Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Brain neoplasm, General physical health deterioration, Loss of consciousness, Neurological symptom, Seizure
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BRAIN NEOPLASM (brain tumor), SEIZURE (seizure), LOSS OF CONSCIOUSNESS (blacked out) and SPINAL FRACTURE (broke several vertebral bodies/ broken his spine in several spots) in a 37-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant). On an unknown date, the patient experienced BRAIN NEOPLASM (brain tumor) (seriousness criterion medically significant), SPINAL FRACTURE (broke several vertebral bodies/ broke his spine in several spots) (seriousness criterion medically significant), NEUROLOGICAL SYMPTOM (stroke symptoms/ brain problems) and GENERAL PHYSICAL HEALTH DETERIORATION (not in good shape at all). The patient was treated with Surgery for Brain neoplasm. At the time of the report, BRAIN NEOPLASM (brain tumor) had resolved, SEIZURE (seizure), LOSS OF CONSCIOUSNESS (blacked out) and SPINAL FRACTURE (broke several vertebral bodies/ broken his spine in several spots) outcome was unknown and NEUROLOGICAL SYMPTOM (stroke symptoms/ brain problems) and GENERAL PHYSICAL HEALTH DETERIORATION (not in good shape at all) had not resolved. Brain tumor, which they just removed yesterday (on 27-Apr-2022). The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. Patient received vaccine few months ago, Past week patient was driving back from work and had a seizure blacked out and crashed car. Patient had removal of tumor. Patient did not had health issues prior to this vaccine. Patient stated he was not in good shape at all. No treatment medications were reported. Company comment: This is a spontaneous case concerning 37-year-old male patient with no medical history reported, who experienced the serious, due to medically significant, unexpected events of brain neoplasm, seizure, loss of consciousness and spinal fracture (reported as broke several vertebral bodies/ broken his spine in several spots) and other non-serious events, which occurred on an unknown date after a dose of mRNA-1273. It was reported that the Patient received vaccine few months ago, the Past week he was driving back from work and had a seizure blacked out and crashed car. Patient had removal of tumor. He did not have health issues prior to this vaccine and stated he was not in good shape at all. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Follow-Up included patient gender updated and event added. Sender's Comments: This is a spontaneous case concerning 37-year-old male patient with no medical history reported, who experienced the serious, due to medically significant, unexpected events of brain neoplasm, seizure, loss of consciousness and spinal fracture (reported as broke several vertebral bodies/ broken his spine in several spots) and other non-serious events, which occurred on an unknown date after a dose of mRNA-1273. It was reported that the Patient received vaccine few months ago, the Past week he was driving back from work and had a seizure blacked out and crashed car. Patient had removal of tumor. He did not have health issues prior to this vaccine and stated he was not in good shape at all. The benefit-risk relationship of mRNA-1273 is not affected by this report.