Published: 2022-02-28

The occurrence of adverse events following immunization after first and/or second dose of Covishield or Covaxin vaccine at a tertiary care hospital: An observational study

Vinay Kumar, Vandana Kashyap, A. G. Shenoy


Background: With the introduction of the COVID-19 vaccine, many cities of India are reporting minor, mild, and severe AEFI cases during half an hour of observation and after that. No vaccine can protect everyone receiving it and is safe too for everyone. Effective vaccines could produce a few unwanted side effects mainly mild and clear up frequently.

Methods: After the COVID-19 vaccination, everyone was asked to wait for 30 minutes in the observation room to check for any type of AEFI. While waiting, all second dose beneficiaries were asked to fill a printed case record form with all demographic details, including AEFI events experienced after their first dose of the COVID-19 vaccine. Phone calls were made to all 500 beneficiaries after seven days of vaccination to know about the type of AEFI experienced after the second dose.

Results: Safety of product is of paramount importance and in this study, we actively captured adverse events post-vaccination. Fever, headache, weakness, body pain, were the most common adverse events along with pain at the injection site. In our study, the younger age group was associated with minor AEFIs. However, we did not find any supporting evidence for high reactogenicity among women, and this may be due to an almost similar proportion of men and women in our sample.

Conclusions: The advantages of immunization in disease prevention have significantly exceeded the risks of immunization-associated adverse events. COVID vaccines have their largest potential to end the COVID-19 pandemic if they are widely accepted and used. As we all want to get rid of the diseases which are not curable easily and spread with very large intensity, now is the time to get vaccinated and control them.


Adverse reactions, COVID-19 vaccine, Covishield, Covaxin

Full Text:



Forni G, Mantovani A. COVID-19 vaccines: where we stand and challenges ahead. Cell Death Differ. 2021;28(2):626-39.

Madhi SA, Baillie V, Cutland CL, Voysey M, Koen AL, Fairlie L. Efficacy of the ChAdOx1 nCoV-19 COVID-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021;16:55-8.

Lim FS, Han HH, Bock HL. Safety, reactogenicity and immunogenicity of the live attenuated combined measles, mumps and rubella vaccine containing the RIT 4385 mumps strain in healthy Singaporean children. Ann Acad Med Singapore. 2007;36:969-73.

Makino S, Sasaki K, Nakayama T, Oka S, Urano T, Kimura M. A new combined trivalent live measles (AIK-C strain), mumps (Hoshino strain), and rubella (Takahashi strain) vaccine. Am J Dis Child. 1990;144:905-10.

Pomara C, Sessa F, Ciaccio M, Dieli F, Esposito M, Giammanco GM, et al. COVID-19 vaccine and death: causality algorithm according to the WHO eligibility diagnosis. Diagnostics. 2021 26;11(6):955.

Thiagarajan K. COVID-19: India is at center of global vaccine manufacturing, but opacity threatens public trust. BMJ. 2021;372:88-92.

Analytica O. India’s vaccine roll-out faces key obstacles. Emerald Expert Briefings. Available at Accessed on 20 November 2021.

Kataria S, Sharma P, Deswal V, Kumar K, Singh M, Alam S, et al. A Real World Evaluation of the safety and immunogenicity of the Covishield vaccine, ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) in National Capital Region (NCR) of India: A preliminary report. Medrxiv. 2022.

Ujjainiya R, Tyagi A, Sardana V, Naushin S, Bhatheja N, Kumar K, et al. Effect monitoring and insights from vaccination program of healthcare workforce from a tertiary level hospital in India against SARS-CoV-2. Med Rxiv. 2021.

Sciences C for IO of M, Organization WHO. definition and application of terms for vaccine pharmacovigilance. Report of CIOMS/WHO working group on vaccine pharmacovigilance. Geneva, Switzerland: CIOMS and WHO; 2012.

Ministry of Health on vaccination. Available at Accessed on December 2020.

Dubé E, Laberge C, Guay M, Bramadat P, Roy R, Bettinger J. Vaccine hesitancy: an overview. Human Vaccines and Immunotherapeutics. 2013;9(8):1763-73.

Malik AA, McFadden SM, Elharake J, Omer SB. Determinants of COVID-19 vaccine acceptance in the US. E Clinical Medicine. Lancet. 2020;26:100495.

Poll shows 61 percent of Americans likely to take COVID-19 vaccine. National Geographic. Available at Accessed on 12 December 2020.

Why 25-50% of vaccine side-effects are ‘anxiety-related and not a result of Covid jab. Available at Accessed on 12 December 2020.

61% post-vaccine adverse events linked to Covid shots in govt study, none fatal. Available at Accessed on 12 January 2021.

Effect of COVID-19 vaccine. Available at Accessed on 12 December 2020.

Defining the interval for monitoring potential adverse events following immunization (AEFIs) after receipt of live viral vectored vaccines. Available at https:// doi. org/ 10.1016/ j.vaccine.2018.08.085. Accessed on 20 December 2020

Adevrese effect following immunization. Available at Accessed on 12 January 2021.

How safe is covishield. Available at https://doi. org/10.1101/2021.03.16.21253744. Accessed on 12 January 2021.

Corona virus vaccine. Available at https:// Accessed on 12 January 2021.

Pomara C, Sessa F, Ciaccio M, Dieli F, Esposito M, Giammanco GM, et al. COVID-19 Vaccine and Death: Causality Algorithm According to the WHO Eligibility Diagnosis. Diagnostics. 2021;11(6):955.