Adverse Effects of Gam-COVID-Vac (Sputnik V) Vaccine

AUTHORS

Hamid Reza Samimagham 1 , Mehdi Hassani Azad 2 , Dariush Hooshyar ORCID 3 , Mohsen Arabi 4 , Zahra Reza Hosseini 3 , Mitra Kazemi Jahromi ORCID 5 , *

1 Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran

2 Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran

3 Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran

4 Preventive Medicine and Public Health Research Center, Family Medicine Department, Iran University of Medical Sciences, Tehran, Iran

5 Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran

How to Cite: Samimagham H R, Hassani Azad M , Hooshyar D, Arabi M, Reza Hosseini Z, et al. Adverse Effects of Gam-COVID-Vac (Sputnik V) Vaccine. Shiraz E-Med J.In Press(In Press):e116278. doi: 10.5812/semj.116278.

ARTICLE INFORMATION

Shiraz E-Medical Journal: In Press (In Press); e116278
Published Online: July 31, 2021
Article Type: Letter
Received: May 16, 2021
Revised: June 7, 2021
Accepted: June 10, 2021
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Dear Editor,

The COVID-19 pandemic caused by Coronavirus-2 Acute Respiratory Syndrome (SARS-CoV-2) has incurred detrimental effects on health systems (1, 2). Given the desperate need to develop vaccines as quickly as possible, much effort has been made to develop and manufacture vaccines to prevent the transmission of COVID-19 to healthy individuals (3-5). Numerous studies have focused on medication therapy and patient recovery; however, vaccination will significantly affect the mortality rate by reducing infection with COVID-19 (3-9). Nonetheless, like any other compound, vaccines can also cause local and systemic complications (4-12).

The present study enrolled 100 healthcare providers of Shahid Mohammadi Hospital in Bandar Abbas city who had received the first dose of Gam-COVID-Vac (Sputnik V). The study was approved by the Ethics Committee of Hormozgan University of Medical Sciences (IR.HUMS.REC.1399.541). An online questionnaire was developed to assess demographic details and local and systemic complications of vaccination. These individuals were assessed at three time points: the first, third, and seventh days after vaccination in terms of local complications, including pain at the injection site, warmth, redness, and swelling, and systemic complications, including weakness and fatigue, headache, myalgia, bone pain, arthralgia, palpitation, diarrhea, nausea and vomiting, anorexia, coughing, sneezing, sore throat, runny nose, fever, chills, and urticaria. The participants were also followed for serious complications or mortality during one month after the first dose of vaccination.

Among the 100 participants studied, 10 had a history of infection with COVID-19 in the past six months. Among these 10 individuals, weakness and lethargy were observed in six individuals on day one, three individuals on day three, and one individual on day seven. Headache was reported by five individuals on day one, and one individual on day three. Myalgia was observed in eight individuals on day one, five individuals on day three, and two individuals on day seven. This complication was more frequent in participants with a history of COVID-19 compared to those without a history of COVID-19 in the past six months (80 vs. 53%). Bone pain was reported by eight individuals on day one, three individuals on day three, and one individual on day seven. Generally, this complication had a higher frequency percentage in those with a history of COVID-19 compared to those without it (80 vs. 43%). Anorexia was reported by three individuals on day one and one individual one day three (30% in group with a history of COVID-19 vs. 12% in group with no history of COVID-19).

Our results showed that 42% of the participants suffered from headaches on day one, 18% on day three, and 5% on day seven. Headache and asthenia were among the most common complications of the vaccine in a study by Logunov et al., in which a similar vaccine to that in the present study was used (5). The present study exhibited more cases of severe myalgia (Table 1). In another study, Zhu et al. reported myalgia in 18% of patients after vaccination with a similar dose (12).

Table 1. Local and Systemic Complications of Gam-COVID-Vaccine on Days One, Three, and Seven
SymptomsDay 1Day 3Day 7
AsymptomaticMildModerateSeverAsymptomaticMildModerateSeverAsymptomaticMildModerateSever
Weakness5313171770199293511
Headache58113482113495221
Myalgia47112319671614392611
Bone pain57101617781011194510
Palpitation844669136096310
Diarrhea953209352098110
Nausea and Vomiting886249323296202
Anorexia7791138875098200
Rhinorrhea935209621197120
Sore throat915409262096211
Fever68205791810100000
Chills641110159163099100
Urticaria9541099100100000
Warmth83611091630100000
Redness9370097300100000
Swelling9243198200100000

Regarding the relationship between the history of COVID-19 in the past six months and vaccination complications, only myalgia and rhinorrhea on day one had a significant relationship with a positive history of COVID-19 in those receiving vaccination, but no significant relationship was noted between this variable on other days (days three and seven). The history of infection with COVID-19 had no significant association with other local complications.

With regard to adenovirus type-5 vaccine, a higher percentage of local and systemic complications were reported in the present study than in previous studies (5, 12). This difference can probably be attributed to the geographical, genetic, or sample size differences. Pain at the injection site was also the most common complication in inactivated SARS-COV-2 vaccines (11). Regarding mRNA-1273 vaccines, pain at the injection site was most frequently reported (10). Fatigue, headache, myalgia, and chills were the most common systemic complications of mRNA-1273-based COVID-19 vaccines (10). With regard to the relationship of history of COVID-19 and post-vaccination complications, rhinorrhea on day one, sneezing on day one, and sneezing on day three were observed in those with a history of COVID-19, respectively 9.5, 23, and 21 times higher than those without such a history. Although the history of COVID-19 was not investigated in their study, Baden et al. indicated that those who had COVID-19 at the time of vaccination experienced fewer complications than those who did not have COVID-19 (10).

In the present study, weakness, myalgia, headache, and pain at the injection site were the most frequently reported adverse reactions among people who received the first dose of Gam-COVID-vac. No serious complications or mortality was seen during the one-month follow-up.

Footnotes

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  • Copyright © 2021, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.
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