{"doi":"10.1093/aje/kwae141","title":"A propensity score approach and a partitioned approach for the self-controlled case series design to evaluate safety of a 2-dose vaccine series: application to myocarditis/pericarditis following mRNA COVID-19 vaccination","abstract":"The assumption that serious adverse events (SAEs) do not affect subsequent exposure might not hold when evaluating 2-dose vaccine safety through a self-controlled case series (SCCS) design. To address this, we developed: (1) propensity score SCCS (PS-SCCS) using a propensity score model involving SAEs during the risk interval after dose 1 (${R}_1$), and (2) partitioned SCCS (P-SCCS) estimating relative incidence (RI) separately for doses 1 and 2. In simulations, both provided unbiased RIs. Conversely, standard SCCS overestimated RI after dose 2. We applied these approaches to assess myocarditis/pericarditis risks after 2-dose mRNA coronavirus disease 2019 (COVID-19) vaccination in 12- to 39-year-olds. For BNT162b2, PS-SCCS yielded RIs of 1.85 (95% CI, 0.75-4.59) and 11.05 (95% CI, 6.53-18.68) 14 days after doses 1 and 2 respectively; standard SCCS provided similar RI after dose 1 and RI of 12.92 (95% CI, 7.56-22.09) after dose 2. For mRNA-1273, standard SCCS showed RIs of 1.96 (95% CI, 0.56-6.91) after dose 1 and 7.87 (95% CI, 3.33-18.57) after dose 2. As no mRNA-1273 recipients with SAEs during ${R}_1$ received dose 2, P-SCCS was used, yielding similar RI after dose 1 and RI of 6.48 (95% CI, 2.83-14.83) after dose 2. mRNA vaccines were associated with elevated myocarditis/pericarditis risks following dose 2 in 12- to 39-year-olds.","journal":"American Journal of Epidemiology","year":2024,"id":464198,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":5,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9583,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":518117,"name":"Lina S. Sy","orcid":"0000-0003-2762-9266","position":1,"is_corresponding":false},{"id":1077919,"name":"Bing Han","orcid":"0009-0008-0514-7745","position":2,"is_corresponding":false},{"id":518118,"name":"Vennis Hong","orcid":"0000-0002-6060-8419","position":3,"is_corresponding":false},{"id":518120,"name":"Katia Bruxvoort","orcid":"0000-0001-8277-2431","position":4,"is_corresponding":false},{"id":740004,"name":"Bruno Lewin","orcid":"0000-0003-1483-2791","position":5,"is_corresponding":false},{"id":1077918,"name":"Kimberly J Holmquist","orcid":"0009-0007-1639-9414","position":6,"is_corresponding":false},{"id":944355,"name":"Lei Qian","orcid":"0000-0001-8001-3992","position":7,"is_corresponding":false},{"id":334206,"name":"Stanley Xu","orcid":"0000-0002-4750-7672","position":0,"is_corresponding":true}],"reference_count":22,"raw_metadata":null,"created_at":"2026-07-19T02:04:37.468651Z","pmid":"38907283","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}