Solicited Adverse Events
If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours. If "yes" is ticked, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.
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Solicited Adverse Events Record - Local Symptoms
Redness
boolean
Swelling
boolean
Ecchymosis
boolean
Pain
boolean
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
integer
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
integer
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
integer
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
integer
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
integer
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
integer
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
integer
Ongoing Symptom
boolean
if ongoing after Day 6
date
Solicited Adverse Events - General Symptoms
Solicited Adverse Events Record - General Symptoms
Fatigue
boolean
Headache
boolean
Muscle Ache
boolean
Shivering
boolean
Arthralgie
boolean
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
integer
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
integer
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
integer
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
integer
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
integer
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
integer
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
integer
Ongoing Symptom
boolean
Date of Last Day of Symptoms
date
Causality
boolean
Solicited Adverse Events - Fever
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C
boolean
If fever is ticked oral is preferred
text
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
float
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
float
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
float
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
float
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
float
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
float
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
float
Day 0 not taken
boolean
Day 1 not taken
boolean
Day 2 not taken
boolean
Day 3 not taken
boolean
Day 4 not taken
boolean
Day 5 not taken
boolean
Day 6 not taken
boolean
Ongoing Symptom
boolean
Date of Last Day of Symptoms
date
Causality
boolean
Unsolicited Adverse Events