Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Fatigue, Product dose omission issue, SARS-CoV-2 test positive, Somnolence
Clinical narrative: More than 36 days have passed since first dose, still hasn't got second shot; Couldn't speak/Couldn't talk; Couldn't wake up; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still hasn't got second shot), APHASIA (Couldn't speak/Couldn't talk), SOMNOLENCE (Couldn't wake up) and FATIGUE (Very tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Infusion (Bamlanivimab Infusion) on 17-Dec-2020 and Stroke in 2010. Concomitant products included APIXABAN (ELIQUIS), OXYBUTYNIN, METOPROLOL, ROSUVASTATIN, FAMOTIDINE and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced SOMNOLENCE (Couldn't wake up) and FATIGUE (Very tired). On 18-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still hasn't got second shot) and APHASIA (Couldn't speak/Couldn't talk). On 17-Feb-2021, SOMNOLENCE (Couldn't wake up) had resolved. On 18-Feb-2021, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still hasn't got second shot) and APHASIA (Couldn't speak/Couldn't talk) had resolved. At the time of the report, FATIGUE (Very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  after first dose was that I had injection at 11 AM and then came home and got very tired like around 6 or 7 pm I went to bed and slept soundly and couldn't wake up. I obliged myself to get up and made coffee and did few things and then I got very tired again. I leigh down on the couch and so this is around 8 in the morning and woke up with the phone ringing and when I answered I couldn't speak; I couldn't talk to my friend. My friend thought I was having a stroke, but I already had a stroke in 2010 so I know what that was and I wasn't having a stroke. My friend then called my sister and she also thought I was having a stroke. This lasted for some hours and then I felt good. I was able to talk again. By four o clock the nurse from the health insurance came for annual check up and I was fine with her. This lasted for about 6 to 8 hours.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information is requested.