Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Decreased appetite, Hypersomnia
Clinical narrative: Slept a bit more than usual; Ate a bit less than usual; We were both infected with COVID-19 in February; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a bit more than usual), DECREASED APPETITE (Ate a bit less than usual) and COVID-19 (We were both infected with COVID-19 in February) in a 5-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.    MEDICAL HISTORY (Parent): The mother's past medical history included COVID-19 (PCR positive) on 22-May-2022. Previously administered products included for COVID-19 prophylaxis: Janssen (Lot number: 203A21A) on 10-Apr-2021 and MODERNA COVID-19 VACCINE (Batch number: 067F21A; Intramuscular injection 0.25ml) on 19-Nov-2021. Past adverse reactions to the above products included No adverse event with Janssen and MODERNA COVID-19 VACCINE. Concurrent medical conditions included Hypertension (worsening) since 01-Jan-2007.    MEDICAL HISTORY (Patient): The patient's past medical history included Foetal exposure during pregnancy. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-Jan-2022 to an unknown date and LABETALOL for an unknown indication.  On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Transplacental) .5 milliliter. In February 2023, the patient experienced HYPERSOMNIA (Slept a bit more than usual), DECREASED APPETITE (Ate a bit less than usual) and COVID-19 (We were both infected with COVID-19 in February). At the time of the report, HYPERSOMNIA (Slept a bit more than usual), DECREASED APPETITE (Ate a bit less than usual) and COVID-19 (We were both infected with COVID-19 in February) had resolved.   No concomitant and treatment medications were reported.  Mother reported that both herself and the baby were doing well and had a clean bill of health. Her daughter would be turning 6 months in Mar (20-26), 2023. Both were infected with COVID-19 in February. However, they were both mild cases. The baby had a slight fever for 2 days, slept a bit more than usual and ate a bit less than usual for a few days before returning to her healthy self.  Mother was taking labetalol and prenatal vitamins daily and is still taking. Mother's pre-pregnancy weight was 155 pounds.  Company comment-This spontaneous case concerns an 5-month-old female infant, with past history of foetal exposure during pregnancy reported, who experienced non serious unexpected AESI of Hypersomnia that occurred about 4-5 months after a booster dose of mRNA-1273.222 vaccination. It was reported that both mother and baby were infected with Covid-19, both mild cases. Baby had a slight fever for 2 days, slept a bit more than usual and ate a bit less than usual for a few days before returning to her healthy self. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-646081, US-MODERNATX, INC.-MOD-2023-715204 (Parent-Child Link).   See case US-MODERNATX, INC.-MOD-2023-715204,US-MODERNATX, INC.-MOD-2022-646081 for details regarding the child case.