Is there any harm in administering extra-doses of vaccine to a person? Excess doses of vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2007–2017

Abstract

BackgroundThe administration of an extra dose of a vaccine may occur due to a programmatic error (e.g., vaccination error) when there is need to provide one of the antigens of a combination vaccine not readily available as a single antigen, or when there is need to provide immunization in a person with uncertain vaccination histories (e.g., refugees). There is little data available on the safety of an extra dose of vaccine. ObjectiveTo assess for the presence of adverse events (AEs) most commonly reported following the administration of excess doses of vaccine in the Vaccine Adverse Event Reporting System (VAERS). MethodsWe searched VAERS for US reports where an excess dose of vaccine was administered to a person received from 1/1/2007 through 1/26/2018. We reviewed medical records for all serious reports and a random sample of non-serious reports. The most common AEs among reports of excess dose of vaccine administered were compared with the corresponding AEs for all vaccines reported to VAERS during the same period. ResultsOut of 366,815 total VAERS reports received, 5067 (1.4%) reported an excess dose of vaccine was administered; 3898 (76.9%) did not describe an adverse health event (AHE). The most common vaccines reported were trivalent inactivated influenza (15.4%), varicella (13.9%), hepatitis A (11.4%), and measles, mumps, rubella, varicella (11.1%). Among reports where only AHEs were reported, the most common were pyrexia (12.8%), injection site erythema (9.7%), injection site pain (8.9%), and headache (6.6%). The percentage of AHEs among these reports was comparable to all reports submitted to VAERS during the same study period. ConclusionMore than three-fourths of reports of an excess dose of vaccine did not describe an AHE. Among reports where an AHE event was reported, we did not observe any unexpected conditions or clustering of AEs.