Safety Results
pulmonary embolism, myalgia, fatigue, hyperlipidemia, cutaneous vasculitis, headache
ADVERSE EVENTS, HYPERLIPIDEMIA, CUTANEOUS VASCULITIS, PULMONARY EMBOLISM
The frequency of any or grade 3 intensity solicited local AEs post–mRNA-1273 or post-RZV1 were similar in both study groups (Percentage of solicited local and systemic adverse events reported per participant after the mRNA-1273 and first RZV vaccinations (exposed set). The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of RZV. The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV. Definitions of grade 3 intensity are provided in the The most frequently reported solicited systemic AEs (percentages for Seq and Coad groups, respectively) were myalgia (57.7%, 64.0%), fatigue (49.3%, 51.7%), and headache (38.6%, 39.0%) (The frequency of solicited AEs of any or grade 3 intensity reported per participant post-RZV2 was similar in the 2 study groups (There were 41.5% of participants in the Seq group and 46.1% in the Coad group who reported at least 1 unsolicited AE within 30 days of any study vaccination (Five participants in the Seq group and 6 in the Coad group reported SAEs. One SAE in the Seq group, pulmonary embolism, in a participant with a history of hyperlipidemia and tobacco use, and with an onset on day 3 after mRNA-1273 vaccination (prior to receiving RZV1), based on temporal association, was assessed by the investigator and sponsor as related to mRNA-1273 and led to discontinuation from further study vaccinations (Three participants in the Seq group and 2 in the Coad group reported AESIs, of which 1 was the pulmonary embolism SAE described above (One participant in each study group reported a pIMD, of which cutaneous vasculitis (no skin biopsy performed) in a participant in the Seq group, with onset on day 10 after mRNA-1273 and spontaneous resolution prior to administration of RZV1, was assessed as related to mRNA-1273 by the investigator and sponsor based on temporal association (