Details:

Alternative Title:
J Pediatr
Publisher's site:
http://dx.doi.org/10.1016/j.jpeds.2014.12.014
Personal Author:
Moro, Pedro L. ; Jankosky, Christopher ; Menschik, David ; Lewis, Paige ; Duffy, Jonathan ; ... More +
Moro, Pedro L. ; Jankosky, Christopher ; Menschik, David ; Lewis, Paige ; Duffy, Jonathan ; Stewart, Brock ; Shimabukuro, Tom T. Less -
Description:
Background:

There are currently five Haemophilus influenzae type b (Hib) vaccines available in the United States for use in the primary vaccination series and/or for the booster dose. Few post-licensure safety studies of these vaccines have been conducted.

Objective:

To characterize adverse events (AEs) after Hib vaccines reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

Methods:

We searched VAERS for US reports after Hib vaccines among reports received from January 1, 1990-December 1, 2013. We reviewed a random sample of reports and accompanying medical records for reports classified as serious. All reports of death were reviewed. Physicians assigned a primary clinical category to each reviewed report. We used empirical Bayesian data mining to identify AEs that were disproportionally reported following Hib vaccines.

Results:

VAERS received 29,747 reports after Hib vaccines; 5,179 (17%) were serious, including 896 reports of deaths. Median age was 6 months (range 0-1022 months). Sudden infant death syndrome was the stated cause of death in 384 (51%) of 749 death reports with autopsy/death certificate records. The most common non-death serious AE categories were neurological conditions (80;37%), other non-infectious (46;22%) (comprised mainly of constitutional signs and symptoms); and gastrointestinal (39;18%). No new safety concerns were identified after clinical review of reports of AEs that exceeded the data mining statistical threshold.

Conclusions:

Review of VAERS reports did not identify any new or unexpected safety concerns for Hib vaccines.


Subject:
[+]
Adverse Drug Reaction Reporting Systems
Bacterial Capsules
Bayes Theorem
Child
Child, Preschool
Female
Follow-Up Studies
Haemophilus Infections
Haemophilus Influenzae Type B
Haemophilus Vaccines
Humans
Infant
Infant, Newborn
Male
Retrospective Studies
Risk Assessment
Survival Rate

Source:
J Pediatr. 166(4):992-997
Pubmed ID:
25598306
Pubmed Central ID:
PMC6500451
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States
Place as Subject:
United States
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:4ca5bf4a65b23f2af6373d5d83a3aeeeb32549d72b6818c74cadc38c53530616
File Type:

Supporting Files

• nihms-1025290.nxml

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