<i>Notes from the Field</i>: Errors in Administration of an Excess Dosage of Yellow Fever Vaccine — United States, 2017

McNeil, Michael M.; Hibbs, Beth; Miller, Elizabeth M.; Cano, Maria

doi:10.15585/mmwr.mm6703a6

Cited by 3 publications

(2 citation statements)

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“…Undetected errors result in failure to revaccinate, potentially propagating the spread of disease [5,15]. Lack of protection from and spread of otherwise preventable disease due to incorrect preparation and administration of 2-component vaccines is a public health concern, which may be prevented with risk-reducing strategies [3,5,15,16].…”

Section: Us Error Reporting For 2-component Vaccinesmentioning

confidence: 99%

Strategies to Reduce Errors Associated with 2-Component Vaccines

et al. 2020

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The high incidence of error reports received by the US Food and Drug Administration (FDA) involving 2-component vaccines led to collaboration between the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). This collaborating group sought to further understand errors associated with all 2-component vaccines (i.e. vaccine components provided by the manufacturer in physically separate containers) and to provide safe practice strategies for storing, preparing, dispensing, and administering these vaccines as intended. Fourteen available 2-component vaccines were identified. The ISMP National Vaccine Errors Reporting Program (VERP) and the FDA Vaccine Adverse Event Reporting System (VAERS) were searched from the initiation of each respective reporting system through December 31, 2019. The three vaccines with the most reported reconstitution errors in the VERP and VAERS are Menveo ® (meningococcal), Pentacel ® (DTaP, Polio, Haemophilus influenzae type b), and ActHIB ® [H. influenzae type b (Hib)]. Manufacturers should design labeling and packaging of vaccines to provide ease of storage and fail-safe preparation to prevent 2-component vaccine errors. Implementing risk reduction strategies, such as training healthcare professionals and affixing storage bin labels, remind healthcare professionals to mix the 2-components and facilitate appropriate administration. Jeanne Tuttle: Retired from Pharmacy Benefits Management Services.

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Section: Us Error Reporting For 2-component Vaccinesmentioning

confidence: 99%

Strategies to Reduce Errors Associated with 2-Component Vaccines

et al. 2020

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“…There are few other studies evaluating the safety of excess doses of any given vaccine. One recent report documented the administration of a five-fold higher dose of yellow fever vaccine to each of four persons in a military clinic [22]. Only one reported symptoms, which included abdominal pain and arm pain and which resolved following supportive intravenous fluid treatment.…”

Section: Discussionmentioning

confidence: 99%

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

Moro

Araña

Marquez

et al. 2019

Vaccine

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Background: The 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. Objective: To 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). Methods: We 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. Results: Out 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. Conclusion: More 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.

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