Received Mar 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
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 an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Surgery (surgery/operation). Previously administered products included for Drug use for unknown indication: ENTYVIO (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 (Patient had severe Crohn's disease and had surgery) since November 2005. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. 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. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were provided. The patient had received all Moderna COVID-19 vaccines (since the first circulation) with a 6-month interval. 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 MOD-2026-794142 (Patient Link).
Crohn's disease (Patient had severe Crohn's disease and had surgery)
Medical History/Concurrent Conditions: Surgery (surgery/operation)