Main Article Content
Abstract
Abstract
Background: Vaccines against Covid-19 are new and developed through fast track process. The study has been conducted to know prevalence of adverse effects following immunization with Covid-19 vaccination and association between AEFI and blood grouping if any.
Methods: The self structured questionnaire based study was conducted over a period of 6 months (February 2021 to July 2021. Vaccine recipients who met inclusion criteria were invited to fill questionnaire using Google forms. Information including demographic characteristics, blood grouping (ABO-Rh type), vaccination, use of analgesics and adverse effects was sought within 3-4 weeks post vaccination. Data generated was analyzed using SPSS version 19 Chicago, USA.
Results: Of all the 315 majority participants receiving received CovishieldTM (79.3%) followed by 9.3% CovaxinTM (9.3%) and others (11.4%). The predominant blood group among participants was B+ (38.3%) followed by O+ (27.5%). About 90% of participants experienced mild to moderate AEFIs following first dose of vaccine. Most common adverse effects were injection site pain 89.6% and 67.8% followed by myalgia 64.2% and 25.3%, fever 26.4% and 7.25%, headache 20% and 13% and sore throat 18.9% and 4%, dry mouth 35.8% and 41% following first and second dose of vaccine respectively. Only 0.5% had serious AEFI, requiring hospitalization. Not a single death was reported during study period.
Conclusion: All Covid-19 combating vaccines exhibit favorable safety profile with mild self limiting adverse effects, relieved by analgesic- anti-inflammatory drugs. No association of AEFI with ABO-Rh blood grouping was found in present study.
Keywords
Article Details
References
- References:
- 1. Kaur SP, Gupta V. COVID-19 Vaccine: A comprehensive status report. Virus Res. 2020 Oct 15;288:198114.
- 2. World Health Organization. (2020). COVID-19 vaccines: safety surveillance manual. World Health Organization. https://apps.who.int/iris/handle/10665/338400.
- 3. Kumar S, Saurabh MK, Maharshi V. Efficacy and safety of potential vaccine candidates against coronavirus disease 2019: A systematic review. J Adv Pharm Technol Res. 2021 Jul-Sep;12(3):215-221.
- 4. Raina, Kumar S, Kumar, Raman. “Covishield and Covaxin” – India's contribution to global COVID-19 pandemic, Journal of Family Medicine and Primary Care: July 2021; 10 ( 7) 2433-2435.
- 5. Kashte, S., Gulbake, A., El-Amin III, SF, Gupta A. COVID-19 vaccines: rapid development, implications, challenges and future prospects. Human Cell 2021; 34, 711–733
- 6. Frederickson R, Herzog RW. RNA-based vaccines and innate immune activation: Not too hot and not too cold. Mol Ther. 2021 Apr 7;29(4):1365-1366.
- 7. Jeon M, Kim J, Oh CE, Lee JY. Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System. J Korean Med Sci. 2021 May 3;36(17):e114.
- 8. Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6.
- 9. McMurtry CM. Managing immunization stress-related response: A contributor to sustaining trust in vaccines. Can Commun Dis Rep. 2020 Jun 4;46(6):210-218.
- 10. Kamal D, Thakur V, Nath N, Malhotra T, Gupta A, Batlish R. Adverse events following ChAdOx1 nCoV-19 Vaccine (COVISHIELD) amongst health care workers: A prospective observational study. Med J Armed Forces India. 2021 Jul; 77(Suppl 2): S283–S288.
- 11. Parida SP, Sahu DP, Singh AK, Alekhya G, Subba SH, Mishra A, Padhy BM, Patro BK. Adverse events following immunization of COVID-19 (Covaxin) vaccine at a tertiary care center of India. J Med Virol. 2022 Jun;94(6):2453-2459.]
- 12. Pandit N, Patel N. Adverse event following immunization and relation with blood group following COVID19 Vaccination among Indian community: A cross-sectional study. J Integr Health Sci 2021;9:60-4
- 13. Goldlin TJ, Kalyanaraman S, Ravichandran M, Ramya JE. A pharmacovigilance study of covishield in a tertiary care teaching hospital in Tamil Nadu. J Pharmacol Pharmacother 2021;12:131-6.
- 14. Montaltia M , Solda G, Valerioa ZD ,Salussoliaa A, Lenzib J , Forcellinic M et al. ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance. EClinicalMedicine 2021;38 : 101027
- 15. Barnkob MB, Pottegard A, Stovring H, Haunstrup TM, Homburg K, Larsen R et al. Reduced prevalence of SARS-CoV-2 infection in ABO blood group O. Blood advances 2020: (4); 4990-4993.
