Solicited adverse events - local symptoms
If you tick yes, please complete No/Yes for each symptom in the following Items. If you tick yes by the symptom please complete all other items too.
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Local symptoms
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Tick for each symptom
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Please tick intensity for each local symptom for every day.
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Fill in for each redness and swelling/induration.
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Pain at injection site: Grade 0: None Grade 1: Pain on touching the site, not otherwise. Grade 2: Pain on moving the limb which interferes with normal activities or requires repeated use of pain relievers Grade 3: Significant pain at rest; prevents normal activities as asses
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Local Symptom ongoing
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day month year
date
Solicited adverse events - general symptoms
If you tick yes, please complete No/Yes for each symptom in the following Items. If you tick yes by the symptom please complete all other items too.
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General symptom
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Tick for each symptom
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Fill in for each symptom. If you ticked "Temperature" as symptom, note the body temperature of subject for each day. If you do not measure tick "not taken".
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If you don't take body temperature, please tick "not taken".
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Temperature to be reported: Axillary >= 37.5°C, >= 99.5°F Oral >= 37.5°C, >= 99.5° Rectal >= 38.0°C, >= 100.4°F
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Body temperature, Unit
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Fill in for each: Fatigue, Headache, Joint pain, Muscle aches, Shivering, sweating increase. Definition: Grade 0: None Grade 1: No effect on normal activities Grade 2: Some interference with normal everyday activities or (for headache, joint or muscle pain) requires repeated use of pain relievers Grade 3: Prevents normal everyday activities as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider
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Symptom ongoing
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day month year
date
Causality of symptom
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Unsolicited Adverse events
If you tick yes, fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. Timepoints: For Dose 1 (Visit 1): between Visit "Day 0" through Visit "Day 21". For Dose 2 (Visit 3): between Visit "Day 21" through Visit "Day 42"
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