Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | 3052586 | — |
arm was a little bit sore; a little hot that night that that was it; a little bit of feeling aches and pains for 24 hours; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm was a little bit sore), FEELING HOT (a little hot that night that that was it) and PAIN (a little bit of feeling aches and pains for 24 hours) in a 30-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052586) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052586) for COVID-19 prophylaxis. Concurrent medical conditions included Lupus syndrome (Lupus). On 29-Sep-2025, the patient received ninth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore), FEELING HOT (a little hot that night that that was it) and PAIN (a little bit of feeling aches and pains for 24 hours). At the time of the report, PAIN IN EXTREMITY (arm was a little bit sore) and FEELING HOT (a little hot that night that that was it) outcome was unknown and PAIN (a little bit of feeling aches and pains for 24 hours) had resolved. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. It was unknown if there were any vaccines within the past 4 weeks prior to receiving the Moderna COVID-19 vaccine. No concomitant medication was reported. The patient had every dose with Moderna COVID-19 vaccine. Reporter also confirmed that every time the patient had the said vaccine, she would have side effects. Patient got the least symptoms this time. Patient got the same side effects as her parents did. Patient was happy that she had a little bit of feeling aches and pains for 24 hours but nothing like getting COVID. It was nothing like getting COVID. The patient did not experience any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2026-794702 (E2B Linked Report). This case was linked to MOD-2026-794719 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-794702:Master case, reporter's case (wife)
Lupus syndrome (Lupus)