Adverse Event Monitoring & VAERS Flashcards
7 cards from real APHA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Adverse Event Monitoring & VAERS flashcards as text
A VAERS report submitted by a patient describes a reaction to a vaccine received 3 years ago. How should this report be handled?
Answer: Accepted, as VAERS has no strict time limit for report submission
VAERS accepts reports at any time after vaccination; there is no expiration deadline for submitting a report.
Which of the following best describes the purpose of the Brighton Collaboration in vaccine safety?
Answer: To develop standardized case definitions for adverse events following immunization
The Brighton Collaboration creates standardized, evidence-based case definitions for adverse events to improve the consistency and comparability of vaccine safety data globally.
During a mass vaccination campaign, a cluster of fainting episodes is observed at one clinic site. Which surveillance system is best designed to rapidly detect and investigate such a cluster signal?
Answer: The Clinical Immunization Safety Assessment (CISA) Project
CISA is designed for rapid clinical consultation and investigation of complex or clustered adverse event cases in coordination with CDC.
A manufacturer receives spontaneous safety reports from post-marketing surveillance showing an unexpected neurological event in 3 out of 500,000 vaccinees. What is the manufacturer's regulatory obligation?
Answer: Submit an expedited report to the FDA within 15 business days if the event is serious and unexpected
FDA regulations (21 CFR 600.80) require manufacturers to submit expedited 15-day safety reports for serious, unexpected adverse experiences identified post-licensure.
Which statement correctly describes who can submit a VAERS report?
Answer: Anyone, including patients, parents, caregivers, and healthcare providers
VAERS accepts reports from anyone, including patients and family members, though healthcare providers and manufacturers also have reporting obligations for certain events.
When analyzing VAERS data, a researcher notices a proportional reporting ratio (PRR) of 4.5 for myocarditis after mRNA COVID-19 vaccination in males aged 12–17. What does this PRR indicate?
Answer: Myocarditis reports are 4.5 times more proportionally frequent after this vaccine/demographic combination than after other vaccines
A PRR measures disproportionality in reporting; a PRR of 4.5 means myocarditis appears 4.5 times more often proportionally for this group than for the comparison group, serving as a signal for further investigation.
A provider notes that a patient experienced a severe local reaction (Arthus reaction) after their 5th dose of Td vaccine. Which action regarding VAERS reporting is most appropriate?
Answer: File a VAERS report because severe local reactions are reportable
Severe local reactions such as Arthus reactions following Td are considered clinically significant and should be reported to VAERS.