Assessment of Post Vaccination Symptoms Following COVID-19 Vaccination in India: A Cross-Sectional Descriptive Study

Introduction: The recent examples of newly emerged diseases that causes alarming situation globally include H1N1, Congo Hemorrhagic fever, Ebola virus diseases, Nipah Virus Infection, Lassa Fever and newly declared global emergency pandemic SARS nCOVID-19 infection. Since its emergence, it has spread around the globe. It tends to spread by the inhalation of the respiratory aerosols, direct human contact. Materials and Methods: This analytical study was carried out among the healthcare workers and people who received either of Covishield or Covaxin. The online survey questionnaire was prepared and data obtained through the responses to the survey proforma. Results: 86.17% respondents were above 40 years, 69.15% males and 30.85% were females. 89.36% were vaccinated with Covishield and 10.64% by Covaxin. 75.53% respondents experienced post vaccination symptoms; commonest were the local pain at injection site (28.72%), fever (12.76%), Myalgia (12.77%). The symptoms were found more in respondents with any of comorbid condition. Discussion: Covishield was used more commonly than Covaxin in study samples. The symptoms Original Research Article Sanjay et al.; JPRI, 33(58B): 415-422, 2021; Article no.JPRI.71006 416 following vaccination were more common in 40-60 age group and persons with co-morbid conditions.


INTRODUCTION
In recent years, we are facing various emerging and re-emerging diseases which were never present in the world or presented with totally new symptomatology. The recent examples of newly emerged diseases that causes alarming situation globally includes H1N1, Congo Hemorrhagic fever, Ebola virus diseases, Nipah Virus Infection, Lassa Fever and newly declared global emergency pandemic disease i.e. SARS nCOVID-19 infection. More than 30 new infectious agents are detected worldwide in last three decades and sixty percent of them have zoonotic origin, more than 2/3 rd originated in wildlife [1]. Unplanned Urbanization leading to habitat destruction of various animals increased contact of humans with the wildlife animals and arthropod vectors of viral infections [2]. The novel SARS-Cov-2 is believed to have originated in the city of Wuhan in 2019 in a bat. Since its inception, it has spread worldwide, despite efforts by the World Health Organization and the Government to curb the virus, largely due to the infectious nature of the virus. It is usually spread by inhaling respiratory aerosols, direct contact with humans and fomites [3]. The World Health Organization on 11 March 2020 declared COVID-19 as a pandemic. Since its inception, millions of people have been infected, and some have even been linked to life-threatening conditions. The death toll associated with the virus is alarming as more and more people around the world are losing their lives due to the COVID-19 infection and the complications that result from it. According to the WHO Corona virus (COVID-19) Dashboard, currently 136,996,364 infected with COVID-19 worldwide and 29,51,832 lost their lives due to COVID-19 infections and counts. In India 138,73,825 cases were reported, of which 172,085 people lost their lives as a result of COVID-19 [4]. This global epidemic is a research center for all organizations and governments to prevent and prevent the deaths associated with this disease. Seeking effective drug treatment and effective vaccinations is an hour-long need to control the spread of the disease and prevent the lives of people who lose their infection.
Vaccine is one of the important solutions for enhancing the immunity against disease and containment of infection. Several countries have joined this battle of vaccine development and have speed up the process of clinical trials and are trying to develop an effective and harmless vaccine against Covid-19 [5]. The effect of an efficacious vaccine on the course of the SARS-CoV-2 pandemic is complex and there are many potential scenarios after deployment. The ability of a vaccine to protect against severe disease and mortality is the most important efficacy endpoint, as hospital and critical-care admissions place the greatest burden on health-care systems [6]. Two

MATERIALS AND METHODS
This is a cross sectional analytical study carried out among the healthcare workers and individuals who received the course of either of Covishield (AstraZeneca's vaccine manufactured by Serum Institute of India) or Covaxin (manufactured by Bharat Biotech Limited) vaccine. The online survey questionnaire was prepared and sent to the vaccine recipients. The data was obtained through the responses to the survey proforma and was used for analyse. A total 94 people responded to the online questionnaire within 16 days span starting from 10 th March 2021 to 26 th March 2021.

Inclusion Criteria
 Individuals who were 18 and above and who were given consent  Individuals who took at least one dose of vaccine  Individuals who were not having any severe disease

Exclusion Criteria
 Individuals Below 18 years  Not Vaccinated Individuals  Diabetic patients, HTN patients  Patients with severe disease were excluded from the study

Statistical Analysis
Collected data on predesigned proforma was coded and tabulated using MS Excel data sheet and Statistical analysis were performed on tabulated data using the Statistical Package for Social Sciences (SPSS) version 20. Mean and percentages were calculated and tables and graphs were prepared using the data. Chi square test was used to draw statistical significance (p=<0.05).

