Study: NCT02992418

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 338 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 338 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 338 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 338 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 338 at risk

Adverse event: Abortion complete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 338 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 338 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 338 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 67 affected / 338 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 229 affected / 338 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 25 affected / 338 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 91 affected / 338 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/fever events that occurred after 14 days post-vaccination were considered as unsolicited AEs.
Frequency: 22 affected / 338 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 338 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 74 affected / 338 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache event that occurred after 14 days post-vaccination was considered as an unsolicited AE.
Frequency: 89 affected / 338 at risk

Adverse event: Hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 342 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 342 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 342 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 342 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 342 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 342 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 342 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 94 affected / 342 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 237 affected / 342 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 32 affected / 342 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 111 affected / 342 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia/fever events that occurred after 14 days post-vaccination were considered as unsolicited AEs.
Frequency: 32 affected / 342 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 342 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 100 affected / 342 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache event that occurred after 14 days post-vaccination was considered as an unsolicited AE.
Frequency: 116 affected / 342 at risk