Received Jul 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Chronic urticaria; Routinely see a mental health therapist; Developed breast cancer - not hereditary; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2026 and was forwarded to Moderna on 15-Jul-2026. This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Developed breast cancer - not hereditary) and URTICARIA CHRONIC (Chronic urticaria) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2023, the patient experienced BREAST CANCER (Developed breast cancer - not hereditary) (seriousness criterion medically significant). On an unknown date, the patient experienced URTICARIA CHRONIC (Chronic urticaria) (seriousness criterion medically significant) and MENTAL DISORDER (Routinely see a mental health therapist). At the time of the report, BREAST CANCER (Developed breast cancer - not hereditary), URTICARIA CHRONIC (Chronic urticaria) and MENTAL DISORDER (Routinely see a mental health therapist) had not resolved. No concomitant medication was reported. The patient had taken a series of COVID shots and had suffered for years from something that the patient could not figure out what it was. The patient was diagnosed with chronic urticaria to the point where it was disabling. The patient could not go from own house to car without breaking out. The patient's quality of life was very poor and the patient routinely saw a mental health therapist. The reporter added that in the event that Moderna's drug was causing this too. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.