| Question | Response |
|---|---|
| Date of assessment | |
| Did the subject have any injection site reacion events? | Yes No |
| What is the date of the injection? | |
| What date did the injection site reaction start? | |
| At what time did the injection site reaction start? | |
| What date did the injection site reaction end? | |
| At what time did the injection site reaction end? | |
| Was there pain (including burning) at the injection site? | 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? | None Less than or equal to 1 cm Greater than 1 cm |
| Was there an open sore at the injection site? | No Yes |
| What was the laterality of the anatomical location of the injection site reaction? | Left Right Bilateral |
| What was the anatomical location of the injection site reaction? | Abdomen Arm Buttock Thigh |