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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.

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  1. Under the National Childhood Vaccine Injury Act (NCVIA), healthcare providers are required to report certain adverse events to VAERS. Which category of events triggers this mandatory provider reporting obligation?

    Answer: Events listed in the Reportable Events Table that occur within the specified timeframe

    The NCVIA mandates provider reporting for adverse events listed in the Reportable Events Table that occur within the designated post-vaccination intervals.

  2. A 4-year-old received DTaP and developed persistent inconsolable crying for 5 hours beginning 10 hours after vaccination. How should this event be classified for VAERS reporting purposes?

    Answer: Reportable as persistent crying (≥3 hours) is a Table injury for DTaP vaccines

    Persistent crying lasting 3 hours or more within 48 hours of DTaP is listed on the Vaccine Injury Table, making it a reportable event.

  3. Which of the following VAERS data fields is considered most critical for identifying a potential safety signal for a new vaccine?

    Answer: MedDRA-coded adverse event terms and vaccination date

    MedDRA-coded adverse event terms combined with vaccination dates allow epidemiologists to quantify onset intervals and cluster adverse events for signal detection.

  4. After VAERS identifies a potential safety signal for a new vaccine, which study design provides the strongest evidence to determine whether the vaccine caused the adverse event?

    Answer: Active surveillance studies using cohort or case-control designs with control groups

    Active surveillance studies with appropriate control groups allow calculation of incidence rates and relative risks, providing causal evidence that passive surveillance cannot establish.

  5. A pharmacist observes a patient lose consciousness 8 minutes after receiving a Tdap vaccine. After providing care, what is the VAERS-relevant timing consideration for this syncope event?

    Answer: Syncope occurring within 15 minutes of vaccination is a Table injury and is reportable

    Syncope (vasovagal) occurring within 15 minutes of vaccination is listed on the Reportable Events Table for vaccines including Tdap and is reportable to VAERS.

  6. Which of the following correctly explains why VAERS data should NOT be used to calculate the true incidence rate of an adverse event?

    Answer: The number of doses administered (denominator) is not consistently linked to VAERS reports, and under-reporting is common

    Without a reliable denominator (doses administered) and because of under-reporting, VAERS data cannot be used to calculate true incidence rates of adverse events.

  7. A clinic is implementing a protocol for post-vaccination observation. According to ACIP and CDC guidance, what is the minimum recommended observation period after vaccination to detect anaphylaxis?

    Answer: 15 minutes

    ACIP recommends observing all vaccine recipients for at least 15 minutes after vaccination to monitor for immediate reactions including anaphylaxis.