{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T19:17:31Z","timestamp":1762888651618,"version":"3.45.0"},"reference-count":29,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2022,7,1]],"date-time":"2022-07-01T00:00:00Z","timestamp":1656633600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,7,1]],"date-time":"2022-07-01T00:00:00Z","timestamp":1656633600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,5,6]],"date-time":"2022-05-06T00:00:00Z","timestamp":1651795200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["thelancet.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["eClinicalMedicine"],"published-print":{"date-parts":[[2022,7]]},"DOI":"10.1016\/j.eclinm.2022.101468","type":"journal-article","created":{"date-parts":[[2022,5,20]],"date-time":"2022-05-20T18:07:17Z","timestamp":1653070037000},"page":"101468","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":6,"special_numbering":"C","title":["ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance"],"prefix":"10.1016","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2422-5699","authenticated-orcid":false,"given":"Zeno","family":"Di Valerio","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giusy","family":"La Fauci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giorgia","family":"Sold\u00e0","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7276-0277","authenticated-orcid":false,"given":"Marco","family":"Montalti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2882-4223","authenticated-orcid":false,"given":"Jacopo","family":"Lenzi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcello","family":"Forcellini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edoardo","family":"Barvas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susanna","family":"Guttmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisabetta","family":"Poluzzi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emanuel","family":"Raschi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rossano","family":"Riccardi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Pia","family":"Fantini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5953-6211","authenticated-orcid":false,"given":"Aurelia","family":"Salussolia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Davide","family":"Gori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.eclinm.2022.101468_bib0001","unstructured":"Coronavirus disease (COVID-19) pandemic. https:\/\/www.who.int\/emergencies\/diseases\/novel-coronavirus-2019. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0002","unstructured":"WHO Coronavirus (COVID-19) Dashboard |Dashboard With Vaccination Data. https:\/\/covid19.who.int\/. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0003","unstructured":"Our World in Data. https:\/\/ourworldindata.org\/#entries. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0004","unstructured":"Institute for Social Security. Piano vaccinale anti-SARS-CoV-2\/COVID-19 vaccination plan of the Republic of San Marino. http:\/\/www.iss.sm. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0005","unstructured":"State Register of Medicines https:\/\/grls.rosminzdrav.ru\/Grls_View_v2.aspx?routingGuid=6c1f7501-7067-45b3-a56d-95e25db89e97&t. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0006","unstructured":"About Sputnik V | Official website vaccine against COVID-19 Sputnik V. https:\/\/sputnikvaccine.com\/about-vaccine\/. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0007","unstructured":"Press release | Official website vaccine against COVID-19 Sputnik V. https:\/\/sputnikvaccine.com\/newsroom\/pressreleases\/. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0008","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1038\/s41541-021-00356-x","article-title":"Adenoviral vector vaccine platforms in the SARS-CoV-2 pandemic","volume":"6","author":"Mendon\u00e7a","year":"2021","journal-title":"NPJ Vaccines"},{"key":"10.1016\/j.eclinm.2022.101468_bib0009","doi-asserted-by":"crossref","first-page":"671","DOI":"10.1016\/S0140-6736(21)00234-8","article-title":"Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia","volume":"397","author":"Logunov","year":"2021","journal-title":"Lancet"},{"key":"10.1016\/j.eclinm.2022.101468_bib0010","unstructured":"CIOMS\/WHO Working Group on Vaccine Pharmacovigilance. Definition and Application of Terms for Vaccine Pharmacovigilance 2012. https:\/\/vaccine-safety-training.org\/tl_files\/vs\/pdf\/report-of-cioms-who-working-group.pdf. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0011","doi-asserted-by":"crossref","DOI":"10.1016\/j.eclinm.2021.101027","article-title":"ROCCA observational study: early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance","author":"Montalti","year":"2021","journal-title":"EClinicalMedicine"},{"key":"10.1016\/j.eclinm.2022.101468_bib0012","unstructured":"Monitoring of COVID-19 medicines | European Medicines Agency https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/public-health-threats\/coronavirus-disease-covid-19\/treatments-vaccines\/monitoring-covid-19-medicines-0. Accessed 2 February, 2022"},{"key":"10.1016\/j.eclinm.2022.101468_bib0013","doi-asserted-by":"crossref","first-page":"607","DOI":"10.1177\/001316447003000308","article-title":"Determining sample size for research activities","volume":"30","author":"Krejcie","year":"1970","journal-title":"Educ Psychol Meas"},{"year":"1977","series-title":"Sampling Techniques","author":"Cochran","key":"10.1016\/j.eclinm.2022.101468_bib0014"},{"year":"2008","series-title":"Sampling of Populations: Methods and Applications","author":"Levy","key":"10.1016\/j.eclinm.2022.101468_bib0015"},{"key":"10.1016\/j.eclinm.2022.101468_bib0016","doi-asserted-by":"crossref","first-page":"681","DOI":"10.1002\/(SICI)1097-0258(19990330)18:6<681::AID-SIM71>3.0.CO;2-R","article-title":"Multiple imputation of missing blood pressure covariates in survival analysis","volume":"18","author":"Van Buuren","year":"1999","journal-title":"Stat Med"},{"key":"10.1016\/j.eclinm.2022.101468_bib0017","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2288-12-73","article-title":"Practical considerations for sensitivity analysis after multiple imputation applied to epidemiological studies with incomplete data","author":"H\u00e9raud-Bousquet","year":"2012","journal-title":"BMC Med Res Methodol"},{"issue":"2","key":"10.1016\/j.eclinm.2022.101468_bib0018","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1177\/1536867X19854021","article-title":"Tips for calculating and displaying risk-standardized hospital outcomes in Stata","volume":"19","author":"Lenzi","year":"2019","journal-title":"Stata J"},{"key":"10.1016\/j.eclinm.2022.101468_bib0019","unstructured":"Patologie croniche - Sorveglianza Passi. https:\/\/www.epicentro.iss.it\/passi\/dati\/croniche. Accessed 2 February, 2022)"},{"key":"10.1016\/j.eclinm.2022.101468_bib0020","unstructured":"Pfizer-BioNTech COVID-19 Vaccine Reactions & Adverse Events | CDC [Internet]. https:\/\/www.cdc.gov\/vaccines\/covid-19\/info-by-product\/pfizer\/reactogenicity.html#persons-18yrs-older. Accessed 2 February, 2022"},{"issue":"13","key":"10.1016\/j.eclinm.2022.101468_bib0021","doi-asserted-by":"crossref","first-page":"1172","DOI":"10.1056\/NEJMoa2107659","article-title":"Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine","volume":"385","author":"Heath","year":"2021","journal-title":"N Engl J Med"},{"key":"10.1016\/j.eclinm.2022.101468_bib0022","unstructured":"Moderna COVID-19 Vaccine's Reactions and Adverse Events | CDC. https:\/\/www.cdc.gov\/vaccines\/covid-19\/info-by-product\/moderna\/reactogenicity.html. Accessed 2 February, 2022"},{"year":"2021","series-title":"COVID-19 Vaccine AstraZeneca","key":"10.1016\/j.eclinm.2022.101468_bib0023"},{"issue":"18","key":"10.1016\/j.eclinm.2022.101468_bib0024","doi-asserted-by":"crossref","first-page":"680","DOI":"10.15585\/mmwr.mm7018e2","article-title":"Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine \u2014 United States, March\u2013April 2021","volume":"70","author":"Shay","year":"2021","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"5","key":"10.1016\/j.eclinm.2022.101468_bib0025","doi-asserted-by":"crossref","first-page":"405","DOI":"10.1016\/j.jogn.2020.08.001","article-title":"Sex-Based Vaccine Response in the Context of COVID-19","volume":"49","author":"McCartney","year":"2020","journal-title":"J Obstet Gynecol Neonatal Nurs"},{"issue":"6","key":"10.1016\/j.eclinm.2022.101468_bib0026","doi-asserted-by":"crossref","first-page":"812","DOI":"10.1016\/j.tjog.2020.09.006","article-title":"A review of vaccine effects on women in light of the COVID-19 pandemic","volume":"59","author":"Chang","year":"2020","journal-title":"Taiwan J Obstet Gynecol"},{"issue":"2","key":"10.1016\/j.eclinm.2022.101468_bib0027","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1258\/jhsrp.2010.009131","article-title":"Do women consult more than men? A review of gender and consultation for back pain and headache","volume":"16","author":"Hunt","year":"2011","journal-title":"J Health Serv Res Policy"},{"issue":"7","key":"10.1016\/j.eclinm.2022.101468_bib0028","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1016\/S0277-9536(97)00217-7","article-title":"Gender differences in consulting a general practitioner for common symptoms of minor illness","volume":"46","author":"Wyke","year":"1998","journal-title":"Soc Sci Med"},{"issue":"7","key":"10.1016\/j.eclinm.2022.101468_bib0029","doi-asserted-by":"crossref","first-page":"939","DOI":"10.1016\/S1473-3099(21)00224-3","article-title":"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","volume":"21","author":"Menni","year":"2021","journal-title":"Lancet Infect Dis"}],"container-title":["eClinicalMedicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2589537022001985?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2589537022001985?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T19:15:00Z","timestamp":1762888500000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2589537022001985"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7]]},"references-count":29,"alternative-id":["S2589537022001985"],"URL":"https:\/\/doi.org\/10.1016\/j.eclinm.2022.101468","relation":{},"ISSN":["2589-5370"],"issn-type":[{"type":"print","value":"2589-5370"}],"subject":[],"published":{"date-parts":[[2022,7]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance","name":"articletitle","label":"Article Title"},{"value":"eClinicalMedicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.eclinm.2022.101468","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2022 The Author(s). Published by Elsevier Ltd.","name":"copyright","label":"Copyright"}],"article-number":"101468"}}