Surveillance of Adverse Events Following Immunization (AEFI) after Third Dose Booster Vaccination with mRNA-Based Vaccine in Universitas Indonesia Hospital Health Personnel

Abstract

Facing the rising cases of with higher fatalities COVID-19, some countries decided to give the third dose of vaccine as a booster. As of 9 January 2022, 90.31% of health workers in Indonesia have received the third dose vaccine. This study aims to provide an evaluation of adverse events following immunization (AEFI) in a single center in Indonesia to form a basis for ensuring safety for booster administration nationally. A retrospective, cross-sectional study was conducted using an online survey. Demographic data, AEFI complaints, and factors influencing AEFIs were evaluated. In this study, there were a total of 311 subjects were gathered. The most common AEFI symptoms found at onset <24 h to 28 days were pain at the injection site, fever, shoulder pain, and headache. Most of the AEFI severity of <24 h to 28 days post-vaccination was grade 1 (reduced or uninterrupted daily activities). There was a significant correlation between AEFI and several factors, such as the history of drug allergy, exercise after vaccination, age, BMI < 25, history of symptoms after the first and second vaccinations, and history of COVID-19. There was no anaphylactic reaction in this study. Several AEFI should be considered for the third dose of COVID-19 vaccine administration.

Adverse events following immunization of mRNA-1273 (Moderna) booster vaccine in clerkship students

“…This study result is similar with the previous study by Pakki et al among health workers that 45.6% subjects were <35 years, which also indicated gender has no relationship with AEFI [12]. A study by Hidayat et al found that there was a significant relationship between the appearance of AEFI symptoms and a previous history of allergies [19]. Kadali et al also found a relationship between a history of COVID-19 infection and the AEFI in the mRNA-1273 vaccine [20].…”

“…AEFI is influenced by age and gender, but people with a history of allergies, comorbid diseases, and those with a history of COVID-19 infection may also experience an AEFI reaction after being vaccinated. According to Hidayat et al age <25 years was found to have a significant effect on the AEFI [19]. This finding is in line with another study stated that the AEFI, was higher in the younger age group than at the elderly age group [13], [32].…”

“…Based on to the value of Cronbach's alpha 0.75, the questionnaire was valid and reliable. The questionnaire was sent to the subject four times to evaluate the AEFI, they might have at 30 minutes, 24 hours, three day, and seven days after they received the booster vaccine [18], [19]. The descriptive and statistically analysis was performed using Microsoft Excel 2019 and SPSS 23.0.…”

“…The characteristics of these subjects are similar with the previous study related to AEFIs of the mRNA-1273 booster vaccine on health workers at Universitas Indonesia Hospital, Indonesia which consisted of 77.8% female and 22.2% male, while 31.5% were age <25. There were 10.5% had comorbidities, 19% had history of food allergy, 19 % had history of drug allergy, and 21.4% had history of COVID-19 [19]. Meanwhile another study in USA showed 89.35% were females and the remaining were males among mRNA-1273 vaccine recipients, with 6.02% belong to the age group between 18-30 years and the mean of the age was 43.76 years [20].…”

Measuring the importance of influencing factor for COVID-19 vaccination intention in China

“…As such, researchers have emphasized the need to enhance the perception of vaccine safety to promote vaccine uptake ( 56 ). To accurately reflect the safety profile of the vaccine, researchers suggest implementing surveillance programs of adverse events ( 57 , 58 ) and systematic use of causality assessment ( 59 ). By providing scientific and practical evidence for limitations and possible side effects, these programs could bolster the perceived vaccine safety and increase public confidence in the vaccination program.…”