Reports of anaphylaxis after coronavirus disease 2019 vaccination, South Korea, 26 February to 30 April 2021

Lee, Eun‐Ju; Lee, Yeon-kyeong; Kim, Tae Eun; Hwang, Insob; Jung, Yeon Haw; Lee, Hye Ryeon; Song, Jeongsuk; Park, Young-Joon; Cho, Enhi

doi:10.2807/1560-7917.es.2021.26.33.2100694

Cited by 11 publications

(20 citation statements)

References 4 publications

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“…Next, we excluded 215 records after titles and abstracts screening and 18 after full-text screening. Finally, our meta-analysis contains 2 research letters from Japan [ 30 ] and U.S. [ 31 ], an interim analysis from 8 data-contributing health plans in the U.S. [ 32 ], and 5 reports from U.S. [ 33 – 35 ], South Korea [ 36 ] and Japan [ 37 ]. Additionally, we used data from 4 databases that contain information about anaphylaxis and anaphylactoid reaction incidence after COVID-19 vaccination of population in the European Union [ 23 ], U.S. [ 25 ], Canada [ 26 ] and United Kingdom [ 27 ].…”

Section: Resultsmentioning

confidence: 99%

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The risk of anaphylaxis behind authorized COVID-19 vaccines: a meta-analysis

Sobczak

Pawliczak

2022

Clin Mol Allergy

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Background A serious allergic reaction that may occur in response to medical products is anaphylaxis, which potentially can lead to anaphylactic shock. In the light of recent COVID-19 pandemic, much public attention had been paid to the severe allergic reactions occurring after COVID-19 vaccination. Therefore, in our study we would like to investigate the risk of authorized COVID-19 vaccines to induce anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and anaphylactoid shock. Methods We searched databases, such as PubMed, Web of Science and Embase and found eight articles about the incidence of anaphylactic and anaphylactoid reactions. Also, we used data from four databases from Canada, the U.S., the European Union and the United Kingdom. To calculate effect sizes, we used random effects model with inverse variance method. The risk ratio with 95% confidence interval were used for dichotomous outcomes. Statistical analysis was prepared in R. Results were considered statistically significant at p < 0.05. Results The most cases of anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and anaphylactoid shock were reported in female aged 18–85 years after BNT162b2 vaccine according to data from the EU. Analyzed COVID-19 vaccines can cause the anaphylaxis/anaphylactic reaction with risk of 106.99 (95% CI [39.95; 286.57], p < 0.0001, I2 = 59%), whereas the anaphylactoid reaction, anaphylactic and anaphylactoid shocks with risk of 113.3 (95% CI [28.11; 456.53], p < 0.0001), 344.2 (95% CI [85.77; 1381.39], p < 0.0001), 14.9, 95% CI [1.96; 112.79], p = 0.009), respectively. Conclusions Our meta-analysis shows that the risk of anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and anaphylactoid shock do not occur only after mRNA COVID-19 vaccines. Therefore, vaccination centers should be prepared to render assistance in the event of a reaction in all cases.

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Section: Resultsmentioning

confidence: 99%

“…A few reports [ 36 , 37 ] and database [ 27 ] reported the cases of anaphylaxis and anaphylactoid reactions after BNT162b and ChAdOx1 nCoV-19 vaccines. As shown Fig.…”

Section: Resultsmentioning

confidence: 99%

The risk of anaphylaxis behind authorized COVID-19 vaccines: a meta-analysis

Sobczak

Pawliczak

2022

Clin Mol Allergy

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“…The characteristics of the 353,535 adverse events reported on the COVID-19 vaccination management system were analyzed by sex, age, and vaccine type. Suspected cases of anaphylaxis were classified into 5 levels using the World Health Organization Brighton Collaboration definition, and cases of levels 1 through 3 were classified as anaphylaxis [4]. Since the current activity was conducted and authorized by the Korea Disease Control and Prevention Agency, the purpose was to disseminate information to the public, and the data are presented in aggregated format, the current study falls under a category of exemptions from the government regulations for ethical board review.…”

Section: Methodsmentioning

confidence: 99%

COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021

Hwang

Park

Kim

et al. 2021

Osong Public Health Res Perspect

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Objectives: This study aimed to present data on reported adverse events following coronavirus disease 2019 (COVID-19) vaccination in Republic of Korea from February 26 to October 31, 2021, and to determine whether any significant patterns emerged from an analysis of the characteristics of suspected adverse event cases for each type of vaccine.Methods: Adverse events following COVID-19 vaccination reported by medical doctors and forensic pathologists were analyzed. Cases of suspected anaphylaxis were classified using the Brighton Collaboration definition.Results: By October 31, 2021, a total of 353,535 (0.45%) adverse events were reported after 78,416,802 COVID-19 vaccine doses. Of the adverse events, 96.4% were non-serious and 3.6% were serious. The most frequently reported adverse events were headache, myalgia, and dizziness. Of the 835 reported deaths after COVID-19 vaccination, 2 vaccine-related deaths were confirmed. Suspected anaphylaxis was confirmed in 454 cases using the Brighton Collaboration definition.Conclusion: The commonly reported symptoms were similar to those described in clinical trials. Most reported adverse events were non-serious, and the reporting rate of adverse events following COVID-19 vaccination was higher in women than in men (581 vs. 315 per 100,000 vaccinations). Confirmed anaphylaxis was reported in 5.8 cases per 1,000,000 vaccinations.

