PMID- 34939617 OWN - NLM STAT- MEDLINE DCOM- 20211224 LR - 20240405 IS - 0025-7818 (Print) IS - 2532-1080 (Electronic) IS - 0025-7818 (Linking) VI - 112 IP - 6 DP - 2021 Dec 23 TI - Side effects among healthcare workers from a large Milan university hospital after second dose of BNT162b2 mRNA COVID-19 vaccine. PG - 477-485 LID - 10.23749/mdl.v112i6.12507 [doi] AB - BACKGROUND: In Italy, healthcare workers (HCWs) were among the first to receive COVID-19 vaccination. Aim of the present study is to evaluate frequency and severity of adverse events (AEs) following the second dose of BNT162b2 vaccine among HCWs of a large university hospital in Milan, Italy. METHODS: One month after having received the second dose of vaccine, HCWs filled-in a form about type, severity, and duration of post-vaccination local and systemic symptoms. We calculated the overall frequency of AEs and used multivariable Poisson regression models (adjusted for sex, age, BMI, smoking, allergy history, previous SARS-CoV-2 infection, anti-hypertensive therapy, and occupation) to calculate risk ratios (RR) and 95% confidence intervals (CI) of AEs according to selected variables. RESULTS: We included 3659 HCWs. Overall, 2801 (76.6%) experienced at least one local event, with pain at injection site being the most frequent (2788, 76.2%). Systemic events were reported by 2080 (56.8%) HCWs, with fatigue (52.3%), muscle pain (42.2%), headache (37.7%), joint pain (31.9%), and fever (26.2%) being the most frequent. Risks of systemic events were associated with female gender (RR=1.14, CI: 1.06-1.23), age (strong decrease with increasing age, p-trend<0.001), allergy history (RR=1.13, CI: 1.05-1.20), and current smoking (RR=0.90, CI: 0.84-0.97). HCWs with previous SARS-CoV-2 infection (even if symptomatic) were not at increased risk. CONCLUSIONS: Both local and systemic acute effects after second dose of BNT162b2 vaccine were frequently reported. However, symptoms were mostly light/mild and of short duration. Thus, our findings support the safety of COVID-19 vaccination in adults in relatively good health. FAU - Borroni, Elisa AU - Borroni E AD - Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy. elisa.borroni@unimi.it. FAU - Consonni, Dario AU - Consonni D AD - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. dario.consonni@unimi.it. FAU - Cugno, Massimo AU - Cugno M AD - Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. massimo.cugno@unimi.it. FAU - Lombardi, Andrea AU - Lombardi A AD - Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. andrea.lombardi@policlinico.mi.it. FAU - Mangioni, Davide AU - Mangioni D AD - Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. davide.mangioni@unimi.it. FAU - Bono, Patrizia AU - Bono P AD - Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. patrizia.bono@policlinico.mi.it. FAU - Oggioni, Massimo AU - Oggioni M AD - Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. massimo.oggioni@policlinico.mi.it. FAU - Uceda Renteria, Sara AU - Uceda Renteria S AD - Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. sara.ucedarenteria@policlinico.mi.it. FAU - Bordini, Lorenzo AU - Bordini L AD - Occupational Health Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. lorenzo.bordini@policlinico.mi.it. FAU - Nava, Carlo Domenico AU - Nava CD AD - Occupational Health Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. carlo.nava@policlinico.mi.it. FAU - Letzgus, Matteo AU - Letzgus M AD - Medical Direction, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. matteo.letzgus@policlinico.mi.it. FAU - Gentiloni Silverj, Flaminia AU - Gentiloni Silverj F AD - Medical Direction, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. flaminia.gentiloni@policlinico.mi.it. FAU - Castaldi, Silvana AU - Castaldi S AD - Department of Biomedical Sciences for Health, University of Milan, Milan, Italy. silvana.castaldi@policlinico.mi.it. FAU - Rognoni, Magda AU - Rognoni M AD - Epidemiology Unit, ATS Brianza, Monza, Italy. magda.rognoni@ats-brianza.it. FAU - Cavallieri D'Oro, Luca AU - Cavallieri D'Oro L AD - Epidemiology Unit, ATS Brianza, Monza, Italy. luca.cavalieridoro@ats-brianza.it. FAU - Carugno, Michele AU - Carugno M AD - Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy. michele.carugno@unimi.it. FAU - Riboldi, Luciano AU - Riboldi L AD - Occupational Health Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. luciano.riboldi@policlinico.mi.it. FAU - Ceriotti, Ferruccio AU - Ceriotti F AD - Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. ferruccio.ceriotti@policlinico.mi.it. FAU - Bandera, Alessandra AU - Bandera A AD - Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. alessandra.bandera@unimi.it. FAU - Gori, Andrea AU - Gori A AD - Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. andrea.gori@unimi.it. FAU - Pesatori, Angela Cecilia AU - Pesatori AC AD - Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy. angela.pesatori@unimi.it. LA - eng PT - Journal Article DEP - 20211223 PL - Italy TA - Med Lav JT - La Medicina del lavoro JID - 0401176 RN - 0 (COVID-19 Vaccines) RN - 0 (RNA, Messenger) RN - N38TVC63NU (BNT162 Vaccine) SB - IM MH - Adult MH - BNT162 Vaccine MH - *COVID-19 MH - *COVID-19 Vaccines MH - Female MH - Health Personnel MH - Hospitals MH - Humans MH - RNA, Messenger MH - SARS-CoV-2 PMC - PMC8759050 COIS- The authors declare no conflict of interest. EDAT- 2021/12/24 06:00 MHDA- 2021/12/25 06:00 PMCR- 2021/01/01 CRDT- 2021/12/23 08:45 PHST- 2021/11/04 00:00 [received] PHST- 2021/12/01 00:00 [accepted] PHST- 2021/12/23 08:45 [entrez] PHST- 2021/12/24 06:00 [pubmed] PHST- 2021/12/25 06:00 [medline] PHST- 2021/01/01 00:00 [pmc-release] AID - MDL-112-477 [pii] AID - 10.23749/mdl.v112i6.12507 [doi] PST - epublish SO - Med Lav. 2021 Dec 23;112(6):477-485. doi: 10.23749/mdl.v112i6.12507.