Received Oct 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | — |
hot and cold symptoms; hot and cold symptoms; fever; lost consciousness; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness), FEELING COLD (hot and cold symptoms), FEELING HOT (hot and cold symptoms) and PYREXIA (fever) in a 56-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (bad case of COVID that had hospitalized him in 2021.) in 2021. On 11-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. On 12-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant). In October 2025, the patient experienced FEELING COLD (hot and cold symptoms) (seriousness criterion hospitalization), FEELING HOT (hot and cold symptoms) (seriousness criterion hospitalization) and PYREXIA (fever) (seriousness criterion hospitalization). The patient was hospitalized from sometime in October 2025 to sometime in October 2025 due to FEELING COLD, FEELING HOT and PYREXIA. On 12-Oct-2025, LOSS OF CONSCIOUSNESS (lost consciousness) had resolved. At the time of the report, FEELING COLD (hot and cold symptoms), FEELING HOT (hot and cold symptoms) and PYREXIA (fever) had not resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Unknown Route) was unknown. Concomitant medications were not reported. It was reported that on 12-Oct-2025, 26 hours after receiving the vaccine, patient lost consciousness for about 3 minutes. The patient had contracted COVID-19 in 2021, had a bad case of COVID that had hospitalized him in 2021. Patient had a very strong reaction to the COVID vaccine because he had COVID. It was confirmed that patient had not received the COVID-19 vaccine in 2021 prior to contracting COVID-19. Patient was hospitalized for 2 days trying to recover from hot and cold symptoms, fever symptoms, it was sated that was patient was expecting it to clear up in 24 hours but unfortunately it did not. The reporter was terrified of the event particularly with the losing consciousness. Treatment information was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: COVID-19 (bad case of COVID that had hospitalized him in 2021.)