Medical occurrence and safety of SARS-CoV-2 vaccination outside of the hospital setting.
COVID-19 vaccines
Early medical intervention
Immunization programs
Mass vaccination
Journal
Internal and emergency medicine
ISSN: 1970-9366
Titre abrégé: Intern Emerg Med
Pays: Italy
ID NLM: 101263418
Informations de publication
Date de publication:
23 Jul 2024
23 Jul 2024
Historique:
received:
02
03
2024
accepted:
08
05
2024
medline:
23
7
2024
pubmed:
23
7
2024
entrez:
23
7
2024
Statut:
aheadofprint
Résumé
During COVID-19 pandemic, vaccination has been strongly recommended and advocated to prevent COVID-19 infection and adverse outcomes, particularly among at-risk populations. The vaccination against SARS-CoV-2 (COVAC) occurred at off-site locations capable of accommodating large crowds, distinct from the hospital setting, where a team of intensivists, emergency physicians, and nurses, ensuring prompt medical attention (medical occurrences, MO) in cases of adverse event following immunization. Our aims were to estimate the incidence of MO, and to assess its association with demographics, and vaccine characteristics. Our retrospective cohort study included all subject aged 12 years and older who received vaccinations at two large out-of-hospital vaccination hubs (Fiera Milano City, Palazzo delle Scintille), between April 12th and August 31st, 2021. Nine hundred and ninety-five thousand and twenty-eight vaccinations were administrated. MOs incidence rate was 278/100,000 doses (95% confidence interval (CI) 268-289). Most MOs were mild (86.27%) and mainly observed in subjects who received the Comirnaty vaccine; 92 MOs (3.32%) were severe and mostly occurred in recipients of the Vaxzeria vaccine. The incidence rate for hospital transfers following vaccination was 4.7/100,000 doses (95% CI 3.5-6.2) and any level of anaphylaxis occurred in 0.4 cases per 100,000 administrated doses (95% CI 0.3.-0.7). Sex, age, type of vaccine and first dose were associated with incidence of MO. Our results showed a low incidence rate in MOs after COVAC, mainly mild and support the feasibility, effectiveness and safety of vaccinations administered in hubs with a dedicated SEU located outside of the hospital setting.
Identifiants
pubmed: 39042210
doi: 10.1007/s11739-024-03641-4
pii: 10.1007/s11739-024-03641-4
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).
Références
Baloch S, Baloch MA, Zheng T, Pei X (2020) The Coronavirus disease 2019 (COVID-19) pandemic. Tohoku J Exp Med 250:271–278. https://doi.org/10.1620/tjem.250.271
doi: 10.1620/tjem.250.271
pubmed: 32321874
Suryawanshi YN, Biswas DA (2023) Herd immunity to fight against COVID-19: a narrative review. Cureus. https://doi.org/10.7759/cureus.33575
doi: 10.7759/cureus.33575
pubmed: 38125244
pmcid: 10732334
Grasselli G, Zanella A, Carlesso E, Florio G, Canakoglu A, Bellani G, Bottino N, Cabrini L, Castelli GP, Catena E, Cecconi M, Cereda D, Chiumello D, Forastieri A, Foti G, Gemma M, Giudici R, Grazioli L, Lombardo A, Lorini FL, Madotto F, Mantovani A, Mistraletti G, Mojoli F, Mongodi S, Monti G, Muttini S, Piva S, Protti A, Rasulo F, Scandroglio AM, Severgnini P, Storti E, Fumagalli R, Pesenti A, Keim R, Vagginelli F, Sala A, Merli G, Ruggeri P, Villani G, Riccio M, Zoia E, Castelli A, Colombo R, Rech R, Gnesin P, Coppini D, Petrucci N, Antonini B, Landolfi L, Arnaiz F, Forlini C, Stefanini F, Micucci A, Marelli JA, Torresani F, Panzeri C, Paolini E, Guzzon D, Maderna L, Russo G, Berselli A, Biondo A, Montalto C, Bianciardi L, Della Mura F, Marino G, Zambon M, Subert M, Citerio G, Saini M, Rona R, Pezzi A, Sabbatini G, Paganini S, Porta V, Benigni A, Bonanomi E, Fabretti F, Gritti P, Arachi G, Raimondi M, Casazza A, De Filippi G, Piccoli F, Umbrello M, Coppola S, Pozzi T, Corona A, Bossi E, Greco S, Besozzi A, Covello RD, Della Morte M, Sangalli F, Gasberti D, Maraggia D, Motta A, Agosteo E, Crottogini L, Leoni O, Tirani