Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
I feel a little groggy/feel there's something in my system that's making me, want to just kind of relax/you might fall asleep for a little bit; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I feel a little groggy/feel there's something in my system that's making me, want to just kind of relax/you might fall asleep for a little bit) and FATIGUE (kind of tired) in a 66-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS. Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. In October 2024, the patient experienced SOMNOLENCE (I feel a little groggy/feel there's something in my system that's making me, want to just kind of relax/you might fall asleep for a little bit) and FATIGUE (kind of tired). In October 2024, SOMNOLENCE (I feel a little groggy/feel there's something in my system that's making me, want to just kind of relax/you might fall asleep for a little bit) and FATIGUE (kind of tired) had resolved with sequelae. It was reported that patient did not have relevant medical history (vaccines within the past 4 weeks, medical conditions), he was very healthy and athletic. Concomitant medications details were not reported by the reporter. He had every Moderna shot and booster since the start of Covid. He had never contracted Covid. Patient reported that afterwards, he felt a little groggy, he got it on a day when he was not doing weight training, so he doesn't have to, cause it's kind of hard to lift weights when got shots in arms, and kind of tired. Patient also reported that put all that into the body it was temporary, it was just a good excuse to have a short nap. He usually just felt there was something in his system that's making him, wanted to just kind of relax, and usually just put head back and, and then relax and suddenly might fall asleep for a little bit. He also stated he has done that with just regular flu shots even prior to COVID, he also stated that just get jabbed and don't have the, from the energy standpoint, 12 to 24 hours for it to kind of let you get back to that full speed. Patient also stated some people say they get a discomfort in the arms. He had never really experienced that. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789787 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2025: Live non-significant information received, Reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789787:Master case (same reporter)