E-ISSN 2231-3206 | ISSN 2320-4672
 

Original Research 


A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India

Meera Varghese, Prathibha V K, Saju C R, Jini M P.

Abstract
Background: The World Health Organization had proclaimed the outbreak of the novel coronavirus (COVID-19) as a worldwide pandemic on March 11, 2020. Immunization against the disease was the need of the hour to curtail the spread of COVID-19 pandemic. Two vaccines manufactured in India were approved for emergency use authorization initially. They are ChAdox1CoV-19 vaccine – CoviShield and Covaxin.

Aims and objectives: This study aimed at assessing the occurrence of adverse effects following immunization (AEFI) among individuals who received the CoviShield vaccine. The objective of this research was to evaluate the type of AEFI among vaccinated beneficiaries and to determine the factors contributing to the development of AEFI.

Materials and Methods: A cross-sectional study was done at a teaching hospital in Kerala. All beneficiaries who were administered CoviShield vaccine during the study period, that is, from January 2021 to June 2022 were incorporated in the study. Data regarding AEFI were collected from all vaccinated individuals by direct or telephonic enquiry.

Results: The incidence rate of AEFI is 4.5/1000 doses (111/24925 doses). The reporting of AEFI was high among age group of 20–30 years and commonly seen in males (97.3%). The most common AEFI reported with CoviShield vaccine were fever (63%), myalgia (51%), and headache (40%). AEFI were seen commonly after administration of first dose (94%). Only 7 cases (6.3%) of serious AEFI were reported which included death, autoimmune encephalitis, Bell’s palsy, hypotension, and hypersensitivity reactions. There was no significant association between age and type of AEFI (P > 0.05) and dose of vaccine and type of AEFI (P > 0.05).

Conclusion: The immunization with CoviShield vaccine is safe among adults (>18 years) with lesser incidence of serious adverse effects. Higher incidence of AEFI is witnessed after administration of first dose and it was commonly seen in males.

Key words: AEFI; CoviShield; Dose; Immunization; Vaccine


 
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How to Cite this Article
Pubmed Style

Varghese M, K PV, R SC, P JM. A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India. Natl J Physiol Pharm Pharmacol. 2022; 12(11): 1842-1847. doi:10.5455/njppp.2023.13.09462202202102022


Web Style

Varghese M, K PV, R SC, P JM. A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India. https://www.njppp.com/?mno=117828 [Access: November 24, 2022]. doi:10.5455/njppp.2023.13.09462202202102022


AMA (American Medical Association) Style

Varghese M, K PV, R SC, P JM. A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India. Natl J Physiol Pharm Pharmacol. 2022; 12(11): 1842-1847. doi:10.5455/njppp.2023.13.09462202202102022



Vancouver/ICMJE Style

Varghese M, K PV, R SC, P JM. A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India. Natl J Physiol Pharm Pharmacol. (2022), [cited November 24, 2022]; 12(11): 1842-1847. doi:10.5455/njppp.2023.13.09462202202102022



Harvard Style

Varghese, M., K, . P. V., R, . S. C. & P, . J. M. (2022) A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India. Natl J Physiol Pharm Pharmacol, 12 (11), 1842-1847. doi:10.5455/njppp.2023.13.09462202202102022



Turabian Style

Varghese, Meera, Prathibha V K, Saju C R, and Jini M P. 2022. A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India. National Journal of Physiology, Pharmacy and Pharmacology, 12 (11), 1842-1847. doi:10.5455/njppp.2023.13.09462202202102022



Chicago Style

Varghese, Meera, Prathibha V K, Saju C R, and Jini M P. "A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India." National Journal of Physiology, Pharmacy and Pharmacology 12 (2022), 1842-1847. doi:10.5455/njppp.2023.13.09462202202102022



MLA (The Modern Language Association) Style

Varghese, Meera, Prathibha V K, Saju C R, and Jini M P. "A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India." National Journal of Physiology, Pharmacy and Pharmacology 12.11 (2022), 1842-1847. Print. doi:10.5455/njppp.2023.13.09462202202102022



APA (American Psychological Association) Style

Varghese, M., K, . P. V., R, . S. C. & P, . J. M. (2022) A cross-sectional study to assess the adverse events following immunization with CoviShield vaccine at a private medical college in South India. National Journal of Physiology, Pharmacy and Pharmacology, 12 (11), 1842-1847. doi:10.5455/njppp.2023.13.09462202202102022