Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
covid 19; sore arm all the time from this vaccine; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Neurological disorder NOS and Pericarditis. Concurrent medical conditions included Systemic lupus erythematosus and Coronary artery disease. Concomitant products included Belimumab (Benlysta) for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid 19) (seriousness criterion hospitalization). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm all the time from this vaccine) and PYREXIA (Fever). At the time of the report, COVID-19 (covid 19), PAIN IN EXTREMITY (sore arm all the time from this vaccine) and PYREXIA (Fever) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. It was reported that patient had more so considering SPIKEVAX due to her medical problems (lupus and coronary artery disease, and some neurologic - a physical mass). When she had COVID-19 back in 2022, and she was fully vaccinated, it nearly put her in hospital. She was sick for 8 weeks. Due to this, was looking at the mNEXSPIKE and was wondering if patient might be better off with SPIKEVAX. It was stated that the Moderna website said it was an alternative, but that patient did not feel like being a guinea pig. Patient received SPIKEVAX every 6 months. Her next vaccine was due in the fall and now patient was looking more and more seriously at SPIKEVAX vs mNEXSPIKE because it had got a higher dose of mRNA. It was stated that that seems to be a little more scientifically global. As far as patient was aware, for mNEXSPIKE this was not known yet. It was hesitant of mNEXSPIKE because it was a lower dose and believed that a lower dose might not always work out for a person who might or might not be able to achieve the ability to have their immune system fight it off to begin with, they might not achieve the proper efficacy. It was stated again that patient also has coronary artery disease which would be a very severe outcome, which already knew, because patient already had COVID-19 and was almost hospitalized back in 2022 which was scary. Due to this, patient masked up as did want to be dealing with that again. Patient was never shown anything for an antibody after getting the SPIKEVAX that she gotten in the past. It was believed it was probably going to come down to the preference of the person in the doctor's office. The doctor might think maybe a higher one might be better, because then they knew for sure that it would be help. No treatment information was reported. It was stated she had a history of pericarditis but still decided to get SPIKEVAX anyway, and she had been fine ever since, even when she got those vaccines, because they checked, and she was constantly at the doctor's office anyway. It was stopped going to patient rheumatologist which she could not understand as the doctor wanted her on Benlysta which she thought would probably be a good thing for patient. When you get vaccinated for influenza and you were over the age of 65 (which the patient was). Patient got it all the time. She got fevers and sore arm all the time from this vaccine. For her, it was only for one whole day, and it was not that inconvenient as knew that when she went out in the public, patient did not have to worry as much and it was worth it. It was stated that another reason for the low dose might be due to the system being messed up with the CDC and everything. Patient was happy she could get through to someone quickly but that the music she heard for a short amount of time was very loud. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2025-789767 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789767:Case for multiple patient
Coronary artery disease; Systemic lupus erythematosus
Medical History/Concurrent Conditions: Neurological disorder NOS; Pericarditis
Benlysta