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ICD-10 anaphylaxis algorithm and the estimate of vaccine-attributable anaphylaxis incidence in Medicare.
Goud, Ravi; Thompson, Deborah; Welsh, Kerry; Lu, Michael; Loc, Julie; Lindaas, Arnstein; Arya, Deepa; Chillarige, Yoganand; Wernecke, Michael; MaCurdy, Thomas E; Kelman, Jeffrey A.
  • Goud R; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Ravi.Goud@fda.hhs.gov.
  • Thompson D; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Welsh K; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Lu M; Acumen LLC, Burlingame, CA, USA.
  • Loc J; Acumen LLC, Burlingame, CA, USA.
  • Lindaas A; Acumen LLC, Burlingame, CA, USA.
  • Arya D; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Chillarige Y; Acumen LLC, Burlingame, CA, USA.
  • Wernecke M; Acumen LLC, Burlingame, CA, USA.
  • MaCurdy TE; Acumen LLC, Burlingame, CA, USA; Stanford University Department of Economics, Stanford, CA, USA.
  • Kelman JA; Centers for Medicare & Medicaid Services, Washington, DC, USA.
Vaccine ; 39(38): 5368-5375, 2021 09 07.
Article in English | MEDLINE | ID: covidwho-1377852
ABSTRACT

BACKGROUND:

Anaphylaxis is a rare, serious allergic reaction. Its identification in large healthcare databases can help better characterize this risk.

OBJECTIVE:

To create an ICD-10 anaphylaxis algorithm, estimate its positive predictive values (PPVs) in a post-vaccination risk window, and estimate vaccination-attributable anaphylaxis rates in the Medicare Fee For Service (FFS) population.

METHODS:

An anaphylaxis algorithm with core and extended portions was constructed analyzing ICD-10 anaphylaxis claims data in Medicare FFS from 2015 to 2017. Cases of post-vaccination anaphylaxis among Medicare FFS beneficiaries were then identified from October 1, 2015 to February 28, 2019 utilizing vaccine relevant anaphylaxis ICD-10 codes. Information from medical records was used to determine true anaphylaxis cases based on the Brighton Collaboration's anaphylaxis case definition. PPVs were estimated for incident anaphylaxis and the subset of vaccine-attributable anaphylaxis within a 2-day post-vaccination risk window. Vaccine-attributable anaphylaxis rates in Medicare FFS were also estimated.

RESULTS:

The study recorded 66,572,128 vaccinations among 21,685,119 unique Medicare FFS beneficiaries. The algorithm identified a total of 190 suspected anaphylaxis cases within the 2-day post-vaccination window; of these 117 (62%) satisfied the core algorithm, and 73 (38%) additional cases satisfied the extended algorithm. The core algorithm's PPV was 66% (95% CI [56%, 76%]) for identifying incident anaphylaxis and 44% (95% CI [34%, 56%]) for vaccine-attributable anaphylaxis. The vaccine-attributable anaphylaxis incidence rate after any vaccination was 0.88 per million doses (95% CI [0.67, 1.16]).

CONCLUSION:

The ICD-10 claims algorithm for anaphylaxis allows the assessment of anaphylaxis risk in real-world data. The algorithm revealed vaccine-attributable anaphylaxis is rare among vaccinated Medicare FFS beneficiaries.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / Anaphylaxis Type of study: Incidence study / Prognostic study / Risk factors Limits: Aged / Humans Country/Region as subject: North America Language: English Journal: Vaccine Year: 2021 Document Type: Article

Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / Anaphylaxis Type of study: Incidence study / Prognostic study / Risk factors Limits: Aged / Humans Country/Region as subject: North America Language: English Journal: Vaccine Year: 2021 Document Type: Article