Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Chronic hepatitis
Clinical narrative: chronic hepatitis; This literature-non-study case was reported in a literature article and describes the occurrence of CHRONIC HEPATITIS (chronic hepatitis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    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 and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC HEPATITIS (chronic hepatitis) (seriousness criterion medically significant). At the time of the report, CHRONIC HEPATITIS (chronic hepatitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Company Comment: This is a Literature non-study case concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Chronic hepatitis, which occurred on an unknown date after mRNA-1273 vaccine, administered as booster dose within COVID-19 vaccination schedule. Co-suspect drug included non-company product of varicella zoster vaccine RGE for an unknown indication; second dose was administered 35 days prior to the event. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case referred to patient 3 of 3 patients described by the reporter.  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.   This case was linked to US-MODERNATX, INC.-MOD-2023-720256 (Linked Report).; Sender's Comments: This is a Literature non-study case concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Chronic hepatitis, which occurred on an unknown date after mRNA-1273 vaccine, administered as booster dose within COVID-19 vaccination schedule. Co-suspect drug included non-company product of varicella zoster vaccine RGE for an unknown indication; second dose was administered 35 days prior to the event. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-720256:Master case Patient 1