The Prevalence of COVID Infection and Adverse Events Following Immunization with COVID-19 Vaccine (Covishield) Among Healthcare Workers and Students of a Dental College in Kerala: A Cross-sectional Study
Shyma Peradi, Josey Mathew, Liza George, Sinju Paul, Aleesha Joy
Adverse events following immunization, Adverse events following vaccination, Coronavirus disease-2019 vaccines
Citation Information :
Peradi S, Mathew J, George L, Paul S, Joy A. The Prevalence of COVID Infection and Adverse Events Following Immunization with COVID-19 Vaccine (Covishield) Among Healthcare Workers and Students of a Dental College in Kerala: A Cross-sectional Study. Cons Dent Endod J 2022; 7 (1):7-10.
Background: Any untoward event following immunization without essentially having a cause-and-effect relationship with usage of vaccine is an “Adverse Event Following Immunization (AEFI).” The study aimed at evaluating adverse events experienced by healthcare workers (HCWs) and students of a dental college, following immunization AEFI, with at least one dose of Covishield vaccine developed by Oxford University and AstraZeneca. The association of AEFI across various sex and age groups was also assessed.
Methods: A cross-sectional survey was conducted online among coronavirus disease-2019 (COVID-19)-vaccinated teaching staff, postgraduate students, interns, undergraduate students, and nonteaching staff of a dental college. The common AEFI, post-vaccination activities, and demographic characteristics were collected from respondents using a questionnaire. The effect of host-related factors on 14 specific symptoms of AEFI was also assessed.
Results: After screening, those above 18 years old and received minimum dose of Covishield, 240 participants were included in the study from the dental college. Only 72/240 (30%) participants did not report any AEFI, whereas 11/240 (4.6%) had symptoms of severe intensity. The commonest AEFI reported were moderate weakness (60.8%), pain at the injection site (60.8%), followed by fever (60%), body ache (10.7%), nausea (6.7%), headache (5.8%), chills (5%), and vomiting (1.7%). Females experienced more AEFI than males, particularly gastrointestinal symptoms. The participant's age and number of doses taken affected AEFI. A decrease in self-reported AEFI was associated with increasing age or number of vaccine doses. There is a significant association of AEFI with age of the participants (p < 0.01).
Conclusions: In the first 48 hours, AEFI was mostly observed. In the following weeks, the incidence decreased, with no AEFI reported after 15 days following both doses. Adverse events following immunization reported were mild and short-lived. No serious incidents were reported. We have assessed risk factors related to AEFI in participants vaccinated with Covishield. The important factors affecting AEFI are gender, age, and vaccine doses in this study.
Jeon M, Kim J, Oh CE, et al. Adverse events following immunization associated with Coronavirus disease 2019 vaccination reported in the mobile vaccine adverse events reporting system. J Korean Med Sci 2021;36(17):e114. DOI: 10.3346/jkms.2021.36.e114.
Principi N, Esposito S. Adverse events following immunization: Real causality and myths. Expert Opin Drug Saf 2016;15(6):825–835. DOI: 10.1517/14740338.2016.1167869.
Bae S, Lee YW, Lim SY. Adverse reactions following the first dose of ChAdOx1 nCoV-19 vaccine and BNT162b2 vaccine for healthcare workers in South Korea. J Korean Med Sci 2021;36(17):e115. DOI: 10.3346/jkms.2021.36.e115.
Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020;383(27): 2603–2615. DOI: 10.1056/NEJMoa2034577.
Meo SA, Bukhari IA, Akram J. COVID-19 vaccines: Comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna vaccines. Eur Rev Med Pharmacol Sci 2021;25(3):1663–1669. DOI: 10.26355/eurrev_202102_24877.
World Health Organization. Global Manual on Surveillance of Adverse Events Following Immunization. Available from: https://www.who.int/vaccine_safety/publications/Global_Manual_on_Surveillance_of_AEFI.pdf [updated 2016 March; cited January 10, 2021].
Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARSCoV-2: An interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021;397(10269):99–111. DOI: 10.1016/S0140-6736(20)32661-1.
Menni C, Klaser K, May A, et al. Vaccine side effects and SARS-CoV-2 infection after vaccination in users of the COVID symptom study app in the UK: A prospective observational study. Lancet Infect Dis 2021;21(7):939–949. DOI: 10.1016/S1473-3099(21)00224-3.
Kim MA, Lee YW, Kim SR, et al. COVID-19 vaccine associated anaphylaxis and allergic reactions: Consensus statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group. Allergy, Asthma Immunol Res 2021;13(4):526–544. DOI: 10.4168/aair.2021.13.4.526.
Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): A single-blind, randomised, controlled, phase 2/3 trial. Lancet 2020;396(10267): 1979–1993. DOI: 10.1016/S0140-6736(20)32466-1.
Folegatti PM, Ewer KJ, Aley PK, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: A preliminary report of a phase 1/2, single-blind, randomized controlled trial. Lancet 2020;396(10249):467–478. DOI: 10.1016/S0140-6736(20)31604-4.
Tapia MD, Sow SO, Mbaye KD, et al. Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: A randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis 2020;20(6):719–730. DOI: 10.1016/S1473-3099(20)30019-0.
Voysey M, Costa Clemens SA, Madhi SA, et al. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: A pooled analysis of four randomised trials. Lancet 2021;397(10277):881–891. DOI: 10.1016/S0140-6736(21)00432-3.
Zhu FC, Guan XH, Li YH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: A randomized, double-blind, placebo-controlled, phase 2 trial. Lancet 2020;396(10249):479–488. DOI: 10.1016/S0140-6736(20)31605-6.
Munoz FM, Englund JA. Vaccines in pregnancy. Infect Dis Clin North Am 2001;15:253–271. DOI: 10.1016/S0891-5520(05)70278-6.
Castells MC, Phillips EJ. Maintaining safety with SARS-CoV-2 vaccines. N Engl J Med 2021;384:643–649. DOI: 10.1056/NEJMra2035343.
Wiersinga WJ, Rhodes A, Cheng AC, et al. Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): A review. JAMA 2020;324(8):782–793. DOI: 10.1001/jama.2020.12.
World Health Organization (WHO). Weekly epidemiological update - 22 December 2020. Geneva: WHO, 2020. https://www.who.int/publications/m/item/weekly-epidemiological-update---22- December-2020.
World Health Organization (WHO). Coronavirus disease 2019 (COVID-19): Dashboard with vaccination data. Geneva: WHO, 2021. https://covid19.who.int/.
Banerji A, Wickner PG, Saff R, et al. mRNA vaccines to prevent COVID-19 disease and reported allergic reactions: Current evidence and suggested approach. J Allergy Clin Immunol Pract 2021;9(4):1423–1437. DOI: 10.1016/j.jaip.2020.12.047.
McNeil MM, Weintraub ES, Duffy J, et al. Risk of anaphylaxis after vaccination in children and adults. J Allergy Clin Immunol 2016; 137(3):868–878. DOI: 10.1016/j.jaci.2015.07.048.