Local Symptoms
The itemgroup has to be completed for every symptom one after the other.
integer
Day 0 = Day of vaccination. This item has to be filled in for every day for every symptom one after the other.
integer
This item has to be filled in only for Redness and for Swelling for every day. Please measure the greatest diameter (in mm).
integer
This item has to be filled in only for pain for every day.
text
This item has to be filled in for every symptom. If YES, please enter date of last day of symptoms below.
boolean
Date of last Day of Symptoms
date
This item has to be filled in for every symptom.
boolean
Other local symptoms
Other local symptoms Description
text
This item has to be filled in for every 'other local symptom'. Mild = easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = sufficiently discomforting to interfere with normal everyday activities. Severe = prevents normal, everyday activities. (In adults/ adolescents, such an adverse event would, forexample, prevent attendance at work/ school and would necessitate the administration ofcorrective therapy).
integer
This item has to be filled in for every 'other local symptom'.
date
This item has to be filled in for every 'other local symptom'.
date
This item has to be filled in for every 'other local symptom'.
boolean
Medication
Trade Generic name
text
This item has to be filled in for every Medication.
text
This item has to be filled in for every Medication.
text
This item has to be filled in for every Medication.
text
Start Date
date
Either 'End Date' or 'Continuing' has to be entered.
date
Either 'End Date' or 'Continuing' has to be entered.
boolean
General Symptoms
The itemgroup has to be completed for every symptom one after the other.
text
Day 0 = Day of vaccination. This item has to be filled in for every day for every symptom one after the other.
integer
This item has to be completed only for general symptom 'temperature'. Rectal measurement is not recommended. Please record the temperature every day in the evening. If temperature has been taken more than once a day, please reportthe highest value for the day.
integer
This item has to be completed for every general symptom (except temperature) one after the other. Please note the different meanings of intensity 0-3 depending on the symptom. Fatigue - Headache - Gastrointestinal symptoms (including nausea,vomiting, diarrhea and / or abdominal pain) - Arthralgia (joint pain: only in joints which are distalfrom the injection site) - Rash - Myalgia: 0 = Normal. 1 = Symptoms that are easily tolerated. 2 = Symptoms that interfere with normal activity. 3 = Symptoms that prevent normal activity. Urticaria: 0 = Normal. 1 = Urticaria distributed on a single body areaonly. 2 = Urticaria distributed on 2 or 3 body areas butnot more. 3 = Urticaria distributed on at least 4 bodyareas
integer
This item has to be filled in for every symptom. If YES, please enter date of last day of symptoms below.
boolean
Date of last Day of Symptoms
date
This item has to be filled in for every symptom.
boolean
Other general symptoms
Other general symptoms Description
text
This item has to be filled in for every 'other general symptom'. Mild = easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = sufficiently discomforting to interfere with normal everyday activities. Severe = prevents normal, everyday activities. (In adults/ adolescents, such an adverse event would, forexample, prevent attendance at work/ school and would necessitate the administration ofcorrective therapy).
integer
This item has to be filled in for every 'other general symptom'.
date
This item has to be filled in for every 'other general symptom'.
date
This item has to be filled in for every 'other general symptom'.
boolean