Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Grip strength decreased, Headache, Hypersomnia, Vaccination site pain
Clinical narrative: began dropping things/cannot hold on to things; sitting on bed 'Indian style', and suddenly fell over in bed; sleeping a lot; Headache everyday,massive headache as very severe from brain stem to forehead; left upper arm got sore and lasted for 12 hours.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GRIP STRENGTH DECREASED (began dropping things/cannot hold on to things), FALL (sitting on bed 'Indian style', and suddenly fell over in bed), HYPERSOMNIA (sleeping a lot), VACCINATION SITE PAIN (left upper arm got sore and lasted for 12 hours.) and HEADACHE (Headache everyday,massive headache as very severe from brain stem to forehead) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 045821A) for COVID-19 vaccination.     The patient's past medical history included Headache. Concomitant products included IBUPROFEN (MOTRIN MIGRAINE PAIN) for Headache, CEFIXIME (FLEXERIL [CEFIXIME]) for Tendonitis, CLONAZEPAM (CLONOPIN), CHOLESTEROL, CLOPIDOGREL BISULFATE (PLAVIX), TRIGLYCERIDES and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (left upper arm got sore and lasted for 12 hours.). On 23-Apr-2021, the patient experienced HEADACHE (Headache everyday,massive headache as very severe from brain stem to forehead). On an unknown date, the patient experienced GRIP STRENGTH DECREASED (began dropping things/cannot hold on to things), FALL (sitting on bed 'Indian style', and suddenly fell over in bed) and HYPERSOMNIA (sleeping a lot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache and Pain, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for Headache and Pain, at a dose of 1 dosage form and CLONAZEPAM (CLONOPIN) ongoing since an unknown date at a dose of 1 dosage form. On 23-Apr-2021, VACCINATION SITE PAIN (left upper arm got sore and lasted for 12 hours.) outcome was unknown. At the time of the report, GRIP STRENGTH DECREASED (began dropping things/cannot hold on to things), FALL (sitting on bed 'Indian style', and suddenly fell over in bed), HYPERSOMNIA (sleeping a lot) and HEADACHE (Headache everyday,massive headache as very severe from brain stem to forehead) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Motrin, Butalb-acetamin-Caff  and Benadryl for headache pain and Flexaril and clonopin for unknown indication.   This case was linked to MOD-2021-095432 (Patient Link).