Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
big stroke/ died from a stroke; His death certificate states he died of a brain herniation; mini strokes/little TIAs/transient ischemic attack/his eyes, his head, being dizzy, blanking out; losing weight and having a lot of problems; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (big stroke/ died from a stroke), BRAIN HERNIATION (His death certificate states he died of a brain herniation) and TRANSIENT ISCHAEMIC ATTACK (mini strokes/little TIAs/transient ischemic attack/his eyes, his head, being dizzy, blanking out) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis in April 2020. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. In March 2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini strokes/little TIAs/transient ischemic attack/his eyes, his head, being dizzy, blanking out) (seriousness criterion medically significant) and WEIGHT DECREASED (losing weight and having a lot of problems). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (big stroke/ died from a stroke) (seriousness criteria death, hospitalization and medically significant) and BRAIN HERNIATION (His death certificate states he died of a brain herniation) (seriousness criteria death and medically significant). The patient died on 07-Jan-2022. The reported cause of death was stroke due brain herniation and big stroke/ died from a stroke. It is unknown if an autopsy was performed. At the time of death, TRANSIENT ISCHAEMIC ATTACK (mini strokes/little TIAs/transient ischemic attack/his eyes, his head, being dizzy, blanking out) had not resolved and WEIGHT DECREASED (losing weight and having a lot of problems) outcome was unknown. Concomitant medications were not reported. The reporter stated that the patient had received the Moderna COVID shot in Mar-2021, and patient immediately had mini strokes, little TIAs which patient thought it was eyes so went to the optometrist for new glasses. The reporter stated that after the vaccine, patient immediately started losing weight and having a lot of problems. The reporter states that patient complained about his eyes, his head, being dizzy, blanking out and had a big stroke at the house. The reporter states that the patient died from a stroke that must have pushed a clot up into his brain. Patient's death certificate reported that he died of a brain herniation. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Patient´s underlying condition of Rheumatoid arthritis is a risk factor for vascular events. Brain herniation is assessed as not related as is more likely to be secondary to the big stroke. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Stroke due brain herniation; big stroke/ died from a stroke
Immunocompromised
Medical History/Concurrent Conditions: Rheumatoid arthritis