M, Carbonara M, Crotti S, Fusaris C, Properzi P, Rossi N, Tagliabue P, Tubiolo D, Maggio G, Pagani M, Sciutti F, Bertelli M, Militano CR, Morandi A, Valsecchi R, Albano G, Barbara E, Ballotta A, Costantini E, Greco M, Perazzo P, Ceriani R, Ranucci M, Resta M, Calvi MR, Colombo S, Dell’Acqua A, Marino F, Sebastiano P, Sala G, Belgiorno N, Cosio R, Guatteri L, Viola U, Galletti M, Primerano V, Visetti E, Giacomini M, Alborghetti A, Bertazzoli A, Bertoni M, Mauri T, Prato G, Stocchetti N, Vivona L, Waccher G, Filippini M, Latronico N, Giani M, Pozzi M (2022) Association of COVID-19 vaccinations with intensive care unit admissions and outcome of critically ill patients with COVID-19 pneumonia in Lombardy. Italy JAMA Netw Open 5:e2238871. https://doi.org/10.1001/jamanetworkopen.2022.38871
doi: 10.1001/jamanetworkopen.2022.38871
pubmed: 36301541
Gruppo di Lavoro ISS Bioetica COVID-19 (2020) Etica della ricerca durante la pandemia di COVID-19: studi osservazionali e in particolare epidemiologici. Versione del 29 maggio 2020. Roma: Istituto Superiore di Sanità; 2020. (Rapporto ISS COVID-19 n. 47/2020
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP (2007) The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 147:573. https://doi.org/10.7326/0003-4819-147-8-200710160-00010
doi: 10.7326/0003-4819-147-8-200710160-00010
Tozzi AE, Asturias EJ, Balakrishnan MR, Halsey NA, Law B, Zuber PLF (2013) Assessment of causality of individual adverse events following immunization (AEFI): a WHO tool for global use. Vaccine 31:5041–5046. https://doi.org/10.1016/j.vaccine.2013.08.087
doi: 10.1016/j.vaccine.2013.08.087
pubmed: 24021304
European Medicines Agency (EMA) (2017) Guidelines on good pharmacovigilance practices (GVP). https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-12-october-2017_en.pdf . Accessed 2 Mar 2024
World Health Organizzation (WHO) (2019) Causality assessment of an adverse event following immunization (AEFI): user manual for the revised WHO classification, 2nd ed., 2019 update
Medicines & Healthcare products Regulatory Agency (2021) Coronavirus vaccine - weekly summary of Yellow Card reporting (Data included: 09/12/2020 to 21/02/2021)
Brighton Collaboration Anaphylaxis Working Group (2021) Anaphylaxis: case definition companion guide. https://brightoncollaboration.us/anaphylaxis-case-definition-companion-guide/ . Accessed 2 Mar 2024
AlHamaidah MA, Noureldin N, Yehia A, Alani I, Al-Qussain A, Abdou O, Ashames A, Kharaba Z (2022) Efficacy and short-term safety of COVID-19 vaccines: a cross-sectional study on vaccinated people in the UAE. Vaccines (Basel) 10:2157. https://doi.org/10.3390/vaccines10122157
doi: 10.3390/vaccines10122157
pubmed: 36560566
El-Shitany NA, Harakeh S, Badr-Eldin SM, Bagher AM, Eid BG, Almukadi HS, Alghamdi BS, Alahmadi AA, Hassan NA, Sindi N, Alghamdi SA, Almohaimeed HM, Mohammedsaleh ZM, Al-Shaikh TM, Almuhayawi MS, Ali SS, El-Hamamsy M (2021) Minor to moderate side effects of Pfizer-BioNTech COVID-19 vaccine among saudi residents: a retrospective cross-sectional study. Int J Gen Med 14:1389–1401. https://doi.org/10.2147/IJGM.S310497
doi: 10.2147/IJGM.S310497
pubmed: 33907443
pmcid: 8068468
Im JH, Kim E, Lee E, Seo Y, Lee Y, Jang Y, Yu S, Maeng Y, Park S, Park S, Kim J, Lee J-S, Baek JH (2021) Adverse events with the Pfizer-BioNTech COVID-19 vaccine among Korean Healthcare Workers. Yonsei Med J 62:1162. https://doi.org/10.3349/ymj.2021.62.12.1162
doi: 10.3349/ymj.2021.62.12.1162
pubmed: 34816647
pmcid: 8612854
Kitagawa H, Kaiki Y, Sugiyama A, Nagashima S, Kurisu A, Nomura T, Omori K, Akita T, Shigemoto N, Tanaka J, Ohge H (2022) Adverse reactions to the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines in Japan. J Infect Chemother 28:576–581. https://doi.org/10.1016/j.jiac.2021.12.034
doi: 10.1016/j.jiac.2021.12.034
pubmed: 35058126
pmcid: 8747950
