Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Bradykinesia, Eating disorder, Hypersomnia, Incoherent
Clinical narrative: She got up, was sitting on the bed and was staring at the wall/ Unusual behavior/ Abnormal behavior/ Sitting in the chair all day; She walked really slow; Has not eaten anything; She has been sleeping; Incoherent; She has experienced a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (She got up, was sitting on the bed and was staring at the wall/ Unusual behavior/ Abnormal behavior/ Sitting in the chair all day), BRADYKINESIA (She walked really slow), EATING DISORDER (Has not eaten anything), HYPERSOMNIA (She has been sleeping) and INCOHERENT (Incoherent) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (She has experienced a sore arm). On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABNORMAL BEHAVIOUR (She got up, was sitting on the bed and was staring at the wall/ Unusual behavior/ Abnormal behavior/ Sitting in the chair all day), BRADYKINESIA (She walked really slow), EATING DISORDER (Has not eaten anything), HYPERSOMNIA (She has been sleeping) and INCOHERENT (Incoherent). At the time of the report, ABNORMAL BEHAVIOUR (She got up, was sitting on the bed and was staring at the wall/ Unusual behavior/ Abnormal behavior/ Sitting in the chair all day), BRADYKINESIA (She walked really slow), EATING DISORDER (Has not eaten anything), HYPERSOMNIA (She has been sleeping), INCOHERENT (Incoherent) and PAIN IN EXTREMITY (She has experienced a sore arm) outcome was unknown.            Patient had been taking daily concomitant medications. Treatment includes use of IV liquids.  Patient had experienced a sore arm with all doses.  On 19-Nov-2021, after receiving the booster dose yesterday, patient got up, was sitting on the bed, and was staring at the wall. This was unusual behavior for patient, and then went back to bed. At around 9:00, patient came out, stood in the hallway and was staring again at the wall. Patient's sister helped, but patient walked really slow, was incoherent, and had not eaten anything. Patient took daily medications but had not consumed anything else. The HCP said that to take patient to the emergency room if symptoms get worse. Patient had been sleeping and sitting in the chair all day which was abnormal behavior.   This case was linked to MOD-2021-393453, MOD-2021-393428 (Patient Link).; Sender's Comments: This case concerns a female patient with unknown age with no reported medical history, who experienced Non-serious , unexpected , AESI event of hypersomnia which occurred  1 day after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . This was accompanied by other non-serous unexpected events of pain in extremity , abnormal behavior, bradykinesia , eating diosrver , incoherent. The re-challenge for this case is positive for pain in extremity since it was reported that the patient experienced this event every after vaccination. The re-challenge for the other events is not applicable since these events occurred after the 3rd dose and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.