Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Apr;166(4):992-7.
doi: 10.1016/j.jpeds.2014.12.014. Epub 2015 Jan 15.

Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013

Pedro L Moro  1 , Christopher Jankosky  2 , David Menschik  2 , Paige Lewis  3 , Jonathan Duffy  3 , Brock Stewart  3 , Tom T Shimabukuro  3
Affiliations

Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013

Pedro L Moro et al. J Pediatr. 2015 Apr.

Abstract

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

Study design: We searched VAERS for US reports after Hib vaccines among reports received from January 1, 1990, to 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 after Hib vaccines.

Results: VAERS received 29,747 reports after Hib vaccines; 5179 (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 nondeath serious AE categories were neurologic (80; 37%), other noninfectious (46; 22%) (comprising mainly constitutional signs and symptoms); and gastrointestinal (39; 18%) conditions. No new safety concerns were identified after clinical review of reports of AEs that exceeded the data mining statistical threshold.

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

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: None of the authors have a conflict of interest.

Similar articles

See all similar articles

Cited by

References

    1. CDC. FDA Approval of USe of a New Haemophilus b Conjugate Vaccine and a Combined Diphtheria-Tetanus-Pertussis and Haemophilus b Conjugate Vaccine for Infants and Children. MMWR 1993;42:296–8. http://www.cdc.gov/mmwr/preview/mmwrhtml/00020301.htm Accessed February 15, 2014 - PubMed
    1. CDC. Prevention and Control of Haemophilus influenzae Type b Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2014;63(No. RR-1) available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6301a1.htm?s_cid=rr6301a1_e - PubMed
    1. Pedvaxhib package insert http://www.merck.com/product/usa/pi_circulars/p/pedvax_hib/pedvax_pi.pdf. Accessed February 15, 2014
    1. Acthib package insert https://www.vaccineshoppe.com/image.cfm?doc_id=11167&image_type=product_pdf. Accessed February 15, 2014
    1. CDC. Licensure of a Haemophilus influenzae Type b (Hib) Vaccine (Hiberix) and Updated Recommendations for Use of Hib Vaccine. MMWR 2009;58:1008–9. - PubMed

Publication types

Substances