{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T03:02:08Z","timestamp":1760151728586,"version":"build-2065373602"},"reference-count":25,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2022,4,6]],"date-time":"2022-04-06T00:00:00Z","timestamp":1649203200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background: Vaccination against SARS-CoV-2 significantly reduces the transmissibility of the virus and the likelihood of a severe course of COVID-19, and is thus a critical component in overcoming the current pandemic. The factors associated with adverse reactions after vaccination against SARS-CoV-2 have not yet been sufficiently evaluated. Methods: We used the Disease Analyzer database (IQVIA) to identify 531,468 individuals who received a total of 908,869 SARS-CoV-2 vaccinations in 827 general practices in Germany between April and September 2021. Cox regression models were used to analyze the frequency of vaccination-related side effects reported within 14 days after SARS-CoV-2 vaccination, as well as subjects\u2019 demographic characteristics and comorbidities. Results: The total number of side effects documented was 28,287 (3.1% of all vaccinations). Pain in the limb (24.3%), fatigue (21.0%), dizziness (17.9%), joint pain (15.7%), fever (9.5%), nausea (7.5%), and myalgia (6.4%) were the most common side effects documented among the 12,575 vaccinations with definite side effects. In the multivariate regression analysis, young age was associated with much higher odds of reported side effects (OR18\u201330 years: 4.45, OR31\u201340 years: 3.50, OR41\u201350 years: 2.89). In addition, pre-existing comorbidities such as dementia (OR: 1.54), somatoform disorder (OR: 1.53), anxiety disorder (OR: 1.43), depression (OR: 1.37), chronic respiratory tract disease (OR: 1.27), hypertension (OR: 1.20), and obesity (1.14) significantly increased the odds of side effects. Finally, the male sex was associated with increased odds of reported side effects (OR: 1.17). Conclusion: Our study, based on a large outpatient database from Germany, identified young age, male sex, and pre-existing comorbidities such as dementia, somatoform disorders, anxiety disorders, and depression as factors associated with vaccine-related adverse events diagnosed in GP practices. These data could help to identify subgroups needing particular advice and care in the context of SARS-CoV-2 vaccinations.<\/jats:p>","DOI":"10.3390\/vaccines10040566","type":"journal-article","created":{"date-parts":[[2022,4,7]],"date-time":"2022-04-07T22:23:23Z","timestamp":1649370203000},"page":"566","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Factors Associated with Non-Severe Adverse Reactions after Vaccination against SARS-CoV-2: A Cohort Study of 908,869 Outpatient Vaccinations in Germany"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2799-2287","authenticated-orcid":false,"given":"Sven H.","family":"Loosen","sequence":"first","affiliation":[{"name":"Clinic for Gastroenterology, Hepatology and Infectious Diseases, University Hospital D\u00fcsseldorf, Medical Faculty of Heinrich Heine University D\u00fcsseldorf, 40225 D\u00fcsseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jens","family":"Bohlken","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerstin","family":"Weber","sequence":"additional","affiliation":[{"name":"Impfzentrum Messe 21 Berlin, 14055 Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6798-5092","authenticated-orcid":false,"given":"Marcel","family":"Konrad","sequence":"additional","affiliation":[{"name":"Health & Social, FOM University of Applied Sciences for Economics and Management, 60549 Frankfurt, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tom","family":"Luedde","sequence":"additional","affiliation":[{"name":"Clinic for Gastroenterology, Hepatology and Infectious Diseases, University Hospital D\u00fcsseldorf, Medical Faculty of Heinrich Heine University D\u00fcsseldorf, 40225 D\u00fcsseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christoph","family":"Roderburg","sequence":"additional","affiliation":[{"name":"Clinic for Gastroenterology, Hepatology and Infectious Diseases, University Hospital D\u00fcsseldorf, Medical Faculty of Heinrich Heine University D\u00fcsseldorf, 40225 D\u00fcsseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2124-7227","authenticated-orcid":false,"given":"Karel","family":"Kostev","sequence":"additional","affiliation":[{"name":"Epidemiology, IQVIA, 60549 Frankfurt, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2022,4,6]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e2142725","DOI":"10.1001\/jamanetworkopen.2021.42725","article-title":"Estimating COVID-19 Infections, Hospitalizations, and Deaths Following the US Vaccination Campaigns During the Pandemic","volume":"5","author":"Vilches","year":"2022","journal-title":"JAMA Netw. Open"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2348","DOI":"10.1056\/NEJMoa2105290","article-title":"Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) COVID-19 Vaccine","volume":"385","author":"Falsey","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1056\/NEJMoa2035389","article-title":"Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine","volume":"384","author":"Baden","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"2603","DOI":"10.1056\/NEJMoa2034577","article-title":"Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine","volume":"383","author":"Polack","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1576","DOI":"10.1056\/NEJMc2036242","article-title":"Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine","volume":"384","author":"Vergnes","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"459","DOI":"10.5414\/CP203320","article-title":"Basic characteristics and representativeness of the German Disease Analyzer database","volume":"56","author":"Rathmann","year":"2018","journal-title":"Int. J. Clin. Pharmacol. Ther."