Study: NCT00231816

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 378 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 378 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 378 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 378 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 378 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 378 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 378 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 378 at risk

Adverse event: Injection Site Erythema (Influenza vaccine injection site)
Serious: no
Organ System: General disorders
Frequency: 46 affected / 378 at risk

Adverse event: Injection Site Erythema (Placebo injection site)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 378 at risk

Adverse event: Injection Site Erythema (ZOSTAVAX™ injection site)
Serious: no
Organ System: General disorders
Frequency: 125 affected / 378 at risk

Adverse event: Injection Site Pain (Influenza vaccine injection site)
Serious: no
Organ System: General disorders
Frequency: 90 affected / 378 at risk

Adverse event: Injection Site Pain (Placebo injection site)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 378 at risk

Adverse event: Injection Site Pain (ZOSTAVAX™ injection site)
Serious: no
Organ System: General disorders
Frequency: 114 affected / 378 at risk

Adverse event: Injection Site Swelling (Influenza vaccine injection site)
Serious: no
Organ System: General disorders
Frequency: 41 affected / 378 at risk

Adverse event: Injection Site Swelling (ZOSTAVAX™ injection site)
Serious: no
Organ System: General disorders
Frequency: 70 affected / 378 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 376 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 376 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 376 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 376 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 376 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 376 at risk

Adverse event: Injection Site Erythema (Influenza vaccine injection site)
Serious: no
Organ System: General disorders
Frequency: 29 affected / 376 at risk

Adverse event: Injection Site Erythema (Placebo injection site)
Serious: no
Organ System: General disorders
Frequency: 19 affected / 376 at risk

Adverse event: Injection Site Erythema (ZOSTAVAX™ injection site)
Serious: no
Organ System: General disorders
Frequency: 101 affected / 376 at risk

Adverse event: Injection Site Pain (Influenza vaccine injection site)
Serious: no
Organ System: General disorders
Frequency: 86 affected / 376 at risk

Adverse event: Injection Site Pain (Placebo injection site)
Serious: no
Organ System: General disorders
Frequency: 23 affected / 376 at risk

Adverse event: Injection Site Pain (ZOSTAVAX™ injection site)
Serious: no
Organ System: General disorders
Frequency: 107 affected / 376 at risk

Adverse event: Injection Site Swelling (Influenza vaccine injection site)
Serious: no
Organ System: General disorders
Frequency: 31 affected / 376 at risk

Adverse event: Injection Site Swelling (ZOSTAVAX™ injection site)
Serious: no
Organ System: General disorders
Frequency: 94 affected / 376 at risk