Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Decreased appetite, Dizziness, Fatigue
Clinical narrative: very tired; Had no appetite; temperature of 100°F; Passed out at home; feeling lightheaded; not able to sleep; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out at home) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017h22a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     patient has no ever COVID + test or diagnosis.  Concurrent medical conditions included Fruit allergy, Iodine contrast media allergy, Sulfonamide allergy, Penicillin allergy, Cancer (Taking prednisone diagnosis for Cancer was received before receiving the 1st dose of the Moderna COVID19 vaccine) and Immunocompromised. Concomitant products included PREDNISONE for Cancer, NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.    On 17-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced LOSS OF CONSCIOUSNESS (Passed out at home) (seriousness criterion medically significant), DIZZINESS (feeling lightheaded), INSOMNIA (not able to sleep) and PYREXIA (temperature of 100°F). On 18-Oct-2022, the patient experienced DECREASED APPETITE (Had no appetite). On an unknown date, the patient experienced FATIGUE (very tired). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out at home) outcome was unknown and DIZZINESS (feeling lightheaded), INSOMNIA (not able to sleep), DECREASED APPETITE (Had no appetite), PYREXIA (temperature of 100°F) and FATIGUE (very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood test: Normal (ok). On 17-Oct-2022, Body temperature: 100°F.         On 03-Feb-2021, the patient received first dose of Moderna vaccine, lot number: 007m20a. On 08-Mar-2021, the patient received second dose of Moderna vaccine, lot number: 011a214. On 09-Nov-2021, the patient received third dose of Moderna vaccine, lot number: 004f21a.  Company comment: This is a spontaneous case concerning a 78-yeasr-old male patient with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of syncope among other non-serious events. The event of syncope occurred 1 day after 4 dose of mRNA-1273.222 vaccine. It is reported that after the vaccination the patient had high temperature of 100 degree F, when to the ED, passed out at home and was not able to sleep. Blood tests were performed and they were normal. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome for the event of syncope was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   On 17-Oct-2022 he went to the ER. He was not dehydrated; HCPs were not able to find out why he passed out.  No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #). He went to the ER for 1 night, took CT scans (result not provided) and other studies. It was reported that patient had the same problem with the 2nd vaccine, and it went on for a month.  Patient Symptoms improved or worsened: they are the same, its only been a couple of days.  No treatment medications were reported.   This case was linked to MOD-2022-661335 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 78-yeasr-old male patient with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of syncope among other non-serious events. The event of syncope occurred 1 day after 4 dose of mRNA-1273.222 vaccine. It is reported that after the vaccination the patient had high temperature of 100 degree F, when to the ED, passed out at home and was not able to sleep. Blood tests were performed and they were normal. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome for the event of syncope was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.