Adverse events following BNT162b2 mRNA COVID-19 vaccine immunization among healthcare workers in a tertiary hospital in Johor, Malaysia

Aie Yen Tan, Chee Tao Chang, Yong King Yu, Yi Xin Low, Najah Fatehah Mohd Razali, Sui Yan Tey, Shaun Wen Huey Lee

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Abstract

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.

Original languageEnglish
Article number509
Number of pages8
JournalVaccines
Volume10
Issue number4
DOIs
Publication statusPublished - Apr 2022

Keywords

  • adverse events
  • COVID-19
  • healthcare workers
  • immunization
  • Malaysia
  • mRNA vaccines

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