Reporting vaccine adverse drug reactions

Abstract

Adverse drug reaction (ADR) reporting helps identify negative effects caused by medications such as vaccines. Healthcare professionals (HCPs) and patients are encouraged to report suspected ADRs. Lack of ADR reporting negatively impacts the understanding of the safety of the product. The aims of the study were (1) to identify vaccine related ADRs and (2) to identify perception, awareness and experiences of HCPs with ADR reporting. Literature review on vaccine related ADRs of COVID-19, Varicella zoster and influenza vaccines was conducted on PubMed® and articles published between 2012 to 2022 were identified. A questionnaire on awareness and experience of ADR reporting was developed, validated and disseminated to HCPs. The questionnaire had 22 questions and was divided into three sections: demographics, ADR reporting awareness and experience of vaccine-related ADRs. One hundred and forty-nine articles were identified in the literature review. Commonly identified ADRs were thrombosis and thrombocytopenia (n=20) for COVID-19 vaccines, injection site reactions (n=16) for Varicella zoster vaccines and fatigue and myalgia (n=20) for influenza vaccines. Questionnaire respondents (N=284) included nurses (n=161), pharmacists (n=68), medical physicians (n=46) and other HCPs (n=9). HCPs were aware on the procedure of ADR reporting as they scored an overall mean score of 3.36 out of 5. Pharmacists had the highest mean score of 4.1 out of 5 from the other HCPs for awareness on ADR reporting. The level of awareness varied between HCPs (p-value= <0.001). The majority of HCPs (n=143) did not receive any training on ADR reporting. Pharmacists received more training than other HCPs (p-value = 0.035). Barriers to ADR reporting which were commonly identified were lack of awareness (n=106), lack of confidence (n=66) and time constraints (n=64). Fourteen respondents have previously reported a vaccine-related ADR. Most commonly reported ADRs include myalgia (n=152), fever & chills (n=125) and injection site reactions (n=116). HCPs are aware on the procedure of ADR reporting, but challenges are still present which prevent HCPs from reporting more.