Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM / LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in a 78-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for Product used for unknown indication: Pfizer (She also said that her A.fib was diagnosed 3 months ago (after Pfizer vaccines)), COVID-19 VACCINE MRNA OMICRON (KP.2) PFIZER/BIONTECH and COVID-19 VACCINE MRNA OMICRON (KP.2) PFIZER/BIONTECH. Past adverse reactions to the above products included Atrial fibrillation with Pfizer; Pain with COVID-19 VACCINE MRNA OMICRON (KP.2) PFIZER/BIONTECH; and Swelling with COVID-19 VACCINE MRNA OMICRON (KP.2) PFIZER/BIONTECH. Concurrent medical conditions included Atrial fibrillation (She also said that her A.fib was diagnosed 3 months ago (after Pfizer vaccines)) in 2025, Ulcerative colitis and Vaginal infection (she was prone to vaginal infections and because of her ulcerative colitis.). Concomitant products included Apixaban (Eliquis) for an unknown indication. In 2025, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 22-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced CELLULITIS (cellulitis). The patient was treated with Hydrocortisone sodium succinate (Cortison) at an unspecified dose and frequency. At the time of the report, CELLULITIS (cellulitis) was resolving. It was reported that patient received mNEXSPIKE on 22-SEP-2025 and 2 or 3 days later she developed cellulitis. It was painful, itchy, burning and stinging. The cellulitis was spread from above her inner elbow up to her shoulder. She stated that it was not at the site of the injection, she said that the injection was in the left deltoid. She then added that when she informed the pharmacist, the pharmacist told her that another female patient had the same thing. She added that when the cellulitis developed, she went immediately to urgent care where she was prescribed a topical cortisone and an antibiotic 3 times a day for 7 days, she did not want to take the antibiotic at the beginning since she was prone to vaginal infections and because of her ulcerative colitis. She said that the infection was currently almost 50% better. She also said that this was her first time to take Moderna vaccine and that she used to always get Pfizer vaccines, with which she only had pain on the side and swelling. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2025-789811 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789811:that another female patient had "the same thing"
Ulcerative colitis; Vaginal infection (she was prone to vaginal infections and because of her ulcerative colitis.)
Medical History/Concurrent Conditions: Atrial fibrillation (She also said that her A.fib was diagnosed 3 months ago (after Pfizer vaccines))
Eliquis