Adverse Events Associated with BNT162b2 and AZD1222 Vaccines in the Real World: Surveillance Report in a Single Italian Vaccine Center

Abstract

Aim: Despite huge efforts in developing specific drugs, vaccination represents the only effective strategy against COVID-19. Efficacy and safety of the COVID-19 vaccines were established during clinical trials. Nonetheless, it is very important to perform continuous surveillance. This observational study aimed to report potential Adverse Events Following Immunization (AEFI) following the first dose of two different COVID-19 vaccines, BNT162b2 and AZD1222. Methods and Results: Subjects who underwent vaccination at the vaccine center of the University Hospital of Salerno, Italy, were interviewed using an ad hoc questionnaire. AZD-vac group (n = 175) who received AZD1222 had a higher number of AEFI than the BNT-vac group (n = 1613) who received BNT162b2 (83% vs. 42%). The most frequent AEFI associated with AZD1222 and BNT162b2 were fever and pain at the injection site, respectively. The AZD-vac group used drugs to contrast AEFI more frequently than the BNT-vac group. In the BNT-vac group, there was a higher incidence of AEFI in women than in men (26.2% vs. 15.8%, p = 0.01), while no gender-related difference was observed in the AZD-vac group. Conclusions: AZD1222 and BNT162b2 vaccines show a good safety profile. Based on our results and literature data, there are no reasons to justify the reluctance that persists towards immunization.

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

“…The median TTO and TTR were in line with existing literature although results were not very consistent across studies ( 23 , 24 , 31 , 54 , 66 , 83 ). For the articles which mentioned the TTR, the differences between males and females were generally less than one day ( 31 , 54 , 66 , 83 ).…”

“…With regard to specific common AEFIs, median ORs of 2.42 (range 2.07-4.72), 2.01 (range 1.57-2.61), and 1.77 (range 1.63-1.84) were reported for headache ( 32 , 51 , 67 , 76 ), fatigue ( 22 , 32 , 51 , 67 , 76 ), and fever ( 32 , 68 , 76 ) respectively. TTR was assessed in four articles, all of which reported higher TTR in females compared to males ranging from 1.2-1.9 days in males to 1.4- 2.2 days in females, though the difference was only statistically significant in one article ( 23 , 31 , 54 , 66 ). The results in the articles regarding health care seeking behaviour, hosptial admissions and absenteeism due to adverse effects were unambiguous across studies.…”

“…68, 76) respectively. TTR was assessed in four articles, all of which reported higher TTR in females compared to males ranging from 1.2-1.9 days in males to 1.4-2.2 days in females, though the difference was only statistically significant in one article (23,31,54,66). The results in the articles regarding health care seeking behaviour, hosptial admissions and absenteeism due to adverse effects were unambiguous across studies.…”

Impact and Value of Hospital Antibiotic Stewardship: Retrospective Pre-COVID-19-Pandemic Analysis

“…The war against antimicrobial resistance should aim to discover and make available new antimicrobials and alternative treatments [ 22 , 37 , 38 , 39 ] and improve the use of existing antimicrobials. This milestone cannot be reached without analyzing real-world data.…”

“…The hospital setting represents an area where specific interventions are urgently needed. Interventions to limit the inappropriate use of antibiotics and healthcare-associated infections (HAIs) include drug-consumption monitoring, vaccine use and the improvement of healthcare professionals’ awareness in these fields [ 20 , 21 , 22 ].…”