Received Sep 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
arthritis flare up again; first set for the lower spine, but then they have to look at the cervical spine, which is bad/ spine is a disaster; having neurological problems; heart condition and heart problems; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis flare up again), SPINAL DISORDER (first set for the lower spine, but then they have to look at the cervical spine, which is bad/ spine is a disaster), NERVOUS SYSTEM DISORDER (having neurological problems) and CARDIAC DISORDER (heart condition and heart problems) in an 8-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Rheumatoid arthritis (Rheumatoid arthritis for 30 years) and Immunocompromised. 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 ARTHRITIS (arthritis flare up again), SPINAL DISORDER (first set for the lower spine, but then they have to look at the cervical spine, which is bad/ spine is a disaster), NERVOUS SYSTEM DISORDER (having neurological problems) and CARDIAC DISORDER (heart condition and heart problems). At the time of the report, ARTHRITIS (arthritis flare up again), SPINAL DISORDER (first set for the lower spine, but then they have to look at the cervical spine, which is bad/ spine is a disaster), NERVOUS SYSTEM DISORDER (having neurological problems) and CARDIAC DISORDER (heart condition and heart problems) outcome was unknown. Concomitant medications were not reported. The reporter stated that patient had 12-13 doses of the Moderna COVID vaccine and needed every 4 to 6 months. The reporter states that patient was trying to find the updated Moderna Spikevax as patient had procedures that need to be done, and patient required the vaccine and patient had to start some of her arthritis medicine before she can get the procedures done and patient could not get her procedures done because she had to hold off. Patient had to hold the arthritic meds, which were steroids, that she's been taking for 30 years, before she had her vaccines which caused the arthritis flare up again. The reporter stated that patient was supposed to go in for treatment and she could not get the vaccine because she needs spinal injections done and stated that she finally broke down and got the spinal injections because her spine was a disaster. The reporter stated that patient had an evaluation for her spine the other day. The reporter stated that patient was on her 4th MRI this past summer. Patient stated that she had the first set for the lower spine, but then they have to look at the cervical spine, which was bad. The reporter stated that it was even worse than to see because patient was having neurological problems and needs a different MRI done. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.; Reporter's Comments: Company comment. The event nervous system disorder was assessed as not related to the vaccine since related to cervical spine disorder. The benefit-risk relationship of the product is not affected by this report.
Immunocompromised; Rheumatoid arthritis (Rheumatoid arthritis for 30 years)