Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
patient had a lot of things happen in the last 7 years; Patient was not feeling that well; This spontaneous case was reported by a consumer and describes the occurrence of ILL-DEFINED DISORDER (patient had a lot of things happen in the last 7 years) and MALAISE (Patient was not feeling that well) in a 70-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Ulcerative colitis and Immunocompromised (extremely). Concomitant products included Vedolizumab (Entyvio) for Ulcerative colitis. In 2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILL-DEFINED DISORDER (patient had a lot of things happen in the last 7 years) and MALAISE (Patient was not feeling that well). At the time of the report, ILL-DEFINED DISORDER (patient had a lot of things happen in the last 7 years) and MALAISE (Patient was not feeling that well) outcome was unknown. It was reported that patient was a senior with multiple comorbidities and was planning to receive mNEXSPIKE, a vaccine he had received previously. Reporter contacted to inquire how long it took for mNEXSPIKE to become fully effective, as patient was scheduled to undergo a colonoscopy and endoscopy at the hospital on 18-Mar-2026 and patient wanted to time his vaccination accordingly. Patient had been ill for years, since before COVID. Patient has had a lot of things happen in the last 7 years. He did not know if anything was due to the vaccine. It was reported that most recent dose of mNEXSPIKE had been administered to patient approximately four months ago. Also, reported that ever since COVID 19 vaccines first became available, patient received a dose approximately every four months. He had kept up with the vaccines since day 1, since 2000. Patient had previously received Spikevax and his last vaccination was mNEXSPIKE and had remained with Moderna vaccines from the beginning. Patient did not believe he had ever received Pfizer or any other brand. The patient had been scheduled to receive another dose of mNEXSPIKE but was not feeling well, so he planned to delay the vaccination. He wanted to ensure the vaccine would reach full effectiveness before his upcoming trip for his hospital appointment and was seeking guidance on how long he could delay the dose while still maintaining adequate protection. It was unknown if the patient experienced any additional symptoms/events No treatment medications were reported. This case was linked to MOD-2026-793922 (Patient Link).
Immunocompromised (extremely); Ulcerative colitis
Entyvio