Study: NCT01280968

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 3 affected / 36 at risk

Adverse event: Weight Changes
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 1 affected / 36 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 2 affected / 36 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 3 affected / 36 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 4 affected / 36 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 2 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 4 affected / 36 at risk

Adverse event: Tenderness at Injection Site
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 2 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 1 affected / 5 at risk

Adverse event: Weight Changes
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 1 affected / 5 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 1 affected / 5 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
Frequency: 1 affected / 5 at risk