Study: NCT04127786

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Exposure to communicable disease
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 607 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 344 affected / 607 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Injection site swelling events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 14 affected / 607 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 161 affected / 607 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia events that started after 7 days post-vaccination were considered as unsolicited AE. Pyrexia events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 51 affected / 607 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 27 affected / 607 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 249 affected / 607 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 130 affected / 607 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 95 affected / 202 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Injection site swelling events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 4 affected / 202 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 45 affected / 202 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia events that started after 7 days post-vaccination were considered as unsolicited AE. Pyrexia events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 12 affected / 202 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 9 affected / 202 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 67 affected / 202 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 50 affected / 202 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Keratorhexis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Imminent abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 200 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 106 affected / 200 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Injection site swelling events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 13 affected / 200 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 48 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia events that started after 7 days post-vaccination were considered as unsolicited AE. Pyrexia events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 5 affected / 200 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 12 affected / 200 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 79 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 47 affected / 200 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 111 affected / 419 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Injection site swelling events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 1 affected / 419 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 37 affected / 419 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia events that started after 7 days post-vaccination were considered as unsolicited AE. Pyrexia events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 3 affected / 419 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 3 affected / 419 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 78 affected / 419 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 40 affected / 419 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 139 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 10 affected / 139 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 12 affected / 139 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 10 affected / 139 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 43 affected / 139 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Injection site swelling events did not meet the 5% frequency threshold criteria in the booster phase.
Frequency: 1 affected / 139 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 12 affected / 139 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 30 affected / 139 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 8 affected / 139 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 94 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 94 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 8 affected / 94 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 24 affected / 94 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 4 affected / 94 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 31 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 3 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 9 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 3 affected / 31 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 32 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 15 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that started after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 32 at risk