Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.; Large, red, hot and painful goose egg lump at injection site.; Large, red, hot and painful goose egg lump at injection site; Large, red, hot and painful goose egg lump at injection site.; Severe fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.), VACCINATION SITE MASS (Large, red, hot and painful goose egg lump at injection site.), VACCINATION SITE PAIN (Large, red, hot and painful goose egg lump at injection site), VACCINATION SITE ERYTHEMA (Large, red, hot and painful goose egg lump at injection site.) and FATIGUE (Severe fatigue) in a 67-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Celiac disease. On 21-Sep-2025, 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 22-Sep-2025, the patient experienced VACCINATION SITE WARMTH (Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.), VACCINATION SITE MASS (Large, red, hot and painful goose egg lump at injection site.), VACCINATION SITE PAIN (Large, red, hot and painful goose egg lump at injection site), VACCINATION SITE ERYTHEMA (Large, red, hot and painful goose egg lump at injection site.), FATIGUE (Severe fatigue) and HEADACHE (headache). On 14-Oct-2025, VACCINATION SITE WARMTH (Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.), VACCINATION SITE MASS (Large, red, hot and painful goose egg lump at injection site.), VACCINATION SITE PAIN (Large, red, hot and painful goose egg lump at injection site), VACCINATION SITE ERYTHEMA (Large, red, hot and painful goose egg lump at injection site.), FATIGUE (Severe fatigue) and HEADACHE (headache) had resolved. The concomitant medication was not reported by the reporter. The patient did not have any additional medical history, concomitant disease or risk factor. The patient did not experience any additional symptoms or events. There was no lab data or results available. The treatment medication was not reported by the reporter.
Celiac disease