RESULTS
A total 94 participants responded to the online questionnaire sent to them. 86.17% participants who responded to online questionnaire were above 40 years, 69.15% males and 30.85% were female respondents. 77.66% participants were either consultant or faculty of medical college; study also had 14.89% non health workers. 89.36% respondent participated in study were vaccinated with Covishield vaccine (AstraZeneca's vaccine manufactured by Serum Institute of India), and 10.64% vaccinated by Covaxin (manufactured by Bharat Biotech Limited) (Fig. 1).
10.64% respondents started experiencing post vaccine symptoms within 6 hours and 10.64% after 24 hours. The symptom lasted for 12-24 hours in 28.72% of participants, 24-48 hours in 20.21% and 10.64% participants experienced symptoms for less than 6 hours. Vaccine recipient (68.09%) immediately resumed their work post vaccination, 24.47% resumed work one day after vaccination. Out of the respondent who received vaccine, 23.40% were Hypertensive, 11.70% were diabetics and 55.33% had no co-morbid conditions. ( Table 1).
The chances of post vaccination symptoms were seen increasing with the increased age. Most common age group affected was between 41-50 years age group (85.18%) followed by 51-60 years (80.64%). After 60 years, the symptoms were shown decreasing with 64.28% of the participants experienced post vaccination symptoms. (Fig. 3).
Female respondents (86.21%) experienced the post vaccination symptoms compared to 72.31% males. The symptoms were seen to have occurred late in females (20%) as compared to males (10%). In most of the male respondents, the duration of symptoms lasted less than 24 hours (72.73%) while in female respondents, 52.17% experienced symptoms for more than 24 hours. The time to resume work was also somewhat more in females (34.49%) as compared to males (24.62%). This shows that the late occurrence of symptoms, duration of suffering and time to resume work is more in female vaccine recipients than other counterpart. There was no statistical significant association between male and females found with respect to post vaccination symptoms, time of occurrence, duration of symptoms and time to resume work. (Table 2).

Percentages of vaccine recipient with symptoms
When assessed the post vaccination symptoms with associated Co-morbid conditions, the symptoms were found more in respondents with any of co-morbid conditions than the respondents with no associated co-morbidity (67.31%). Statistically significant association between co-morbidity and post vaccination symptoms was found (p=0.017). (Table 3) The assessment of post vaccination symptoms with number of doses received by the respondents, it was found no statistical significant association (p value > 0.5). It reflects that the chances of post vaccination symptoms are almost similar after first and second doses ( Table 4).
Comparison of the post vaccination symptoms with the type of vaccine used for COVID-19 prevention, it was observed that Covishield (84 respondents) had more vaccine related symptoms (79.76%) as compared to the (10 respondents) Covaxin (50%). Comparison is not feasible as only 10.63% respondents vaccinated by Covaxin, the association was also not found statistically significant (p=0.879) ( Table 5).

DISCUSSION
The Indian Vaccination drive against COVID-19 vaccination started from 16 st January 2021 and till date, most of the Health Workers, front line workers and people aged more than 60 years and 45 Years people with co-morbid conditions were the population included in for the vaccination against the infection. In India, Covishield (AstraZeneca's vaccine manufactured by Serum Institute of India) and Covaxin (manufactured by Bharat Biotech Limited) are the vaccines used for the immunization purpose. The study was directed to analyse the vaccination experience and post vaccination symptoms perceived by the vaccine recipient. A total of 94 respondent shared their experiences through online questionnaire.
The study found that around 75.53% respondents experienced the post vaccination symptoms following immunization with either of COVID-19 vaccine. 24.47% vaccine recipient had no symptoms following vaccination. The study conducted by Jayadevan R [7] titled 'Survey of Symptoms Following COVID-19 Vaccination in India' found around 65.92% participants with post vaccination symptoms.
When compared the post vaccination symptoms with the type of vaccine used, Covishield had more vaccine related symptoms (79.76%) as compared to the Covaxin (50%) in our study. The study conducted by Jayadevan R [7] showed vaccine related symptoms i.e. 66% with Covishield, 53% with COVAXIN, 70.7% for PFIZER and 24.4% with Sinopharm.
The time of occurrence of post vaccination symptoms was most commonly 12-24 hours (32.98%) followed by 6-12 hours (22.34%). The duration of symptom was 12-24 hours in 28.72% participants, 24-48 hours in 20.21% and 10.64% participants experience symptoms for less than 6 hours. Jayadevan R [7] reported that 79% respondents who experienced symptoms were within first 12 hours.
86.21% female experienced the post vaccination symptoms compared to 72.31% Males. The symptoms also occurred late in females (20%) as compared to Males (10%). Most female respondents (52.17%) experienced symptoms for more than 24 hours. The time to resume work was also somewhat more in females (34.49%) as compared to males (24.62%). The results were found consistent with study conducted by Jayadevan R [7][8][9].
In our study, symptoms were found more common in respondents with any of the comorbid conditions than the respondents with no associated co-morbidity (67.31%). This suggests that extra precaution is necessary for the individuals aged more than 60 years and people with co-morbid conditions [10][11][12][13][14].

CONCLUSION
Symptoms of mild and temporary immunizations were noted in two thirds of health care workers who responded to the study. The most common complaints were fatigue, myalgia, and fever. These symptoms are similar to those seen in the previous phase 2/3 of the test and were associated with an immunological response often linked to vaccination. In 90% of cases, the results were less severe than predicted or met the vaccine recipient's expectations. No serious incidents were recorded. Symptoms were more common in young people. There were no symptom differences between people who had COVID-19 in the past and those who did not.

LIMITATIONS
The study sample of this online questionnaire based cross sectional analytical study is small. Along with it, the online survey is also interest based, so the persons who experienced some post vaccination symptoms following vaccination to prevent COVID-19 may be more interested in participation in the study than the other vaccine takers (Volunteer Bias). Also the comparison between the vaccines is difficult as only few peoples taken COVAXIN as compared to the COVISHIELD vaccine. The symptoms following vaccination is also taken as the vaccine recipient perceived in short duration after vaccination, studies are needed to explore the long term post vaccination symptoms.

ETHICAL APPROVAL
The study was conducted after taking ethical clearance from Institutional Ethical Committee.

CONSENT
As per international standard or university standard, respondents' written consent has been collected and preserved by the author(s).