Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | IM |
dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain; neuropathy/vaccine my feet started burning/intense pain after an exertion/many nights I can't even sleep because of the searing pain; my immune system hyperactive; why I always get dizzy when I stand up/POTS; high SED rates; This spontaneous case was reported by a consumer and describes the occurrence of AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/intense pain after an exertion/many nights I can't even sleep because of the searing pain), IMMUNE SYSTEM DISORDER (my immune system hyperactive) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatism. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/intense pain after an exertion/many nights I can't even sleep because of the searing pain) (seriousness criterion medically significant), IMMUNE SYSTEM DISORDER (my immune system hyperactive) (seriousness criterion medically significant), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) (seriousness criterion medically significant) and RED BLOOD CELL SEDIMENTATION RATE INCREASED (high SED rates). At the time of the report, AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/intense pain after an exertion/many nights I can't even sleep because of the searing pain), IMMUNE SYSTEM DISORDER (my immune system hyperactive), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) and RED BLOOD CELL SEDIMENTATION RATE INCREASED (high SED rates) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell sedimentation rate: high. No concomitant medications were reported. After the outbreak of Covid, the patient got only Moderna vaccines. She got her first vaccine when they first came out and then got two additional shots. Unfortunately, shortly after her first Moderna vaccine her feet started burning, even though at the time she did not make any connection to the vaccine. It was reported that, the doctor had concluded that her symptoms were connected to the Moderna vaccine. Her immunologist and neurologist had concluded that it was most likely that she had an adverse response to the vaccine that made her immune system hyperactive. They thought it kicked up her immune system and caused dysautonomia, high SED rates, neuropathy and POTS and intense pain after an exertion. Her symptoms became disabling. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-787344 (Patient Link).; Reporter's Comments: Company comment: The concurrent medical condition of Rheumatism remains as a confounder. The benefit-risk relationship of product is not affected by this report.
Rheumatism
Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: high