Adverse events reported after administration of BNT162b2 and mRNA-1273 COVID-19 vaccines among hospital workers: a cross-sectional survey-based study in a Spanish hospital

Abstract

Background The World Health Organization declared COVID-19 a pandemic in March 2020. The first vaccine became available in December, with practically no post-marketing data. Methods An analytical cross-sectional survey-based study was conducted in a third-level hospital in Spain between March and April 2021 to describe the difference in adverse events with the BNT162b2 and mRNA-1273 COVID-19 vaccines. The participants were hospital workers who completed a survey voluntarily at least 14 days after the last vaccine. The STROBE checklist was followed. Results One thousand two hundred and forty-nine respondents completed the survey; 48% (599) received mRNA-1273 and 52% (650) BNT162b2. Fourteen thousand four hundred and two adverse reactions were recorded, 6896 local (3939 with mRNA-1273 and 2957 with BNT162b2 (6.6 vs 4.4 reactions per patient)) and 7506 systemic (4460 with mRNA-1273 and 3046 with BNT162b2 (7.4 vs 4.7 per patient)). Local reactions were more frequent after the first dose, while systemic reactions were higher after the second, for both vaccines and in a higher percentage with mRNA-1273 compared to BNT162b2 (p-value<0.05). Conclusions Licensed mRNA vaccines were highly safe when administered under post-marketing conditions among working-age adults. The main adverse events were mild, although they occurred in most patients, especially after the mRNA-1273 vaccine.

Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose

“…Among mRNA vaccines, the IR of AE in mRNA1273 was similarly higher than in BNT162b2. The results were supported by the previous research [ 18 , 19 , 20 ]. Since there was still a scarcity of information about the protein subunit vaccine, the current finding provides important reference for the gap.…”

Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme

“…Nevertheless, data from AE surveillance systems are affected by several biases and cannot quantify the real burden of mild adverse events and those for whom adverse events may be more common. There are several studies to date reporting adverse events from different perspectives or populations, neurological AEs [ 13 ], AEs requiring admissions to EDs [ 14 ], and AEs among HCWs [ 15 , 16 , 17 ]. However, there are few comprehensive population-based reports, especially stratified according to the risk of allergic reactions.…”

Does COVID-19 Vaccination Cause Storage Lower Urinary Tract Symptoms?

“…By the end of February 2022, 60% of the world population and 80% of the Taiwanese population has received at least one dose of a COVID-19 vaccine [ 10 , 11 ]. Despite these vaccines showing proven protection against serious illness, hospitalization, and death [ 12 ], some AEs are reported after vaccination [ 1 , 2 , 3 , 4 , 5 ].…”

“…Recently, only three studies have discussed the potential for urinary-related AEs [ 1 , 5 , 13 ]. However, common AEs following COVID-19 vaccination, namely, sore arm or pain around the injection site and generalized weakness or fatigue, have been widely reported and are carefully monitored [ 1 , 2 , 3 , 4 , 5 ]. Renuka et al investigated the AEs following COVID-19 vaccination using an online questionnaire and reported that the most common urological AE was urinary urgency, with occurrence rates of 0.75% and 1.16% following BNT162b2 mRNA COVID-19 vaccine and COVID-19 mRNA-1273 vaccine, respectively [ 1 , 5 ].…”

“…Regarding the post-vaccination adverse effects (AEs), several recent studies on self-reported side effects with the mRNA-based (Moderna and Pfizer-BioNTech) and viral vector-based (AstraZeneca) vaccine in healthcare sector workers have reported a broad spectrum of symptomatology, with the most common being localized symptoms, such as pain around injection site or a sore arm, and generalized symptoms, such as weakness or fatigue [ 1 , 2 , 3 , 4 , 5 ]. Among them, urological AEs were reported in three studies, in which the majority of the observed urological AEs were storage lower urinary tract symptoms (LUTS), including urinary urgency (occurrence rate: 0.75%–1.16%) and urinary frequency (occurrence rate: 0.37%) [ 1 , 5 ].…”