Procedures
redness, myalgia, Accidents, diarrhea, swelling, fatigue, pain, headache, tenderness
ADVERSE REACTIONS, ADVERSE EVENT, EMERGENCY
We monitored immediate reactions and vital signs following vaccine injections for half an hour at the clinical trial centers. All collected information was recorded in the web-based study software.We asked the participants to report their daily local (pain, tenderness, swelling, and redness) and systemic (nausea/vomiting, diarrhea, headache, fatigue, and myalgia) adverse reactions in a mobile application during the week after each injection. In the same session, the mobile application was installed and activated on the participants' mobile phones and was an integral part of the web-based study software. Participants were also asked to report weekly any visits to local surgery or hospital A&E (Accidents and Emergency) on their mobile application during the four months of active follow-up. Missing two successive weekly reports triggered a notification for the follow-up team to contact the participant. They could also phone at any time (24/7) study follow-up center where they could consult a resident physician or report their illness or any other matter of concern. Any report of illness or seeking medical advice in the mobile application or direct contact with the follow-up center opened an electronic adverse event file that was followed up until complete resolution.