Study: NCT04669691

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 69 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 69 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Injection site tenderness or pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 69 at risk

Adverse event: Change of eating habits
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 69 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 69 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Fever (≥38.0°C)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 69 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 69 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 69 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for prevention of pain/fever
Frequency: 6 affected / 69 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for treatment of pain/fever
Frequency: 7 affected / 69 at risk

Adverse event: Klebsiella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 72 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 72 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 72 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 72 at risk

Adverse event: Injection site tenderness or pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 72 at risk

Adverse event: Change of eating habits
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 72 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 72 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 72 at risk

Adverse event: Fever (≥38.0°C)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 72 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 72 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 72 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 72 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for prevention of pain/fever
Frequency: 6 affected / 72 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for treatment of pain/fever
Frequency: 7 affected / 72 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 70 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 70 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 70 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Injection site tenderness or pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 70 at risk

Adverse event: Change of eating habits
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Fever (≥38.0°C)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 70 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 70 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for prevention of pain/fever
Frequency: 5 affected / 70 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for treatment of pain/fever
Frequency: 5 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 70 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 5 affected / 70 at risk

Adverse event: Injection site tenderness or pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 70 at risk

Adverse event: Change of eating habits
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Fever (≥38.0°C)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 70 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for prevention of pain/fever
Frequency: 3 affected / 70 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for treatment of pain/fever
Frequency: 3 affected / 70 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 69 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 69 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 69 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 5 affected / 69 at risk

Adverse event: Injection site tenderness or pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 69 at risk

Adverse event: Change of eating habits
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 69 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 69 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 69 at risk

Adverse event: Fever (≥38.0°C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 69 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 69 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 69 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 69 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for prevention of pain/fever
Frequency: 4 affected / 69 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for treatment of pain/fever
Frequency: 4 affected / 69 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 70 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 70 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Injection site tenderness or pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 70 at risk

Adverse event: Change of eating habits
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 70 at risk

Adverse event: Fever (≥38.0°C)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 70 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 70 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for prevention of pain/fever
Frequency: 5 affected / 70 at risk

Adverse event: Other solicited AE
Serious: no
Organ System: General disorders
Notes: Analgesic/antipyretic use for treatment of pain/fever
Frequency: 7 affected / 70 at risk