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April 14, 2021, 6:04 a.m. irct

Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within two hours of receiving the vaccine at each doses will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked up to two hours after each vaccination. The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching) that will be assessed based on the severity score, duration and peak intensity. The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) that will be assessed based on the severity score, duration and intensity. Serum levels of specific IgG antibodies against S, S1, S2,NTC, RBD components of SARS-CoV-2 spike protein antigen(s). Changes in these factors as well as showing no response against N antigen will be explored.

Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within two hours of receiving the vaccine at each doses will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked up to two hours after each vaccination. The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching) that will be assessed based on the severity score, duration and peak intensity. The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) that will be assessed based on the severity score, duration and intensity. Serum levels of specific IgG antibodies against S, S1, S2,NTC, RBD components of SARS-CoV-2 spike protein antigen(s). Changes in these factors as well as showing no response against N antigen will be explored.