ORIGINAL ARTICLE Year : 2023  |  Volume : 50  |  Issue : 1  |  Page : 61-65

Assessment and Correlation of Adverse Events Following Coronavirus Disease Vaccination with Blood Group and Dietary Style

Prabhakar Adake1, Mahalaxmi S Petimani2, Kumar Gourav3, AG Balakrishna4
1 Department of Pharmacology, KAHER's JGMM Medical College, Hubballi, Karnataka, India
2 Department of Biochemistry, KAHER's JGMM Medical College, Hubballi, Karnataka, India
3 Department of Pharmacology, Yenepoya Medical College, Yenepoya University, Mangaluru, Karnataka, India
4 Department of Community Medicine, Yenepoya Medical College, Yenepoya University, Mangaluru, Karnataka, India

Date of Submission25-Jul-2022Date of Decision13-Aug-2022Date of Acceptance27-Aug-2022Date of Web Publication24-Mar-2023

Correspondence Address:
Kumar Gourav
Department of Pharmacology, Yenepoya Medical College, Yenepoya University, Mangaluru - 575 018, Karnataka
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/jss.jss_159_22

Objectives: The objective of this study is to assess and correlate adverse drug events following coronavirus disease (COVID) vaccination with blood group and dietary style. Methodology: This is a cross-sectional study carried out from May 2021 to July 2021. A prevalidated Google questionnaire containing demographic details, dietary style, blood group, preexisting diseases, and adverse events of the COVID vaccine was circulated to all health-care professionals of our institution through mail/WhatsApp. Informed consent was obtained (in Google Forms) from all the participants after describing the purpose of the study and the assurance to maintain anonymity and confidentiality. A total of 102 responses were collected, out of which 100 (n = 100) responses were analyzed and interpreted (two responses were excluded since participants are not vaccinated). The descriptive statistical method is applied for the assessment of adverse events. The Chi-square test is applied to assess the correlation between adverse events with blood group and dietary style. P < 0.05 is considered statistically significant. Results: The majority of the participants had comorbidities (80%) and were not infected with COVID (90%) before vaccination. Pain at the injection site is very frequently experienced followed by body aches, fatigue, fever, and weakness of the arm. The Chi-square correlation test showed that nonvegetarians had a significantly higher incidence of pain at the injection site compared to vegetarians [χ2 = 7.799, P < 0.004]. However, the study did not find a significant association between other adverse events with blood group and dietary style of the participants (P > 0.05). Conclusion: The present study concludes that study participants experienced minor adverse events following Covishield and Covaxin; pain at the injection site, myalgia, and fever are more frequent. Moreover, there is a higher incidence of injection site pain in nonvegetarians compared to vegetarians. However, there is no significant association between other adverse events with blood group and dietary style of the participants.

Keywords: Blood group, coronavirus disease vaccination, Covaxin, Covishield, dietary style

How to cite this article:
Adake P, Petimani MS, Gourav K, Balakrishna A G. Assessment and Correlation of Adverse Events Following Coronavirus Disease Vaccination with Blood Group and Dietary Style. J Sci Soc 2023;50:61-5
How to cite this URL:
Adake P, Petimani MS, Gourav K, Balakrishna A G. Assessment and Correlation of Adverse Events Following Coronavirus Disease Vaccination with Blood Group and Dietary Style. J Sci Soc [serial online] 2023 [cited 2023 Mar 25];50:61-5. Available from: https://www.jscisociety.com/text.asp?2023/50/1/61/372398   Introduction 

Coronavirus disease 2019 (COVID-19) is an emerging disease caused by a novel coronavirus and it was first detected in December 2019 in Wuhan, China. The disease is highly contagious. Infected individuals present with high fever, dry cough, fatigue, myalgia, and dyspnea.[1] COVID-19 can lead to the severe stage, characterized by acute respiratory distress syndrome, septic shock, difficult-to-tackle metabolic acidosis, and coagulation dysfunction.[2],[3]

