Received Mar 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052133 | IM |
Feeling unwell; General sense of discomfort; Low-grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), DISCOMFORT (General sense of discomfort), PYREXIA (Low-grade fever) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052133) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052133) for COVID-19 prophylaxis. The patient's past medical history included Surgery (had severe Crohn's disease and had surgery). Previously administered products included for Drug use for unknown indication: Entyvio (was taken after the operation) and Remicade (was taken with an unknown immunosuppressant (but this immunosuppressant was no longer taken since 2022 or 2024)). Past adverse reactions to the above products included No adverse effect with Entyvio and Remicade. Concurrent medical conditions included Crohn's disease (had severe Crohn's disease and had surgery) since November 2005. On 05-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Feeling unwell), DISCOMFORT (General sense of discomfort), PYREXIA (Low-grade fever) and FATIGUE (Fatigue). At the time of the report, MALAISE (Feeling unwell), DISCOMFORT (General sense of discomfort), PYREXIA (Low-grade fever) and FATIGUE (Fatigue) had resolved. No concomitant medications were reported. The patient had no other vaccines in the 4 weeks prior to receiving the mNEXSPIKE but had the flu shot a few weeks after mNEXSPIKE. It was reported that the patient would be traveling and attending a very large religious event with 100 people, and as the sole caregiver for her husband, she was concerned about contracting COVID-19. It was clearly stated that the patient was no longer on immunosuppressant. The patient already asked her doctor about needing a booster but did not receive a clear answer. The reporter inquired if the patient needed a booster after receiving mNEXSPIKE. Additionally, the patient had exclusively received COVID-19 vaccines from Moderna. It was explicitly reported that the patient received the vaccine every six months since its availability. The patient experienced only mild reactions, such as feeling unwell for a day or two, with symptoms including a low-grade fever, fatigue, and a general sense of discomfort, which was described as not feeling like herself. However, it was clarified that those symptoms were not severe and occurred with each dose of the Moderna COVID-19 Vaccine. The patient did not experience any additional symptoms/events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2026-794156 (E2B Linked Report). This case was linked to MOD-2026-794155 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-794156:Husband case
Crohn's disease (had severe Crohn's disease and had surgery)
Medical History/Concurrent Conditions: Surgery (had severe Crohn's disease and had surgery)