Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disturbance in attention, Hypersomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (Concentration impaired), HYPERSOMNIA (Sleep for 12 hours) and COVID-19 (COVID-19, sickness, body aches and tiredness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (Concentration impaired), HYPERSOMNIA (Sleep for 12 hours) and COVID-19 (COVID-19, sickness, body aches and tiredness). At the time of the report, DISTURBANCE IN ATTENTION (Concentration impaired) and HYPERSOMNIA (Sleep for 12 hours) outcome was unknown and COVID-19 (COVID-19, sickness, body aches and tiredness) had not resolved. No concomitant medications were reported. On an unknown date in 2022, the patient experienced very tired for at least four hours after taking the Humira and also had body aches. It was unknown whether patient was enrolled in a COVID-19 vaccine Trial. No treatment medications were reported. Company comment: This spontaneous case concerns a 29-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of Hypersomnia and COVID-19. The exact date of onset of the events was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The initial two doses of mRNA-1273 were given approximately 8 months prior to the third dose of mRNA-1273, the interval between the two doses is 31 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 29-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of Hypersomnia and COVID-19. The exact date of onset of the events was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The initial two doses of mRNA-1273 were given approximately 8 months prior to the third dose of mRNA-1273, the interval between the two doses is 31 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.