Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Has affected her bone marrow from her fingers to her toes; antiphospholipid syndrome; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID SYNDROME (antiphospholipid syndrome) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Protein S deficiency (Protein-S deficiency at least 25 years). Concomitant products included Warfarin for Protein S deficiency. In 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In April 2025, the patient experienced ANTIPHOSPHOLIPID SYNDROME (antiphospholipid syndrome) (seriousness criterion medically significant). On an unknown date, the patient experienced BONE MARROW DISORDER (Has affected her bone marrow from her fingers to her toes). At the time of the report, ANTIPHOSPHOLIPID SYNDROME (antiphospholipid syndrome) and BONE MARROW DISORDER (Has affected her bone marrow from her fingers to her toes) outcome was unknown. It was reported that patient received COVID Moderna ever since they came out and it was worked well for the patient. It was reported that the patient most recent dose was in Mar-2025 or Apr-2025. The patient antiphospholipid syndrome was diagnosed in Apr-2025 which was related to autoimmune disease. The antiphospholipid syndrome has affected to the patient bone marrow from her fingers and to her toes. It was in the lining of vessels and arteries. No treatment medications provided by the reporter.; Reporter's Comments: Company comment: Medical history of Protein S deficiency could be a risk factor. The benefit-risk relationship of the product is not affected by this report
Protein S deficiency (Protein-S deficiency at least 25 years)
Warfarin