PMID- 36872064 OWN - NLM STAT- MEDLINE DCOM- 20230602 LR - 20240215 IS - 2233-6087 (Electronic) IS - 2233-6079 (Print) IS - 2233-6079 (Linking) VI - 47 IP - 3 DP - 2023 May TI - Safety of COVID-19 Vaccines among Patients with Type 2 Diabetes Mellitus: Real-World Data Analysis. PG - 356-365 LID - 10.4093/dmj.2022.0129 [doi] AB - BACKGROUND: Little is known about the adverse events (AEs) associated with coronavirus disease 2019 (COVID-19) vaccination in patients with type 2 diabetes mellitus (T2DM). METHODS: This study used vaccine AE reporting system data to investigate severe AEs among vaccinated patients with T2DM. A natural language processing algorithm was applied to identify people with and without diabetes. After 1:3 matching, we collected data for 6,829 patients with T2DM and 20,487 healthy controls. Multiple logistic regression analysis was used to calculate the odds ratio for severe AEs. RESULTS: After COVID-19 vaccination, patients with T2DM were more likely to experience eight severe AEs than controls: cerebral venous sinus thrombosis, encephalitis myelitis encephalomyelitis, Bell's palsy, lymphadenopathy, ischemic stroke, deep vein thrombosis (DVT), thrombocytopenia (TP), and pulmonary embolism (PE). Moreover, patients with T2DM vaccinated with BNT162b2 and mRNA-1273 were more vulnerable to DVT and TP than those vaccinated with JNJ-78436735. Among patients with T2DM administered mRNA vaccines, mRNA-1273 was safer than BNT162b2 in terms of the risk of DVT and PE. CONCLUSION: Careful monitoring of severe AEs in patients with T2DM may be necessary, especially for those related to thrombotic events and neurological dysfunctions after COVID-19 vaccination. FAU - Kim, Hye Jun AU - Kim HJ AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. FAU - Lee, Sang Jun AU - Lee SJ AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. FAU - Sa, Soonok AU - Sa S AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. FAU - Bae, Jung Ho AU - Bae JH AD - Department of Internal Medicine and Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, Korea. FAU - Song, Gyuseon AU - Song G AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. FAU - Lee, Chae Won AU - Lee CW AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. FAU - Kim, Ju Hee AU - Kim JH AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. FAU - Shim, Sung Ryul AU - Shim SR AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Department of Health and Medical Informatics, Kyungnam University College of Health Sciences, Changwon, Korea. FAU - Hong, Myunghee AU - Hong M AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. FAU - Han, Hyun Wook AU - Han HW AD - Department of Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. AD - Institute of Basic Medical Sciences, CHA University School of Medicine, Seongnam, Korea. AD - Institute for Biomedical Informatics, CHA University School of Medicine, Seongnam, Korea. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230306 PL - Korea (South) TA - Diabetes Metab J JT - Diabetes & metabolism journal JID - 101556588 RN - 0 (COVID-19 Vaccines) RN - 0 (BNT162 Vaccine) RN - EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273) RN - JT2NS6183B (Ad26COVS1) SB - IM CIN - Diabetes Metab J. 2023 Sep;47(5):715-716. PMID: 37793981 CIN - Diabetes Metab J. 2023 Sep;47(5):717-718. PMID: 37793982 MH - Humans MH - COVID-19 Vaccines/adverse effects MH - *Diabetes Mellitus, Type 2/complications MH - BNT162 Vaccine MH - 2019-nCoV Vaccine mRNA-1273 MH - Ad26COVS1 MH - *COVID-19/prevention & control MH - Data Analysis PMC - PMC10244203 OTO - NOTNLM OT - Adverse effects OT - COVID-19 OT - Diabetes mellitus, type 2 OT - Vaccines COIS- CONFLICTS OF INTEREST No potential conflict of interest relevant to this article was reported. EDAT- 2023/03/06 06:00 MHDA- 2023/06/02 06:42 PMCR- 2023/05/01 CRDT- 2023/03/05 21:23 PHST- 2022/04/11 00:00 [received] PHST- 2022/08/04 00:00 [accepted] PHST- 2023/06/02 06:42 [medline] PHST- 2023/03/06 06:00 [pubmed] PHST- 2023/03/05 21:23 [entrez] PHST- 2023/05/01 00:00 [pmc-release] AID - dmj.2022.0129 [pii] AID - dmj-2022-0129 [pii] AID - 10.4093/dmj.2022.0129 [doi] PST - ppublish SO - Diabetes Metab J. 2023 May;47(3):356-365. doi: 10.4093/dmj.2022.0129. Epub 2023 Mar 6.