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
- PMID: 31155414
- PMCID: PMC6925972
- DOI: 10.1016/j.vaccine.2019.04.088
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
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.
Keywords: Adverse event; Epidemiology; Excess dose; Extra dose; Surveillance; Vaccination errors; Vaccine safety.
Published by Elsevier Ltd.
Conflict of interest statement
Declaration of interest
The authors declare that there are no conflict of interest.
Similar articles
-
Safety of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the vaccine adverse event reporting system (VAERS) during July 1, 2021-June 30, 2022.Vaccine. 2023 Mar 10;41(11):1859-1863. doi: 10.1016/j.vaccine.2022.12.069. Epub 2023 Jan 9. Vaccine. 2023. PMID: 36669964 Free PMC article. Review.
-
Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020.J Infect Dis. 2022 Oct 21;226(Suppl 4):S431-S440. doi: 10.1093/infdis/jiac306. J Infect Dis. 2022. PMID: 36265846 Review.
-
Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018.Vaccine. 2019 Mar 7;37(11):1516-1520. doi: 10.1016/j.vaccine.2019.01.052. Epub 2019 Feb 7. Vaccine. 2019. PMID: 30739795
-
Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.Vaccine. 2018 Jan 25;36(4):559-564. doi: 10.1016/j.vaccine.2017.11.079. Epub 2017 Dec 11. Vaccine. 2018. PMID: 29241647
-
Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.MMWR Surveill Summ. 2003 Jan 24;52(1):1-24. MMWR Surveill Summ. 2003. PMID: 12825543
Cited by
-
A worldwide overview for hexavalent vaccines and a glimpse into Turkiye's perspective.Hum Vaccin Immunother. 2024 Dec 31;20(1):2345493. doi: 10.1080/21645515.2024.2345493. Epub 2024 May 23. Hum Vaccin Immunother. 2024. PMID: 38780074 Free PMC article. Review.
-
Predicting Dominant Genotypes in Norovirus Seasons in Japan.Life (Basel). 2023 Jul 27;13(8):1634. doi: 10.3390/life13081634. Life (Basel). 2023. PMID: 37629491 Free PMC article.
-
Are you vaccinated correctly? - Addressing the concerns surfacing over COVID-19 vaccination in India.J Family Med Prim Care. 2022 Jan;11(1):396-397. doi: 10.4103/jfmpc.jfmpc_1397_21. Epub 2022 Jan 31. J Family Med Prim Care. 2022. PMID: 35309615 Free PMC article. No abstract available.
-
Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1. MMWR Recomm Rep. 2021. PMID: 34292926 Free PMC article.
-
Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020.MMWR Recomm Rep. 2020 Jul 3;69(5):1-38. doi: 10.15585/mmwr.rr6905a1. MMWR Recomm Rep. 2020. PMID: 32614811 Free PMC article.
References
-
- Kroger AT, Duchin J, Vázquez M. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). [www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf]. Accessed on April 12, 2019.
-
- Midthun K, Horne AD, Goldenthal KL. Clinical safety evaluation of combination vaccines. Dev Biol Stand 1998;95:245–9. - PubMed
-
- Pichichero ME, Blatter MM, Reisinger KS, et al. Impact of a birth dose of hepatitis B vaccine on the reactogenicity and immunogenicity of diphtheriatetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b combination vaccination. Pediatr Infect Dis J 2002;21(9):854–9. 10.1097/01.inf.0000027669.37444.24. - DOI - PubMed
-
- CDC. Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 1997;46 (RR-8):1–24. - PubMed
-
- CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 1997;46(RR-7):1–25. - PubMed
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Medical