Sex: U
Vaccine: COVID19
Symptoms: Cutaneous vasculitis
Clinical narrative: cutaneous vasculitis; This literature-non-study case was reported in a literature article and describes the occurrence of CUTANEOUS VASCULITIS (cutaneous vasculitis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CUTANEOUS VASCULITIS (cutaneous vasculitis) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (cutaneous vasculitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CUTANEOUS VASCULITIS (cutaneous vasculitis) to be related.    Concomitant and treatment medications were not reported.  Author stated in this phase 3, randomized, open-label, multi-center study (NCT05047770), adults aged =50 years were randomized 1:1 to receive the first RZV dose with mRNA-1273 booster (50 µg) at day 1 and the second RZV dose at week (W)8 (Co-Administration group [Co-Ad]), or mRNA-1273 at day 1, the first RZV dose at W2 and the second RZV dose at W10 (Sequential group [Seq]). Descriptive analyses of solicited/unsolicited adverse events (AEs) with onset within 7/30 days post-mRNA-1273 or first RZV dose, and of serious AEs/potential immune-mediated diseases/AEs of special interest (SAEs/pIMDs/AESIs) reported until database freeze was reviewed.  The exposed set comprised 267 (Co-Ad) and 272 (Seq) participants. In each group, most solicited AEs were mild/moderate in intensity and each with =2.5 days median duration, the most frequent were injection site pain, myalgia, and fatigue. Unsolicited (vaccines-related) AEs were reported by 25.0% (2.9%) of participants post-mRNA-1273 in Seq, 25.2% (0.8%) post-RZV in Seq, and 37.1% (3.7%) in Co-Ad. SAEs/pIMDs/AESIs were reported for 6/1/2 participants in Co-Ad and 5/1/3 in Seq. In Seq, one SAE/AESI (pulmonary embolism) and one pIMD/AESI (cutaneous vasculitis) occurred 2 and 9 days postmRNA-1273 (before RZV administration), respectively, and were considered mRNA-1273-related by investigators. In Co-Ad, one AESI (chronic hepatitis) occurred 35 days post-second RZV dose, considered vaccines-related by Sponsor. No fatalities occurred.  Author concluded no safety concerns were identified. The frequency/severity/type of AEs were comparable between groups and consistent with the known safety profile of each vaccine, whether RZV and mRNA-1273 booster were administered concomitantly or sequentially. Co-administration may enhance vaccine coverage rates.  Company Comment: This is a literature case concerning an adult patient with no medical history reported, who experienced the unexpected serious (medically significant) event of cutaneous vasculitis. The event occurred 2 to 9 days after a dose of mRNA-1273 vaccine gives in combination with recombinant herpes zoster vaccine. No information disclosed about diagnostic tests performed or treatments received. Author concluded no safety concerns were identified. The frequency/severity/type of adverse events were comparable between groups and consistent with the known safety profile of each vaccine, whether RZV and mRNA-1273 booster were administered concomitantly or sequentially. Co-administration may enhance vaccine coverage rates. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-720256 (E2B Linked Report). Reporter's Comments: This is a literature case concerning an adult patient with no medical history reported, who experienced the unexpected serious (medically significant) event of cutaneous vasculitis. The event occurred 2 to 9 days after a dose of mRNA-1273 vaccine gives in combination with recombinant herpes zoster vaccine. No information disclosed about diagnostic tests performed or treatments received. Author concluded no safety concerns were identified. The frequency/severity/type of adverse events were comparable between groups and consistent with the known safety profile of each vaccine, whether RZV and mRNA-1273 booster were administered concomitantly or sequentially. Co-administration may enhance vaccine coverage rates. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning an adult patient with no medical history reported, who experienced the unexpected serious (medically significant) event of cutaneous vasculitis. The event occurred 2 to 9 days after a dose of mRNA-1273 vaccine gives in combination with recombinant herpes zoster vaccine. No information disclosed about diagnostic tests performed or treatments received. Author concluded no safety concerns were identified. The frequency/severity/type of adverse events were comparable between groups and consistent with the known safety profile of each vaccine, whether RZV and mRNA-1273 booster were administered concomitantly or sequentially. Co-administration may enhance vaccine coverage rates. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-720256:Master case (Adult patient 1)