Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
I'm still off balance; My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy; My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy; Body stuff was going on and I couldn't, when I thought I could get up to go to the bathroom, my legs was/I thought I could have walked but I still couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy), DIZZINESS (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy), GAIT DISTURBANCE (Body stuff was going on and I couldn't, when I thought I could get up to go to the bathroom, my legs was/I thought I could have walked but I still couldn't walk) and BALANCE DISORDER (I'm still off balance) in a 65-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu (Patient had past history of receiving COVID shots and flu shots) and COVID-19 Vaccine (Patient had past history of receiving COVID shots and flu shots). Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine and Flu. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced NAUSEA (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy) (seriousness criterion hospitalization), DIZZINESS (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Body stuff was going on and I couldn't, when I thought I could get up to go to the bathroom, my legs was/I thought I could have walked but I still couldn't walk) (seriousness criterion hospitalization). On an unknown date, the patient experienced BALANCE DISORDER (I'm still off balance) (seriousness criterion hospitalization). The patient was treated with Physical therapy for Balance disorder. At the time of the report, NAUSEA (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy), DIZZINESS (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy), GAIT DISTURBANCE (Body stuff was going on and I couldn't, when I thought I could get up to go to the bathroom, my legs was/I thought I could have walked but I still couldn't walk) and BALANCE DISORDER (I'm still off balance) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided. Patient took no vaccines in past four weeks. Patient had a COVID shot which was for age 65 and over which left her with a bad side effect. It was not the first COVID vaccine she had. Patient was not sure about administration date, and thinks it was on 22-oct-2024 which was on Thursday. The patient was not sure if it was Moderna COVID vaccine as she had to get the information from hospital where she works at and there it was like mandatory thing to take vaccine. Patient received a shot every year, regular COVID shot and did not affect her but the shot for age 65 and older got affected her. On Friday she started feeling like a little fluid acting and Saturday morning she was feeling a little dizzy. The patient could not walk and had to crawl on the floor so taken to hospital and stayed for 2 almost 3 days. She had therapy to come by the house because she thinks it was that when she went back to work. Patient don't know if it had interfered with her regular medicine, and she had a reaction which was like allergic reaction after eating something which happened right after the shot. Patient was still experiencing the symptoms and cannot drive the car herself and had to depend on other people to come back from work for over a month. Patient had to use a walker when she goes outside as she was off balance. Patient went to doctor and doctor said it was a pre and must be her medical condition, but she always had known the condition that she had, and she took regular COVID shot but this time it was so different and that was when everything came down on her. Patient had to take the shot every year and at first, she used to get the flu shot and when COVID came out she got COVID shot which she had to get it. It was unknown if patient experienced any additional symptoms or events. Patient was still a little off balance so getting a therapy sometimes once a week and twice a week and had physical therapy.; Reporter's Comments: Company comment: The benefit-risk relationship of the product is not affected by this report.