Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUCELVAX) | SEQIRUS, INC. | UNK | — | — |
swelling; redness; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (swelling) and ERYTHEMA (redness) in a 45-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine inact sAg 3v (Flucelvax) for an unknown indication. Concomitant products included Naproxen for an unknown indication. On 24-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine inact sAg 3v (Flucelvax) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 25-Oct-2025, the patient experienced SWELLING (swelling) and ERYTHEMA (redness). At the time of the report, SWELLING (swelling) and ERYTHEMA (redness) was resolving. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. It was reported that for patient increased swelling and redness as compared to previous years. It was unknown if the patient experienced any additional symptoms/events No treatment medications provided by the reporter.
Naproxen