Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | 5 | 046H22A | — |
Fell; hobbling; Zetia did not bring down her cholesterol enough; 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; Coronary artery disease; an aneurysm; 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 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 046H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 1, Batch no. - 026L20A) on 12-Feb-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 2, Batch no. - 026L20A) on 15-Apr-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 3, Batch no. - 939676) on 01-Nov-2021, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4, Batch no. - 056M21A) in 2022, Moderna vaccine (Dose 4 and Batch no. - 056M21A) in 2022. Past adverse reactions to the above products included Aneurysm with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; Coronary artery disease with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; Fall with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; High cholesterol with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; Rash with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine; and Walking difficulty with Moderna vaccine, Moderna vaccine, Moderna vaccine and Moderna vaccine. In 2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 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) ongoing since an unknown date 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. No concomitant medications were reported. 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. 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 had gotten smaller every time patient had gotten the shot. 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.