Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Recently finished cancer treatment; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Recently finished cancer treatment) in a 78-year-old patient of an unknown gender 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 (Recently finished cancer treatment) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Recently finished cancer treatment) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient was due for another shot on September 27th. The patient did not know whether to go ahead and get the existing mNexspike then if ACIP had not acted. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: Lack of information on patient´s medical history, concomitant medication and latency precludes a more meaningful assessment. Further information is being requested. The benefit-risk relationship of product is not affected by this report.