If you are reporting an initial event
, create a new EAE in DAERS. Go directly to the Study Vaccine page if you have entered the information prior to this page. Fields will no longer be grayed out once you select your study vaccine when entering information for the first time in an Initial EAE
If you are updating an event which requires adding the dates of administration, start by searching for the event, select Update, and save the Reporter Information screen to create the EAE update. Once you create the update, go to the Study Vaccine page. For an update, the bottom of the screen will list the vaccine(s) that you have previously entered, in blue. Once you click on the vaccine, you will be able to edit the vaccine information.
Entering dates of administration: First select a date on the calendar or type directly into the Dates of Administration field in the DD/MM/YYYY format. Once you have selected or typed the first date of administration, click the blue (+) icon to the right of the date. This adds the date to the system. *Important note:* Even if you are entering only one vaccination date, you still need to click the blue (+) icon in order for the date to save in the system. You will notice that action adds the dates below the Dates of administration field.
In order to enter additional dates, repeat the same steps as above. Select a date on the calendar or type it directly into the field, and then click on the blue (+) icon to add the date to the system. You will then see both dates listed below the Dates of Administration field, indicating both dates have been entered. If you enter a date incorrectly, there are blue (-) icons next to each date, which you can click on to delete the date.
Once you have entered all dates of vaccination, click the Save button at the bottom of the page and wait for the green “Successfully saved…” message to ensure that the information has been properly captured in the system. To enter another vaccine, click New and repeat above steps for entering the date(s) of administration.
For an Initial: continue to enter all other applicable information on the other screens, and go through Completion Check once you have entered all pertinent information. The Submitter can then submit the event.
For an Update: If this is the only information you are updating, go through Completion Check and have the Submitter at your site submit the update. If there is additional information to be added, complete all other updated information and then go through Completion Check and have the Submitter at your site submit the update.