Received Nov 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
aortitis; This spontaneous case was reported by a pharmacist and describes the occurrence of AORTITIS (aortitis) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced AORTITIS (aortitis) (seriousness criterion medically significant). At the time of the report, AORTITIS (aortitis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Negative. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. The patient had received 5th dose of moderna vaccine on 27-Nov-2023 (batch number:3030372) intramuscularly. The patient had received Flu shot (unspecified) on 14-OCT-2025. It was reported that the patient had been experiencing a persistent side effect and was uncertain of its origin. She believed it might have been caused by the Moderna COVID-19 vaccines she had received, although she was not entirely sure. She explained that all diagnostic tests had returned negative, and the vaccine was the only plausible explanation she could identify. She reported that symptoms had begun approximately three to four months prior to June 2023, and she had undergone testing around that time which eventually led to a diagnosis of aortitis (inflammation of the aorta). She mentioned relocating to [withheld state] in Aug-2023 and noted that it had taken five to six months to consult various healthcare providers. The diagnosis was likely confirmed in January or Feb-2024. She stated that she continued to experience symptoms and had been under the care of a rheumatologist who had conducted extensive testing. She added that her internist was less familiar with the condition. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Test Name: Diagnostic test; Test Result: Negative