The World Health Organization (WHO) reported a total of 3,759,967 infected cases and 259,474 deaths due to COVID-19 by May 8, 2020, globally.[4] In response to this ongoing serious situation, the WHO declared it a public health emergency of international concern on January 30, 2021, and called for collaborative efforts of all countries to prevent the rapid spread of COVID-19.[5]

Most people who are infected with COVID-19 are being able to recover at home. Getting enough rest, staying well hydrated, and taking medications to relieve fever, aches, and pains – help with COVID-19. The complications of COVID-19 are not uniform to the general public. A retrospective cohort study concluded that patient with blood group “A” has a high risk of cardiovascular complications when compared to other ABO blood groups.[6] Similarly, it was found that diabetes, hypertension, and cancer patients are more prone to COVID-19 infection. These comorbidities can be prevented and sometimes reversed with a plant-based diet. Fruits, vegetables, grains, and beans are also loaded with nutrients – such as beta-carotene, Vitamin C, Vitamin E, and zinc – that can boost immune function. While a plant-based diet cannot prevent COVID-19, it can treat the underlying conditions that can exacerbate its severity.[7] Many drugs have proven effective against COVID-19 infection and reduced mortality and morbidity. Even in India, hydroxychloroquine, remdesivir, dexamethasone, and various monoclonal antibodies played a crucial role in the management of severe COVID infection. However, there was a need for an effective vaccine that would prevent community transmission of COVID-19 infection. Several vaccine candidates discovered worldwide and some have successfully finished phase 3 clinical trials. In India, The drugs regulatory authority, Drugs Controller General of India has given approval to the vaccines developed by AstraZeneca with Oxford University – Covishield and by Bharat Biotech's Covaxin. India started vaccination against COVID-19 on January 16, 2021, initially for health warriors and elderly patients with comorbidities.[8]

Like other vaccines, Covaxin and Covishield have adverse effects which can be minor to serious.[9] Covaxin is prepared from inactivated coronavirus. Whereas, Covishield contains a chimpanzee adenovirus – ChAdOx1 carrying the COVID-19 spike protein.[10],[11],[12],[13]

Scientific literature found that dietary supplements and blood groups can influence the severity of COVID in individuals. Hence, the present study was carried out to assess and find out if any correlation exists between adverse events following immunization (AEFI) following the COVID vaccine with blood group and dietary style of an individual.

  Material and Methods 

Study setting and design

This is a questionnaire-based time-bound cross-sectional study carried out from May 2021 to July 2021. The present study was initiated after the approval of the Scientific Review Board and Institutional Ethics committee (YEC-2/797). The study is registered in the Clinical Trial Registry of India (CTRI/2021/06/034208). Since there were no similar studies carried out in the Indian scenario for the calculation of sample size, this time-bound pilot study got approval to recruit 100 (n = 100) participants.

Inclusion criteria

The health-care professionals (age >18 years) of either gender working in a private tertiary care institution were included in the study.

Exclusion criteria

Health-care professionals who are not vaccinated and were not willing to give their consent for the study were excluded from the study.

  Methodology 

A prevalidated Google questionnaire containing demographic details, dietary style, blood group, adverse effects of COVID vaccine, and preexisting diseases was circulated to all the health-care professionals of our institution through mail/WhatsApp. Informed consent was obtained (in Google Forms) from all the participants after describing the purpose of the study and the assurance to maintain anonymity and confidentiality. A total of 102 responses were collected, out of which 100 (n = 100) responses were analyzed and interpreted (two responses were excluded since participants are not vaccinated). Statistical analysis was performed using SPSS – version 23 software (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp). The descriptive statistical method is applied for the assessment of adverse events following COVID vaccination. The Chi-square test is applied to assess the correlation between adverse events with blood group and dietary style. P < 0.05 is considered statistically significant.

