Received Jun 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Redness at the injection site; Swelling at the injection site; Tenderness at the injection site/Soreness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site/Soreness to the touch at the injection site) in a 71-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 vaccine. Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine. On 29-May-2026, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site/Soreness to the touch at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site/Soreness to the touch at the injection site) had not resolved. Relevant Medical History of vaccines within the past 4 weeks and medical conditions was reported as none. No concomitant medication was reported. It was reported that after taking the vaccine patient had symptoms and they were still ongoing. Patient went to the pharmacy, and the pharmacist gave her the product information leaflet and explained that these were part of the most experienced side effects. She then added that it was not her first covid shot, however, it was the first time patient had these symptoms. She never had redness and swelling that lingered behind the date of injection, but because she would have a band-aid, she never noticed those symptoms with the previous vaccines. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.