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PSM · Communicable diseases: classifying an adverse event following immunisation
Sample itemTwelve children at an immunisation session develop fever and injection-site abscesses within hours. Investigation shows that a vial reconstituted the previous day was used. Under the AEFI cause classification, what is the cause?
Original practice item, not a recalled exam question. Nothing here is recorded.
The answer and the reasoning
A. Immunisation error-related reaction
Using a reconstituted vial beyond the permitted time is a programme error, so the cluster is classified as an immunisation error-related reaction. Product-related reactions are inherent properties of the vaccine. A cluster of identical adverse events from a vial suggests a handling problem.
Option by option
A. Immunisation error-related reaction (correct)
Correct. A handling error in reconstituted vial use is an immunisation error.
B. Vaccine quality defect-related reaction
Quality defect-related events arise from a manufacturing defect, not from vial handling at the site.
C. Coincidental event
A coincidental event would have no link to the vaccination.
D. Vaccine product-related reaction
Product-related reactions are inherent to the vaccine and occur even with correct handling.
Source note: Original NextPrep sample item — pending expert review. This item is original practice material awaiting independent expert review, so confirm important facts in a standard textbook.
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