Lee DY, Kang DY, Kim E, Lee S, Baek JH, Lee J-S, Park MY, Im JH (2023) Adverse events of a third dose of BNT162b2 mRNA COVID-19 vaccine among Korean healthcare workers. Medicine 102:e33236. https://doi.org/10.1097/MD.0000000000033236
doi: 10.1097/MD.0000000000033236
pubmed: 36930126
pmcid: 10018524
Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, Sudre CH, Nguyen LH, Drew DA, Merino J, Hu C, Selvachandran S, Antonelli M, Murray B, Canas LS, Molteni E, Graham MS, Modat M, Joshi AD, Mangino M, Hammers A, Goodman AL, Chan AT, Wolf J, Steves CJ, Valdes AM, Ourselin S, Spector TD (2021) Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis 21:939–949. https://doi.org/10.1016/S1473-3099(21)00224-3
doi: 10.1016/S1473-3099(21)00224-3
pubmed: 33930320
pmcid: 8078878
Öztürk BÖ, Akdemir İ, Azap A, Çelik G, Bavbek S, Mungan D (2022) Anaphylaxis is rare due to CoronaVac in a population of healthcare workers. Asia Pac Allergy 12:e35. https://doi.org/10.5415/apallergy.2022.12.e35
doi: 10.5415/apallergy.2022.12.e35
pubmed: 36452009
pmcid: 9669466
Riad A, Pokorná A, Attia S, Klugarová J, Koščík M, Klugar M (2021) Prevalence of COVID-19 vaccine side effects among healthcare workers in the Czech Republic. J Clin Med 10:1428. https://doi.org/10.3390/jcm10071428
doi: 10.3390/jcm10071428
pubmed: 33916020
pmcid: 8037149
Riad A, Sağıroğlu D, Üstün B, Pokorná A, Klugarová J, Attia S, Klugar M (2021) Prevalence and risk factors of CoronaVac side effects: an independent cross-sectional study among healthcare workers in Turkey. J Clin Med 10:2629. https://doi.org/10.3390/jcm10122629
doi: 10.3390/jcm10122629
pubmed: 34203769
pmcid: 8232682
Urakawa R, Isomura ET, Matsunaga K, Kubota K, Ike M (2022) Impact of age, sex and medical history on adverse reactions to the first and second dose of BNT162b2 mRNA COVID-19 vaccine in Japan: a cross-sectional study. BMC Infect Dis 22:179. https://doi.org/10.1186/s12879-022-07175-y
doi: 10.1186/s12879-022-07175-y
pubmed: 35197017
pmcid: 8864597
Shimabukuro TT, Cole M, Su JR (2021) Reports of anaphylaxis after receipt of mRNA COVID-19 vaccines in the US—December 14, 2020–January 18, 2021. JAMA 325:1101. https://doi.org/10.1001/jama.2021.1967
doi: 10.1001/jama.2021.1967
pubmed: 33576785
pmcid: 8890485
Japanese Ministry of Health L and Welfare (2021) The 57th health science council vaccination/vaccine subcommittee side reaction study subcommittee, the 4th pharmaceutical affairs/food sanitation council pharmaceutical affairs subcommittee safety measures study group (jointly held) conference materials [Internet]. https://www.mhlw.go.jp/stf/shingi2/0000208910_00021.html . Accessed 13 Sep 2023
Korea Disease Control and Prevention Agency (2021) Korea disease control and prevention agency. Updates on COVID-19 in Republic of Korea (as of 9 May, 2021 from 26 February, 2021). http://ncov.mohw.go.kr/en/tcmBoardList.do?brdId=12&brdGubun=125&dataGubun=&ncvContSeq=&contSeq=&board_id=&gubun= . Accessed 13 Sep 2023
Kim M-A, Lee YW, Kim SR, Kim J-H, Min TK, Park H-S, Shin M, Ye Y-M, Lee S, Lee J, Choi J-H, Jang GC, Chang Y-S (2021) COVID-19 vaccine-associated anaphylaxis and allergic reactions: consensus statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group. Allergy Asthma Immunol Res 13:526. https://doi.org/10.4168/aair.2021.13.4.526
doi: 10.4168/aair.2021.13.4.526
pubmed: 34212542
pmcid: 8255352
Caballero M, Quirce S (2021) Excipients as potential agents of anaphylaxis in vaccines: analyzing the formulations of currently authorized COVID-19 vaccines. J Investig Allergol Clin Immunol 31:92–93. https://doi.org/10.18176/jiaci.0667
doi: 10.18176/jiaci.0667
pubmed: 33433387
Klimek L, Novak N, Cabanillas B, Jutel M, Bousquet J, Akdis CA (2021) Allergenic components of the mRNA-1273 vaccine for COVID-19: possible involvement of polyethylene glycol and IgG-mediated complement activation. Allergy 76:3307–3313. https://doi.org/10.1111/all.14794
doi: 10.1111/all.14794
pubmed: 33657648
