Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 6 | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
a couple of tests were done and found out that only 20% of her left bundle was functioning; she didn't feel well; lethargic; had pain from both shots in both arms; was very tired; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (a couple of tests were done and found out that only 20% of her left bundle was functioning) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. The patient's past medical history included Implantable cardioverter defibrillator insertion (ICD implanted in the chest since April of 2023.) in April 2023. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Dose 1, Lot/Batch Number: 026L20A, Expiration Date: 28JUN2021) on 22-Jan-2021, Spikevax NOS (Dose 2, Lot/Batch Number: 013L20A, Expiration Date: 08JUL2021) on 20-Feb-2021, Spikevax NOS (Dose 3 Booster, Lot/Batch Number: 038C21A, Expiration Date: 27OCT2021) on 26-Oct-2021, Spikevax NOS (Dose 4 and Lot/Batch Number: 007M21A) on 02-Apr-2022. Past adverse reactions to the above products included No adverse effect with Spikevax NOS, Spikevax NOS, Spikevax NOS and Spikevax NOS. Concurrent medical conditions included Heart disease, unspecified (over with heart issues). In October 2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DYSFUNCTION (a couple of tests were done and found out that only 20% of her left bundle was functioning) (seriousness criterion medically significant), MALAISE (she didn't feel well), LETHARGY (lethargic), PAIN IN EXTREMITY (had pain from both shots in both arms) and FATIGUE (was very tired). At the time of the report, CARDIAC DYSFUNCTION (a couple of tests were done and found out that only 20% of her left bundle was functioning), MALAISE (she didn't feel well), LETHARGY (lethargic), PAIN IN EXTREMITY (had pain from both shots in both arms) and FATIGUE (was very tired) had resolved with sequelae. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not provided. The patient was asking about further details regarding mNEXSPIKE for 65 years and older with heart issues when receiving the mNEXSPIKE as she just had gotten an ICD implanted in the chest the meaning of which she did not elaborate, but she shared that she had it since Apr-2023. The patient stated that she should be concerned about getting the product as it is a lower dosage but had precautions for seniors with heart issues. She also desired to get it, having booked an appointment at Walgreens. The patient added she was concerned because she had never had this "heart thing" which she added had just happened. The patient verbalized that she had not realized she had a heart issue, but when she thought she had heartburn, a couple of tests were done and found out that only 20% of her left bundle was functioning. She was then on medicine and a life vest, but the condition didn't improve and that was when the cardiologist along with her primary HCP decided that she needed to have the implant but still she feels the same way as before. It was further stated that she was a regular recipient of the COVID-19 vaccines since 2020 except last year because her husband was ill. She added that in Oct-2023, she received both Moderna COVID-19 vaccine with the flu shot on the same day while she was going to a street fair. She recalled that she had not felt well, was very tired, had pain from both shots in both arms, very lethargic and that her arms were killing her. It was reported that the patient was going to her Primary HCP in 2 weeks specifically on 01-Oct-2025 for her annual physical exam. She added that she would have her next dose with Moderna COVID-19 vaccine on a Tuesday afternoon, but it was unknown to her yet if it would be Spikevax or mNEXSPIKE hence her calling Moderna. It was also reported that the patient had not received any other brands of Moderna COVID-19 vaccine. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789734 (E2B Linked Report). This case was linked to MOD-2025-789733 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789734:Reporter's husband case
Medical History/Concurrent Conditions: Heart disease, unspecified (over with heart issues); Implantable cardioverter defibrillator insertion (ICD implanted in the chest since April of 2023.)