PMID- 36374363 OWN - NLM STAT- MEDLINE DCOM- 20230206 LR - 20240122 IS - 1573-2592 (Electronic) IS - 0271-9142 (Print) IS - 0271-9142 (Linking) VI - 43 IP - 2 DP - 2023 Feb TI - Safety of mRNA COVID-19 Vaccines in Patients with Inborn Errors of Immunity: an Italian Multicentric Study. PG - 299-307 LID - 10.1007/s10875-022-01402-6 [doi] AB - PURPOSE: Little is known about vaccine safety in inborn errors of immunity (IEI) patients during the current vaccination campaign for COVID-19. To better investigate the reactogenicity and adverse event profile after two, three, and four doses of mRNA vaccines, we conducted an observational, multicentric study on 342 PID patients from four Italian Referral Centres. METHODS: We conducted a survey on self-reported adverse reactions in IEI patients who received mRNA vaccine by administering a questionnaire after each dose. RESULTS: Over the whole study period, none of the patients needed hospitalization or had hypersensitivity reactions, including anaphylaxis and delayed injection site reaction. After two vaccination doses, 35.4% of patients showed only local reactogenicity-related symptoms (RrS), 44.4% reported both systemic and local RrS, and 5% reported only systemic RrS. In more than 60% of cases, local or systemic RrS were mild. After the first and second booster doses, patients showed fewer adverse events (AEs) than after the first vaccination course. Patients aged 50 years and older reported adverse events and RrS less frequently. Among AEs requiring treatment, one common variable immune deficiency patient affected by T cell large granular lymphocytic leukemia developed neutropenia and one patient had Bell's paralysis perhaps during herpes zoster reactivation. CONCLUSION: Although our follow-up period is relatively short, the safety data we reported are reassuring. This data would help to contrast the vaccine hesitancy often manifested by patients with IEI and to better inform their healthcare providers. CI - (c) 2022. The Author(s). FAU - Milito, Cinzia AU - Milito C AD - Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy. FAU - Cinetto, Francesco AU - Cinetto F AD - Department of Medicine-DIMED, University of Padova, Padua, Italy. AD - Rare Diseases Referral Center, Internal Medicine I, Ca' Foncello Hospital, AULSS2 Marca Trevigiana, Treviso, Italy. FAU - Garzi, Giulia AU - Garzi G AD - Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy. FAU - Palladino, Andrea AU - Palladino A AD - Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy. FAU - Puca, Marco AU - Puca M AD - Department of Medical Sciences and Public Health, University of Cagliari, Azienda Ospedaliero Universitaria, SS 554-Bivio Sestu, 09042, Monserrato, CA, Italy. FAU - Brambilla, Elena AU - Brambilla E AD - Department of Medicine-DIMED, University of Padova, Padua, Italy. AD - Rare Diseases Referral Center, Internal Medicine I, Ca' Foncello Hospital, AULSS2 Marca Trevigiana, Treviso, Italy. FAU - De Vitis, Camilla AU - De Vitis C AD - Department of Medicine-DIMED, University of Padova, Padua, Italy. AD - Rare Diseases Referral Center, Internal Medicine I, Ca' Foncello Hospital, AULSS2 Marca Trevigiana, Treviso, Italy. FAU - Costanzo, Giulia AU - Costanzo G AD - Department of Medical Sciences and Public Health, University of Cagliari, Azienda Ospedaliero Universitaria, SS 554-Bivio Sestu, 09042, Monserrato, CA, Italy. FAU - Scarpa, Riccardo AU - Scarpa R AD - Department of Medicine-DIMED, University of Padova, Padua, Italy. AD - Rare Diseases Referral Center, Internal Medicine I, Ca' Foncello Hospital, AULSS2 Marca Trevigiana, Treviso, Italy. FAU - Punziano, Alessandra AU - Punziano A AD - Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy. FAU - Lagnese, Gianluca AU - Lagnese G AD - Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy. FAU - Del Giacco, Stefano AU - Del Giacco S AD - Department of Medical Sciences and Public Health, University of Cagliari, Azienda Ospedaliero Universitaria, SS 554-Bivio Sestu, 09042, Monserrato, CA, Italy. FAU - Spadaro, Giuseppe AU - Spadaro G AD - Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy. FAU - Quinti, Isabella AU - Quinti I AD - Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy. FAU - Firinu, Davide AU - Firinu D AUID- ORCID: 0000-0002-5768-391X AD - Department of Medical Sciences and Public Health, University of Cagliari, Azienda Ospedaliero Universitaria, SS 554-Bivio Sestu, 09042, Monserrato, CA, Italy. davide.firinu@unica.it. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20221114 PL - Netherlands TA - J Clin Immunol JT - Journal of clinical immunology JID - 8102137 RN - 0 (COVID-19 Vaccines) RN - 0 (RNA, Messenger) SB - IM MH - Aged MH - Humans MH - Middle Aged MH - *Anaphylaxis/etiology MH - *COVID-19/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - RNA, Messenger MH - Vaccination/adverse effects PMC - PMC9662105 OTO - NOTNLM OT - COVID-19 OT - CVID OT - IEI patients OT - Vaccines OT - adverse reaction OT - immunodeficiency OT - safety profile COIS- The authors declare no competing interests. EDAT- 2022/11/15 06:00 MHDA- 2023/02/04 06:00 PMCR- 2022/11/14 CRDT- 2022/11/14 11:29 PHST- 2022/08/23 00:00 [received] PHST- 2022/10/31 00:00 [accepted] PHST- 2022/11/15 06:00 [pubmed] PHST- 2023/02/04 06:00 [medline] PHST- 2022/11/14 11:29 [entrez] PHST- 2022/11/14 00:00 [pmc-release] AID - 10.1007/s10875-022-01402-6 [pii] AID - 1402 [pii] AID - 10.1007/s10875-022-01402-6 [doi] PST - ppublish SO - J Clin Immunol. 2023 Feb;43(2):299-307. doi: 10.1007/s10875-022-01402-6. Epub 2022 Nov 14.