Local symptoms (at injection site)
day month year
date
Local symptoms
integer
Day after Vaccination
integer
Fill in for each symptom (redness and swelling/induration) for every day.
integer
Fill in for every day. Pain at injection site: 0: Absent 1: Pain on touching the site, not otherwise. 2: Pain on moving the limb which interferes with normal activities or requires repeated use of pain relievers 3: Significant pain at rest; prevents normal activities as as assessed by inability to attend/do work or school.
integer
Symptom ongoing
text
day month year
date
Other local symptoms (From Visit "Day 0" to Visit "Day 7")
Other local symptoms, description
text
Definition: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an AE would, for example, prevent attendance at work or school and would necessitate the administration of prescription (symptomatic or specific) therapy.
integer
day month year
date
day month year. or check box below, if continuing
date
Other symptom ongoing
boolean
Medically attended Visit
text
Medication (From Visit "Day 0" to Visit "Day 7")
Trade / Generic Name of medication
text
Indication of medication
text
Total daily dose
text
day month year
date
day month year. or check box below, if continuing.
date
Medication ongoing
boolean
General Symptoms
day month year
date
Please give information for each symptom and day mentioned.
integer
Please give information for each symptom and day mentioned.
integer
Body temperature, route of measurement
text
Please record the temperature every day in the evening. If temperature has been taken more than once a day, please report the highest value for the day.
float
Definition of intensity: 0: None 1: No effect on normal activities 2: Some interference with normal everyday activities or (for headache, joint or muscle pain) requires repeated use of pain relievers 3: Prevents normal everyday activities as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider
integer
Symptom ongoing
text
day month year
date
Other general symptoms (From Visit "Day 0" to Visit "Day 7")
Other general symptoms, description
text
Definition: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an AE would, for example, prevent attendance at work or school and would necessitate the administration of prescription (symptomatic or specific) therapy.
integer
day month year
date
day month year. or check box below, if continuing.
date
Other general symptom ongoing
boolean
Medically attended Visit
text
Adverse event form - symptoms
Adverse event symptoms, description
text
Definition: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an AE would, for example, prevent attendance at work or school and would necessitate the administration of prescription (symptomatic or specific) therapy.
integer
day month year
date
day month year. or check box below, if continuing.
date
Symptom ongoing
boolean
Medically attended Visit
text
Adverse event - Medication
Trade / Generic Name of medication
text
Indication of medication
text
Total daily dose
text
day month year
date
day month year. or check box below, if continuing.
date
Medication ongoing
boolean