Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
having a cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (having a cancer) in an elderly 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 NEOPLASM MALIGNANT (having a cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (having a cancer) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication use information was not provided by reporter. The patient had cancer and received Moderna COVID-19 shots before. It was not specified if the cancer developed after the Moderna COVID-19 shots. The reporter narrated that now some pharmacies required a prescription, even though the patient qualified because she was over 65 and a cancer patient. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter.; Reporter's Comments: Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.