- 16. Zietz M, Zucker J, Tatonetti NP. Testing the association between blood type and COVID-19 infection, intubation, and death. medRxiv [Preprint]. 2020 Sep 10:2020.04.08.20058073. doi: 10.1101/2020.04.08.20058073. Update in: Nat Commun. 2020 Nov 13;11(1):5761. PMID: 32511586; PMCID: PMC7276013
- 17. Allan JD, McMillan D, Levi ML. COVID-19 mRNA Vaccination, ABO Blood Type and the Severity of Self-Reported Reactogenicity in a Large Healthcare System: A Brief Report of a Cross-Sectional Study. Cureus. 2021 Dec 29;13(12):e20810
- 18. Alessa M Y, Aledili F J, Alnasser A A, Aldharman SS, Dehailan AMA, Abuseer HO et al. The Side Effects of COVID-19 Vaccines and Its Association With ABO Blood Type Among the General Surgeons in Saudi Arabia. Cureus 2022 March 29; 14(3): e23628. doi:10.7759/cureus.23628
References
References:
1. Kaur SP, Gupta V. COVID-19 Vaccine: A comprehensive status report. Virus Res. 2020 Oct 15;288:198114.
2. World Health Organization. (2020). COVID-19 vaccines: safety surveillance manual. World Health Organization. https://apps.who.int/iris/handle/10665/338400.
3. Kumar S, Saurabh MK, Maharshi V. Efficacy and safety of potential vaccine candidates against coronavirus disease 2019: A systematic review. J Adv Pharm Technol Res. 2021 Jul-Sep;12(3):215-221.
4. Raina, Kumar S, Kumar, Raman. “Covishield and Covaxin” – India's contribution to global COVID-19 pandemic, Journal of Family Medicine and Primary Care: July 2021; 10 ( 7) 2433-2435.
5. Kashte, S., Gulbake, A., El-Amin III, SF, Gupta A. COVID-19 vaccines: rapid development, implications, challenges and future prospects. Human Cell 2021; 34, 711–733
6. Frederickson R, Herzog RW. RNA-based vaccines and innate immune activation: Not too hot and not too cold. Mol Ther. 2021 Apr 7;29(4):1365-1366.
7. Jeon M, Kim J, Oh CE, Lee JY. Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System. J Korean Med Sci. 2021 May 3;36(17):e114.
8. Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6.
9. McMurtry CM. Managing immunization stress-related response: A contributor to sustaining trust in vaccines. Can Commun Dis Rep. 2020 Jun 4;46(6):210-218.
10. Kamal D, Thakur V, Nath N, Malhotra T, Gupta A, Batlish R. Adverse events following ChAdOx1 nCoV-19 Vaccine (COVISHIELD) amongst health care workers: A prospective observational study. Med J Armed Forces India. 2021 Jul; 77(Suppl 2): S283–S288.
11. Parida SP, Sahu DP, Singh AK, Alekhya G, Subba SH, Mishra A, Padhy BM, Patro BK. Adverse events following immunization of COVID-19 (Covaxin) vaccine at a tertiary care center of India. J Med Virol. 2022 Jun;94(6):2453-2459.]
12. Pandit N, Patel N. Adverse event following immunization and relation with blood group following COVID19 Vaccination among Indian community: A cross-sectional study. J Integr Health Sci 2021;9:60-4
13. Goldlin TJ, Kalyanaraman S, Ravichandran M, Ramya JE. A pharmacovigilance study of covishield in a tertiary care teaching hospital in Tamil Nadu. J Pharmacol Pharmacother 2021;12:131-6.
14. Montaltia M , Solda G, Valerioa ZD ,Salussoliaa A, Lenzib J , Forcellinic M et al. ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance. EClinicalMedicine 2021;38 : 101027
15. Barnkob MB, Pottegard A, Stovring H, Haunstrup TM, Homburg K, Larsen R et al. Reduced prevalence of SARS-CoV-2 infection in ABO blood group O. Blood advances 2020: (4); 4990-4993.
16. Zietz M, Zucker J, Tatonetti NP. Testing the association between blood type and COVID-19 infection, intubation, and death. medRxiv [Preprint]. 2020 Sep 10:2020.04.08.20058073. doi: 10.1101/2020.04.08.20058073. Update in: Nat Commun. 2020 Nov 13;11(1):5761. PMID: 32511586; PMCID: PMC7276013
17. Allan JD, McMillan D, Levi ML. COVID-19 mRNA Vaccination, ABO Blood Type and the Severity of Self-Reported Reactogenicity in a Large Healthcare System: A Brief Report of a Cross-Sectional Study. Cureus. 2021 Dec 29;13(12):e20810
18. Alessa M Y, Aledili F J, Alnasser A A, Aldharman SS, Dehailan AMA, Abuseer HO et al. The Side Effects of COVID-19 Vaccines and Its Association With ABO Blood Type Among the General Surgeons in Saudi Arabia. Cureus 2022 March 29; 14(3): e23628. doi:10.7759/cureus.23628