Deaths Reported to the Vaccine Adverse Event Reporting System, United States, 1997-2013

Abstract

Background: Vaccines are among the safest medical products in use today. Hundreds of millions of vaccinations are administered in the United States each year. Serious adverse reactions are uncommon. However, temporally associated deaths can occur following vaccination. Our aim was to characterize main causes of death among reports submitted to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous vaccine safety surveillance system.

Methods: We searched VAERS for US reports of death after any vaccination from 1 July 1997 through 31 December 2013. Available medical records, autopsy reports, and death certificates were reviewed to identify cause of death.

Results: VAERS received 2149 death reports, most (n = 1469 [68.4%]) in children. Median age was 0.5 years (range, 0-100 years); males accounted for 1226 (57%) reports. The total annual number of death reports generally decreased during the latter part of the study period. Most common causes of death among 1244 child reports with available death certificates/autopsy reports included sudden infant death syndrome (n = 544 [44%]), asphyxia (n = 74 [6.0%]), septicemia (n = 61 [4.9%]), and pneumonia (n = 57 [4.6%]). Among 526 adult reports, most common causes of death included diseases of the circulatory (n = 247 [46.9%]) and respiratory systems (n = 77 [14.6%]), certain infections and parasitic diseases (n = 62 [11.8%]), and malignant neoplasms (n = 20 [3.8%]). For child death reports, 79.4% received >1 vaccine on the same day. Inactivated influenza vaccine given alone was most commonly associated with death reports in adults (51.4%).

Conclusions: No concerning pattern was noted among death reports submitted to VAERS during 1997-2013. The main causes of death were consistent with the most common causes of death in the US population.

Keywords: death; epidemiology; surveillance; vaccine safety; vaccines.

Figure 1.

Trends in death reports in children (0–17 years old) and adults (≥18 years old) in the Vaccine Adverse Event Reporting System, 1 July 1997–31 December 2013.

Figure 2.

Trends in death reports by vaccine type in children aged 0–17 years, Vaccine Adverse Event Reporting System, 1 July 1997–31 December 2013. Only the most common vaccines associated with death reports are shown. Vaccines shown may be given alone or with other vaccines and may be single or combined antigen vaccines, so percentages of death reports in any given year may exceed 100%. Abbreviations: DTaP, diphtheria, tetanus, and acellular pertussis vaccine; DTaP-HepB-IPV, combination diphtheria, tetanus, and acellular pertussis, hepatitis B, and inactivated poliovirus vaccine; DTaP-IPV-Hib, combination diphtheria, tetanus, and acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine; HepB, hepatitis B vaccine; Hib, Haemophilus influenzae type b conjugate vaccine; IPV, inactivated poliovirus vaccine; PCV7, 7-valent pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; RV5, rotavirus vaccine ( pentavalent).