Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Fatigue, Off label use, Skin laceration
Clinical narrative: Groggy/ They were falling down and falling asleep while standing/ slept for around 20 hours; They were falling down and falling asleep while standing; vertigo kicked in; At one point they fell through the baby chair they use because their vertigo kicked in, and they cut their chest open on the chair edge; Cut their chest open on the chair edge; , it hurt a lot/ major pain on the injection site; injection site was swollen red/red,lymph node red, patch 4-6 inches long in a circle underneath the injection site; fatigue; injection site was swollen red; caller' sibling got the third dose of the vaccine, not sure if immunocompromised; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of vertigo kicked in in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. notprovided) 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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (caller' sibling got the third dose of the vaccine, not sure if immunocompromised), VACCINATION SITE PAIN (, it hurt a lot/ major pain on the injection site), VACCINATION SITE ERYTHEMA (injection site was swollen red/red,lymph node red, patch 4-6 inches long in a circle underneath the injection site), FATIGUE (fatigue), SOMNOLENCE (Groggy/ They were falling down and falling asleep while standing/ slept for around 20 hours), BALANCE DISORDER (They were falling down and falling asleep while standing), vertigo kicked in (seriousness criterion medically significant), FALL (At one point they fell through the baby chair they use because their vertigo kicked in, and they cut their chest open on the chair edge), VACCINATION SITE SWELLING (injection site was swollen red) and SKIN LACERATION (Cut their chest open on the chair edge). At the time of the report, OFF LABEL USE (caller' sibling got the third dose of the vaccine, not sure if immunocompromised), VACCINATION SITE PAIN (, it hurt a lot/ major pain on the injection site), VACCINATION SITE ERYTHEMA (injection site was swollen red/red,lymph node red, patch 4-6 inches long in a circle underneath the injection site), FATIGUE (fatigue), SOMNOLENCE (Groggy/ They were falling down and falling asleep while standing/ slept for around 20 hours), BALANCE DISORDER (They were falling down and falling asleep while standing), vertigo kicked in, FALL (At one point they fell through the baby chair they use because their vertigo kicked in, and they cut their chest open on the chair edge), VACCINATION SITE SWELLING (injection site was swollen red) and SKIN LACERATION (Cut their chest open on the chair edge) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported No Treatment Drug was reported   This case was linked to MOD-2021-314905 (Patient Link).; Sender's Comments: This is a case of Off Label Use for mRNA-1273 (lot #022C21A) (given third dose of vaccine to patient who is not immunocompromised) with associated AEs. Very limited information regarding these events has been provided at this time. Further information has been requested.