Vaccine administration
day month year. (fill in only if different from visit date).
date
Pre-Vaccination temperature
float
Route of temperature measurement
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(only one box must be ticked by vaccine). NOTE: "OPV Vaccine" is for workbook 1. "IPV Vaccine" is for wokbook 2. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
integer
If you tick "not administered", please complete following Itemgroup. "Not administered" has to be ticked, if you do not take the original vaccine.
text
Replacement vial Identifier
text
Wrong vial number
integer
According to the protocol: -For 10Pn-PD-DiT or Prevenar Vaccine take the right thigh I.M. -For DTPw-HBV/Hib Vaccine take the left upper thigh I.M. -For OPV Vaccine administer oral -For IPV Vaccine take the left lower thigh I.M. If you administered differently than protocol intended tick "Not according to the protocol".
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Vaccine administration NOT according to the Protocol: Side
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For 10Pn-PD-DiT or Prevenar Vaccine: Deltoid, Thigh, Buttock For DTPw-HBV/Hib Vaccine: Deltoid, Upper thigh, Lower thigh, Buttock For IPV: Deltoid, Upper thigh, Lower thigh, Buttock
integer
OPV is excluded.
text
No vaccine administration
Vaccine
integer
If you tick SAE: Please complete and submit SAE report If you tick AEX: Please complete Non-serious Adverse Event section If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box.
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SAE Identifier
integer
AE Identifier
integer
(e.g.: consent withdrawal, Protocol violation, …)
text
Decision taken
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