Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Fibrin D dimer, Full blood count, Head injury
Clinical narrative: Unwitnessed syncope with head injury and witnessed syncope with paramedics requiring emergency room evaluation; Unwitnessed syncope with head injury and witnessed syncope with paramedics requiring emergency room evaluation; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Unwitnessed syncope with head injury and witnessed syncope with paramedics requiring emergency room evaluation) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Sep-2022, the patient experienced SYNCOPE (Unwitnessed syncope with head injury and witnessed syncope with paramedics requiring emergency room evaluation) (seriousness criterion medically significant) and HEAD INJURY (Unwitnessed syncope with head injury and witnessed syncope with paramedics requiring emergency room evaluation). At the time of the report, SYNCOPE (Unwitnessed syncope with head injury and witnessed syncope with paramedics requiring emergency room evaluation) and HEAD INJURY (Unwitnessed syncope with head injury and witnessed syncope with paramedics requiring emergency room evaluation) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. Patient had CT head, ECG and labs with unspecified results. Patient had IV fluids. Company comment: This is a spontaneous case concerning a 36-year-old male patient, with no relevant medical history or risk factors, who experienced the unexpected and serious (due to medically significant) event of syncope (among other non-serious events), on the following day of the additional booster dose of mRNA-1273 BIVALENT .222 vaccine. No details of previous doses were provided. He was evaluated in the emergency room due to syncope with head injury, where he received intravenous fluids and a head Computerized Tomography head, an electrocardiogram and lab tests were performed with no results available. No information disclosed about clinical course or other treatments received. The benefit-risk relationship of mRNA-1273 BIVALENT .222 vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 36-year-old male patient, with no relevant medical history or risk factors, who experienced the unexpected and serious (due to medically significant) event of syncope (among other non-serious events), on the following day of the additional booster dose of mRNA-1273 BIVALENT .222 vaccine. No details of previous doses were provided. He was evaluated in the emergency room due to syncope with head injury, where he received intravenous fluids and a head Computerized Tomography head, an electrocardiogram and lab tests were performed with no results available. No information disclosed about clinical course or other treatments received. The benefit-risk relationship of mRNA-1273 BIVALENT .222 vaccine, is not affected by this report.