Reporting of Adverse Events due to the COVID-19 Vaccine at Sriboonruang Hospital in Nong Bua Lamphu Province, Thailand

Abstract

Background: The increasing COVID-19 pandemic has prompted more vaccinations. These vaccines were being developed and produced urgently. There was still limited information, as well as a lack of information on its use in clinical practise, especially in Thailand, including available adverse event information that was only available from the manufacturer. The researchers therefore foresee the benefit of the adverse event data found in each vaccine for surveillance and protection.

Objective: To research the frequency and attribute of adverse event following COVID-19 immunization.

Methods: This research was a cross-sectional descriptive study from 1 June to 1 December 2021, using adverse event data recorded from the Patient Monitoring Services Information System database (HOSxP) of Sriboonruang Hospital, Nong Bua Lamphu Province, Thailand. It was analyzed by breaking down the data into frequency and percentage.

Result: A total of 82,349 doses were recruited, and 646 cases were reported following immunisation. The prevalence was 784.47 cases per 100,000 doses. AstraZeneca^® was the most frequent; the prevalence of AstraZeneca^® was 843.39 cases per 100,000 doses. A total of 37 serious adverse events were identified: 19 (51.3%) cases related with Coronavac^®, 16 (43.2%) cases from Aztrazeneca^®, and 2 (5.4%) cases from Comirnaty^TM. Two deaths-acute liver failure associated with the AstraZeneca^® vaccine, and acute leukemia (severe thrombocytopenia) from Coronavac^®, were considered probable. In addition, most common serious adverse events were stroke: 12 cases, from Coronavac^® 8 (66.7%), and 4 cases from Aztrazeneca^® (33.33%). The first dose found more severe adverse events than other doses. A total of 609 non-serious adverse events were identified, of which 1,251 symptoms were reported. The top 10 most common adverse events were classified as dizziness, accounting for 11.26% of the total number of events. It was followed by headache (9.90), nausea (9.27), myalgia (7.75), colic (7.59), chest tightness (6.47), numbness (4.48), fever (4.71), injection site pain (3.91), and rash (3.43), respectively.

Conclusion: Prevalence of adverse events occurring after the COVID-19 vaccination compared to the amount of vaccine injected was low. The majority of adverse events were non-serious. However, serious adverse events, although rare, were life-threatening and caused disability Therefore, it is necessary to follow up and be vigilant in order to prevent incident that may occur.