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 state health department epidemiologist receives a cluster of VAERS reports describing fever and rash following a specific lot of MMR vaccine. What is the most appropriate next step?
Answer: Conduct a lot-specific investigation and notify the FDA and CDC for further evaluation
A cluster of reports linked to a specific lot requires coordinated investigation with FDA and CDC to assess whether the lot has a manufacturing defect or true safety signal.
Which of the following is a key difference between the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD)?
Answer: VAERS is passive and hypothesis-generating; VSD is active and can test hypotheses with denominator data
VAERS is a passive signal-detection system, while VSD uses linked electronic health records from HMOs to actively study vaccine safety with population denominators.
A healthcare provider wants to check whether a specific adverse event has already been reported in VAERS for a recently approved vaccine. Where can they access de-identified VAERS data for this purpose?
Answer: The CDC WONDER database and the VAERS website provide publicly searchable de-identified data
De-identified VAERS reports are publicly accessible through the VAERS website and CDC WONDER, allowing anyone to search and download safety data.
During an immunization clinic, a teenager experiences a tonic-clonic seizure 20 minutes after receiving the HPV vaccine. After emergency care, which parties have a legal obligation to report this event to VAERS?
Answer: The healthcare provider who administered the vaccine and the vaccine manufacturer
Both vaccine administrators (healthcare providers) and manufacturers are legally required under NCVIA to report Table-listed events and other serious adverse events to VAERS.
A parent contacts a public health nurse insisting that a VAERS report proves the flu vaccine caused autism in their child. What is the most accurate and appropriate response?
Answer: Explain that VAERS reports indicate an event occurred after vaccination but do not establish causation, and that extensive studies have found no link between flu vaccine and autism
VAERS is a hypothesis-generating system; a report only indicates temporal association, not causation, and large-scale studies have not found a causal link between influenza vaccines and autism.
Which of the following adverse events following varicella vaccination is specifically listed on the Reportable Events Table with a 42-day (6-week) reporting timeframe?
Answer: Vaccine-strain viral infection in an immunocompromised recipient
Vaccine-strain varicella infection, particularly in immunocompromised individuals, is listed on the Reportable Events Table with a 42-day interval for varicella vaccines.
What is the primary purpose of the Post-licensure Rapid Immunization Safety Monitoring (PRISM) network in the context of vaccine pharmacovigilance?
Answer: To conduct rapid active surveillance using health insurance claims data to evaluate vaccine safety signals in near real-time
PRISM uses large health insurance claims databases to perform rapid active safety surveillance post-licensure, complementing passive VAERS reporting with population-level data.