Epidemiology and Health

COVID-19: Original Article

Barriers to COVID-19 vaccine surveillance: the issue of under-reporting adverse events: Yunha Noh, Hwa Yeon Ko, Ju Hwan Kim, Dongwon Yoon, Young June Choe, Seung-Ah Choe, Jaehun Jung, Ju-Young Shin; Epidemiol Health. 2023;45:e2023054. Published online June 7, 2023; DOI: https://doi.org/10.4178/epih.e2023054

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Abstract Summary PDF Supplementary Material

Abstract

OBJECTIVES
This study investigated the reporting rates of adverse events following immunization (AEFIs) to the spontaneous reporting system (SRS) and its predictors among individuals with AEFIs after coronavirus disease 2019 (COVID-19) vaccination.

METHODS

A cross-sectional, web-based survey was conducted from December 2, 2021 to December 20, 2021, recruiting participants >14 days after completion of a primary COVID-19 vaccination series. Reporting rates were calculated by dividing the number of participants who reported AEFIs to the SRS by the total number of participants who experienced AEFIs. We estimated adjusted odds ratios (aORs) using multivariate logistic regression to determine factors associated with spontaneous AEFIs reporting.

RESULTS

Among 2,993 participants, 90.9% and 88.7% experienced AEFIs after the first and second vaccine doses, respectively (reporting rates, 11.6 and 12.7%). Furthermore, 3.3% and 4.2% suffered moderate to severe AEFIs, respectively (reporting rates, 50.5 and 50.0%). Spontaneous reporting was more prevalent in female (aOR, 1.54; 95% confidence interval [CI], 1.31 to 1.81); those with moderate to severe AEFIs (aOR, 5.47; 95% CI, 4.45 to 6.73), comorbidities (aOR, 1.31; 95% CI, 1.09 to 1.57), a history of severe allergic reactions (aOR, 2.02; 95% CI, 1.47 to 2.77); and those who had received mRNA-1273 (aOR, 1.25; 95% CI, 1.05 to 1.49) or ChAdOx1 (aOR, 1.62; 95% CI, 1.15 to 2.30) vaccines versus BNT162b2. Reporting was less likely in older individuals (aOR, 0.98; 95% CI, 0.98 to 0.99 per 1-year age increment).

CONCLUSIONS

Spontaneous reporting of AEFIs after COVID-19 vaccination was associated with younger age, female sex, moderate to severe AEFIs, comorbidities, history of allergic reactions, and vaccine type. AEFIs under-reporting should be considered when delivering information to the community and in public health decision-making.

Summary

Korean summary
본 연구는 국내 19-49세 성인을 대상으로, 코로나19 예방 백신 접종 후 이상반응 경험에 대한 자발적 보고율을 조사하고, 자발적 보고와 관련된 요인을 파악하고자 하였다. 2021년 12월 2일부터 20일까지 온라인 설문조사를 통하여 자료를 수집하였으며, 연구대상자는 코로나19 예방 백신의 기초접종을 완료한 후 2주 경과한 19-49세 성인으로, 전국 대표성을 확보하기 위해 성별, 연령, 지역별로 층화하여 모집하였다. 이상반응 자발적 보고율은 1차 접종과 2차 접종 후 각각 약 11.6%, 12.7%로 나타났으며, 중등도에서 중증의 이상반응에 대한 자발적 보고율은 약 50.5%, 50.0%로 나타났다. 이상반응 자발적 보고율 관련 영향요인으로는 젊은 연령층, 여성, 이상반응의 중증도, 동반질환, 알러지 반응 이력, 기초접종 백신 종류가 포함되었다.

Key Message
Spontaneous reporting rates of adverse events following immunization (AEFIs) against coronavirus disease 2019 (COVID-19) were low, at around 12 % of any AEFIs and 50 % of moderate-to-severe AEFIs. Younger age, female sex, severe AEFIs, comorbidities, history of allergic reactions, and the type of COVID-19 vaccine were associated with the AEFIs reporting.

Citations

Citations to this article as recorded by

The effect of covid vaccination on menstruation and attitude to the vaccine among Indian women – Results of a prospective survey
Anbukkani Subbian, Jeevithan Shanmugam, Uma Ram
Indian Journal of Obstetrics and Gynecology Research.2024; 11(1): 70. CrossRef

Review

Studies on the Association between Phenylpropanolamine (PPA) and Hemorrhagic Stroke in Other Countries.: Seung Mi Lee, Byung Woo Yoon, Byung Joo Park; Korean J Epidemiol. 2004;26(2):1-7.

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Abstract PDF: Abstract
OBJECTIVES
Phenylpropanolamine (PPA) had been used widely as cold remedies or appetite suppressants. However, products containing PPA were withdrawn in sequence in the US, Japan, and Korea due to the increased risk of hemorrhagic stroke. The purpose of this paper was to review safety issues related with the PPA use and hemorrhagic stroke in view of pharmacoepidemiology and pharmacovigilance.
METHODS
AND MATERIALS: Researches conducted for evaluating the association between the PPA use and hemorrhagic stroke in other countries were reviewed, which involved case reports, case series, case-control studies, and cohort studies.
RESULTS
In terms of pharmacologic and clinical features, PPA may increase the risk of hemorrhagic stroke through increased blood pressure, heart rate, or vasculitis. The association between the PPA use and hemorrhagic stroke among young women was suggested by case reports from spontaneous adverse events reporting systems or medical journals. The cohort study, using the large prescription database in the US and published in 1984, failed to reveal the association in the population aged below 65. The case-control study conducted as the Yale Hemorrhagic Stroke Project, published in 2000, was the first study to find the association between the PPA as appetite suppressants and hemorrhagic stroke among women ages 18-49 years by well-designed analytic epidemiological research. It led to withdrawal of all products containing PPA in the US and many other countries since 2000. However, the association between PPA and cerebral hemorrhage could not be confirmed by the case-control study conducted in Mexico due to inappropriate recruitment of control group.
CONCLUSIONS
During several years case reports have suggested that hemorrhagic stroke could be induced by PPA, and the Yale Hemorrhagic Stroke Project revealed the association by case-control study and provided a useful model for pharmacovigilance. Nevertheless, their finding could not be applied to other population such as elderly women and male population. And they could not provide any evidence on the association between PPA and stroke when PPA was used as cold remedy taken daily dose below 100mg.; Summary

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