key: cord-0705147-wqys5q02
authors: Song, Je Eun; Oh, Gang-Bok; Park, Hye Kyeong; Lee, Sung-Soon; Kwak, Yee Gyung
title: Survey of Adverse Events After The First Dose of The ChAdOx1 nCoV-19 Vaccine: A Single-Center Experience in Korea
date: 2021-07-22
journal: Infect Chemother
DOI: 10.3947/ic.2021.0044
sha: a0a5f53c46bfb28719c551e35c963e8d6ce2435b
doc_id: 705147
cord_uid: wqys5q02

Vaccination is an important strategy for controlling the coronavirus disease 2019 (COVID-19) pandemic. We conducted a web-based cross-sectional survey based on Google Forms to collect data on adverse events (AEs) after the first dose of the ChAdOx1 nCoV-19 vaccine for healthcare workers (HCWs). Among the 1,676 vaccinated HCWs, 59.5% (998/1,676) responded to the survey. In total, 809 (81.1%) respondents reported experiencing AEs. There were no serious AEs, such as anaphylaxis. The most common AE was pain at the injection site (76.2%), followed by fatigue (75.9%), myalgia (74.9%), and fever (58.4%). HCWs in the younger age group experienced significantly more AEs than in the older age group.

Conceptualization: SSL, YGK. Data curation: GBO, JES, HKP. Writing-original draft preparation: JES. Writing-review and editing: YGK, SSL. study was approved by the institutional review board of Inje University Ilsan Paik Hospital (IRB number: ISPAIK 2021-03-030), with a waiver of consent. Data on basic information such as age, sex, height, and weight as well as local AEs (pain at the injection site, redness, and swelling) and systemic AEs (fever, chills, myalgia, headache, arthralgia, nausea, vomiting, diarrhea, dizziness, and fatigue) after vaccination were collected. For fever, the onset, duration, body temperature, and use of antipyretics after vaccination were investigated. In the case of myalgia, headache, arthralgia, and pain at the injection site, the degree of pain was investigated using the numeric rating scale (NRS), which is an 11-point scale for the self-reporting of pain. NRS scores of 1 -5, 6 -7, and 8 -10 indicated mild, moderate, and severe pain, respectively [5] . The survey also contained questions about the duration of the longest lasting symptom after vaccination, regardless of the type of AE, and whether the HCWs had visited the outpatient clinic or emergency department due to AEs. Of the 998 respondents, 809 (81.1%) reported experiencing AEs. There were no serious AEs, such as anaphylaxis. The occurrence of AEs after vaccination was significantly related to age ( Table 1) . The rates of AEs by age group were as follows: 87.6%, 20 -29 years age group; 82.4%, 30 -39 age group; 83.2%, 40 -49 years age group; 68.9%, 50 -59 years age group; and 54.1%, 60 -64 years age group (P <0.001). AEs were more common in women (83.7%) than in men (71.7%) (P <0.001). The most common AEs were local symptoms, including pain at the injection site (76.2%, 760/998), followed by systemic symptoms, such as fatigue (75.9%, 757/998), myalgia (74.9%, 748/998), fever (58.4%, 583/998), headache (57.4%, 573/998), dizziness (44.7%, 446/998), nausea (28.9%, 288/998), and diarrhea (12.9%, 129/998) ( Fig. 1 ; Table 2 ). Among the 998 respondents, pain at the injection site (P <0.001), injection site swelling (P <0.001), injection site redness (P = 0.010), fatigue (P <0.001), myalgia (P <0.001), chills (P <0.001), fever (P <0.001), headache (P <0.001), dizziness (P <0.001), arthralgia (P = 0.001), and nausea (P <0.001) were more commonly reported in younger age groups ( Table 2) .

The characteristics of fever were analyzed in 583 respondents who reported having fever. Fever occurred within 12 h of injection in 50.9% (297/583) respondents, between 12 and 24 h in 44.6% (260/583) respondents, and after 24 h in 4.5% (26/583) respondents. The duration of fever was 2 In this study, all HCWs received the ChAdOx1 nCoV-19 vaccine. The ChAdOx1 nCoV-19 vaccine was developed by Oxford University in the United Kingdom. It is developed with a replication-deficient chimpanzee adenoviral vector ChAdOx1 and contains the SARS-CoV-2 structural surface glycoprotein antigen (spike protein nCoV-19) gene [1, 6] . According to a previous phase 2/3 ChAdOx1 nCoV-1 vaccine clinical trial, pain at the injection site (41.4%, 53/128) and tenderness (63.3%, 81/128) were the most common local AEs in the standarddose-vaccinated group [2] , as in our study. The reactogenicity was lower and the vaccine was more tolerable in older adults than in younger adults, with similar immunogenicity across age groups after a booster dose [2] .

The strength of this study is that it used large-scale data (998 respondents, corresponding to 58.8% vaccinated HCWs) and that it was possible to compare AEs across a range of adult ages. Among the respondents who reported experiencing AEs in this study, 94.6% respondents had self-limiting AEs that resolved without visiting an outpatient clinic or emergency department and were sufficiently controlled with acetaminophen. In a previous study, pain at the injection site and systemic pain were reported by fewer participants after prophylactic acetaminophen use [7] . The Korea Centers for Disease Control and Prevention has established a reporting system for COVID-19 vaccine-related AEs to monitor the occurrence of AEs after COVID-19 vaccination [8] , but there is a possibility that minor symptoms may not be reported via this system. Although the relationship between BMI and AEs of COVID-19 vaccine is not clear, a recent study reported that humoral response was more efficient in the underweight and normal-weight groups than in the pre-obesity and obesity groups after the second dose of the BNT162b2 vaccine [9] . More research is needed on the relationship between BMI and AEs or vaccine efficacy. The results of this study are meaningful for predicting AEs that may occur when vaccinating the entire community.

Since AEs were not investigated prospectively and not all vaccinated HCWs participated, the accuracy of the data in this study may be limited. In addition, we cannot completely rule out the possibility that a single HCW may have responded to the questionnaire multiple times because of the anonymous survey. However, our results showed that a large number of vaccinated HCWs experienced AEs; thus, preparation to manage this issue is necessary. Furthermore, follow-up investigations after the second vaccination will also be meaningful.

After the first dose of the COVID-19 vaccine, a significant number of HCWs developed fever and pain at the injection site. AEs were more frequent in young HCWs. Therefore, before the second dose of COVID-19 vaccination, sufficient education and preparation are needed.

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We would like to express our gratitude to all respondents and HCWs of Inje University Ilsan Paik Hospital.