Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | — | — |
dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain; neuropathy/vaccine my feet started burning/same burning and pain has spread to other parts of my body, including my calves, thighs and my arms/intense pain after an exertion/nights I can't even sleep because of the searing pain; why I always get dizzy when I stand up/POTS; 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/same burning and pain has spread to other parts of my body, including my calves, thighs and my arms/intense pain after an exertion/nights I can't even sleep because of the searing pain) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) in a 59-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 2) and Moderna covid-19 vaccine (Dose 1). Past adverse reactions to the above products included Burning sensation with Moderna covid-19 vaccine and Moderna covid-19 vaccine. Concurrent medical conditions included Rheumatism. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 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 disability), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/same burning and pain has spread to other parts of my body, including my calves, thighs and my arms/intense pain after an exertion/nights I can't even sleep because of the searing pain) (seriousness criteria disability and medically significant) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) (seriousness criterion disability). 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/same burning and pain has spread to other parts of my body, including my calves, thighs and my arms/intense pain after an exertion/nights I can't even sleep because of the searing pain) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) 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 but when she got her second one, they started burning intermittently more, and by her third shot basically the burning had become chronic. And unfortunately, the same burning and pain had spread to other parts of her body, including her calves, thighs and her arms. 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-2025-787281 (Patient Link).; Reporter's Comments: Underlying rheumatism could be a confounding factor for the case. The benefit-risk relationship of product is not affected by this report.
Rheumatism
Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: high