Evaluation of Factor V Leiden Mutation among COVID-19 vaccinated Sudanese individuals and complications of COVID-19 Vaccines

Background: Factor V Leiden (FVL) (G1691A) is a modified version of human factor V that may increase the risk of venous thromboembolism (VTE). It is generally accepted that the COVID-19 vaccinations have contributed to lowering the transmission of the virus and its severity and fatality. Among Sudanese people who received the COVID-19 vaccination, the research sought to examine the mutation of factor V Leiden (FVL) as well as any side effects. Methodology: Between June 2022 and March 2023, this case-control experiment was carried out in Khartoum State to examine the mutation of factor V in Sudanese people who received the COVID-19 vaccine as well as side effects of the vaccine. The research included 150 participants who had been vaccinated against COVID-19 and 150 healthy, non-vaccinated individuals as a control group. Both men and women above the age of 18 years were participated in the research, which took place at Hayatt University College and Exon Laboratory in Khartoum, Sudan. The presence of FVL in blood samples was determined by real time PCR after DNA extraction. The best study design for accomplishing our objectives with regard to COVID19 problems and side effects was a direct interview utilizing a questionnaire for people who have received one or two doses of the Pfizer, AstraZeneca, or Johnson-Johnson vaccination. Results: Among the 150 volunteers included in this study, 7 cases (4.7%) had FVL mutation (6 (4.0%) were heterozygous and 1 (0.7%) were homozygous), with an allelic frequency of 0.026, while no mutation was found in any of the healthy controls. This indicates that factor V Leiden was slightly frequently found in vaccinated individuals than in controls (P-value ˂ 0.05). The most prevalent side effect was pain at the injection site (32.6%), followed by general fatigue (28.7%), headaches (22.7%), fever (21.3%), joint pain (13.3%), dizziness (11.3%), swelling at the injection site (9.3%), shivering (5.6%), abdominal pain (4.9%), palpitations (4.7%), and thrombosis being the least common (0.7%). The most common related disease in terms of comorbidities include hypertension (13.5%), obesity (12,8%), diabetes mellitus (12.0%), allergy (8.6%), heart disease (6.1%), asthma (5.3%), and renal disease (3.7%). The majority of participants (47%) received the Pfizer vaccine, followed by Astra-Zeneca (31%), and Johnson-Johnson (22%). About (58.8%) received single dose, while (41.2%) received two doses, whether from Pfizer, Astra-Zeneca, or Johnson-Johnson. The prevalence of respondents who experienced side effects after taking the vaccination was (47.9%). COVID-19 vaccine side effects had lower rates in the participants who received the Pfizer vaccine (p˂ 0.05). Conclusions: We conclude that the presence of the Factor V Leiden (FVL) in COVID-19 vaccinated individuals in Sudan is very low and does not lead to the incidence of thromboembolism (VTE). The study suggests that COVID-19 vaccines cannot impact or attributed in FVL mutation. It considers various factors other than COVID-19 vaccines that may lead to this mutation. The study found that the incidence of side effects of the COVID-19 vaccine was lower in those who received the Pfizer vaccine. The study revealed the most important complications of taking COVID-19 vaccines among Sudanese population. It takes into account many elements that may contribute to the development of complications. We found that COVID-19 vaccination has only few complications. Therefore, we expect that this study will help in removing tension about dangerous complications of the COVID-19 vaccine.