrators from different institutions (Medical, Pharmacy, Nursing, Engineering, Science, and Education) and hospitals (AH&RC) that are affiliated with the ACU as the population size. The estimated sample size for the study was 258 with a margin of error of 5%, a confidence level of 90%, and a response distribution of 50% using the Roasoft® sample size calculator. The study included individuals over the age of 18 who satisfied the Ministry of Health and Family Welfare's vaccination eligibility criteria (https://www.mohfw.gov.in/covid_vaccination/vaccination/index.html) and had been immunized with the Oxford/AstraZeneca COVID-19 vaccine (AZD1222®) or Bharat Biotech COVID-19 vaccine (BBV152®) for at least a month after their last jab of vaccine before participating in the study. Those who had received any other COVID-19 vaccines, or who had been inoculated with study vaccines but did not complete the full dose or a month after the second dose within the study's duration, were excluded from the study. Participants with chronic diseases such as diabetes, arthritis, asthma, or COPD and those who had recovered from COVID-19 infection were also excluded from the study. We approached and communicated the details of the study to the Dean & Principle or Medical Superintendent of all seven institutes affiliated with the ACU for the conductance of the study. All seven institutes agreed and gave their approval for the survey to be conducted, with the suggestion that it be conducted online to increase participation. The validated data collection form was then translated into a Google form that comprised informed consent, epidemiological data (age, gender, personal habits, comorbidities, vaccination date, and name of the vaccine), recent health issues, and various questionnaires to obtain evidence on possible long-term effects of online participation. Participants in the study have the option of choosing either a face-to-face or an online mode to participate in the study. Those who were interested in face-to-face participation were requested to visit the Department of Pharmacy Practice located in AH&RC. The EuroQol group created the EQ-5D-5L scale in 2011, which is often used to assess healthrelated quality of life (HRQoL). 21 Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression are among the five health dimensions of the EQ-5D-5L. Each health dimension offers five categories of response possibilities to define all relevant health states (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). Using a scoring algorithm based on public preferences, EQ-5D-5L health statuses are transformed into a single index utility score. 22 and interquartile range (IQR). An independent sample t-test was used to compare the utility scores between vaccines and Chi-Square was used to determine the relationship between various variables and vaccines, considering 0.05 as a significant level. Of the 498 responses to the screening questionnaire, 197 did not meet the inclusion criteria, were undergraduate and postgraduate students, 7.7% (20) were other workers, 7.4% (19) were lecturers, 5.8% (15) were doctors, 3.1% (8) were researchers, and 2.7% (7) were nurses ( There were no significant differences in the occurrence of side-effects between the two vaccines (P = 0.328). 30.6% (79) of the participants were required to take time off after vaccination (P = 0.009) ( Journal Pre-proof The study was conducted with 258 participants who had received one of two vaccines, either AZD1222® or BBV152®, to determine the COVID-19 vaccine's inverse impact and its longterm health consequences. We found that 74.1% (191) of the participants had at least one of the vaccine side effects, with no statistically significant differences in the occurrence of side effects between AZD1222® and BBV152® (P = 0.328) ( reported a higher incidence than we did, while Dziedzic A et al. 26 reported a lower incidence. It's possible that the difference in the occurrence of side effects between studies is attributed to the usage of drugs after immunization. In the study, 58.9% of the participants used medicine to prevent side effects ( 28 Similarly, 80-90% of people infected with SARS-CoV-2 are protected from reinfection for up to 7 months after infection. 29 It required a more detailed study with consideration of neutralizing antibodies to corroborate the results. In the study, around half of the individuals who are suffering from coughs and colds during the study period believe that coughs and colds are becoming more frequent and that recovery time is taking longer. Coughing appears to be dry, with more episodes occurring in the morning and evening. To support the participant's experiences with coughs and colds, we used the mMRC scale to assess dyspnoea. On the mMRC scale, we observed shortness of breath from grade 1 to grade 4, and the incidence of coughs and colds appears to be nearly equal (29.45% vs 30.6% (Table no. 3)). In both immunizations, we did not observe statistically significant variations in the occurrence of coughs and colds, as well as dyspnoea. The anxiety/ depression dimension of the EQ-5D-5L assessment is compared to the sum of the participant's experiences of sadness/irritability (2.31%) and lack of concentration/excessive worry (3.1%). The total number of moderate to severe problems in the EQ-5D-5L anxiety/depression dimension is nearly equal to the total number of participant's experiences of sadness/irritability and lack of concentration/excessive worry (5.82% vs 5.41%) (Table no. 3). Overall, the EQ-5D-5L scale assessment finds minor concerns in each of the five health dimensions, and both immunizations yield similar consequences. In both vaccinations, the utility score (mean 0.95 (SD 0.14) versus 0.97 (SD 0.08); p = 0.220), which is analogous to the participant's quality of life as measured by the EQ-5D-5L, is not statistically significant (Table No. 2). When compared to AZD1222®, BBV152® has a slightly higher quality of life. However, since the study shows the COVID-19 vaccination has long-term inverse health consequences, it is worthwhile to inoculate for disease prevention when there is no specific drug to cure the disease. One of the study's limitations is that we assessed vaccination's long-term health consequences regardless of vaccine design platforms, and the number of participants for each vaccine group was not equal. Another limitation is that the study is carried out both online and offline, which may have the possibility that important details from online participants will be missed, while face-to-face or offline participation may yield better results. The study is also limited by the fact that it is a one-time observational study. It required more study with multi-time observation to confirm the findings of this study. In the study, we observed that 36.05% of the participants experienced long-term health consequences post-immunization, and females are more susceptible than males. Myalgia, fatigue, paraesthesia, ageusia, coughs and colds, dyspnoea, sadness/irritability, and lack of concentration or excessive worry are health consequences related to the COVID-19 vaccination, which follow a similar pattern to the post-COVID syndrome. Both AZD1222® and BBV152® vaccines have the potential to cause an equal number of long-term health problems in vaccinated individuals. 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Cross-Sectional Study and Pooled Analysis of CoVaST Project Results in Central Europe Sixty-day outcomes among patients hospitalized with COVID-19 WHO-Interim statement on booster doses for COVID-19 vaccination updated 22 World Health Organization. COVID-19 natural immunity: scientific brief We thank Dr. B Ramesh (Dean & Principal, Sri Adichunchanagiri College of Pharmacy) andDr. M. G. Shivaramu (Principal, Adichunchanagiri Institute of Medical Sciences) for providing a favourable environment to conduct the study.Funding: This study was not supported by any agency or commercial entity. The study was approved from the Institutional Ethical Committee of Adichunchanagiri Hospital and Research Center (Approval No. IEC/AH&RC/AC/022/2021).