Stone CA, Liu Y, Relling MV, Krantz MS, Pratt AL, Abreo A, Hemler JA, Phillips EJ (2019) Immediate hypersensitivity to polyethylene glycols and polysorbates: more common than we have recognized. J Allergy Clin Immunol Pract 7:1533-1540.e8. https://doi.org/10.1016/j.jaip.2018.12.003
doi: 10.1016/j.jaip.2018.12.003
pubmed: 30557713
Taylor S, Asmundson GJG (2021) Immunization stress-related responses: implications for vaccination hesitancy and vaccination processes during the COVID-19 pandemic. J Anxiety Disord 84:102489. https://doi.org/10.1016/j.janxdis.2021.102489
doi: 10.1016/j.janxdis.2021.102489
pubmed: 34627104
pmcid: 8483981
AIFA (2021) Nono rapporto AIFA sulla sorveglianza dei vaccini COVID-19. https://www.aifa.gov.it/-/nono-rapporto-aifa-sulla-sorveglianza-dei-vaccini-covid-19 . Accessed 1 Aug 2023
Agenzia Italiana del Farmaco (AIFA) Vaccini COVID-19. https://www.aifa.gov.it/vaccini-covid-19 . Accessed 2 Mar 2024
Mathioudakis AG, Ghrew M, Ustianowski A, Ahmad S, Borrow R, Papavasileiou LP, Petrakis D, Bakerly ND (2021) Self-reported real-world safety and reactogenicity of COVID-19 vaccines: a vaccine recipient survey. Life 11:249. https://doi.org/10.3390/life11030249
doi: 10.3390/life11030249
pubmed: 33803014
pmcid: 8002738
Klugar M, Riad A, Mekhemar M, Conrad J, Buchbender M, Howaldt H-P, Attia S (2021) Side effects of mRNA-based and viral vector-based COVID-19 vaccines among German Healthcare Workers. Biology (Basel) 10:752. https://doi.org/10.3390/biology10080752
doi: 10.3390/biology10080752
pubmed: 34439984
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC (2020) Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 383:2603–2615. https://doi.org/10.1056/NEJMoa2034577
doi: 10.1056/NEJMoa2034577
pubmed: 33301246
Yesuf EA, Riad A, Sofi-Mahmudi A, Sudhakar M, Mekonnen A, Endalkachew S, Mama F, Muhidin S, Ayele B, Yahya M, Usman A, Abafita J, Klugar M (2022) Self-reported side effects of the Oxford AstraZeneca COVID-19 vaccine among healthcare workers in Ethiopia, Africa: a cross-sectional study. Front Public Health. https://doi.org/10.3389/fpubh.2022.937794
doi: 10.3389/fpubh.2022.937794
pubmed: 35928493
pmcid: 9343757
Green MS, Peer V, Magid A, Hagani N, Anis E, Nitzan D (2022) Gender differences in adverse events following the Pfizer-BioNTech COVID-19 vaccine. Vaccines (Basel) 10:233. https://doi.org/10.3390/vaccines10020233
doi: 10.3390/vaccines10020233
pubmed: 35214694
Ahsan W, Syed NK, Alsraeya AA, Alhazmi HA, Najmi A, Al BM, Javed S, Makeen HA, Meraya AM, Albarraq AA, Alqahtani SS (2021) Post-vaccination survey for monitoring the side effects associated with COVID-19 vaccines among healthcare professionals of Jazan province, Saudi Arabia. Saudi Med J 42:1341–1352. https://doi.org/10.15537/smj.2021.42.12.20210576
doi: 10.15537/smj.2021.42.12.20210576
pubmed: 34853140
pmcid: 9149761
Walsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi P-Y, Türeci Ö, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Şahin U, Gruber WC (2020) Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med 383:2439–2450. https://doi.org/10.1056/NEJMoa2027906
doi: 10.1056/NEJMoa2027906
pubmed: 33053279
Nikolich-Žugich J (2018) The twilight of immunity: emerging concepts in aging of the immune system. Nat Immunol 19:10–19. https://doi.org/10.1038/s41590-017-0006-x
doi: 10.1038/s41590-017-0006-x
pubmed: 29242543
Potluri T, Fink AL, Sylvia KE, Dhakal S, Vermillion MS, vom Steeg L, Deshpande S, Narasimhan H, Klein SL (2019) Age-associated changes in the impact of sex steroids on influenza vaccine responses in males and females. NPJ Vaccines 4:29. https://doi.org/10.1038/s41541-019-0124-6
doi: 10.1038/s41541-019-0124-6
pubmed: 31312529
pmcid: 6626024
Ossato A, Tessari R, Trabucchi C, Zuppini T, Realdon N, Marchesini F (2023) Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. Eur J Hosp Pharm 30:e15–e15. https://doi.org/10.1136/ejhpharm-2021-002933
doi: 10.1136/ejhpharm-2021-002933
pubmed: 34315774