AEFIs to be Reported Immediately to EFDA

• Serious AEFIs in vaccinated patients that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in:
• Persistent or significant disability/incapacity, or;
• Result in a congenital anomaly or birth defect or is a medically important event or reaction.
• The occurrence of events with an unexpected high rate or unusual severity.
• Signals generated as a result of individual or clustered cases.
• Significant events of unexplained cause, occurring up to 1 year after COVID-19 vaccination (and that are not listed in the product information).
• Events causing significant parental, family or community concerns.

Other AEFIs should be recorded on the standardized COVID-19 AEFI line list and sent to the national level every 15 days.