Study: NCT03965962

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 320 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 320 at risk

Adverse event: Eating disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 320 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 320 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 142 affected / 320 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 34 affected / 320 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 118 affected / 320 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 113 affected / 320 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 107 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 107 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 37 affected / 107 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 107 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 37 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 35 affected / 107 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 107 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 14 affected / 107 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 38 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 41 affected / 107 at risk

Adverse event: Meningioma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 104 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 104 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 104 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 104 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 104 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 34 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 40 affected / 104 at risk