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

Details

• Alternative Title:
  J Pediatr
• Personal Author:
  Moro, Pedro L. ; Jankosky, Christopher ; Menschik, David ; Lewis, Paige ; Duffy, Jonathan ; Stewart, Brock ; Shimabukuro, Tom T.
• 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.
  
  
• Subjects:
  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 United States

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• Keywords:
  Epidemiology Haemophilus Influenzae Type B (Hib) Vaccines Surveillance Vaccine Safety
• Source:
  J Pediatr. 166(4):992-997
• Pubmed ID:
  25598306
• Pubmed Central ID:
  PMC6500451
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHSUnited States/
• Volume:
  166
• Issue:
  4
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:7d874016263cb58495a73147ec7c7892d47159c90525812a7f03b78a001419e8ad3c3339a014b512252c66488ee4dc9f264c3a6f8eb5722c9f096309678dd5b3
• Download URL:
  https://stacks.cdc.gov/view/cdc/78342/cdc_78342_DS1.pdf
• File Type:
  [PDF - 83.98 KB ]