A CROSS-SECTIONAL STUDY ON COVID-19 VACCINE SIDE-EFFECTS SELF-REPORTS COLLECTED VIA AN ONLINE SURVEY IN MALAYSIA – International Journal of Research in Education Humanities and Commerce

A CROSS-SECTIONAL STUDY ON COVID-19 VACCINE SIDE-EFFECTS SELF-REPORTS COLLECTED VIA AN ONLINE SURVEY IN MALAYSIA

Authors: Adlina Suleiman, Nurhasanah Mazalan., Siti Jamilah Muhammad Haneef Ali, Nurulhuda Mohammed Zabidi & Aqil Mohd. Daher

ABSTRACT

Objective: It is important to collect data on adverse events following vaccination in order to evaluate the safety of any new vaccine, such as the Coronavirus-19 (COVID-19) vaccines. This study aimed to collect data on adverse effects following COVID-19 immunisation (AEFCI) among the Malaysian population via an online data collection portal and to ascertain if a similar report was made to the National Pharmaceutical Regulatory Agency (NPRA). This study also explored the patients’ perspectives on how responsive the doctors were when they reported an AEFI as well as any patterns of non-reporting.

Method: This cross-sectional study used the convenient sampling method to collect data. The questionnaire was placed on the online Zoho Form platform from July 2021 to February 2022. The questionnaire was in Malay and the link ‘bit.ly/Laporankesansampingan’ was distributed widely using social media platforms such as of Facebook, WhatsApp, and Telegram. The questionnaire design was partly based on the Vaccine Adverse Event Reporting System (VAERS), with modifications tailored to acceptance by the Malaysian populations towards the type and design of the questionnaire.

Results: There were 2667 AEFCI reports received through the web link up to 26 Feb 2022. Around 30.6% and 6% of the respondents reported their adverse events to MySejahtera and to NPRA, respectively. In addition, only 24.2% of the medical doctors acknowledged the possibility of AEFCI, while 31.2% disagreed and 44.6% did not comment. The mean age of the respondents was 39 years. The majority were female (59%) and were Malays (91%). Most of the AEFCI appear to occur with the first dose (53%), and in particular with the Pfizer vaccine (53.5%). The majority (87.1%) of AEFCI occurred at two weeks or less after vaccine administration, of which 87.6% were moderate to severe events.

Conclusion: There should be concerted effort on the part of relevant authorities to improve the reporting of AEFCI since only 30.6% of the respondents of this study reported on My Sejahtera. This study found that only 24.2% acknowledged the possibility of AEFCI as such health authorities should make reporting of AEFCI by doctors mandatory to reduce under-reporting and under-recognition of rare but serious AEFCI.

Keywords: adverse events following COVID-19 immunisation

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