Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: On the floor and was out for 4 days/She went over on the side of her face and she didn't know what happened/ She was taken to the hospital and stayed there for 5 days/ doctor said it was from the shot; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (On the floor and was out for 4 days/She went over on the side of her face and she didn't know what happened/ She was taken to the hospital and stayed there for 5 days/ doctor said it was from the shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (On the floor and was out for 4 days/She went over on the side of her face and she didn't know what happened/ She was taken to the hospital and stayed there for 5 days/ doctor said it was from the shot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 5 days due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (On the floor and was out for 4 days/She went over on the side of her face and she didn't know what happened/ She was taken to the hospital and stayed there for 5 days/ doctor said it was from the shot) outcome was unknown.            After the second vaccination, patient came home, changed into clothes and then next thing she knew she was on the floor and was out for 4 days. Patient went over on the side of her face and she didn't know what happened. Patient was taken to the hospital and stayed there for 5 days. The doctor said it was from the shot and the fibromyalgia she has all over her body.  Concomitant medications:Blood pressure medicine.  Company comment: This case concerns a 70-year-old female patient with a medical history of fibromyalgia, who experienced the unexpected, serious (hospitalization) event of loss of consciousness. The event occurred approximately 1 month after the first dose of mRNA-1273 and the same day after the second dose of mRNA-1273. The rechallenge was unknown since booster dose has not been administered yet. The medical history of fibromyalgia is a confounder. The patient reports that after the second dose she was unconscious for 4 days and after that she was taken to the hospital and was admitted for 5 days. Further details regarding diagnostic tests and medical notes have not been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 70-year-old female patient with a medical history of fibromyalgia, who experienced the unexpected, serious (hospitalization) event of loss of consciousness. The event occurred approximately 1 month after the first dose of mRNA-1273 and the same day after the second dose of mRNA-1273. The rechallenge was unknown since booster dose has not been administered yet. The medical history of fibromyalgia is a confounder. The patient reports that after the second dose she was unconscious for 4 days and after that she was taken to the hospital and was admitted for 5 days. Further details regarding diagnostic tests and medical notes have not been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.