Received Oct 6, 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 | — | LA |
shortness of breath passed; exhaustion; he said " it's itching and it's making me a little bit insane. It itches and it hurts."; inflammation; cold; is a sizable hot red welt that if I were to measure it about almost 2 inches diameter. That is not going down and it's itchy and red and hot.; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath passed), NASOPHARYNGITIS (cold), VACCINATION SITE URTICARIA (is a sizable hot red welt that if I were to measure it about almost 2 inches diameter. That is not going down and it's itchy and red and hot.), CHILLS (chills) and FATIGUE (exhaustion) in a 56-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 19-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 19-Sep-2025, the patient experienced NASOPHARYNGITIS (cold), VACCINATION SITE URTICARIA (is a sizable hot red welt that if I were to measure it about almost 2 inches diameter. That is not going down and it's itchy and red and hot.), CHILLS (chills), VACCINATION SITE PAIN (he said " it's itching and it's making me a little bit insane. It itches and it hurts.") and VACCINATION SITE INFLAMMATION (inflammation). On 20-Sep-2025, the patient experienced DYSPNOEA (shortness of breath passed) and FATIGUE (exhaustion). The patient was treated with Clobetasol propionate (Clobetasol) for Inflammation, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath passed) and FATIGUE (exhaustion) was resolving, NASOPHARYNGITIS (cold), CHILLS (chills), VACCINATION SITE PAIN (he said " it's itching and it's making me a little bit insane. It itches and it hurts.") and VACCINATION SITE INFLAMMATION (inflammation) outcome was unknown and VACCINATION SITE URTICARIA (is a sizable hot red welt that if I were to measure it about almost 2 inches diameter. That is not going down and it's itchy and red and hot.) had not resolved. No concomitant medication was reported. It was reported that patient had a new strange reaction that was not gone, that's why she had called. At the time of reporting she added that there was a sizable hot red welt that if she measured it was about almost 2 inches diameter. That was not going down, and it was itchy and red and hot. She also had short of breath on the weekend. She later confirmed during the call that the shortness of breath passed, but that was on Saturday and Sunday. It was Friday night. she had chills and she had a cold, but that would happen on Friday night and then she had chill. She had shortness of breath on Saturday and exhaustion and part of the days short of breath too And then she felt better, but that thing had remained on her arm for a few days." She stated that she actually received 2 vaccines that day, one was a flu shot, and the other was Spikevax. She stated that the flu shot was given in the upper arm, and the COVID was the lower arm. Both were given in the same arm (Left) and she had been applying clobetasol on it to reduce the inflammation. She said it was itching, and it was making her a little bit insane. She said that it itches, and it hurts. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-789610 (Patient Link).