PMID- 36672673 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230123 IS - 2227-9059 (Print) IS - 2227-9059 (Electronic) IS - 2227-9059 (Linking) VI - 11 IP - 1 DP - 2023 Jan 9 TI - Short-Term Safety and Psychosocial Impact of the BNT162b2 mRNA COVID-19 Vaccine in Cancer Patients-An Italian Single-Center Experience. LID - 10.3390/biomedicines11010165 [doi] LID - 165 AB - Safety data regarding BNT162b2 in cancer patients (CPs) are scarce. Herein we report the side effects (SEs), the adverse events (AEs), and the patient-reported outcomes (PROs) following BNT162b2 administration in CPs treated at the San Luigi Gonzaga University Hospital. All CPs who agreed to participate in our vaccination campaign received BNT162b2 and were included in the descriptive analysis. An anonymous questionnaire investigating the occurrence of SEs/AEs and PROs was administered to the study population 21 days after the first dose. Pearson's chi-squared test was used to estimate the risk of experiencing SEs/AEs according to selected variables. A total of 997 patients were included in the study: 62.0% had stage IV cancer, and 68.8% were receiving an active treatment, of whom 15.9% were receiving immunotherapy. SEs/AEs were recorded in 37.1% of cases after the first dose and in 48.5% of cases after the second dose. The most common SEs were muscle pain/local rash (27.9% and 28%, after the first and second dose, respectively). Patients older than 70 years showed lower risk of SEs/AEs, while women showed a higher risk. Before receiving the vaccine, 18.2% of patients felt fearful and/or insecure about the vaccination. After the first dose, 57.5% of patients changed their feelings positively. Our data support the short-term safety of BNT162b2 in CPs, regardless of disease stage and concurrent treatments. Overall, the vaccination showed a positive impact on quality of life. FAU - Persano, Irene AU - Persano I AUID- ORCID: 0000-0003-2004-4644 AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Cani, Massimiliano AU - Cani M AUID- ORCID: 0000-0001-9608-4840 AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Del Rio, Benedetta AU - Del Rio B AUID- ORCID: 0000-0003-3053-6597 AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Ferrari, Giorgia AU - Ferrari G AUID- ORCID: 0000-0001-6424-7211 AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Garbo, Edoardo AU - Garbo E AUID- ORCID: 0000-0003-2394-9895 AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Parlagreco, Elena AU - Parlagreco E AUID- ORCID: 0000-0003-0368-755X AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Pisano, Chiara AU - Pisano C AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Cetoretta, Valeria AU - Cetoretta V AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Delcuratolo, Marco Donatello AU - Delcuratolo MD AUID- ORCID: 0000-0003-3151-9166 AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Turco, Fabio AU - Turco F AUID- ORCID: 0000-0003-3111-7888 AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Audisio, Alessandro AU - Audisio A AUID- ORCID: 0000-0002-7101-2100 AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Cecchi, Cristina AU - Cecchi C AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Leone, Gianmarco AU - Leone G AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Napoli, Valerio Maria AU - Napoli VM AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Bertaglia, Valentina AU - Bertaglia V AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Bianco, Valentina AU - Bianco V AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Capelletto, Enrica AU - Capelletto E AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - D'Amiano, Carmen AU - D'Amiano C AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Di Maio, Massimo AU - Di Maio M AUID- ORCID: 0000-0001-8906-3785 AD - Department of Oncology, University of Turin, Mauriziano Hospital, 10128 Torino, Italy. FAU - Gianetta, Martina AU - Gianetta M AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Novello, Silvia AU - Novello S AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Passiglia, Francesco AU - Passiglia F AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Scagliotti, Giorgio Vittorio AU - Scagliotti GV AUID- ORCID: 0000-0001-6646-958X AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. FAU - Bironzo, Paolo AU - Bironzo P AD - Department of Oncology, University of Turin, San Luigi Gonzaga University Hospital, 10043 Orbassano, Italy. LA - eng PT - Journal Article DEP - 20230109 PL - Switzerland TA - Biomedicines JT - Biomedicines JID - 101691304 PMC - PMC9855735 OTO - NOTNLM OT - COVID-19 pandemic OT - COVID-19 vaccination OT - SARS-CoV-2 infection OT - cancer patients OT - patients reported outcomes OT - prevention strategies OT - thoracic malignancies COIS- Paolo Bironzo received honoraria and had roles as a consultant and advisor for AstraZeneca, Bristol Myers Squibb, MSD Oncology, BeiGene, Roche, and Takeda and received an institutional research grant (not related to the present work) from Pfizer and a travel grant from Amgen; Enrica Capelletto had roles as a consultant or advisor for AstraZeneca, MSD, and Boehringer Ingelheim; Massimo Di Maio received honoraria and had roles as a consultant or advisor for AstraZeneca, Pfizer, Novartis, Roche, Eisai, Janssen, Astellas, Boehringer Ingelheim, Merck Sharp & Dohme and received an institutional research grant by Tesaro-GlaxoSmithKline, outside this work; Francesco Passiglia had roles as a consultant or advisor for AstraZeneca, MSD Oncology, Amgen and received a travel grant from MSD Oncology and Roche; Silvia Novello received honoraria and had roles as a consultant or advisor for AstraZeneca, Amgen, Eli Lilly, Beigene, Boehringer Ingelheim, MSD, Roche, Takeda, Pfizer, Novartis, and Sanofi; Giorgio Vittorio Scagliotti received honoraria and had roles as a consultant or advisor for AstraZeneca, Eli Lilly, Beigene, MSD, Roche, Takeda, Pfizer, Johnson & Johnson, Verastem, and Tesaro. No other potential conflicts of interest were reported. EDAT- 2023/01/22 06:00 MHDA- 2023/01/22 06:01 PMCR- 2023/01/09 CRDT- 2023/01/21 01:14 PHST- 2022/11/26 00:00 [received] PHST- 2022/12/23 00:00 [revised] PHST- 2023/01/06 00:00 [accepted] PHST- 2023/01/21 01:14 [entrez] PHST- 2023/01/22 06:00 [pubmed] PHST- 2023/01/22 06:01 [medline] PHST- 2023/01/09 00:00 [pmc-release] AID - biomedicines11010165 [pii] AID - biomedicines-11-00165 [pii] AID - 10.3390/biomedicines11010165 [doi] PST - epublish SO - Biomedicines. 2023 Jan 9;11(1):165. doi: 10.3390/biomedicines11010165.