Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 6 | 8057965 | IM |
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; This spontaneous case was reported by a consumer and describes the occurrence of 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) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057965) for COVID-19 prophylaxis. Concurrent medical conditions included Coronary artery disease since 2023 and Aneurysm since 2023. In 2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. 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 Blood cholesterol increased, at an unspecified dose and frequency and Evolocumab (Repatha) at an unspecified dose and frequency. At the time of the report, 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 and GAIT DISTURBANCE (hobbling) and BLOOD CHOLESTEROL INCREASED (Zetia did not bring down her cholesterol enough) outcome was unknown. Concomitant medications were not reported. Date of administration of sixth dose was reported as either 07-Feb-2024 or 17-Oct-2024 at pharmacy. 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 years 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. For her last shot, patient hardly, didn't had much at all, and it went away pretty quickly. It lasted for 2 days after her last shot. This case was linked to US-MODERNATX, INC.-MOD-2025-790025 (E2B Linked Report). This case was linked to MOD-2025-790023, MOD-2025-790024 (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: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790025:Invalid case for multiple people
Aneurysm; Coronary artery disease