Received Apr 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Intense inflammation; Still feel it in arm; Had every reaction listed; Almost was vomiting/was like gonna vomit all day; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Intense inflammation), LIMB DISCOMFORT (Still feel it in arm), IMMUNISATION REACTION (Had every reaction listed), NAUSEA (Almost was vomiting/was like gonna vomit all day) and FATIGUE (Little tired) in a female patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: flu, SHINGRIX (Patient received it long time ago and like 2018 or something). Past adverse reactions to the above products included No adverse effect with flu; and Vaccination adverse reaction with SHINGRIX. On 01-Apr-2026, 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 INFLAMMATION (Intense inflammation), LIMB DISCOMFORT (Still feel it in arm), IMMUNISATION REACTION (Had every reaction listed), NAUSEA (Almost was vomiting/was like gonna vomit all day) and FATIGUE (Little tired). At the time of the report, INFLAMMATION (Intense inflammation), LIMB DISCOMFORT (Still feel it in arm), IMMUNISATION REACTION (Had every reaction listed) and FATIGUE (Little tired) had not resolved and NAUSEA (Almost was vomiting/was like gonna vomit all day) had resolved. No concomitant medications were reported. It was reported that the patient received mNEXSPIKE (normal dose) on 01-Apr-2026 (Wednesday) and reported that it hit hard. Other than mNEXSPIKE, the patient had not received any other vaccines in the past 4 weeks. The patient had allergy shots, but that was not a vaccine. It was reported that patient had every reaction listed and almost vomited and, it had gone now, but it was an intense inflammation, and it was kind of like the Shingrix vaccine, which was the worst ever had. It was reported that they use a heavy-duty adjuvant there. The patient had hoped that immune system was doing well. It was reported that the patient had reacted to all the COVID vaccines too. This one was just stronger; the patient was within the normal range of all these reactions. The patient had received Spikevax in the past as well. It reacted to all of the COVID vaccines a lot, but this one (mNEXSPIKE) was just more. It was reported that the patient was a little tired. The patient could still feel it in arm. The patient was like going to vomit all day for the first 30 hours or something, but that it was gone, all of that was gone now, so that was fine. The patient did not need medical advice. There, it had gone. It just wondered what they did to make it react more than Spikevax. They did to make mNEXSPIKE stimulate the immune system more than Spikevax. The patient was worried about overstimulating the immune system sometimes, because it seemed to have good reactions to it. The patient did not have any reactions that was not on the list, on the general list, but they were just very strong and so it seemed like that vaccine was working to do this. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. This case was linked to MOD-2026-794704 (Patient Link).