Assessment 4

Question 3

Some AEFI reports will need further investigation, some do not.
Which of the following statements are correct?

Select one or more:

A. Two or more cases of the same, minor adverse event, if related in time, place or the vaccine administered should be investigated.
B. Investigation is limited to the follow up of serious adverse events following immunization.
C. Signals and events associated with newly introduced vaccines should be investigated.
D. Investigation is recommended when the events are causing significant parental or community concern.
E. Following the reporting of an adverse event following immunization, vaccine testing should be an integral part of its investigations.

Answer

Answers A, C and D are correct.

Answers A – D
Reported events requiring the initiation of an investigation are:

  • Serious AEFIs, i.e. adverse events or reactions that result in death, hospitalization (or prolongation of existing hospital stay), persistent or significant disability or incapacity (e.g. paralysis), or are potentially life-threatening,
  • Clusters of minor AEFIs,
  • Signals and events associated with newly introduced vaccines, 
  • Other AEFIs recommended by WHO: 
    • AEFIs that may have been caused by immunization error (e.g. bacterial abscess, severe local reaction, high fever or sepsis, BCG lymphadenitis, toxic shock syndrome, clusters of AEFIs),
    • Significant events of unexplained cause occurring within 30 days after a vaccination,
    • Events causing significant parental or community concern.

Answer E
Vaccine testing is not an integral part of an investigation. It is only appropriate if the working hypothesis about the possible causes of an AEFI suggests there may be a problem with vaccine quality, e.g. bacterial contamination, damage due to inadequate maintenance of the cold chain, a reconstitution error, etc.