Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
breast cancer; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST CANCER FEMALE (breast cancer) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER FEMALE (breast cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER FEMALE (breast cancer) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that when patient called the pharmacy to confirm, they informed patient that they do not have the vaccine in stock and suggested to check back after the first of the month. Patient have had all the vaccines, and boosters since day one of the outbreak. All the vaccines were the Moderna product. Treatment information was not reported.; Reporter's Comments: The event of breast cancer was assessed as not related to to lack of biological plausibility additional it is unknown if patient developed breast cancer before or after vaccination. The benefit-risk relationship of product is not affected by this report.