Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Tingling, pain on inner side of knees; pain on inner side of knees; swelling extended to her thighs, had hard lumps behind knees and up to top of thighs; swelling extended to her thighs, had hard lumps behind knees and up to top of thighs; Discomfort continued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling, pain on inner side of knees), ARTHRALGIA (pain on inner side of knees), JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) and OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 29-Apr-2025, the patient experienced PARAESTHESIA (Tingling, pain on inner side of knees) (seriousness criterion medically significant) and ARTHRALGIA (pain on inner side of knees) (seriousness criterion medically significant). In 2025, the patient experienced JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) (seriousness criterion medically significant), OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) (seriousness criterion medically significant) and DISCOMFORT (Discomfort continued). At the time of the report, PARAESTHESIA (Tingling, pain on inner side of knees) outcome was unknown, ARTHRALGIA (pain on inner side of knees), JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) and OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) had resolved and DISCOMFORT (Discomfort continued) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No Concomitant medication was reported. A reporter reporting that patient suffered side effects after vaccinated with Moderna vaccine on 19-Apr-2025. It was mentioned the following: Tingling, pain on inner side of knees, around 29-Apr-2025. Discomfort continued and swelling extended to her thighs, had hard lumps behind knees and up to top of thighs. Reporter added that similar symptoms happened around 3 years ago, after Moderna vaccine. it was started manual lymphatic drainage for lymphedema after first episode. Patient contacted GP 3rd week in May for pain relief, and started manual lymphatic drainage again as was successful after 18 months. It was unknown if the patient experienced any additional symptoms/events. No treatment drug was reported. This case was linked to MOD-2025-787686 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.