Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Loss of consciousness, Product dose omission issue, Somnolence, Vaccination complication
Clinical narrative: sick; more than 35 days passed since the first dose and she has not received the second dose; vaccination went horribly; couldn't wake up,forced herself to wake up, was in and out; blacked out, was out for 38hs,opened her eyes and everything was dark although all the lights in her bedroom were on, couldn't see, everything was dark, it was shadowed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out, was out for 38hs,opened her eyes and everything was dark although all the lights in her bedroom were on, couldn't see, everything was dark, it was shadowed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out, was out for 38hs,opened her eyes and everything was dark although all the lights in her bedroom were on, couldn't see, everything was dark, it was shadowed) (seriousness criterion medically significant) and SOMNOLENCE (couldn't wake up,forced herself to wake up, was in and out). On an unknown date, the patient experienced ILLNESS (sick), PRODUCT DOSE OMISSION ISSUE (more than 35 days passed since the first dose and she has not received the second dose) and VACCINATION COMPLICATION (vaccination went horribly). In July 2021, LOSS OF CONSCIOUSNESS (blacked out, was out for 38hs,opened her eyes and everything was dark although all the lights in her bedroom were on, couldn't see, everything was dark, it was shadowed) and SOMNOLENCE (couldn't wake up,forced herself to wake up, was in and out) had resolved. At the time of the report, ILLNESS (sick) and VACCINATION COMPLICATION (vaccination went horribly) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed since the first dose and she has not received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  She was sick on the day that she was supposed to get her second dose and she missed it. She talked to her doctor and she said if she could not get it by last Friday (27Aug2021), then she had to start all over again. She was in her doctor's office this week again and she said "go ahead and get the second shot, she would be fine". So she was not sure what to do. After hearing the information, she said she went to get it done this week.  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.