Study: NCT01644565

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Related to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: AST elevation
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Generalized eruption, truncal proximal UE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Vascular disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Left metatarsal stress fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Knee hyperflexion, right
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: Right knee pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Vaccine site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 4 affected / 5 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 5 affected / 5 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: AST elevation
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Left upper groin wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Ankel sprain, right
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: RUE Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 4 affected / 5 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 5 affected / 5 at risk

Adverse event: Vaccine site swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: ALT elevation
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Ankle trauma, left
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: AST elevation
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 4 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 4 affected / 5 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 5 affected / 5 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: Dorsal foot pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: Vaccine site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 5 affected / 5 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 5 affected / 5 at risk

Adverse event: Vaccine site swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 3 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Facial trauma, left eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 4 affected / 7 at risk

Adverse event: Vaccine site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 5 affected / 7 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 7 affected / 7 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 6 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Bilateral bicep strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 4 affected / 7 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 4 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 7 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 7 at risk

Adverse event: Right axillary pain
Serious: no
Organ System: General disorders
Notes: Related to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 5 affected / 7 at risk

Adverse event: Vaccine site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 6 affected / 7 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 7 affected / 7 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 6 affected / 7 at risk

Adverse event: AST elevation
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 3 affected / 7 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 3 affected / 7 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related to vaccine
Frequency: 2 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 5 affected / 10 at risk

Adverse event: Vaccine site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 8 affected / 10 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 10 affected / 10 at risk

Adverse event: Vaccine site swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 2 affected / 10 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 8 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 3 affected / 10 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 3 affected / 10 at risk

Adverse event: Calf soreness, left
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Allergies, seasonal
Serious: no
Organ System: Immune system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Subsurface blood clot, left calf
Serious: no
Organ System: Vascular disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Related to vaccine
Frequency: 2 affected / 8 at risk

Adverse event: Tegaderm reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to vaccine
Frequency: 2 affected / 8 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 8 affected / 8 at risk

Adverse event: Vaccine site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 8 affected / 8 at risk

Adverse event: Vaccine site swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 2 affected / 8 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 3 affected / 8 at risk

Adverse event: Vaccine site warmth
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Related to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: BP elevation
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Creatinine elevation
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 8 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 2 affected / 8 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 8 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Platelet decrease
Serious: no
Organ System: Investigations
Notes: Unrelated to vaccine
Frequency: 1 affected / 8 at risk

Adverse event: Allergies, seasonal
Serious: no
Organ System: Immune system disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 8 at risk

Adverse event: Tegaderm reaction
Serious: no
Organ System: Immune system disorders
Notes: Unrelated to vaccine
Frequency: 8 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to vaccine
Frequency: 2 affected / 8 at risk