{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T17:07:14Z","timestamp":1786122434742,"version":"build-2736575974"},"reference-count":23,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T00:00:00Z","timestamp":1779148800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"donation-based crowdfunding","award":["23-700-06725"],"award-info":[{"award-number":["23-700-06725"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Risk &amp; Safety in Medicine"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Preliminary reports have suggested a batch-dependent safety signal for COVID-19 vaccines. It is important to establish if these findings can be replicated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We used publicly available nationwide data from Germany spanning the first 3.5 years of the vaccination campaign to calculate weekly rates of spontaneously reported suspected adverse events (SAEs) per 1000 administered vaccine doses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>SAE rates ranged between 2.2 and 22.8 per 1000 doses and women accounted for 72% of all SAEs. Crucially, SAE rates for Comirnaty (Pfizer-BioNTech), Spikevax (Moderna), and Vaxzevria (AstraZeneca) were very high in the initial phase of vaccination rollout and hereafter declined precipitously. For example, SAE rates in weeks 1\u20134 of 2021 were 8.2, 50.8, and 620.9 per 1000 doses of Comirnaty, Spikevax, and Vaxzevria, respectively, but fell to 4.4, 11.6, and 7.4 per 1000 doses in weeks 12\u201316 of 2021.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>SAE rates in Germany were highly elevated in the initial phase of COVID-19 vaccination rollout and then fell precipitously, a pattern compatible with a batch-dependent safety signal. Furthermore, there was a considerable overrepresentation of women with SAEs. These preliminary results call for more definitive studies of batch-dependent COVID-19 vaccine safety.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/09246479261453789","type":"journal-article","created":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T23:05:49Z","timestamp":1779231949000},"page":"458-462","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Batch-dependent safety signal: Nationwide analysis of suspected adverse events following COVID-19 vaccination in Germany"],"prefix":"10.1177","volume":"37","author":[{"given":"Vibeke","family":"Manniche","sequence":"first","affiliation":[{"name":"LIVA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-1638-2778","authenticated-orcid":false,"given":"V\u00edt","family":"Kar\u00e1sek","sequence":"additional","affiliation":[{"name":"University of Pardubice"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Max","family":"Schmeling","sequence":"additional","affiliation":[{"name":"Innometric"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan D.","family":"Gilthorpe","sequence":"additional","affiliation":[{"name":"Ume\u00e5 University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom\u00e1\u0161","family":"F\u00fcrst","sequence":"additional","affiliation":[{"name":"Palacky University Olomouc"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9056-535X","authenticated-orcid":false,"given":"Peter Riis","family":"Hansen","sequence":"additional","affiliation":[{"name":"Copenhagen University Hospital - Herlev and Gentofte"},{"name":"University of Copenhagen"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,5,19]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/eci.13998"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.3390\/medicina60081343"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/eci.14271"},{"key":"e_1_3_4_5_2","unstructured":"Jablonowski K Hooker B. Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine in the United States. Sci Pub Health Policy Law 2024 Sep 26; v5.2019\u20132024."},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/eci.14102"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2021.09.065"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-023-03548-3"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.70207"},{"key":"e_1_3_4_10_2","unstructured":"Paul Erlich Institute. Reported suspected adverse events and vaccine complications following use of COVID-19 vaccines [Internet]. Langen Germany: Paul Erlich Institute; 2025 [accessed 2025 Oct 24]. Available from: https:\/\/www.pei.de\/DE\/arzneimittelsicherheit\/pharmakovigilanz\/uaw-daten\/uaw-daten-node.html"},{"key":"e_1_3_4_11_2","unstructured":"Robert Koch Institute. COVID-19-implugen in Deutchland [Internet]. Berlin Germany: Robert Koch Institute; 2025 [accessed 2025 Nov 27]. Available from: https:\/\/robert-koch-institut.github.io\/COVID-19-Impfungen_in_Deutschland\/"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11115-022-00614-z"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1111\/rego.12497"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1126\/sciadv.adg1391"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjsrh-2024-202274"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1038\/d41573-022-00191-2"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n627"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2024.1336906"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.prp.2023.155030"},{"key":"e_1_3_4_20_2","unstructured":"European Medicines Agency. Periodic Safety Update Report #1 for Covid-19 mRNA vaccine (nucleoside modified) (BNT162b2) [Internet]. Amsterdam The Netherlands: The European Medicines Agency; 2021 [made publicly available 2023 Jan 17 in response to a Freedom of Information Act (FOIA) request published by the Austrian science and political blog \u2018tkp'; accessed on 2025 Sept 1]. 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