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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.
Open accessAbstract
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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Vaccinating persons immune from natural infection carries no known risk, nor does giving extra doses of hepatitis A vaccine.
“Vaccinating persons immune from natural infection carries no known risk, nor does giving extra doses of hepatitis A vaccine (1307).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [1307]
The Results report that hepatitis A was among the vaccines given in excess, and the Conclusion says the VAERS review found no new or unexpected safety issues. But the Results also record adverse-health-event reports involving extra hepatitis A doses, so the paper does not establish that they carry no risk. It does not assess vaccination of people immune from natural infection. (LLM, conf=0.86)
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References 22 · Cited by 17
Research works printed but not linked: 2
- Kretsinger, 2006, MMWR Recomm Rep, 55, 1
- Food and Drug Administration, 1997, 21 CFR Part 600.80. Postmarketing reporting of adverse experiences, Fed Regist, 62, 52252
Metadata
- Authors
- Moro, P. L., Arana, J., Marquez, P. L., Ng, C., Barash, F., Hibbs, B. F., & Cano, M.
- Affiliations
- Centers for Disease Control and Prevention (US)
- Center for Biologics Evaluation and Research (US)
- Corresponding author
- Moro, Pedro L.
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 2019-06
- Volume
- 37
- Issue
- 28
- Pages
- 3730-3734
- ISSN
- 0264-410X (ISSN-L)
- PMC
- PMC6925972
- OpenAlex
- W2947950853
- Cited by
- 17
- References
- 22
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 3 · 2023: 3 · 2022: 2 · 2021: 1 · 2020: 3
- FWCI
- 1.11
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Vaccine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- CDC
- FDA
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Patient Safety and Medication Errors
- Health Sciences › Medicine › Emergency Medicine › Intramuscular injections and effects
- Keywords
- vaccine adverse events, VAERS, vaccination errors, combined vaccine, influenza vaccination, varicella vaccine, hepatitis A vaccine, measles-mumps-rubella-varicella vaccine, fever, injection site reactions, vaccine safety
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, United States, Vaccination, Vaccines, Adverse Drug Reaction Reporting Systems, Young Adult, Drug Overdose
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