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“…Proposed mechanisms of allergic reactions to these 2 COVID-19 vaccines include IgE- and non-IgE-mediated reactions, mast cell and complement activation, and delayed hypersensitivity [ 56 , 57 ]. Compared to an estimated rate of anaphylaxis of 2.2 per million doses of CoronaVac [ 57 ], the administration of BNT162b2 was associated with higher rates of anaphylaxis, ranging from 4.7 to 13.7 per million doses, which could vary depending on the priority groups for vaccination [ 15 , 58 , 59 ]. Consistent with previous observations that anaphylaxis was clinically manifested more frequently after the first dose of either vaccine [ 57 , 59 ], it remains to be determined if these events would be considered anaphylaxis with previous sensitization to specific components of the vaccines, or anaphylactoid reactions occurring on their first exposure [ 60 ].…”

Section: Discussionmentioning

confidence: 99%

Adverse events of special interest and mortality following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines in Hong Kong: A retrospective study

et al. 2022

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Background Safety monitoring of coronavirus disease 2019 (COVID-19) vaccines is crucial during mass vaccination rollout to inform the choice of vaccines and reduce vaccine hesitancy. Considering the scant evidence directly comparing the safety profiles of mRNA and inactivated SARS-CoV-2 vaccines, this territory-wide cohort study aims to compare the incidence of various adverse events of special interest (AESIs) and all-cause mortality between CoronaVac (inactivated vaccine) and BNT162b2 (mRNA-based vaccine). Our results can help vaccine recipients make an informed choice. Methods and findings A retrospective, population-based cohort of individuals who had received at least 1 dose of BNT162b2 or CoronaVac from 23 February to 9 September 2021 in Hong Kong, and had data linkage to the electronic medical records of the Hong Kong Hospital Authority, were included. Those who had received mixed doses were excluded. Individuals were observed from the date of vaccination (first or second dose) until mortality, second dose vaccination (for first dose analysis), 21 days after vaccination, or 30 September 2021, whichever came first. Baseline characteristics of vaccinated individuals were balanced between groups using propensity score weighting. Outcome events were AESIs and all-cause mortality recorded during 21 days of post-vaccination follow-up after each dose, except anaphylaxis, for which the observation period was restricted to 2 days after each dose. Incidence rate ratios (IRRs) of AESIs and mortality comparing between CoronaVac and BNT162b2 recipients were estimated after each dose using Poisson regression models. Among 2,333,379 vaccinated individuals aged 18 years or above, the first dose analysis included 1,308,820 BNT162b2 and 955,859 CoronaVac recipients, while the second dose analysis included 1,116,677 and 821,560 individuals, respectively. The most frequently reported AESI among CoronaVac and BNT162b2 recipients was thromboembolism (first dose: 431 and 290 per 100,000 person-years; second dose: 385 and 266 per 100,000 person-years). After the first dose, incidence rates of overall AESIs (IRR = 0.98, 95% CI 0.89–1.08, p = 0.703) and mortality (IRR = 0.96, 95% CI 0.63–1.48, p = 0.868) associated with CoronaVac were generally comparable to those for BNT162b2, except for Bell palsy (IRR = 1.95, 95% CI 1.12–3.41, p = 0.018), anaphylaxis (IRR = 0.34, 95% CI 0.14–0.79, p = 0.012), and sleeping disturbance or disorder (IRR = 0.66, 95% CI 0.49–0.89, p = 0.006). After the second dose, incidence rates of overall AESIs (IRR = 0.97, 95% CI 0.87–1.08, p = 0.545) and mortality (IRR = 0.85, 95% CI 0.51–1.40, p = 0.516) were comparable between CoronaVac and BNT162b2 recipients, with no significant differences observed for specific AESIs. The main limitations of this study include residual confounding due to its observational nature, and the possibility of its being underpowered for some AESIs with very low observed incidences. Conclusions In this study, we observed that the incidences of AESIs (cumulative incidence rate of 0.06%–0.09%) and mortality following the first and second doses of CoronaVac and BNT162b2 vaccination were very low. The safety profiles of the vaccines were generally comparable, except for a significantly higher incidence rate of Bell palsy, but lower incidence rates of anaphylaxis and sleeping disturbance or disorder, following first dose CoronaVac versus BNT162b2 vaccination. Our results could help inform the choice of inactivated COVID-19 vaccines, mainly administered in low- and middle-income countries with large populations, in comparison to the safety of mRNA vaccines. Long-term surveillance on the safety profile of COVID-19 vaccines should continue.

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Reports of anaphylaxis after coronavirus disease 2019 vaccination, South Korea, 26 February to 30 April 2021

Cited by 11 publications

References 4 publications

The risk of anaphylaxis behind authorized COVID-19 vaccines: a meta-analysis

The risk of anaphylaxis behind authorized COVID-19 vaccines: a meta-analysis

COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021

Adverse events of special interest and mortality following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines in Hong Kong: A retrospective study

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