Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
severe, raised welts/It began with firmness and warmth to the touch, progressed to a rash, and then turned into full-blown welts.; her arm is still in pain with lingering signs of the rash; skin is tightening and pulling; her arm is still in pain with lingering signs of the rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (severe, raised welts/It began with firmness and warmth to the touch, progressed to a rash, and then turned into full-blown welts.), PAIN IN EXTREMITY (her arm is still in pain with lingering signs of the rash), SKIN TIGHTNESS (skin is tightening and pulling) and RASH (her arm is still in pain with lingering signs of the rash) in a 69-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. Concomitant products included Influenza vaccine (Flu) for an unknown indication. On 15-Dec-2025, 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 23-Dec-2025, the patient experienced URTICARIA (severe, raised welts/It began with firmness and warmth to the touch, progressed to a rash, and then turned into full-blown welts.), PAIN IN EXTREMITY (her arm is still in pain with lingering signs of the rash), SKIN TIGHTNESS (skin is tightening and pulling) and RASH (her arm is still in pain with lingering signs of the rash). At the time of the report, URTICARIA (severe, raised welts/It began with firmness and warmth to the touch, progressed to a rash, and then turned into full-blown welts.), PAIN IN EXTREMITY (her arm is still in pain with lingering signs of the rash), SKIN TIGHTNESS (skin is tightening and pulling) and RASH (her arm is still in pain with lingering signs of the rash) had not resolved. Patient had 2.5 weeks before had flu shot. Patient had no medical conditions. It was reported that eight days following the COVID shot, she developed severe, raised welts. It began with firmness and warmth to the touch, progressed to a rash, and then turned into full-blown welts. This occurred two weeks ago, and her arm was still in pain with lingering signs of the rash. It felt as though the skin was tightening and pulling. It was unknown if the patient experienced any additional symptoms/events No treatment information was reported.; Reporter's Comments: Company comment: Influenza vaccine administration is a confounder. The benefit-risk relationship of product is not affected by this report.
Flu