Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Enuresis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lethargic/totally out of it; Wet the Bed; Agitated; Could Not Remember Anything; Tremor; Heated Injection Site on the Left Arm; Swollen Injection Site on the Left Arm (3" Diameter); Red Injection Site on the Left Arm (3" Diameter); This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic/totally out of it), ENURESIS (Wet the Bed), AGITATION (Agitated), MEMORY IMPAIRMENT (Could Not Remember Anything) and TREMOR (Tremor) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included GABAPENTIN and RIVAROXABAN (XARELTO) for an unknown indication.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced INJECTION SITE WARMTH (Heated Injection Site on the Left Arm), INJECTION SITE SWELLING (Swollen Injection Site on the Left Arm (3" Diameter)) and INJECTION SITE ERYTHEMA (Red Injection Site on the Left Arm (3" Diameter)). On 24-Jun-2021, the patient experienced LETHARGY (Lethargic/totally out of it) (seriousness criterion hospitalization prolonged), ENURESIS (Wet the Bed) (seriousness criterion hospitalization), AGITATION (Agitated) (seriousness criterion hospitalization prolonged), MEMORY IMPAIRMENT (Could Not Remember Anything) (seriousness criterion hospitalization prolonged) and TREMOR (Tremor) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 24-Jun-2021 to 28-Jun-2021 due to AGITATION, ENURESIS, LETHARGY, MEMORY IMPAIRMENT and TREMOR. On 28-Jun-2021, INJECTION SITE WARMTH (Heated Injection Site on the Left Arm), INJECTION SITE SWELLING (Swollen Injection Site on the Left Arm (3" Diameter)) and INJECTION SITE ERYTHEMA (Red Injection Site on the Left Arm (3" Diameter)) outcome was unknown. At the time of the report, LETHARGY (Lethargic/totally out of it), ENURESIS (Wet the Bed), AGITATION (Agitated), MEMORY IMPAIRMENT (Could Not Remember Anything) and TREMOR (Tremor) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24-Jun-2021 the patient became very lethargic, wet the bed, was agitated, could not remember anything and had tremor. The patient's wife called 911 and the patient was totally out of it when he was taken to the hospital. While hospitalized, the patient had a CT(computerized tomography) scan, an MRI (magnetic resonance imaging) test and a brain activity scan and the results for all tests were reported as normal. The patient was discharged on 28-Jun-2021 and at the time of this report had not recovered 100% (events not specified). Specific treatment information was not provided by the reporter.  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. Further information has been requested.   Reporter did not allow further contact; 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. Further information has been requested.