Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | 3052586 | — |
Just like a little cold; Body malaise, general malaise; Just a little bit of feeling aches and pains for 24 hours; Had the pain in the vaccinated arm, which arm was not specified; This spontaneous case was reported by a physician and describes the occurrence of NASOPHARYNGITIS (Just like a little cold), MALAISE (Body malaise, general malaise), PAIN (Just a little bit of feeling aches and pains for 24 hours) and VACCINATION SITE PAIN (Had the pain in the vaccinated arm, which arm was not specified) in a 65-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052586) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052586) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Sep-2025, the patient received ninth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Just like a little cold), MALAISE (Body malaise, general malaise), PAIN (Just a little bit of feeling aches and pains for 24 hours) and VACCINATION SITE PAIN (Had the pain in the vaccinated arm, which arm was not specified). At the time of the report, NASOPHARYNGITIS (Just like a little cold) outcome was unknown and MALAISE (Body malaise, general malaise), PAIN (Just a little bit of feeling aches and pains for 24 hours) and VACCINATION SITE PAIN (Had the pain in the vaccinated arm, which arm was not specified) 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. The patient would be turning 66 years in a few weeks. It was unknown if there were any vaccines received within the past 4 weeks prior to receiving the Moderna COVID-19 vaccine. No concomitant medication was reported. The patient had all 9 doses with Moderna COVID-19 vaccine. Reporter also confirmed that every time the patient had the said vaccine, he would have side effects. The reporter reiterated that the side effects experienced by the patient were normal but nothing horrible. Patient was happy that he had a little bit of feeling aches and pains for 24 hours but 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-2026-794720 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-794702:Master case, reporter's case (wife)