Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052036 | IM |
2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot) in an 82-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052036) for COVID-19 prophylaxis. Concurrent medical conditions included Iritis, Arthritis, Spinal stenosis, Allergy to animal (dog and cat), Grass allergy (various grasses), IBD and Colitis. On 17-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced URTICARIA (2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot). At the time of the report, URTICARIA (2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: EKG showed something with the left ventricle possible causes. The Patient received allergy shot to avoid allergic reaction from dog, cat and various grasses as concomitant medication on Sep-2025 and she received the allergy shot two and half week prior to vaccination. It was reported that patient has iritis so she must take ketorolac. The patient had another scheduled for allergy shot week after vaccination. The patient should have a stress test because the EKG showed for the patient something with the left ventricle possible causes. But the patient avoided stress test because she thought that there was a 1 in 5000 risk of dying from the test. The patient got a 2 inch round bright pink harder lump on her arm from the MNEXSPIKE PFS vaccination, and she did not have that symptom with other covid-19 vaccines. The patient still had a semi-hard 2 inch by 1- and 1/2-inch allergic bright pink thing swelling on her upper arm. It was reported that the patient did not have those symptoms before, and it was interpreted that this shot must have added something different. It was reported that post vaccination swelling on her upper arm started to itch a little the night of the shot and there was about a 1-inch pink thing there, but then the next day it was 2 inches, and it turned as itchier and harder, but not soft. It was now finally got a little less hard, but it was still firm and still bright pink. The Patient put off her allergy shot for another week due to the symptom. No treatment medications provided by the reporter. This case was linked to MOD-2025-789602 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2025: Live significant follow-up received in which suspect product lot number was added and new reference number was added.; Reporter's Comments: Concurrent medical condition several allergies are confounders for the event. The benefit -risk relationship of product is not affected by this report.
Allergy to animal (dog and cat); Arthritis; Colitis; Grass allergy (various grasses); IBD; Iritis; Spinal stenosis
Test Name: EKG; Result Unstructured Data: EKG showed something with the left ventricle possible causes