Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
breastfeeding; sore throats; diarrhea; fevers; queasy; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throats), DIARRHOEA (diarrhea), PYREXIA (fevers), NAUSEA (queasy) and MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) in a female 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. No Medical History information was reported. 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 OROPHARYNGEAL PAIN (sore throats), DIARRHOEA (diarrhea), PYREXIA (fevers) and NAUSEA (queasy). On 31-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding). On 31-Oct-2025, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throats), DIARRHOEA (diarrhea), PYREXIA (fevers) and NAUSEA (queasy) outcome was unknown. No concomitant medications were provided. 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. 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, US-MODERNATX, INC.-MOD-2025-790841 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790823:Master case (Husband case) US-MODERNATX, INC.-MOD-2025-790841:Child case