Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052030 | SC |
administered the vaccine subcutaneous and not intramuscular; dizzy; bump at the injection site and bruising.; bump at the injection site and bruising; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (dizzy), VACCINATION SITE BRUISING (bump at the injection site and bruising.), VACCINATION SITE SWELLING (bump at the injection site and bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered the vaccine subcutaneous and not intramuscular) in a 65-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052030) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Subcutaneous use) .2 milliliter. In September 2025, the patient experienced DIZZINESS (dizzy), VACCINATION SITE BRUISING (bump at the injection site and bruising.) and VACCINATION SITE SWELLING (bump at the injection site and bruising). On 22-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered the vaccine subcutaneous and not intramuscular). At the time of the report, DIZZINESS (dizzy), VACCINATION SITE BRUISING (bump at the injection site and bruising.), VACCINATION SITE SWELLING (bump at the injection site and bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered the vaccine subcutaneous and not intramuscular) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Subcutaneous use), the reporter did not provide any causality assessments. The relevant medical history (vaccines within the past 4 weeks, medical conditions) was reported as none. The concomitant medication was not reported by the reporter. The patient said that after receiving the mNEXSPIKE last week, she had a bump at the injection site and bruising. She spoke with the nurse who administered the medication, and the nurse explained that the needle might have hit a fat pocket, that was why the patient had some bruising. The patient also said that after going home, she started seeing stars and felt very dizzy. She was worried that the nurse administered the vaccine subcutaneously instead of intramuscularly. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.