Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | 3031894 | — |
she also got COVID around 6 months after her breast cancer surgery; after each COVID vaccine her shins and joints ache for 8-10 hours; fast growing triple negative breast cancer (40%); This spontaneous case was reported by a consumer and describes the occurrence of TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) and COVID-19 (she also got COVID around 6 months after her breast cancer surgery) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch nos. 3031894 and 204H23-2A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus syndrome (Lupus). On 14-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 28-Jul-2024, received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) dosage was changed to 1 dosage form. In July 2024, the patient experienced TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (she also got COVID around 6 months after her breast cancer surgery) (seriousness criterion medically significant) and ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) and COVID-19 (she also got COVID around 6 months after her breast cancer surgery) outcome was unknown and ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved. No concomitant medication was reported. The patient was diagnosed with fast growing triple negative breast cancer (40%) in Jul-2024. It took one year and a half to become large enough to find and they found it early. They started chemo two weeks after they found it. She reported that triple negative was the deadliest form of breast cancer, so her team jumped on it and did a really good job. Over the past year she had been done with 2 rounds of chemotherapy and a full round of radiation and reported that she did not have an immune system. She was told by her cancer specialist to hurry, and she got a COVID shot for her immune system. She also got COVID around 6 months after her breast cancer surgery. Her breast cancer surgery was in Jul-2024. She reported that she was sick, but Moderna saved her life. If she hadn't had that vaccine, even if she would have Pfizer, the percentage was much lower. She blamed Moderna for saving her life. She reported that that after each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. She was 3 months out of radiation and did not have her first check-up. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-788868, MOD-2025-788869 (Patient Link).; Reporter's Comments: Concurrent medical condition Lupus syndrome is a confounder for arthralgia event. Due to lack of biological plausibility, the causality of the event Triple negative breast cancer was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Lupus syndrome (Lupus)