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

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.

Automated summary

This observational study reports potential adverse events following immunization with two different COVID-19 vaccines, AZD1222 and BNT162b2. The study found a higher incidence of adverse events in the AZD-vac group compared to the BNT-vac group. Fever was the most frequent adverse event associated with AZD1222, while pain at the injection site was most frequent with BNT162b2. The study also found a higher incidence of adverse events in women after receiving the BNT162b2 vaccine.