Received Mar 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3053756 | IM |
Lost consciousness during the 1 hour and a half/had no memory of the following 1.5 hours; Started feeling achy/body aches; Feverish/started feeling feverish; Chills; Utter exhaustion/completely zapped of energy like he had just run a marathon; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Lost consciousness during the 1 hour and a half/had no memory of the following 1.5 hours) in a 73-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3053756) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 3053756) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 vaccination (lost the count how many and but follow every 6-month recommendation). Past adverse reactions to the above products included No adverse effect with COVID-19 vaccination. On 12-Mar-2026, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 13-Mar-2026, the patient experienced LOSS OF CONSCIOUSNESS (Lost consciousness during the 1 hour and a half/had no memory of the following 1.5 hours) (seriousness criterion medically significant), PAIN (Started feeling achy/body aches), PYREXIA (Feverish/started feeling feverish), CHILLS (Chills) and FATIGUE (Utter exhaustion/completely zapped of energy like he had just run a marathon). On 13-Mar-2026, LOSS OF CONSCIOUSNESS (Lost consciousness during the 1 hour and a half/had no memory of the following 1.5 hours) had resolved. On 15-Mar-2026, PAIN (Started feeling achy/body aches), PYREXIA (Feverish/started feeling feverish), CHILLS (Chills) and FATIGUE (Utter exhaustion/completely zapped of energy like he had just run a marathon) had resolved. No concomitant medications were reported. It was reported that about 24 hours after receiving the mNEXSPIKE vaccination, patient visited a friend and started feeling like he was about to experience a side effect. Reporter mentioned that patient usually never had side effects from COVID vaccinations, even though he had taken many over the years. As he drove home, patient began feeling feverish and achy. By the time he reached his apartment, he was shaking. He said his health was normally excellent, and he only felt this kind of fever, chills, and shaking before when he had the flu. When he got inside, the shaking became very strong. He went to bed, turned on the heated mattress, and pulled the blankets over himself. He was shaking so badly that he couldn't hold his phone. He said it was the worst shaking he had ever experienced from a fever. At home, the patient experienced severe tremors. He lay on his left side to get comfortable, and then the next thing he knew, it was an hour and a half later. He had no memory of that time. He felt as though he had lost consciousness and wondered if he might have had a small seizure. He said he could not be sure, but he knew he suddenly lost the time and then suddenly came back, as if someone plugged him back in. After waking up, he felt extremely exhausted, like he had run a marathon. Later, he got up and ate, then went to bed early again. By the Sunday (15-Mar-2026), he felt fine. The day after incident patient reported it to healthcare provider, and advised going to the emergency room, but he chose not to because he not felt it was necessary. The event happened about 26 hours after the vaccination. Reporter said patient felt perfectly fine afterward and still appreciated mRNA technology, as he had been a long-term Moderna supporter. No treatment medications were reported. Information received on 16-Mar-2026 and 17-Mar-2026 has been processed together in the same case cycle This case was linked to MOD-2026-794318 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2026: Live non-significant follow-up received. Reference numbers were added and narrative was updated.; Reporter's Comments: All events have been assessed as related to suspected vaccine due to temporal association and known safety profile of suspected vaccine. The benefit-risk relationship of the product is not affected by this report.