Adverse reactions to Pfizer‐BioNTech vaccination of healthcare workers at Malta's state hospital

Abstract

Background The long‐term control of COVID‐19 depends on an effective global vaccination strategy. Protecting healthcare workers (HCWs) from serious infection is critical. Malta, a European country, initiated the vaccination roll‐out using Pfizer‐BioNTech COVID‐19 vaccine targeting HCWs. This study determined vaccination adverse effects (AEs) in this cohort. Method An online survey was disseminated to all HCWs via work email (29/3/21 to 9/4/21) to gather AEs regarding pain, redness and swelling at injection site, fever, chills, fatigue, muscle/joint pains, headache, vomiting and diarrhoea severity following each dose (Likert scale). Descriptive, comparative and multiple binary regression analyses were performed. Results A response of 30.30% (n = 1480) was achieved with the commonest AEs being pain at injection site (88.92% CI 95%: 87.21‐90.42), mostly mild (51%) and moderate (43%). Fatigue was reported by 72.97% (CI 95%: 70.65‐75.17), 42% were mild and 41% were moderate. Females reported significantly ( P ≤ .05, respectively) more pain (OR: 1.90), redness (OR: 2.49), swelling at injection site (OR: 1.33), fever (OR: 1.74), chills (OR: 2.32), fatigue (OR: 2.43), muscle (OR: 1.54) and joint pains (OR: 2.01), headache (OR: 2.07) and vomiting (OR: 3.43) when adjusted for age and HCW role. Localised AEs were reported following both vaccine doses unlike systemic AEs that were mostly reported after second doses. Conclusion Vaccination benefits outweigh the minor AEs experienced, with females exhibiting a higher susceptibility. The general low vaccination AEs observed within the HCW cohort is encouraging and should help in allaying vaccine hesitancy among the population.

Side Effects of mRNA-Based COVID-19 Vaccine: Nationwide Phase IV Study among Healthcare Workers in Slovakia

“…To date, several independent (non-sponsored) phase IV studies on mRNA-based COVID-19 vaccines have been published from various countries, e.g., Czech Republic, Germany, Greece, Iraq, Italy, Jordan, Malta, Poland, Saudi Arabia, the UK, and the USA [13,[19][20][21][22][23][24][25][26][27][28][29][30]. The results of these phase IV studies generally agreed with the results of the phase III trials executed by the manufacturers and published by the regulators, i.e., the Centers for Disease Control and Prevention (CDC) [31,32].…”

“…Menni et al (2021) found that systemic side effects were significantly more common among the ≤55 years than the >55 years old recipients of BNT162b2 in the UK [20]. Cuschieri et al (2021) found that the BNT162b2 side effects reported by Maltese healthcare workers were significantly higher among those aged below 45 years old regardless of their sex [27]. Almufty et al (2021) found that the <50-year-old participants were prone to increased prevalence and intensity of post-vaccination side effects in Iraq [24].…”

Active Surveillance of Adverse Events in Healthcare Workers Recipients After Vaccination with COVID-19 BNT162b2 Vaccine (Pfizer-BioNTech, Comirnaty): A Cross-Sectional Study

“…The potential sex disparity in vaccine adverse events is not a new occurrence, according to findings related to other vaccines [ 24 , 25 ], due to a relative suppression of the cellular immune response of males compared to females [ 26 ]. These differences may be explained with important biological associations between sex and immune responses [ 27 ], and effects on disease susceptibility, transmission, and vaccination outcomes [ 28 ]. The major sex hormones seem to exhibit opposing effects on the adaptive and innate immune system, with elevated estradiol increasing and testosterone decreasing the vaccine-induced antibody responses [ 29 , 30 ].…”

“…The major sex hormones seem to exhibit opposing effects on the adaptive and innate immune system, with elevated estradiol increasing and testosterone decreasing the vaccine-induced antibody responses [ 29 , 30 ]. Moreover, autoimmune disorders are more common reported in women than men [ 31 ], together with behavioral attitudes to report adverse events [ 27 ]. Females could be also more susceptible to adverse effects due to higher body fat content affecting both volume of distribution and drug clearance [ 32 ].…”

Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12–18 Years in Saudi Arabia

“…Participants were also allowed to report no symptoms by leaving the box unchecked. We have included a subsection for side effects where we listed the most frequent side effects reported by other studies [20,[29][30][31][32], including pain at the sites of injection, fatigue, headache, fever and chills, nausea, and vomiting. Additionally, we also provided a section for reporting other unlisted side effects which might have been experienced by our study participants.…”