Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System

Abstract

Background Vaccination against coronavirus disease 2019 (COVID-19) is underway globally to prevent the infection caused by the severe acute respiratory syndrome coronavirus 2. We aimed to investigate the adverse events following immunization (AEFIs) for COVID-19 among healthcare workers (HCWs). Methods This was a retrospective study of the AEFIs associated with the first dose of the ChAdOx1 nCoV-19 vaccine at the Kosin University Gospel Hospital from March 3 to March 22, 2021. We investigated the systemic and local adverse events during the 7 days following the vaccination using the Mobile Vaccine Adverse Events Reporting System (MVAERS) developed by our hospital. Results A total of 1,503 HCWs were vaccinated, and the data of 994 HCWs were reported in the MVAERS. The most commonly reported AEFIs were tenderness at the injection site (94.5%), fatigue (92.9%), pain at the injection site (88.0%), and malaise (83.8%). The severity of most AEFIs was mild-to-moderate, and the severity and number of AEFIs were less in the older age group. There were no serious events requiring hospitalization, and most AEFIs improved within a few days. Conclusion The AEFIs associated with the ChAdOx1 nCoV-19 vaccine were tolerable, and the use of the MVAERS was helpful in monitoring the AEFIs. The use of MVAERS will help in sharing accurate and ample information about vaccination against COVID-19.

ChAdOx1 nCoV-19 vaccine and its self-reported adverse events: a cross-sectional study from Western Nepal

“…10 A retrospective study from Korea included 994 health care workers who took the ChAdOx1 nCoV-19 vaccine (where the data was collected using mobile vaccine adverse events reporting system), has also shown that the severity of most AEFIs to be mild-to-moderate and the severity of AEFI to be less in older age group. 11 Our study has shown that the severity of AEFI was moderate in intensity in the majority of the population. The chances of moderate AEFI were found to vary with age and sex significantly in binary logistic regression.…”

COVID-19 Vaccine-associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group

“…40 Recently, 3 academic Korean hospitals have reported 2 prospective and 1 retrospective studies with healthcare workers (7,625, 1,483, and 1,503 subjects, respectively) who received COVID-19 vaccines (Pfizer-BioNTech or Oxford-AstraZeneca) via survey or mobile adverse event reporting systems. 41 42 43 These studies suggested that adverse reactions to COVID-19 vaccination with the above 2 vaccines were mostly mild to moderate, and more frequently reported in female, younger age, and Oxford-AstraZeneca vaccinated groups. The drug permission requirement labels endorsed by the Korean Ministry of Food and Drug Safety state that the anaphylaxis risk of the 2 vaccines is unknown (non-assessable).…”

“…In principle, COVID-19 vaccination includes all subjects without contraindications. 43 46 It is recommended to exclude and delay vaccination if subjects have a current COVID-19 infection or fever ≥ 37.5°C. People who are pregnant or ≤18 years old are also excluded from the vaccination because of a lack of safety and efficacy data.…”

Emergency Department Utilization by In-hospital Healthcare Workers after COVID-19 Vaccination

“…Some members of the Korean Society of Emergency Medicine raised concerns that this public anxiety could eventually increase the number of ED visitors and cause difficulties in emergency patient care. However, although many studies of adverse events of vaccinations exist, 4 6 studies on the post-vaccination utilization of the ED are exceedingly rare. Fertel et al's study 8 briefly reported 380 ED visitors (due to reactions to COVID-19 vaccination) over 7 weeks, whereas 70.3% of cases required laboratory work, 61.6% were given intravenous medications, and 17.9% were hospitalized.…”

“…Many ED staff members have reported struggling to secure enough quarantine space for the treatment of febrile patients. Importantly, most systemic symptoms of post-vaccination patients resemble COVID-19 symptomatology 4 6 7 ; therefore, if nationwide vaccination begins, additional overcrowding is expected in the EDs. 7 Despite these concerns, studies on the adverse post-vaccination events are being conducted, but studies on these events, specifically within the context of ED utilization, remain scarce.…”