Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Malaise, Metabolic function test, Pyrexia
Clinical narrative: she was feeling bad in the first hour; ER doctor said he never seen a reaction like that before; Sick; Patient laid down from Friday afternoon until Sunday. missed Saturday; Running a fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she was feeling bad in the first hour), IMMUNISATION REACTION (ER doctor said he never seen a reaction like that before), ILLNESS (Sick), HYPERSOMNIA (Patient laid down from Friday afternoon until Sunday. missed Saturday) and PYREXIA (Running a fever) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058628) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu Vaccine. Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Heart disease, unspecified and Lung disorder NOS. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 13-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 13-Oct-2023, the patient experienced FEELING ABNORMAL (she was feeling bad in the first hour), IMMUNISATION REACTION (ER doctor said he never seen a reaction like that before), ILLNESS (Sick), HYPERSOMNIA (Patient laid down from Friday afternoon until Sunday. missed Saturday) and PYREXIA (Running a fever). At the time of the report, FEELING ABNORMAL (she was feeling bad in the first hour), IMMUNISATION REACTION (ER doctor said he never seen a reaction like that before), ILLNESS (Sick), HYPERSOMNIA (Patient laid down from Friday afternoon until Sunday. missed Saturday) and PYREXIA (Running a fever) outcome was unknown.            Patient reported that she called her doctor and was told to go to the ER. They ran a lot of test and then send her home. They also told her she should see her doctor. They ran a metabolic panel, complete blood count with differential, and hepatic function panel however, the outcomes/results of the tests were not provided. No treatment information was reported.  Company Comment: This is a Spontaneous case concerning a 79-year-old female patient with concurrent medical history of heart disease and unspecified lung disorder, who experienced the non-serious unexpected AESI of Hypersomnia which occurred on the same day after a dose of mRNA-1273.815 received as the fifth dose for COVID-19 Vaccination.  It was also reported that the patient received Flu vaccine on the same day which remains a confounder. Laboratory tests were performed; however, the results were not provided. The medical history of concurrent heart disease and unspecified lung disorder also remains confounding. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-745891 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745891:Same Reporter Different Patient