Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 8146367 | IM |
Tested positive for COVID-19 shortly thereafter, experiencing severe symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 shortly thereafter, experiencing severe symptoms) in a 54-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146367) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 8146367) for COVID-19 prophylaxis. Concurrent medical conditions included Ulcerative colitis. Concomitant products included Vedolizumab (Entyvio) for an unknown indication. On 27-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced COVID-19 (Tested positive for COVID-19 shortly thereafter, experiencing severe symptoms). At the time of the report, COVID-19 (Tested positive for COVID-19 shortly thereafter, experiencing severe symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, SARS-CoV-2 test: Positive. On 27-Sep-2025, the patient received her first dose of the season. Despite this, she tested positive for COVID-19 shortly, thereafter, experiencing severe symptoms. The patient was concerned about the vaccine's effectiveness, whether additional boosting was necessary or if new variants were not covered by the vaccine. It was unknown if the patient experienced any additional symptoms/events. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. No treatment medication was reported.
Ulcerative colitis
Entyvio
Test Date: 2025; Test Name: tested positive for COVID-19; Test Result: Positive