Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Fatigue; Headaches; Skin rash/Skin rashes; Blood clots; extreme shortness of breath/shortness of breath extremely serious; Palpitations; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and DYSPNOEA (extreme shortness of breath/shortness of breath extremely serious) in a 24-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. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 24-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 17-Dec-2024, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant), DYSPNOEA (extreme shortness of breath/shortness of breath extremely serious) (seriousness criterion medically significant), PALPITATIONS (Palpitations), DIZZINESS (Dizziness), HEADACHE (Headaches) and RASH (Skin rash/Skin rashes). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, THROMBOSIS (Blood clots), DYSPNOEA (extreme shortness of breath/shortness of breath extremely serious), PALPITATIONS (Palpitations), DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headaches) and RASH (Skin rash/Skin rashes) had not resolved. No concomitant medications were reported. The patient had no medical history, concomitant disease or risk factor. The patient was vaccinated with Moderna vaccine in September 2024 and ever since then she had symptoms that would not go away, such as palpitations, extreme shortness of breath, fatigue, headaches, blood clots and skin rash. She had been for a whole year trying to figure out what was going on with her until she figured the vaccine caused all that. She had been to all doctors and had probably a thousand medical records of exams performed, everything came back clear, although she struggled every day to do basic daily routine. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2025: Live significant follow-up received contains significant information included reporter details, patient's DOB, age, suspect start date, event onset and new event dizziness added, event verbatims and narrative updated, and reference numbers were added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.