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June 20, 2022, 7:32 p.m. irct

Abnormal vital signs and anaphylactic reactions immediately after vaccination: Number and percentages of participants who develop abnormal vital signs within half an hour of receiving the vaccine at each doses will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and after vaccination. 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 after each vaccination. Local adverse reactions: The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching) Systemic adverse event: The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) ََAbnormal laboratory findings: The number and percentage of people who show abnormal laboratory findings one week after vaccination (Based on toxicity scores), including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes, Neutrophils, Eosinophils, Platelets ESR, CRP, Sodium, Potassium, BUN, Creatinine, Alkaline phosphatase, ALT, AST, and U/A, Urine protein, Urine glucose, Urine RBC Measurement of neutralizing antibody titers to assess humoral immunity

Abnormal vital signs and anaphylactic reactions immediately after vaccination: Number and percentages of participants who develop abnormal vital signs within half an hour of receiving the vaccine at each doses will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and after vaccination. 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 after each vaccination. Local adverse reactions: The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching) Systemic adverse event: The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) ََAbnormal laboratory findings: The number and percentage of people who show abnormal laboratory findings one week after vaccination (Based on toxicity scores), including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes, Neutrophils, Eosinophils, Platelets ESR, CRP, Sodium, Potassium, BUN, Creatinine, Alkaline phosphatase, ALT, AST, and U/A, Urine protein, Urine glucose, Urine RBC Measurement of neutralizing antibody titers to assess humoral immunity

Feb. 10, 2022, 3:42 p.m. irct

Abnormal vital signs and anaphylactic reactions immediately after vaccination: Number and percentages of participants who develop abnormal vital signs within half-hours of receiving the vaccine at each doses. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and after vaccination will be recorded. 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 after each vaccination. Local adverse reactions: The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching) Systemic adverse event: The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) ََAbnormal laboratory findings: The number and percentage of people who shows abnormal laboratory findings one week after vaccination (Based on FDA toxicity score), including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes, Neutrophils, Eosinophils, Platelets ESR, CRP, Sodium, Potassium, BUN, Creatinine, Alkaline phosphatase, ALT, AST, and U/A, Urine protein, Urine glucose, Urine RBC Measurement of neutralizing antibody titers to assess humoral immunity

Abnormal vital signs and anaphylactic reactions immediately after vaccination: Number and percentages of participants who develop abnormal vital signs within half-hours of receiving the vaccine at each doses. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and after vaccination will be recorded. 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 after each vaccination. Local adverse reactions: The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching) Systemic adverse event: The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) ََAbnormal laboratory findings: The number and percentage of people who shows abnormal laboratory findings one week after vaccination (Based on FDA toxicity score), including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes, Neutrophils, Eosinophils, Platelets ESR, CRP, Sodium, Potassium, BUN, Creatinine, Alkaline phosphatase, ALT, AST, and U/A, Urine protein, Urine glucose, Urine RBC Measurement of neutralizing antibody titers to assess humoral immunity