Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Irritability
Clinical narrative: Lost appetite; In the morning he felt sleepy; Little irritability; Fatigue; That evening he felt a little funny before going to bed/In the morning his brain was foggy, not working with the usual ability, he had trouble sorting things out; Overnight fever; Chills; Nausea; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (In the morning he felt sleepy), IRRITABILITY (Little irritability), FEELING ABNORMAL (That evening he felt a little funny before going to bed/In the morning his brain was foggy, not working with the usual ability, he had trouble sorting things out), DECREASED APPETITE (Lost appetite) and PYREXIA (Overnight fever) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient did not had any allergies (medications, food and other products).  Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Heart disease, unspecified, Fibrillation cardiac (Heart fibrillation), Hemochromatosis, Hypothyroidism, Heart rate abnormal (Heart rate) and Blood pressure abnormal (Blood pressure). Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL) for Heart rate abnormal and Blood pressure management, INFLUENZA VACCINE, ASPIRIN [ACETYLSALICYLIC ACID], DOXYCYCLINE and VITAMINS NOS for an unknown indication.    On 05-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced FEELING ABNORMAL (That evening he felt a little funny before going to bed/In the morning his brain was foggy, not working with the usual ability, he had trouble sorting things out), PYREXIA (Overnight fever), CHILLS (Chills) and NAUSEA (Nausea). On 06-Oct-2022, the patient experienced SOMNOLENCE (In the morning he felt sleepy), IRRITABILITY (Little irritability), DECREASED APPETITE (Lost appetite) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (In the morning he felt sleepy), IRRITABILITY (Little irritability), FEELING ABNORMAL (That evening he felt a little funny before going to bed/In the morning his brain was foggy, not working with the usual ability, he had trouble sorting things out), DECREASED APPETITE (Lost appetite), PYREXIA (Overnight fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) was resolving.            The concomitant medication included unspecified thyroid medication for hypothyroidism. Patient was taking Xarelto as blood thinner.  It was reported that patient had received primary series, 1st and 2nd booster, bivalent vaccine all from Moderna.  The patient got the flu vaccine at the same time on 05 Oct 2022.  It was reported that, on 05 Oct 2022 evening patient felt a little funny before going to bed, he had overnight fever, chills, nausea and in the morning he felt sleepy, fatigue, lost appetite, his brain was foggy, not working with the usual ability, he had trouble sorting things out and had a little irritability.  AE did not caused patient to seek medical care (office visit, Urgent care, ER, hospitalized).  Patient had experienced a similar event in the past with 2nd primary dose.  It was reported that patient still had fuzziness but it was going away and symptoms had improved.   This case was linked to MOD-2022-656371 (Patient Link).