Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
diarrhea; vomited; fevers; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VOMITING (vomited) and PYREXIA (fevers) in a male patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. MEDICAL HISTORY (Parent): The patient had the vaccine and had fever, which was expected. However, the patient had sore throats, which was not expected. She had a light vomiting. She felt queasy. She was breastfeeding. MEDICAL HISTORY (Patient): Concurrent medical conditions included Exposure during breast feeding. On 31-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced DIARRHOEA (diarrhea) and VOMITING (vomited). 2025, the patient experienced PYREXIA (fevers). At the time of the report, DIARRHOEA (diarrhea), VOMITING (vomited) and PYREXIA (fevers) was resolving. No concomitant medications were provided. The patient had the vaccine and had fever, which was expected. He had a vomiting and light diarrhoea. It was reported that the patient had more or less recovered and that it had probably been the strongest reaction patient had to a vaccine. And added that he was not certain if he also had another infection at the same time. It was unknown if the patient experienced any additional symptoms/events. There were no additional lab data/result available. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790823 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2025: Follow up received contains significant information, events outcome and narrative updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790823:Master case (Husband case)
Exposure during breast feeding