Received May 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | IM |
problems with blood pressure/blood pressure high; bad back; I feel like I'm in a fog; headaches; hives/blotches all over skin/ was itching, had breakouts and hives; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (problems with blood pressure/blood pressure high), BACK DISORDER (bad back), BRAIN FOG (I feel like I'm in a fog), HEADACHE (headaches) and URTICARIA (hives/blotches all over skin/ was itching, had breakouts and hives) in an adult male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Accident at work and Splenectomy. Concurrent medical conditions included Spleen disorder (Lost spleen in a construction accident years ago and was fine after the splenectomy). In 2022, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2022, the patient experienced HYPERTENSION (problems with blood pressure/blood pressure high), BACK DISORDER (bad back), BRAIN FOG (I feel like I'm in a fog), HEADACHE (headaches) and URTICARIA (hives/blotches all over skin/ was itching, had breakouts and hives). At the time of the report, HYPERTENSION (problems with blood pressure/blood pressure high), BACK DISORDER (bad back), BRAIN FOG (I feel like I'm in a fog) and HEADACHE (headaches) had not resolved and URTICARIA (hives/blotches all over skin/ was itching, had breakouts and hives) was resolving. Concomitant medication was not reported. The patient had got only 2 shots of Moderna COVID vaccine but had gotten sick after his second shot which was around 3.5 years ago. He had to get the vaccines to get back to work. He got blotches all over his skin, having problems with blood pressure, headaches, the whole nine yards. The doctor said that they would go away, but they had not gone away. It had been going on for now over 3 years. He had gone to dermatology department, and they were claiming it was something else, but it wasn't clearing up. He had one in the refrigerator. He gave his first two shots in the leg himself. They said it was called Naruvio or something like that. Before that, they had him on another medication, and this one seemed to be helping, but it still wasn't clearing up as quickly as it should have. Patient never had any skin problems in whole entire life, and it's all happened after getting the COVID shot. He had no information about the product details, as it would really be hard to find them at this point. It was helping but slowly and taken a long time. They had never done a skin test or anything else on him. They were claiming that it was dermatological problem. This all happened right after getting the shots, it was itching, had breakouts and hives. His HCP had sent him to everything. He told them about his problems, and they finally ended up sending him to dermatology department. Patient currently took shots once a month for his skin condition but it was not clearing up (it was the second medication prescribed by the dermatologist to help with his symptoms). Patient was otherwise fine and believed it was the vaccines that caused this, as no other vaccines administered. Patient did not know exact name or spelling of the drug but was trying to pronounce as 'Neumo or Naruvio' so reporting as it might be potentially Nemluvio. Patient was taking two injections in the leg once monthly. This case was linked to US-MODERNATX, INC.-MOD-2026-795682 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-795682:case
Medical History/Concurrent Conditions: Accident at work; Spleen disorder (Lost spleen in a construction accident years ago and was fine after the splenectomy); Splenectomy