{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,30]],"date-time":"2025-11-30T13:35:36Z","timestamp":1764509736396,"version":"3.46.0"},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T00:00:00Z","timestamp":1748736000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Fundamemntal Clinical Pharma"],"published-print":{"date-parts":[[2025,8]]},"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n COVID\u201019 vaccination raises questions in patients with autoimmune or inflammatory diseases (AIID), not included in clinical trials. Concern exists about the risk of activating the immune system or worsening the AIID. However, cases of AIID flare\u2010ups or new\u2010onset reported in literature are limited and do not allow conclusions to be drawn on the potential effect of vaccination.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To explore the clinical features of AIID that occurred after vaccination.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We performed a retrospective analysis of adverse event following immunization (AEFI) reported in the French National Pharmacovigilance Database (BNPV) following vaccination with SPIKEVAX (mRNA\u20101273\/Moderna), regardless of the dose received, between Jan 31, 2021 and Jan 31, 2022.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Among the 20\u2009169 AEFI cases recorded in BNPV, 2594 cases identified with Standardized MedDRA Queries \u201cImmune\/Mediated\/Autoimmune Conditions\u201d were analyzed to select cases of interest. After review by two experts, 368 cases of AIID were finally retained for analysis [age 54 (42\u201369); female 234 (63.6%); onset median time 4\u2009days (from <\u200924\u2009h to 179d); serious cases 226 (61.4%)] and divided into two groups: AIID flare\u2010ups (\n n<\/jats:italic>\n \u2009=\u2009174) and AIID new\u2010onset (\n n<\/jats:italic>\n \u2009=\u2009194). SOCs \u201cMusculoskeletal and connective tissue disorders\u201d and \u201cNervous system disorders\u201d recorded the most of AIID cases whatever flare\u2010up or new\u2010onset. Cases reported are mainly ankylosing spondylitis (\n n<\/jats:italic>\n \u2009=\u200920), rheumatoid arthritis (\n n<\/jats:italic>\n \u2009=\u200917), multiple sclerosis (\n n<\/jats:italic>\n \u2009=\u200919) for flare\u2010ups and Guillain\u2010Barre syndrome (\n n<\/jats:italic>\n \u2009=\u200927) for new\u2010onset.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n No safety concerns related to AIID following vaccination with SPIKEVAX were found after the reviewing of 368 French cases.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/fcp.70027","type":"journal-article","created":{"date-parts":[[2025,6,2]],"date-time":"2025-06-02T01:48:41Z","timestamp":1748828921000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Relapse and New\u2010Onset of Autoimmune or Inflammatory Diseases Following Vaccination With SPIKEVAX: Pharmacovigilance Overview From the French Spontaneous Reported System"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1138-8341","authenticated-orcid":false,"given":"Lucie","family":"Vettoretti","sequence":"first","affiliation":[{"name":"Regional Centre of Pharmacovigilance, Department of Pharmacology Besan\u00e7on University Hospital Besan\u00e7on France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C\u00e9lia","family":"Bouaskeur","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance, Department of Pharmacology Besan\u00e7on University Hospital Besan\u00e7on France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nadine","family":"Magy\u2010Bertrand","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Besan\u00e7on University Hospital Besan\u00e7on France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sophie","family":"Gautier","sequence":"additional","affiliation":[{"name":"Centre of Pharmacovigilance, Department of Clinical Pharmacology Lille University, Lille University Hospital Lille France"},{"name":"French Network of Regional Pharmacovigilance Centres Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie\u00a0Blanche\u00a0Valnet","family":"Rabier","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance, Department of Pharmacology Besan\u00e7on University Hospital Besan\u00e7on France"},{"name":"French Network of Regional Pharmacovigilance Centres Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,6]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2021.656362"},{"key":"e_1_2_13_3_1","unstructured":"\u201cVaccination Contre la Covid\u201019 des Patients Atteints de Maladies Inflammatoires \u00e0 M\u00e9diation Immune.\u201dLa Soci\u00e9t\u00e9 Fran\u00e7aise de Rhumatologie(2021) https:\/\/sfr.larhumatologie.fr\/actualit%C3%A9s\/vaccination\u2010contre\u2010covid\u201019\u2010patients\u2010atteints\u2010maladies\u2010inflammatoires\u2010mediation\u2010immune."},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2021.279442"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2022015470"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00415\u2010021\u201010780\u20107"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.13978"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41937"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2866"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.26132"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jneuroim.2021.577785"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.5582\/ddt.2023.01022"},{"key":"e_1_2_13_13_1","unstructured":"World Health Organization \u201cCausality Assessment of an Adverse Event Following Immunization (AEFI): User Manual for the Revised WHO Classification 2018.\u201d Manual World Health Organization; (2018)."},{"key":"e_1_2_13_14_1","unstructured":"\u201cCOVID\u201019 Vaccine Tracker \u201d European Centre for Disease Prevention and Control accessed August 21 2023 https:\/\/vaccinetracker.ecdc.europa.eu\/public\/extensions\/COVID\u201019\/vaccine\u2010tracker.html#distribution\u2010tab."},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2021.05.003"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2023.03.002"},{"key":"e_1_2_13_17_1","unstructured":"\u201cEffets ind\u00e9sirables des vaccins contre le Covid\u201019 \u201d Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des produits de sant\u00e9 https:\/\/ansm.sante.fr\/dossiers\u2010thematiques\/covid\u201019\u2010suivi\u2010hebdomadaire\u2010des\u2010cas\u2010deffets\u2010indesirables\u2010des\u2010vaccins."},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228\u2010023\u201003618\u2010w"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.27424"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000207847"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2024.2334084"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(03)14802\u20107"}],"container-title":["Fundamental & Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/fcp.70027","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,30]],"date-time":"2025-11-30T13:33:44Z","timestamp":1764509624000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/fcp.70027"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":21,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["10.1111\/fcp.70027"],"URL":"https:\/\/doi.org\/10.1111\/fcp.70027","archive":["Portico"],"relation":{},"ISSN":["0767-3981","1472-8206"],"issn-type":[{"type":"print","value":"0767-3981"},{"type":"electronic","value":"1472-8206"}],"subject":[],"published":{"date-parts":[[2025,6]]},"assertion":[{"value":"2024-07-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-01","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70027"}}