Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052586 | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
weakness in that same arm; pain; swelling in the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (weakness in that same arm), PAIN IN EXTREMITY (pain) and PERIPHERAL SWELLING (swelling in the arm) in a 61-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052586) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052586) for COVID-19 prophylaxis. The non-company product included Influenza vaccine for an unknown indication. Concurrent medical conditions included Blood pressure high. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced MUSCULAR WEAKNESS (weakness in that same arm), PAIN IN EXTREMITY (pain) and PERIPHERAL SWELLING (swelling in the arm). In 2025, PERIPHERAL SWELLING (swelling in the arm) had resolved. At the time of the report, MUSCULAR WEAKNESS (weakness in that same arm) and PAIN IN EXTREMITY (pain) had not resolved. 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. No concomitant medication was reported. HCP reported that her patient experienced swelling in the arm she received the vaccine in, affecting all of her arm and not only the injection site. This swelling lasted for 1 week then went down. She then experienced weakness in that same arm and pain. According to the HCP the pain was severe enough that she was unable to hold a blow dryer. Patient was a hairdresser. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Event causality was not reported.
Blood pressure high