| Question | Response |
|---|---|
| Date of assessment |
FA.FADTC |
| Did the subject have any injection site reacion events? |
FA.FAORRES when FATESTCD="ISR1" Yes No |
| What is the date of the injection? |
FA.FASTTPT |
| What date did the injection site reaction start? |
FA.FASTDTC |
| At what time did the injection site reaction start? |
FA.FASTDTC |
| What date did the injection site reaction end? |
FA.FAENDTC |
| At what time did the injection site reaction end? |
FA.FAENDTC |
| Was there pain (including burning) at the injection site? |
FA.FAORRES when FATESTCD="ISR2" None Mild Moderate Severe |
| Was there itching at the injection site? | None Mild - lasted for less than one minute Moderate - lasted for more than one minute but less than one hour Severe - constant |
| Was there a rash (or redness) at the injection site? | None Mild - less than or equal to 1 cm Moderate - greater than 1 cm Severe - greater than 1 cm and raised |
| Was there hardening (that includes a knot or lump) at the injection site? |
FA.FAORRES when FATESTCD="ISR3" None Less than or equal to 1 cm Greater than 1 cm |
| Was there an open sore at the injection site? |
FA.FAORRES when FATESTCD="ISR4" No Yes |
| What was the laterality of the anatomical location of the injection site reaction? |
FA.FAORRES when FATESTCD="ISR5" Left Right Bilateral |
| What was the anatomical location of the injection site reaction? |
FA.FAORRES when FATESTCD="ISR6" Abdomen Arm Buttock Thigh |