Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cyanosis, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Fatigue; Brain fog; Sweating a lot; Was ghost white; severe chills,freezing; Very very high fever; Nausea; Had a seizure; Blue lips; Fainted; Was out for like 30 minutes; Something white on the patient's mouth; Little lightheaded; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Had a seizure), CYANOSIS (Blue lips), SYNCOPE (Fainted) and LOSS OF CONSCIOUSNESS (Was out for like 30 minutes) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.  On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced SEIZURE (Had a seizure) (seriousness criteria medically significant and life threatening), CYANOSIS (Blue lips) (seriousness criterion life threatening), SYNCOPE (Fainted) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Was out for like 30 minutes) (seriousness criterion medically significant), ORAL DISCHARGE (Something white on the patient's mouth), DIZZINESS (Little lightheaded), HYPERHIDROSIS (Sweating a lot), PALLOR (Was ghost white), CHILLS (severe chills,freezing), PYREXIA (Very very high fever) and NAUSEA (Nausea). On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue). On 06-Apr-2021, SEIZURE (Had a seizure), CYANOSIS (Blue lips), SYNCOPE (Fainted), LOSS OF CONSCIOUSNESS (Was out for like 30 minutes), ORAL DISCHARGE (Something white on the patient's mouth), HYPERHIDROSIS (Sweating a lot), PALLOR (Was ghost white), CHILLS (severe chills,freezing) and PYREXIA (Very very high fever) had resolved. At the time of the report, DIZZINESS (Little lightheaded), FEELING ABNORMAL (Brain fog), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The patient's concomitant medication included Adderol used for an unknown indication.  The patient had received 1st dose of Modena vaccine and was monitored for 30 minutes at the facility where she got the vaccine , the patient went to her house and had little light headed and nausea, that evening she went to sleep and around 9 or 10 Hours after she had received the 1st dose of the Moderna vaccine she¨ fainted and had a seizure. She was out for like 30 minutes, she had blue lips, had something white on her mouth. The HCP told, that she should go to the hospital but it was really busy so they stabilized her at her house. The patient had never had seizures, it is a life threatening event. The patient is being seen by a neurologist and her primary care, and ¨they have just started with the CT scans and the studies(caller did not specify)¨ with pending results, so once the caller has all the test results she wouldlike to call back and give the most updated details on the patient´s case.   The patient had fatigue and brain fogs, but she did not have another seizure, Caller reported that ¨for now, we are dealing with the symptoms she had on the 06-Apr-2021. The patient had cancelled her 2nd dose appointment.  The patient treatment medication included Advil on 06-Apr-2021.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. chills, nausea, pyrexia and fatigue are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. chills, nausea, pyrexia and fatigue are consistent with the product safety profile.