Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Product dose omission issue
Clinical narrative: It damaged my brain in sort of a concussion would damage the brain; They believe there was so much inflammation in my body due to the vaccine that it damaged my brain; Couldn't look at screens or computer screens, because would make me very nauseous and make my headache even worst; Never received the second dose; Headache/worsening headaches/headaches so severe I couldn't work; Muscle aches/body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN INJURY (It damaged my brain in sort of a concussion would damage the brain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache/worsening headaches/headaches so severe I couldn't work), MYALGIA (Muscle aches/body aches) and FATIGUE (Fatigue). On an unknown date, the patient experienced BRAIN INJURY (It damaged my brain in sort of a concussion would damage the brain) (seriousness criterion medically significant), INFLAMMATION (They believe there was so much inflammation in my body due to the vaccine that it damaged my brain), NAUSEA (Couldn't look at screens or computer screens, because would make me very nauseous and make my headache even worst) and PRODUCT DOSE OMISSION ISSUE (Never received the second dose). At the time of the report, BRAIN INJURY (It damaged my brain in sort of a concussion would damage the brain), INFLAMMATION (They believe there was so much inflammation in my body due to the vaccine that it damaged my brain), MYALGIA (Muscle aches/body aches), FATIGUE (Fatigue) and NAUSEA (Couldn't look at screens or computer screens, because would make me very nauseous and make my headache even worst) outcome was unknown, HEADACHE (Headache/worsening headaches/headaches so severe I couldn't work) had not resolved and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication listed.   No treatment information provided.  The patient said the symptoms started about 6 hours after getting the vaccine and had the normal side effects, muscle aches, body aches, head ache, and fatigue. Then the patient said that had worsening headaches, headaches so severe I couldn't work and had to take pain medicines. Then the patient reported concussion like symptom's, couldn't look at screens or computer screens, because would make me very nauseous  and make my headache even worst. The patient said that talked to a Neurologist and a Physical therapist ( and to the primary care doctor) which said that those are symptoms of concussions but the patient said that nothing happened besides getting the vaccine. The patient states that still have daily head aches twice a day and that  it's been 5 months. The patient said they believe there was so much inflammation in my body due to the vaccine that it damaged my brain in sort of a concussion would damage the brain. The patient never received the second dose because of the severe reaction to the first.  Company Comment - This case concerns a 50-year-old, female patient with no relevant medical history, who experienced the unexpected event of brain damage and product dose omission was considered as an additional event. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable. The patient had severe headaches and reported concussion like symptom's, couldn't look at screens or computer screens, because it would make him very nauseous and make his headache worst. The patient said patient's neurologist and physical therapist believe there was so much inflammation in my body due to the vaccine that it damaged patient's brain in sort of a way a concussion would damage the brain. The patient never received the second dose because of the severe reaction to the first. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 50-year-old, female patient with no relevant medical history, who experienced the unexpected event of brain damage and product dose omission was considered as an additional event. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable. The patient had severe headaches and reported concussion like symptom's, couldn't look at screens or computer screens, because it would make him very nauseous and make his headache worst. The patient said patient's neurologist and physical therapist believe there was so much inflammation in my body due to the vaccine that it damaged patient's brain in sort of a way a concussion would damage the brain. The patient never received the second dose because of the severe reaction to the first. The benefit-risk relationship of Spikevax in not affected by this report.