IJCRR - 2nd Wave of COVID-19: Role of Social Awareness, Health and Technology Sector, June, 2021
Date of Publication: 11-Jun-2021
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Adverse Events Following COVID 19 Vaccine Shot
Author: Lathamangeswari C, Pandurangan H, Ramaiah P, Muthukrishnan A
Abstract:Background: Coronavirus disease 2019 (COVID-19) is a rampant disease caused by severe acute respiratory syndrome coronavirus 2. The initial case was diagnosed in China, in late 2019. Since then, the disease had spread globally, leading to the current pandemic situation. Signs and symptoms of coronavirus disease are unpredictable, but includes mild to moderate fever, coughing, weakness, dyspnoea, and decreased sensation of smell and taste. Swift development of an efficient vaccine is needed to control and prevent the coronavirus disease 2019. Objective: To assess the incidence of adverse events following the Covid 19 vaccine shot. Methods: It is a descriptive study conducted among the health care students (nursing and paramedical) who took the first dose of the Covishield vaccine. This study aimed to assess the incidence of adverse events following the Covid 19 vaccine shot. A total of 150 students were selected by using the convenience sampling technique. The adverse events checklist was prepared to collect data from health care students by structured interview technique. Results: The findings of the study show that 57 % had very common adverse events such as pain, itching, tiredness, headache, nausea, muscle ache 16% had common adverse events such as joint pain, lump at the injection site, vomiting, flu-like symptoms, 4% had uncommon adverse events loss of appetite, abdominal pain, excessive sweating. Conclusion: Even though few newly developed vaccines demonstrate the efficacy up to 95%, multi-disciplinary level rigorous studies are required to determine the safety of vaccine which includes minimizing the adverse events following the vaccination shot.
Keywords: Adverse events, Coronavirus, Health care students, Pandemic, Vaccine
Coronavirus disease 2019 (COVID-19) is a rampant disease caused by severe acute respiratory syndrome coronavirus 2. The initial case was diagnosed in China, in late 2019. Since then, the disease had spread globally, leading to the current pandemic situation. Signs and symptoms of coronavirus disease are unpredictable, but includes mild to moderate fever, coughing, weakness, dyspnoea, and decreased sensation of smell and taste.1-4 Mostly the person infected with coronavirus develops mild to moderate symptoms such fever and cough, and less than 15% develop severe symptoms such as severe dyspnoea, Hypoxemia pneumonia, and less than 5% has critical symptoms such as respiratory failure and multiple organ dysfunction. The disease signs and symptoms commence from 1 to 14 days after exposure to the deadly virus.5-8 Currently, there is no specific antiviral drug therapy available to treat ever spreading coronavirus disease, so we must use the existing treatment modalities for this pandemic disease. On the other hand, a preventive measure which includes physical distancing (6 feet), quarantining, aeration of indoor spaces, covering coughs and sneezes with the handkerchief, washing hands frequently, wearing a face mask can reduce transmission of infection. The vaccines also play a vital role in the prevention of Coronavirus disease.9-12
A COVID?19 vaccine is expected to provide protection against severe acute respiratory syndrome coronavirus 2, the virus causing coronavirus disease 2019. Before the COVID?19 pandemic, there was an established body of knowledge about the structure and function of coronaviruses causing diseases which enabled accelerated development of various vaccine technologies during early 2020.13-16 For rapid development of an efficient vaccine against the severe acute respiratory syndrome coronavirus-2, the cause of the coronavirus disease 2019 (COVID-19) pandemic, and multi-disciplinary level rigorous studies are required to determine the safety of vaccine which includes minimising the adverse events following the vaccination shot. In Phase III trials, several COVID?19 vaccines have shown efficacy as high as 95% in the prevention of symptomatic COVID?19 infections.17-20
Even though this newly developed vaccine has an efficacy of up to 95% in the prevention of coronavirus virus disease, many adverse events are reported globally. Logunov et al. conducted a study on the safety and efficacy of vector-based heterologous prime-boost COVID-19 vaccine by non-randomised trial consist of 76 participants between the age group 18 to 60 years. In this study, the most common adverse events reported were pain at the injection site 58%, fever 50%, headache 42%, and muscle and joint pain 24%. Most adverse events were mild to moderate and no serious adverse events were detected.21 Ella et al. conducted a study on safety and efficacy of inactivated COVID-19 vaccine by randomised trial consist of 375 participants between the age group 18 to 55 years and reported that most common adverse events were pain at the injection site 5%, fever 50%, headache 3 %, nausea and vomiting 2% muscle and joint pain 24%. Most adverse events were mild 69 %, moderate 31% and no serious adverse events were detected.22
MATERIALS AND METHODS
A descriptive study was conducted among the health care students (nursing and paramedical) who took the first dose of the Covishield vaccine between January – February 2021. The study aimed to assess the incidence of adverse events following the Covid 19 vaccine shot. A total of 150 students were selected by using the convenience sampling technique. The tool has five sections which include demographic variables and an adverse events checklist. The demographic variables consist of Age, Gender, History of Allergy, History of respiratory problems, symptoms before vaccination, vaccination has taken in the past 6 months, participants ever tested for positive COVID 19, Family members ever tested positive for COVID 19, Motivation for vaccination. The adverse events Checklist consists of 3 sections which include very common adverse events, common adverse events, uncommon adverse events. Each section is further subdivided into two subparts namely the onset of symptoms of adverse events and duration of symptoms. The visual analogue pain scale was used to assess the level of pain at the injection site, a Modified 5D itch scale was used to assess the severity of itching at the injection site, the modified verbal rating scale was used to assess the level of swelling at the injection site, the infrared thermometer was used to assess the body temperature. The tool was validated by 5 medical experts in the field of pharmacology. The content validity index was found to be S-CVI/Ave = 0.9 and the reliability of the tool was calculated using Cronbach’s alpha it was found to be 0.8. Before data collection, informed consent was obtained from the participants and the purpose of the study was explained to them. In the 30 minutes structured interview, the adverse events checklist was used to collect data and it is rated as Yes for the presence of adverse events and No for the absence of adverse events. Data analysis was done by using descriptive and inferential statistics using SPSS 20.
