Risk of anaphylaxis after vaccination in children and adults.
Open accessAbstract
Background Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children.Objective We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis.Methods Using health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines.Results We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a nonsignificant female predominance. Vaccine-specific rates included 1.35 (95% CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95% CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases).Conclusion Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat.
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Anaphylaxis is an established rare but life-threatening side effect of vaccines, with a rate of 1.31 (95% CI, 0.90-1.84) per million vaccine doses and no deaths in recent US data.
“Anaphylaxis is example of an established rare but life threatening side effect of vaccines with the most recent United States data from the vaccine safety data link identifying a rate of anaphylaxis of 1.31 (95% CI, 0.90–1.84) per million vaccine doses and no deaths (McNeil et al., 2016).”
From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as McNeil et al., 2016
Anaphylaxis rates after mRNA COVID-19 vaccines are about two- to fourfold more than is typically seen with more traditional vaccines.
“which is about two- to fourfold more than is typically seen with more traditional vaccines214.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [214]
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- Authors
- McNeil, M. M., Weintraub, E. S., Duffy, J., Sukumaran, L., Jacobsen, S. J., Klein, N. P., Hambidge, S. J., Lee, G. M., Jackson, L. A., Irving, S. A., King, J. P., Kharbanda, E. O., Bednarczyk, R. A., & DeStefano, F.
- Affiliations
- Centers for Disease Control and Prevention (US)
- Kaiser Permanente (US)
- Harvard University (US)
- Kaiser Permanente Washington Health Research Institute (US)
- Marshfield Clinic Research Foundation (US)
- HealthPartners (US)
- Emory University (US)
- Corresponding author
- McNeil, Michael M.
- ORCID
- Venue
- Journal of Allergy and Clinical Immunology
- Publisher
- Elsevier BV
- Published
- 2016-03
- Volume
- 137
- Issue
- 3
- Pages
- 868-878
- ISSN
- 0091-6749 (ISSN-L)
- PMC
- PMC4783279
- OpenAlex
- W1918065319
- Cited by
- 381
- References
- 54
- Citations by year
- 2026: 20 · 2025: 15 · 2024: 34 · 2023: 41 · 2022: 67 · 2021: 91 · 2020: 23 · 2019: 31 · 2018: 25 · 2017: 17 · 2016: 15 · 2015: 1 · 2013: 1
- FWCI
- 17.08
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Allergy and Clinical Immunology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (CC999999)
- National Institute of Allergy and Infectious Diseases (T32AI074492)
- Topics
- Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
- Keywords
- vaccine anaphylaxis, vaccine safety, inactivated influenza vaccine, trivalent influenza vaccine, monovalent influenza vaccine, children, adults, symptom onset timing
- MeSH terms
- Adolescent, Adult, Aged, Anaphylaxis, Child, Child, Preschool, Female, Humans, Male, Middle Aged, Risk, Vaccination, Vaccines, Incidence, Young Adult
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