Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Vertigo; Higher blood pressure148/91; Dizziness; Fever; Flu symptoms; slept all day; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Flu symptoms), HYPERSOMNIA (slept all day), VERTIGO (Vertigo), HYPERTENSION (Higher blood pressure148/91) and DIZZINESS (Dizziness) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient was generally in good health and strong condition.  Concurrent medical conditions included Blood pressure abnormal and Allergy (Allergies). Concomitant products included NEBIVOLOL for Blood pressure abnormal.    On 04-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Dec-2023, the patient experienced INFLUENZA (Flu symptoms), HYPERSOMNIA (slept all day) and PYREXIA (Fever). On 06-Dec-2023, the patient experienced VERTIGO (Vertigo), HYPERTENSION (Higher blood pressure148/91) and DIZZINESS (Dizziness). On 06-Dec-2023, INFLUENZA (Flu symptoms) had resolved. At the time of the report, HYPERSOMNIA (slept all day), VERTIGO (Vertigo) and PYREXIA (Fever) outcome was unknown, HYPERTENSION (Higher blood pressure148/91) had resolved and DIZZINESS (Dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: higher blood pressure 148/91.         On the second day of taking the vaccine, the patient had fever and flu symptoms and slept all day, and on the third day, the flu symptoms were gone (that was a familiar reaction for the patient) However, on the third day from taking the vaccine, the patient woke up with dizziness and vertigo - all new symptoms ever for the patient, and the patient had higher blood pressure of 148/91 which required the patient to double up the blood pressure medication (2.5 mg daily) to bring the pressure down to normal. The blood pressure was medicated but the dizziness continued mildly on the previous day and still on the reporting day. The patient was seeing the physician on Monday but was wondering if the patient could receive full information about the side effects of this vaccine.  No treatment medications were reported. Company comment This spontaneous case concerns a 69-year-old female patient, with relevant medical history of Blood pressure abnormal, who experienced the unexpected non-serious AESI of Hypersomnia that occurred 1 day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024). It was reported that on the second day of taking the vaccine, the patient had fever and flu symptoms and slept all day, and on the third day, the flu symptoms were gone (that was a familiar reaction for the patient). However, on the third day from taking the vaccine, the patient woke up with dizziness and vertigo, and the patient had higher blood pressure of 148/91 which required more blood pressure medication to bring the pressure down to normal. The patient was going to see the physician. No further clinical information was provided. The medical history of Blood pressure abnormal could be a contributory factor for hypertension. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine in not affected by this report.