Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), or 2019 coronavirus disease (COVID-19), was declared as pandemic in early 2020. While several studies reported the short-term adverse events (AE) of the mRNA COVID-19 vaccines, medium-term AE have not been extensively evaluated. This study aimed to evaluate the 6-month side effect profiles of the BNT162b2 mRNA vaccine.
Methods: This was a descriptive cross-sectional study conducted in a tertiary hospital. Hospital workers who received two doses of the Cominarty (BNT162b2) mRNA vaccine, six months post-vaccination, were invited to participate in this study. All participants completed a self-reported survey assessing AEs occurrence and severity, duration of onset and recovery and if they previously reported these AEs.
Results: Of the 670 respondents who completed the survey, 229 (34.2%) experienced at least one AEs, with a total of 937 AEs reported during the 6-month period. After the first dose, the most common reported localized symptoms were pain (n = 106, 27.2%), swelling (n = 38, 9.8%) and erythematous (n = 12, 3.1%) at injection site. Systemic symptoms reported include fatigue (n = 72, 18.5%), fever (n = 55, 14.1%) and headache (n = 46, 11.8%). After the second dose, pain at site of injection (n = 112, 20.4%), swelling (n = 42, 7.7%) and erythematous (n = 14, 2.6%) were among the localized AE reported, while fever (n = 121, 22.1%), fatigue (n = 101, 18.4%) and headache (n = 61, 11.1%) were the most common systemic AE. The proportion of respondents who experienced moderate (first dose: 156 events; second dose: 272 events) and severe (1st dose: 21 events; 2nd dose: 30 events) AEs were higher after the second dose. Most AEs commonly resolved within 1-2 days, and none required hospitalization. No new onset of AE was observed 7 days post-vaccination. A total of 137 (59.8%) participants did not proceed to formal AE reporting.
Conclusion: Most of the AEs reported were of mild to moderate intensity and short-term, consistent with those reported in previous studies. No medium-term finding was detected in the survey. AE reporting was not routinely performed, necessitating the attention of health authorities in order to enhance pharmacovigilance.
Keywords: COVID-19; Malaysia; adverse events; healthcare workers; immunization; mRNA vaccines.