Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection; COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle; Elevated D-dimer; Very sick with COVID 2024; Severe hypertension; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Severe hypertension) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced HYPERTENSION (Severe hypertension) (seriousness criterion medically significant), FIBRIN D DIMER INCREASED (Elevated D-dimer) and COVID-19 (Very sick with COVID 2024). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection) and VACCINATION SITE ERYTHEMA (COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle). At the time of the report, HYPERTENSION (Severe hypertension), VACCINATION SITE PRURITUS (Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection), VACCINATION SITE ERYTHEMA (COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle), FIBRIN D DIMER INCREASED (Elevated D-dimer) and COVID-19 (Very sick with COVID 2024) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, Fibrin D dimer: elevated. Concomitant medications were not reported. It was reported that patient had Moderna vaccines in the past for COVID, and it has been a couple of years though. And last year patient got very sick with COVID and had an elevated D-dimer and severe hypertension. The patient was at risk for blood clots if patient get COVID again, so the patient was looking at getting a booster, just wanted to make sure, it was unclear with the primary doctor if there was an elevated risk of blood clots from the vaccine itself, or if it was only like myocarditis risks from the vaccine. Patient had received vaccine in January or February of 2021, patient was in one of the first batches. It was reported that whenever patient had Moderna in the past, patient had the big, it was COVID arm, where it gets all like almost looks purple from like the shoulder to my elbow in a big round circle, but it's very hard. And it gets very itchy, but patient don't have systemic itching or anything else. It was all localized on the arm that got the injection on. Patient was told earlier on when that happened that it was probably just a really robust immune response and it definitely wasn't mNEXSPIKE, and don't even know if it was Spikevax that patient had left. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to MOD-2025-791160 (Patient Link).; Reporter's Comments: COVID-19 could be a confounder for the event hypertension. Further information is being requested. The benefit-risk relationship of product is not affected by this report.
Test Date: 2024; Test Name: Fibrin d-dimer; Result Unstructured Data: elevated