BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy

Abstract

Millions of people have died because of the COVID-19 pandemic. The vaccination campaign helped tackle the pandemic and saved millions of lives. In a retrospective pharmacovigilance study, we explored the safety of the BNT162b2 (Comirnaty) vaccine among healthcare workers (HCWs) in a large Italian teaching hospital, and 2428 Adverse Events Reports (AERs) filed by HCWs after the administration of the first dose of vaccine were collected and analyzed, reporting the results quantitively and comparing them to the vaccine Summary of Product Characteristics (SPC). Spearman’s correlation coefficients were computed to investigate the correlation among reported adverse effects, and recurrent clusters of symptoms were investigated through the Principal Component Analysis (PCA) and k-means Cluster Analysis. The BNT162b2 vaccine’s safety profile was favorable, with predominant reports of early onset, mild, non-serious and short-term resolved symptoms. We observed higher than the expected frequency for various non-serious undesirable effects, especially among those listed and classified as less common in the SPC. Furthermore, we identified three clusters of adverse effects that were frequently reported together, defined by the presence/absence of fatigue, malaise, localized pain, chills, pyrexia, insomnia, nausea and injection site pain. Post-marketing pharmacovigilance activities, together with targeted public health interventions, can be valuable tools to promote vaccination and improve the control of the spread of the pandemic, especially in sensitive settings and populations such as hospitals and healthcare professionals.

Assessment of safety and adverse events following COVID-19 vaccination and their predictors in first 30 days among healthcare workers of a tertiary care teaching hospital in North India

“…Among those participants experiencing any AEFI in our study, majority (119, 99.0 %) experienced only mild/minor grade AEFI with only 2(1.0 %) experiencing a severe AEFI requiring hospitalization but without any sequelae or long-term complication. Similar results were reports by other studies from various parts of India [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] and across the globe [29] , [30] , [31] , [32] , [33] . In the study by Kamal et al [22] , two serious AEFI (altered sensorium) were reported within 48 h after the 1st dose of COVISHIELD TM vaccine.…”

“…Kadali et al [29] assessing the side effects of BNT162b2 mRNA COVID-19 vaccine reported soreness, fatigue, myalgia, headache, chills, fever and joint pain as the most commonly reported symptoms. In the study by Beccia et al [33] from Italy three clusters of adverse effects defined by the presence/absence of fatigue, malaise, localized pain, chills, pyrexia, insomnia, nausea and injection site pain, were frequently reported together.…”