Adverse Event Monitoring & VAERS Flashcards
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Read the first 7 Adverse Event Monitoring & VAERS flashcards as text
Which of the following adverse events following influenza vaccination is specifically listed as a VAERS-reportable event regardless of whether causality is established?
Answer: Anaphylaxis occurring within 4 hours of vaccination
Anaphylaxis is a Table injury and must be reported to VAERS regardless of presumed causation.
A healthcare provider suspects a patient developed Guillain-Barré syndrome (GBS) 6 weeks after receiving the influenza vaccine. What is the correct VAERS reporting timeframe threshold for GBS following influenza vaccination?
Answer: 6 weeks
GBS occurring within 6 weeks of influenza vaccination meets the VICP Table injury timeframe and should be reported to VAERS.
When completing a VAERS report, what does the 'Onset interval' field refer to?
Answer: The time between vaccination and the first symptom of the adverse event
The onset interval captures how much time elapsed between vaccine administration and the first appearance of the adverse event.
A nurse administered an incorrect vaccine to a patient who was scheduled for a different immunization. No adverse reaction occurred. Should a VAERS report be filed?
Answer: Yes, because administration errors resulting in vaccination are reportable
Vaccine administration errors that result in vaccination, even without an adverse event, should be reported to VAERS.
Which federal agency operates the Vaccine Safety Datalink (VSD) as a complement to VAERS surveillance?
Answer: CDC
The CDC operates the VSD in partnership with several large health systems to conduct active surveillance and complement VAERS passive reporting.
A patient reports arm pain and limited shoulder range of motion beginning 48 hours after receiving a flu shot. This presentation is most consistent with which VAERS-reportable condition?
Answer: Shoulder injury related to vaccine administration (SIRVA)
SIRVA presents with shoulder pain and limited motion within 48 hours of vaccination, typically caused by improper injection into the subdeltoid bursa.
In VAERS data analysis, what is the primary limitation that prevents determining whether a vaccine caused a reported adverse event?
Answer: VAERS is a passive surveillance system without control groups, making causality assessment impossible from reports alone
Because VAERS lacks denominator data and a comparison group, rates of adverse events cannot be compared to background rates, preventing causal inference.