Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Myalgia, Pyrexia, Syncope
Clinical narrative: COVID-19; Thirsty; he fainted on the kitchen floor and experienced multiple episodes of fainting afterward; body aches/ ached some; Fever/ was hot; lack of energy/was tired; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (he fainted on the kitchen floor and experienced multiple episodes of fainting afterward) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (First covid; nearly dying) in August 2020. Previously administered products included for Product used for unknown indication: Johnson & Johnson (Dose 1). Past adverse reactions to the above products included No adverse effect with Johnson & Johnson. Concurrent medical conditions included Chronic lymphocytic leukemia (body cannot adequately produce white blood cells that fight infections).    On 12-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Nov-2023, the patient experienced SYNCOPE (he fainted on the kitchen floor and experienced multiple episodes of fainting afterward) (seriousness criterion medically significant) and THIRST (Thirsty). In November 2023, the patient experienced MYALGIA (body aches/ ached some), PYREXIA (Fever/ was hot) and FATIGUE (lack of energy/was tired). In August 2024, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, SYNCOPE (he fainted on the kitchen floor and experienced multiple episodes of fainting afterward), COVID-19 (COVID-19), THIRST (Thirsty), MYALGIA (body aches/ ached some), PYREXIA (Fever/ was hot) and FATIGUE (lack of energy/was tired) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received the COVID-19 vaccine as soon as it became available, starting with the Johnson & Johnson vaccine and then receiving subsequent Moderna vaccines.  During his most recent vaccination, his reaction was different. At first everything was same, he developed fever, body aches, ached some and was tired. On the early morning of 14-Nov-2023, he awoke at about 2:00 needing to go to the bathroom. Patient was hot and thirsty. After using the bathroom, he went to kitchen to get a drink of water. He fainted on the kitchen floor with no warning and experienced multiple episodes of fainting afterward. He consulted both his general practitioner and oncologist, who advised against receiving further COVID-19 vaccinations. Despite this advice, the consumer wishes to continue with his regular COVID-19 vaccinations. He also reported contracting COVID-19 again and was treated with an emergency dose of Paxlovid.   Company comment: This spontaneous case concerns a male patient of unknown age, with medical history of chronic lymphocytic leukemia, who experienced the unexpected serious (medically significant) event of syncope along with other non serious events. The events occurred after a dose of SPIKEVAX 2023-2024. Exact temporal association is unclear. The patient was previously vaccinated with one dose of Johnson & Johnson and subsequent vaccinations were with Moderna vaccine. As reported, after most recent vaccination patient developed fever, body aches, ached some and was tired. On the early morning of 14-Nov-2023, he awoke at about 2:00 needing to go to the bathroom. Patient was hot and thirsty. After using the bathroom, patient went to kitchen to get a drink of water and fainted on the kitchen floor with no warning and experienced multiple episodes of fainting afterwards. Patient also experienced COVID 19 on unknown date. No further information about the events was provided. Above mentioned medical history may be considered as contributing factor. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.   This case was linked to MOD-2024-773966 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2024: Live follow-up received contains non-significant information (reference number added). On 11-Sep-2024: Live significant follow-up received: Additional events of fatigue and thirst were added.