Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
shaky reaction that almost required a hospital visit, but it eventually subsided; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (shaky reaction that almost required a hospital visit, but it eventually subsided) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced NERVOUSNESS (shaky reaction that almost required a hospital visit, but it eventually subsided). At the time of the report, NERVOUSNESS (shaky reaction that almost required a hospital visit, but it eventually subsided) had resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had inquire about the Moderna COVID vaccine and had expressed concerns about its ingredients and a past reaction. She mentioned that she had been hesitant because of a shaky reaction the previous year and her small stature and had almost required a hospital visit, but it had eventually subsided, and she had sought information on the vaccine's components. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.