Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | 2071123-29 (or | IM |
had a big rash across the chest above and below the breasts and under the arms; arm soreness; swallowing; warm; a little bit sick that evening; I got itching in the eyes and the head; I got itching in the eyes and the head; heart surgery took place on 30OCT2024; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart surgery took place on 30OCT2024) in an 81-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 2071123-29 (or 207H23-29 )) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (The patient had 7 previous Moderna injections). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. On 15-Jul-2024, the patient received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2024, the patient experienced CARDIAC DISORDER (heart surgery took place on 30OCT2024) (seriousness criterion medically significant). On 15-Jul-2024, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DYSPHAGIA (swallowing), FEELING HOT (warm), ILLNESS (a little bit sick that evening) and PAIN IN EXTREMITY (arm soreness). In July 2024, the patient experienced PRURITUS (I got itching in the eyes and the head) and EYE PRURITUS (I got itching in the eyes and the head). On 18-Jul-2024, the patient experienced RASH (had a big rash across the chest above and below the breasts and under the arms). In 2024, CARDIAC DISORDER (heart surgery took place on 30OCT2024) had resolved. In July 2024, PRURITUS (I got itching in the eyes and the head), EYE PRURITUS (I got itching in the eyes and the head) and RASH (had a big rash across the chest above and below the breasts and under the arms) had resolved. On 17-Jul-2024, DYSPHAGIA (swallowing), FEELING HOT (warm), ILLNESS (a little bit sick that evening) and PAIN IN EXTREMITY (arm soreness) had resolved. No concomitant medication was reported. The patient had no vaccines in the past 4 weeks. On 15-Jul-2024 patient had 8th vaccine and had some side effects including arm soreness and swallowing, and that wasn't a big deal, and warm and a little bit sick that evening and it was no big deal, but the next, it felt better on the 17-Jul-2024, but on the 18-Jul-2024, he took a shower and had a big rash across the chest above and below the breasts and under the arms and that lasted a couple of days. And as that started diminishing, he got itching in the eyes and the head and that lasted a day or two. Those were just a few days, and he had heart surgery in the intervening period. The heart surgery took place on 30-Oct-2024. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789062 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789062:Invalid case for multiple people