Abstract
COVID pandemic has brought the life to a standstill in all the nations of the world. Amidst which, covid vaccine appeared as a ray of hope.
Objective: To study the safety profile of the candidate vaccine and to assess the risk factors for development of side effects.
Materials and Methods: This is a hospital based prospective observational study in a tertiary care center in North India. All consecutive beneficiaries who got vaccinated at the vaccination site in the first phase were enrolled for the study. They were followed over a period of 3 months.
Results: This study included 1034 beneficiaries. The mean age group was 31.40 ± 11.24 years old. There were 612 females and 422 males. Adverse effects following immunization were seen in 784 (75.8%) participants with systemic effects in 748 (72.3%) and local adverse effects in 57.06% (590) of total participants. Pain at the injection site was the commonest local and fever was the commonest systemic side effect seen. Most of the systemic symptoms resolved in 1-2 days and few persisted for 5-7 days. Maximum side effects were observed in the age group of 21-30 years. The participants reporting side effects were significantly younger in age and were observed more frequently in females. Presence of co-morbidities was not associated with significantly higher incidence of adverse effects.
Conclusion: ChAdOx 1 nCov-19 corona virus vaccine (Recombinant) being used in mass campaign in our country has minor side effects and almost all usually resolve within a week. Presence of co-morbidities does not confer any significantly higher risk of developing adverse effects following immunization.
Keywords: AEFI, covid-19 vaccination, health care workers, risk factors.
References
- Helmy YA, Fawzy M, Elaswad A, Sobieh A, Kenney SP, Shehata AA. The COVID-19 pandemic: a comprehensive review of taxonomy, genetics, epidemiology, diagnosis, treatment, and control. J Clin Med 2020;9:1225. https://doi.org/10.3390/jcm9041225
- World Health Organization. WHO coronavirus disease (COVID-19) dashboard. Accessed August 2, 2021. https://covid19.who.int/
- World Health Organization. Draft landscape of COVID-19 candidate vaccines. Accessed January 29, 2021. https://www.who.int/publications/m/item/ draft-landscape-of-covid-19-candidate-vaccines
- Oliver, S.E.; Gargano, J.W.; Marin, M.; Wallace, M.; Curran, K.G.; Chamber land, M.; McClung, N.; Campos-Outcalt, D.; Morgan, R.L.; Mbaeyi, S.; et al. The Advisory Committeeon Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine—United States, December 2020. Morb. Mortal. Wkly. Rep. 2020, 69, 1922–1924. [CrossRef]
- Serum institute of India Pvt. Ltd.(2021). Covishield: ChAdOx1 nCov-19 Corona Virus Vaccine (Recombinant) [package insert]. Pune, India. https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.seruminstitute.com/pdf/covishield_fact_sheet.pdf&ved=2ahUKEwj-2tfzrMPuAhVX9nMBHYORB_8QFjAAegQIARAB&usg=AOvVaw1sN-NRCTp9IBrRasYtv7gl
- Riad, A.; Pokorná, A.; Attia, S.; Klugarová, J.; Košcˇík, M.; Klugar, M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. Clin. Med. 2021, 10,1428. https://doi.org/ 10.3390/jcm10071428
- Fillingim RB, Christopher CD, Ribeiro-Dasilva MC, Rahim- WilliamsB, Riley III Sex, Gender, and Pain: A Review of Recent Clinical and Experimental Findings. J Pain. 2009 May; 10(5): 447–485. doi:10.1016/j.jpain.2008.12.001.
- Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, 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: 939–49. https://doi.org/10.1016/ S1473-3099(21)00224-3
- Krammer F, Srivastava K, Simon V. Robust spike antibody responses and increased reactogenicity in seropositive individuals after a single dose of SARS-CoV-2 mRNA vaccine. medRxiv 2021; published online Feb 1. https://doi.org/10.1101/2021.01.29.21250653 (preprint).
- Voysey M, Clemens SAC et al. Safety and efficacy of ChAdOx1 nCov-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomized controlled trials in Brazil, South Africa, and the UK. Lancet.2021; 397(10269): 98.
Corresponding Author
Dr Saru Thakur
Senior Resident, Department of Dermatology, Venereology and Leprosy, Shri Lal Bahadur Shastri Govt. Medical College, Nerchowk, Distt. Mandi (H.P.), India