Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Paraesthesia, Paraesthesia oral, Product dose omission issue, Slow speech
Clinical narrative: tingling on left side of face/mouth; memory issues; weak; shaky; can't stay awake; speech slow and slurry; speech slow and slurry; knees gave out; loss control of bladder /incontinence; sounded intoxicated; TINGLING ON LEFT SIDE OF FACE; cannot drive with no warning; advised her to not take the second shot; MISSED DOSE; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (can't stay awake), DYSARTHRIA (speech slow and slurry), SLOW SPEECH (speech slow and slurry), INCONTINENCE (loss control of bladder /incontinence), PARAESTHESIA ORAL (tingling on left side of face/mouth), MEMORY IMPAIRMENT (memory issues), ASTHENIA (weak), NERVOUSNESS (shaky), MUSCULOSKELETAL DISCOMFORT (knees gave out), FEELING ABNORMAL (sounded intoxicated) and PARAESTHESIA (TINGLING ON LEFT SIDE OF FACE) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced INCONTINENCE (loss control of bladder /incontinence) (seriousness criterion hospitalization). On 09-Jul-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (knees gave out) (seriousness criterion hospitalization). On an unknown date, the patient experienced SOMNOLENCE (can't stay awake) (seriousness criterion hospitalization), DYSARTHRIA (speech slow and slurry) (seriousness criterion hospitalization), SLOW SPEECH (speech slow and slurry) (seriousness criterion hospitalization), PARAESTHESIA ORAL (tingling on left side of face/mouth) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (memory issues) (seriousness criterion hospitalization), ASTHENIA (weak) (seriousness criterion hospitalization), NERVOUSNESS (shaky) (seriousness criterion hospitalization), FEELING ABNORMAL (sounded intoxicated) (seriousness criterion hospitalization), PARAESTHESIA (TINGLING ON LEFT SIDE OF FACE) (seriousness criterion hospitalization), IMPAIRED DRIVING ABILITY (cannot drive with no warning), PRODUCT DOSE OMISSION ISSUE (advised her to not take the second shot) and OFF LABEL USE (MISSED DOSE ). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to FEELING ABNORMAL and PARAESTHESIA. At the time of the report, SOMNOLENCE (can't stay awake), DYSARTHRIA (speech slow and slurry), SLOW SPEECH (speech slow and slurry), INCONTINENCE (loss control of bladder /incontinence), PARAESTHESIA ORAL (tingling on left side of face/mouth), MEMORY IMPAIRMENT (memory issues), ASTHENIA (weak), NERVOUSNESS (shaky), MUSCULOSKELETAL DISCOMFORT (knees gave out), FEELING ABNORMAL (sounded intoxicated), PARAESTHESIA (TINGLING ON LEFT SIDE OF FACE), IMPAIRED DRIVING ABILITY (cannot drive with no warning), PRODUCT DOSE OMISSION ISSUE (advised her to not take the second shot) and OFF LABEL USE (MISSED DOSE ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, Blood pressure measurement: 60 (Low) Low. On an unknown date, Heart rate: 30 (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.  Patient received the first dose of the Moderna Vaccine (Lot #:045A21A) in her right arm on 18March2021. The patient reported she had a total of 9 episodes since 19March2021, the day after her first shot. Patient reported experiencing episodes where she cannot drive with no warning, can't stay awake, speech slow and slurry, sounded intoxicated, loss control of bladder and tingling on the left side of her face/mouth, memory issues, weak, shaky, heart rate in the 30's. Patient reported that her EKG test and blood work comes out normal.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.