Study: NCT04024228

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 772 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 772 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 772 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 772 at risk

Adverse event: Pilonidal disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 772 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 772 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 772 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 772 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 772 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 772 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 772 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 772 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 772 at risk

Adverse event: Cerebral thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 772 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 772 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 772 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 772 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 772 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Chills/Shivering events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 128 affected / 772 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 157 affected / 772 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 132 affected / 772 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Pain events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 350 affected / 772 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 140 affected / 772 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 168 affected / 772 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: 206 affected / 772 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: 190 affected / 772 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 761 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 761 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 761 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 761 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 761 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 761 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 761 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 761 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 761 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 761 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 761 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 761 at risk

Adverse event: Polycythaemia vera
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 761 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 761 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 761 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 761 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 761 at risk

Adverse event: VIth nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 761 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 761 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 761 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Chills/Shivering events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 57 affected / 761 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 85 affected / 761 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 64 affected / 761 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Pain events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 161 affected / 761 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 62 affected / 761 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 90 affected / 761 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: 94 affected / 761 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: 149 affected / 761 at risk