Table 1 shows the distribution of demographic variables among health care students. Out of 150 students, 90 (60%) were in the age group of 18-20 years. Regarding gender, 105 (70%) were female. Regarding allergy 142 (95 %) had no history of allergy. Regarding respiratory problems, 135 (90%) had no history of respiratory problems. In symptoms before 127 (85) had no symptoms before vaccination. Regarding motivation for vaccination 38 (26%) were motivated by vaccine awareness program. No students tested positive for COVID-19 before vaccination.
Table 2 shows the frequency and percentage distribution of very common adverse events after vaccination among health care students. Out of 150 students, 98 (65%) had pain, redness, warmth, swelling, itching at the injection site, 102 (68%) felt unwell after vaccination, 90 (60%) had the symptoms of tiredness after vaccination, 87 (58%) had a headache after vaccination. 72 (48%) had muscle pain after vaccination.
Table 3 shows the frequency and percentage distribution of common adverse events after vaccination among health students. Out of 150 students, 30 (20%) had joint pain, 18 (12%) had a lump at the injection site, 21 (14%) had the symptoms of vomiting, 27 (18%) had flu-like symptoms.
Table 3: Frequency and percentage distribution of common adverse events after the first dose of vaccination among health care students (N=150)
Table 4 shows frequency and percentage distribution of uncommon adverse events after vaccination among health care students. Out of 150 students, 5 (3%) had a feeling of dizziness, 3 (2%) had a loss of appetite, 6 (4%) had abdominal pain, 2 (1%) had excessive sweating.
Table 4: Frequency and percentage distribution of uncommon adverse events after the first dose of vaccination among health care Students (N=150)
Table 5 shows that there was no significant association of gender, history of allergy and history of respiratory problems with the body temperature among health care students.
Table 5: Association between selected demographic variables with body temperature among health care students (N=150)
This study was conducted to assess the incidence of adverse events following the Covid 19 vaccine shot among health care students. The findings of the study show that 57 % had very common adverse events, 16% had common adverse events, 4 % had uncommon adverse events. This was supported by Polack et al. in the study on the safety and efficacy of the BNT162b2 mRNA Covid-19 Vaccine. It is a randomised clinical trial with a sample of 43,548. Participants are randomly assigned in a ratio of 1:1 to the experimental group and the control group. The experimental group and control group received two doses of BNT162b2 vaccine and placebo 21 days apart respectively. The results the indicated that BNT162b2 vaccine was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). The participants were developed adverse events such as short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low.23 The study concluded that a two-dose regimen of BNT162b2 gave 95% protection against Covid-19. The present study is also consistent with a study conducted by Zhu et al. aimed to assess the immunogenicity property of recombinant adenovirus type 5 vectored COVID-19 vaccine.
It is a randomised clinical trial consist of 195 samples. Adults aged between 18 and 60 years were registered and allotted to any one of three dose groups (Low, Medium, High) divided based on the concentration of viral particles to receive an intramuscular injection of vaccine. Adverse events were studied one-week post-vaccination. The results of the study indicated that at least one adverse reaction within the first 7 days of post-vaccination was reported in 83% of participants in the low dose group, 83% participants in the medium-dose group, and 75% participants in the higher dose group. The commonly reported adverse reaction was injection site pain in 54% of recipients, and the most reported systematic adverse reactions were fever 46%, fatigue 44%, headache 39%, and muscle pain 17%. Most adverse reactions that were reported in all groups were mild or moderate level of severity. The study concluded that the adenovirus type 5 vector vaccine needs further investigation.24
Even though few newly developed vaccines demonstrate efficacy up to 95%, multi-disciplinary level rigorous studies are required to determine the safety of the vaccine which includes minimizing the adverse events following the vaccination shot.
ACKNOWLEDGEMENT: The investigator expresses to deep gratitude towards the authors cited in this study which was not limited to Dr.Fernando P. Polack, M.D, Fundacion INFANT (F.P.P.) and trials-Hospital Militar Central (G.P.M.), Prof Feng-Cai Zhu, NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China, Dr Denis Y Logunov, N F Gamaleya National Research Centre for Epidemiology and Microbiology, Moscow, Russia, Dr. Richa Ellas, Bharat Biotech, Hyderabad, India.
ETHICAL CLEARANCE: The principal investigator obtained informed written consent from the samples before commencing the study. The study was conducted according to the World Medical Association Declaration of Helsinki ethical principles for Medical Research Involving Human Subjects.25
Lathamangeswari C - Conception and drafting of the work, analysis and interpretation of data, critical revision, Manuscript writing and accountability for the work.
Pandurangan H – Collection and interpretation of data, critical revision, finalizing the Manuscript and accountability for the work.
Ramaiah P- Literature review, interpretation of data, critical revision, finalizing the Manuscript and accountability for the work.
Muthukrishnan A -Design of the work, analysis and interpretation of data, critical revision, Manuscript writing and accountability for the work.
CONFLICT OF INTEREST: The authors declare no conflict of interest
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