  Results 

A total of 102 responses from the health-care professionals working in our institution were collected. Two health professionals had not received COVID vaccination and their responses were excluded from the study. Hence, we analyzed 100 (n = 100) responses from health-care professionals. [Table 1] shows demographic details, dietary styles, and blood group details of study participants. None of our participants had serious adverse events following COVID vaccination. The majority of the participants had comorbidities (80%) and were not infected with COVID (90%) before vaccination. [Figure 1] depicts details of adverse events experienced by study participants following COVID vaccination. Pain at the injection site is very frequently experienced followed by body aches, fatigue, fever, and weakness of the arm. A Chi-square correlation test was applied to find the association between adverse events following COVID vaccination and dietary style and blood group of the study participants [Table 2], [Table 3], [Table 4]. The present study result has shown that nonvegetarians had a significantly higher incidence of pain at injection sites compared to vegetarians [Table 2: χ2 = 7.799, P < 0.004]. However, we did not find a significant association between other adverse events following COVID vaccination with blood group and dietary style of the study participants (P > 0.05).

Figure 1: Details of adverse events experienced by the participants following COVID vaccination. COVID: Coronavirus disease

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Table 2: Correlation between various adverse events following COVID vaccination with blood group and dietary style of participants

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Table 3: Correlation between various adverse events following COVID vaccination with blood group and dietary style of participants

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Table 4: Correlation between various adverse events following COVID vaccination with blood group and dietary style of participants

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  Discussion 

AEFI can be defined as any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom, or disease.[14] AEFI can be a minor ailment in the form of pain at the injection site, fever, rashes, myalgia, joint pain, nausea, vomiting, rashes, etc., or can be severe/serious in case of anaphylaxis, and requires hospitalization and death. There is a need to monitor these AEFI for patient safety concerns. The Ministry of Health and Family Welfare initiated collecting the AEFI through the COWIN portal which is linked to the Pharmacovigilance Programme of India. However, there are chances of underreporting of AEFI due to the lack of knowledge, problems in approaching medical officers, and so on. Many adverse events go unnoticed due to underreporting. AEFI is very essential for patient safety and care. The lack of awareness, nonavailability of the medical officers, and lack of communication can lead to underreporting of AEFI. The accessibility of the COWIN portal is available only in immunization centers and if the adverse event occurs beyond 30 min of vaccination, the individual needs to report to the vaccination center again which is difficult for individuals who are staying in remote places. Hence, the present study is planned to assess AEFI and correlate with blood group and dietary style through the Google platform which is more convenient for vaccine beneficiaries.

The present study included health-care professionals of our institution, keeping in mind to get more accurate information on adverse events following COVID vaccination with less chance of recall bias.

This is the first study done to correlate adverse events following COVID vaccination with dietary style and blood group of an individual. Recently, a study on adverse events following the Covishield vaccine done by Deep Kamal et al. in South India concluded that feeling unwell and headache are the most common adverse events following COVID vaccination but in our study, pain at the injection site and body aches are most frequently experienced by the participants. Moreover, only two cases out of 1022 experienced serious adverse events following vaccination in the same study.[15] Even in our study, no serious adverse events were experienced by the study participants.

One more study on surveillance for adverse effects after Pfizer-BioNTech and Moderna vaccination done by Nicola P Klein et al. reported 183 anaphylactic reactions and 12 individuals admitted for severe acute respiratory distress syndrome within 21 days of Pfizer-BioNTech and Moderna COVID vaccination.[16] However, our study did not encounter such serious events, confirming the safety profile of Covishield and Covaxin.

The small sample size is one of the limitations of our study. Since it is a pilot study we recruited only 100 participants. The present study did not compare the adverse events following Covishield and Covaxin, which would be more beneficial to society.

  Conclusion 

The present study concludes that study participants experienced minor adverse events following Covishield and Covaxin; pain at the injection site, myalgia, and fever are more frequent. Moreover, there is a higher incidence of injection site pain in nonvegetarians compared to vegetarians. However, there is no significant association between other adverse events with blood group and dietary style of the participants.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 

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  [Figure 1]
 
 
  [Table 1], [Table 2], [Table 3], [Table 4]