Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 4 | 026L20A | — |
fell; hobbling; Zetia did not bring down her cholesterol enough; coronary artery disease; an aneurysm; Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash; This spontaneous case was reported by a consumer and describes the occurrence of CORONARY ARTERY DISEASE (coronary artery disease), ANEURYSM (an aneurysm), FALL (fell), GAIT DISTURBANCE (hobbling) and BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 026L20A, 939676 and 056M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced CORONARY ARTERY DISEASE (coronary artery disease) and ANEURYSM (an aneurysm). On an unknown date, the patient experienced FALL (fell), GAIT DISTURBANCE (hobbling), BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash). The patient was treated with Ezetimibe (Zetia) for High cholesterol, at an unspecified dose and frequency and Evolocumab (Repatha) for High cholesterol, at an unspecified dose and frequency. At the time of the report, CORONARY ARTERY DISEASE (coronary artery disease), ANEURYSM (an aneurysm), GAIT DISTURBANCE (hobbling) and BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) outcome was unknown and FALL (fell) and RASH (Moderna arm/She would get the rash/The rash and it extended to the elbow (it would go from her shoulder to her elbow)/Big rash) had resolved. Concomitant medications were not reported. Date of administration of Fourth dose was reported as either 25-Apr-2022 or 25-Nov-2022. Patient was diagnosed two years ago with coronary artery disease and an aneurysm. Patient was trying to diet and she took Zetia, which she was still on. Zetia did not bring down her cholesterol enough, so they put her on Repatha too. She was currently on Repatha and her next dose would be her 3rd shot. It was reported that in the past she was not on Repatha so she has never had a COVID vaccine at the same time as her Repatha. It was reported that after every vaccine, patient experienced the Moderna arm. Patient would get the rash but no big side effects, just the rash and it got extended to the elbow (it would go from her shoulder to her elbow). It was a big rash and guesses that it was called the COVID rash or something. It was reported that the rash has gotten smaller every time patient had gotten the shot. Patient's last year shot, it was much smaller in reaction. Patient had the first rash which was the worst, and it was just "like crazy" and went away in one week. This case was linked to MOD-2025-790020 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2025: Live non-significant follow-up received. Reporter's email address and reference numbers added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.