Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: "arm warm", "arm hot", "arm really really hot"; vaccination site itching; hive on top of the arm, about the size of a half-dollar-bill coin; feels like "someone punched me in the back real hard like I'm out of breathe, like its harder to breathe, like my blood pressure drop"; my blood pressure drop"; "Hard to move and get up"; "I'm so sleepy", "I take two naps during the day", "can't stay up", "awake 4 to 5 hours then back to sleep"; I'm so tired/fatigue; "out of it now" / "Feels like "she is high from some heavy drugs" when she wakes up"; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE ("I'm so sleepy", "I take two naps during the day", "can't stay up", "awake 4 to 5 hours then back to sleep") and FATIGUE (I'm so tired/fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006-C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Antihistamine therapy, EPINEPHRINE (EPIPEN), FUROSEMIDE, FAMOTIDINE, SALBUTAMOL (ALBUTEROL HFA), MONTELUKAST SODIUM (SINGULAIR), POTASSIUM, VITAMIN D NOS, METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]), FLUTICASONE PROPIONATE (FLOVENT) and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced SOMNOLENCE ("I'm so sleepy", "I take two naps during the day", "can't stay up", "awake 4 to 5 hours then back to sleep") (seriousness criterion disability), FATIGUE (I'm so tired/fatigue) (seriousness criterion disability) and FEELING ABNORMAL ("out of it now" / "Feels like "she is high from some heavy drugs" when she wakes up"). On 10-May-2021, the patient experienced DYSPNOEA (feels like "someone punched me in the back real hard like I'm out of breathe, like its harder to breathe, like my blood pressure drop"), BLOOD PRESSURE DECREASED (my blood pressure drop") and ASTHENIA ("Hard to move and get up"). On 12-May-2021, the patient experienced VACCINATION SITE WARMTH ("arm warm", "arm hot", "arm really really hot"), VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE URTICARIA (hive on top of the arm, about the size of a half-dollar-bill coin). At the time of the report, SOMNOLENCE ("I'm so sleepy", "I take two naps during the day", "can't stay up", "awake 4 to 5 hours then back to sleep"), FATIGUE (I'm so tired/fatigue), FEELING ABNORMAL ("out of it now" / "Feels like "she is high from some heavy drugs" when she wakes up"), DYSPNOEA (feels like "someone punched me in the back real hard like I'm out of breathe, like its harder to breathe, like my blood pressure drop"), BLOOD PRESSURE DECREASED (my blood pressure drop"), ASTHENIA ("Hard to move and get up"), VACCINATION SITE WARMTH ("arm warm", "arm hot", "arm really really hot"), VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE URTICARIA (hive on top of the arm, about the size of a half-dollar-bill coin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was so tired that she took two naps during the day and drank sports drink like Red bull to stay awake. After being awake for 4-5 hours she went back to sleep. Patient drank plenty of water and fluids.   Treatment medication information was not provided by the reporter.  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. The SD does not state any information that supports a persistent disability, which open to doubt the seriousness criteria.; 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. The SD does not state any information that supports a persistent disability, which open to doubt the seriousness criteria.