Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) (seriousness criterion medically significant). At the time of the report, MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: she used to be 196 lbs and is currently down to 140 lbs.. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. In 2020 or 2021, when the first vaccine came out, patient took it. Patient took another one a year later. She had since been sick all the time. She got flare-ups in the forms of hives and rashes. She felt pain in her body and limbs, and they always felt weak. Her joints hurt. She went to a dermatologist, but he was not able to diagnose her. She also had ongoing vomiting and diarrhea accompanied by abdominal pain. When she went to the ER, they were not able to tell her what the problem was. She used to be 196 lbs and was currently down to 140 lbs. She was finally diagnosed to have Mast Cell Syndrome. It was also reported that she had mast cells in her stomach. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to MOD-2025-788256 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Test Name: Body weight; Result Unstructured Data: she used to be 196 lbs and is currently down to 140 lbs.