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Incidence and Risk Factors of Immediate Hypersensitivity Reactions and Immunization Stress-Related Responses With COVID-19 mRNA Vaccine.
Imai, Kazuo; Tanaka, Fumika; Kawano, Shuichi; Esaki, Kotoba; Arakawa, Junko; Nishiyama, Takashi; Seno, Soichiro; Hatanaka, Kosuke; Sugiura, Takao; Kodama, Yu; Yamada, Seigo; Iwamoto, Shinichiro; Takeshima, Shigeto; Abe, Nobujiro; Kamae, Chikako; Aono, Shigeaki; Ito, Toshimitsu; Yamamoto, Tetsuo; Mizuguchi, Yasunori.
  • Imai K; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Internal Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan; NBC Countermeasure Medical Unit, Japan Ground Self-Defence Force, Tokyo, Japan. Electronic address: k_imai@saitama-med.ac.jp.
  • Tanaka F; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Kawano S; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Internal Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Esaki K; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Internal Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan; NBC Countermeasure Medical Unit, Japan Ground Self-Defence Force, Tokyo, Japan.
  • Arakawa J; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Internal Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan; NBC Countermeasure Medical Unit, Japan Ground Self-Defence Force, Tokyo, Japan.
  • Nishiyama T; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Seno S; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Hatanaka K; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Sugiura T; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Kodama Y; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Yamada S; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Iwamoto S; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Takeshima S; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Abe N; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Internal Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan; NBC Countermeasure Medical Unit, Japan Ground Self-Defence Force, Tokyo, Japan.
  • Kamae C; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Eastern Army Medical Unit, Japan Ground Self-Defence Force, Tokyo, Japan.
  • Aono S; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Internal Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Ito T; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Internal Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
  • Yamamoto T; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; NBC Countermeasure Medical Unit, Japan Ground Self-Defence Force, Tokyo, Japan.
  • Mizuguchi Y; Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Urology, Self-Defence Forces Central Hospital, Tokyo, Japan.
J Allergy Clin Immunol Pract ; 10(10): 2667-2676.e10, 2022 10.
Article in English | MEDLINE | ID: covidwho-2028161
ABSTRACT

BACKGROUND:

With the implementation of mass vaccination campaigns against COVID-19, the safety of vaccine needs to be evaluated.

OBJECTIVE:

We aimed to assess the incidence and risk factors for immediate hypersensitivity reactions (IHSR) and immunization stress-related responses (ISRR) with the Moderna COVID-19 vaccine.

METHODS:

This nested case-control study included recipients who received the Moderna vaccine at a mass vaccination center, Japan. Recipients with IHSR and ISRR were designated as cases 1 and 2, respectively. Controls 1 and 2 were selected from recipients without IHSR or ISRR and matched (1 case 4 controls) with cases 1 and cases 2, respectively. Conditional logistic regression analysis was used to identify risk factors associated with IHSR and ISRR.

RESULTS:

Of the 614,151 vaccine recipients who received 1,201,688 vaccine doses, 306 recipients (cases 1) and 2478 recipients (cases 2) showed 318 events of IHSR and 2558 events of ISRR, respectively. The incidence rates per million doses were estimated as IHSR 266 cases, ISRR 2129 cases, anaphylaxis 2 cases, and vasovagal syncope 72 cases. Risk factors associated with IHSR included female, asthma, atopic dermatitis, thyroid diseases, and a history of allergy; for ISRR, the risk factors were younger age, female, asthma, thyroid diseases, mental disorders, and a history of allergy and vasovagal reflex.

CONCLUSION:

In the mass vaccination settings, the Moderna vaccine can be used safely owing to the low incidence rates of IHSR and anaphylaxis. However, providers should be aware of the occurrence of ISRR. Although recipients with risk factors are associated with slightly increased risks of IHSR and ISRR, this is not of sufficient magnitude to warrant special measures regarding their vaccination.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / 2019-nCoV Vaccine mRNA-1273 / Hypersensitivity, Immediate / Anaphylaxis Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: Asia Language: English Journal: J Allergy Clin Immunol Pract Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / 2019-nCoV Vaccine mRNA-1273 / Hypersensitivity, Immediate / Anaphylaxis Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: Asia Language: English Journal: J Allergy Clin Immunol Pract Year: 2022 Document Type: Article