Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebral haemorrhage, Concussion, Fall, Syncope, Vaccination site pain
Clinical narrative: Some bleeding into the brain; Patient has a concussion; Later that day the patient fainted, fell to the ground and hit her head; Later that day the patient fainted, fell to the ground and hit her head; Sore left injection site arm; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL HEMORRHAGE (Some bleeding into the brain), CONCUSSION (Patient has a concussion), FALL (Later that day the patient fainted, fell to the ground and hit her head) and SYNCOPE (Later that day the patient fainted, fell to the ground and hit her head) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol.    On 27-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 27-Oct-2022, the patient experienced CEREBRAL HEMORRHAGE (Some bleeding into the brain) (seriousness criteria hospitalization and medically significant), CONCUSSION (Patient has a concussion) (seriousness criterion hospitalization), FALL (Later that day the patient fainted, fell to the ground and hit her head) (seriousness criterion hospitalization), SYNCOPE (Later that day the patient fainted, fell to the ground and hit her head) (seriousness criteria hospitalization and medically significant) and VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, CEREBRAL HEMORRHAGE (Some bleeding into the brain), CONCUSSION (Patient has a concussion), FALL (Later that day the patient fainted, fell to the ground and hit her head), SYNCOPE (Later that day the patient fainted, fell to the ground and hit her head) and VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.            Patient's height was 5 foot 6 inch.  Concomitant medication included high cholesterol medication.  The patient received the first dose of Moderna Covid-19 vaccine on 26-Feb-2021 of lot number 001A21A on the left arm.  The patient received the second dose of Moderna Covid-19 vaccine on 26-Mar-2021 of lot number 008B21A on the left arm.  The patient received the first booster dose of Moderna Covid-19 vaccine on 28-Oct-2021 of lot number 001A21A on the left arm.  On 27-Oct-2022, the patient received first Moderna Covid-19 bivalent vaccine booster dose.  Later on the day of bivalent booster dose administration, the patient fainted, fell to the ground and hit the head and the patient went to the emergency room and was admitted to the hospital.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 75-year-old female with high blood cholesterol who experienced the unexpected, serious (hospitalization, medically significant) event of cerebral hemorrhage, the unexpected serious (hospitalization) event of concussion and fall and the expected serious (hospitalization, medically significant) event of syncope, which occurred the same day after receiving a dose of mRNA1273 bivalent BA .4/5 as fourth dose in the COVID-19 vaccine series. The events of this case may be in association with each other. Approximately a few hours post vaccination the patient fainted, fell to the ground and hit her head. This prompted her to visit the emergency room and was subsequently admitted. Further details on the clinical course, diagnostic and ancillary test done were not provided. The patient's advanced age may be considered as a risk factor for cerebral hemorrhage, fall and syncope. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgment.   This case was linked to MOD-2022-666798, MOD-2022-666790 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 75 year old female with high blood cholesterol who experienced the unexpected, serious  (hospitalization, medically significant) event of cerebral hemorrhage, the unexpected serious (hospitalization) event of concussion and fall and the expected serious (hospitalization, medically significant) event of syncope, which occurred the same day after receiving a dose of mRNA1273 bivalent BA .4/5 as fourth dose in the COVID-19 vaccine series. The events of this case may be in association with each other. Approximately a few hours post vaccination the patient fainted, fell to the ground and hit her head. This prompted her to visit the emergency room and was subsequently admitted. Further details on the clinical course, diagnostic and ancillary test done were not provided. The patient's advanced age may be considered as a risk factor for cerebral haemorrhage, fall and syncope. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgment.