Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
| TTOX | TETANUS TOXOID (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic; high blood pressure; sensitivity to light; headaches; fatigue; rashes; This spontaneous case was reported by a consumer and describes the occurrence of MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic) in a 21-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) for HPV vaccine and Tetanus vaccine toxoid (Tetanus vaccine) for an unknown indication. The patient's past medical history included Raynaud's disease (Two different times, once in middle school and once in high school, the patient was diagnosed with Raynaud's Disease. Fingers were painful, difficulty opening bottles. Some days were better than others, but no comparison to how she was prior to receiving the three shots). On 13-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form, dose of HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) (unknown route) 1 dosage form and dose of Tetanus vaccine toxoid (Tetanus vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic) (seriousness criterion medically significant), HYPERTENSION (high blood pressure), PHOTOPHOBIA (sensitivity to light), HEADACHE (headaches), FATIGUE (fatigue) and RASH (rashes). At the time of the report, MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic), HYPERTENSION (high blood pressure), PHOTOPHOBIA (sensitivity to light), HEADACHE (headaches), FATIGUE (fatigue) and RASH (rashes) outcome was unknown. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient did not have any known allergies. The patient had adverse effect impacts for more than a year due to taking Gardasil 9. She received the Gardasil 9 vaccine, a Moderna vaccine shot and a Tetanus shot. Ever since receiving the shots, she had been a shell of herself. The patient was in bed from 15-May-2024 through all last summer. She went to her senior year of college in the fall of 2024. During the year, the patient missed a lot of classes and needed a lot of rest. She had been to numerous doctors at the clinic while in college. The patient wanted to know if it was safe to administer the Gardasil 9 along with the Covid and Tetanus shots, and asked about how to know for sure that which vaccine was causing the issues. She was trying to find out which vaccine had caused the issues. Patient had undergone bloodwork, ziopatch test for heart monitoring and Gold Standard Potts Diagnosis tests and results were not reported. Treatment medication was not reported.; Reporter's Comments: Co-suspect products HPV vaccine VLP rL1 9v, Tetanus vaccine and past medical history of Raynaud's disease are confounders for the events. The benefit -risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Raynaud's disease (Two different times, once in middle school and once in high school, the patient was diagnosed with Raynaud's Disease. Fingers were painful, difficulty opening bottles. Some days were better than others, but no comparison to how she was prior to receiving the three shots)