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"136","DOI":"10.5414\/CP204178","article-title":"Demographic and clinical characteristics of primary care patients vaccinated against COVID-19 in spring 2021","volume":"60","author":"Kostev","year":"2022","journal-title":"Int. J. Clin. Pharmacol. Ther."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1016\/j.puhe.2021.12.006","article-title":"Investigation of the prevalence of non-COVID-19 infectious diseases during the COVID-19 pandemic","volume":"203","author":"Tanislav","year":"2021","journal-title":"Public Health"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"298","DOI":"10.1002\/jmv.27321","article-title":"Fewer non-COVID-19 respiratory tract infections and gastrointestinal infections during the COVID-19 pandemic","volume":"94","author":"Tanislav","year":"2021","journal-title":"J. Med. Virol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1016\/j.jpsychires.2022.01.013","article-title":"No significant association between COVID-19 diagnosis and the incidence of depression and anxiety disorder? A retrospective cohort study conducted in Germany","volume":"147","author":"Jacob","year":"2022","journal-title":"J. Psychiatr. Res."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1016\/j.jpsychires.2021.08.016","article-title":"Effect of the COVID-19 pandemic on stress, anxiety, and depressive disorders in German primary care: A cross-sectional study","volume":"143","author":"Bohlken","year":"2021","journal-title":"J. Psychiatr. Res."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"e2140364","DOI":"10.1001\/jamanetworkopen.2021.40364","article-title":"Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination","volume":"4","author":"Beatty","year":"2021","journal-title":"JAMA Netw. Open"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e2143955","DOI":"10.1001\/jamanetworkopen.2021.43955","article-title":"Frequency of Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials","volume":"5","author":"Haas","year":"2022","journal-title":"JAMA Netw. Open"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"110679","DOI":"10.1016\/j.jpsychores.2021.110679","article-title":"Side-effect expectations from COVID-19 vaccination: Findings from a nationally representative cross-sectional survey (CoVAccS-wave 2)","volume":"152","author":"Smith","year":"2021","journal-title":"J. Psychosom. Res."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1016\/j.maturitas.2020.07.011","article-title":"Nocebo phenomena may be enhanced in aging: Implications for clinical practice","volume":"143","author":"Kravvariti","year":"2021","journal-title":"Maturitas"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"100273","DOI":"10.1016\/j.lanepe.2021.100273","article-title":"Nocebo affects after COVID-19 vaccination","volume":"12","author":"Sever","year":"2021","journal-title":"Lancet Reg. Health Eur."},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Sekizawa, Y., Hashimoto, S., Denda, K., Ochi, S., and So, M. (2022). Association between COVID-19 vaccine hesitancy and generalized trust, depression, generalized anxiety, and fear of COVID-19. BMC Public Health, 22.","DOI":"10.1186\/s12889-021-12479-w"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1016\/j.maturitas.2021.02.006","article-title":"The twilight of the immune system: The impact of immunosenescence in aging","volume":"147","author":"Feehan","year":"2021","journal-title":"Maturitas"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"435","DOI":"10.1111\/j.1365-2567.2007.02555.x","article-title":"Immunosenescence: Emerging challenges for an ageing population","volume":"120","author":"Aw","year":"2007","journal-title":"Immunology"},{"key":"ref_20","first-page":"14","article-title":"Sex\/gender bias in the management of chest pain in ambulatory care","volume":"14","author":"Liaudat","year":"2018","journal-title":"Women\u2019s Health"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"6358624","DOI":"10.1155\/2018\/6358624","article-title":"\u201cBrave Men\u201d and \u201cEmotional Women\u201d: A Theory-Guided Literature Review on Gender Bias in Health Care and Gendered Norms towards Patients with Chronic Pain","volume":"2018","author":"Samulowitz","year":"2018","journal-title":"Pain Res. Manag."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1799","DOI":"10.1001\/jama.284.14.1799","article-title":"Differences in prognostic factors and outcomes between women and men undergoing coronary artery stenting","volume":"284","author":"Mehilli","year":"2000","journal-title":"JAMA J. Am. Med. Assoc."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1007\/s10549-020-05675-6","article-title":"Association between thyroid gland diseases and breast cancer: A case-control study","volume":"182","author":"Bach","year":"2020","journal-title":"Breast Cancer Res. Treat."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"617","DOI":"10.5414\/CPP47617","article-title":"Validity and representativeness of the \u201cDisease Analyzer\u201d patient database for use in pharmaco-epidemiological and pharmacoeconomic studies","volume":"47","author":"Becher","year":"2009","journal-title":"Int. J. Clin. Pharmacol. Ther."},{"key":"ref_25","first-page":"3179","article-title":"Incident Dementia in Elderly Patients with Nonalcoholic Fatty Liver Disease in Germany","volume":"66","author":"Labenz","year":"2021","journal-title":"Am. J. Dig. Dis."}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/10\/4\/566\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T22:48:59Z","timestamp":1760136539000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/10\/4\/566"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,6]]},"references-count":25,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2022,4]]}},"alternative-id":["vaccines10040566"],"URL":"https:\/\/doi.org\/10.3390\/vaccines10040566","relation":{},"ISSN":["2076-393X"],"issn-type":[{"type":"electronic","value":"2076-393X"}],"subject":[],"published":{"date-parts":[[2022,4,6]]}}}