Food, drug, insect sting allergy, and anaphylaxis
Risk of anaphylaxis after vaccination in children and adults

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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.

Section snippets

Study population

Our study population included all children and adults enrolled in the health plans at 9 VSD sites who received 1 or more vaccines during the period from January 1, 2009 through December 31, 2011. Currently, the VSD has data on approximately 9.3 million subjects available annually, including 2.1 million children and 7.2 million adults.13 The participating VSD sites maintain automated databases of health care encounters, including immunization registries with detailed information on vaccines

Results

From January 1, 2009 through December 31, 2011, we identified a total of 17,606,500 vaccination visits at which a total 25,173,965 vaccine doses were administered. Among all visits, 1,117 potential anaphylaxis cases were identified by using electronic data. We identified 76 cases of chart-confirmed anaphylaxis (Brighton Levels 1 and 2); 33 anaphylaxis cases were associated with vaccination, and 43 were attributed to other causes.

Characteristics of the 33 cases of postvaccination anaphylaxis are

Discussion

In a large population-based study with extensive case finding, we identified 33 confirmed cases of anaphylaxis after administration of 25,173,965 vaccine doses or 1.31 (95% CI, 0.90-1.84) cases per million vaccine doses. With the largest number of doses and the largest number of cases, inactivated TIV was the major contributor to the number of vaccine-triggered anaphylaxis cases in the population, although the rate (1.35 [95% CI, 0.65-2.47] cases per million vaccine doses of TIV given alone)

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  • Cited by (0)

    The findings and conclusions of this report are those of the authors and do not necessarily represent the official policy or position of the Centers for Disease Control and Prevention (CDC). Use of trade names and commercial sources is for identification only and does not imply endorsement by the CDC. The Vaccine Safety Datalink Project is funded by the CDC. This study was supported by the CDC, and no external funding was secured.

    Disclosure of potential conflict of interest: L. Sukumaran has received research support from the National Institutes of Health (NIH). N. P. Klein has received research and travel support, as well as payment for writing/reviewing the manuscript, from the Centers for Disease Control and Prevention (CDC) and has received research support from Sanofi Pasteur, GlaxoSmithKline, Novartis, MedImmune, Protein Science, Merck, Pfizer, and Nuron Biotech. S. J. Hambidge has received research support from the CDC Vaccine Safety Datalink. G. M. Lee and L. A. Jackson have received research support from the CDC. S. A. Irving has received research and travel support from the CDC. J. P. King has received research support from the CDC. The rest of the authors declare that they have no relevant conflicts of interest.

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