Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Confusional state, Feeling abnormal, Headache, International normalised ratio
Clinical narrative: Memory lapse, difficulty with memory recall; Confused; Blood clots; Cerebral Ischemic Attack; Brain Fog; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall), CONFUSIONAL STATE (Confused), THROMBOSIS (Blood clots) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart valve operation. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confused) (seriousness criterion hospitalization), THROMBOSIS (Blood clots) (seriousness criterion hospitalization) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) (seriousness criterion hospitalization). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Brain Fog) and HEADACHE (Headache). The patient was hospitalized from 10-Apr-2021 to 12-Apr-2021 due to CONFUSIONAL STATE, MEMORY IMPAIRMENT, THROMBOSIS and TRANSIENT ISCHAEMIC ATTACK. At the time of the report, MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall), FEELING ABNORMAL (Brain Fog) and HEADACHE (Headache) had not resolved and CONFUSIONAL STATE (Confused), THROMBOSIS (Blood clots) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Computerised tomogram: abnormal (abnormal) revealed blood clots. On 10-Apr-2021, International normalised ratio: low (Low) Low. On 10-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) revealed blood clots. On 15-Apr-2021, International normalised ratio: low (Low) Low.         It was reported that the patient still has difficulty with memory recall, brain fog, headache, and still having trouble with low INR. The patient did not have any side effects after the first dose. Treatment for the events included Levonox injections and Coumadin (increased dose).  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Headache is consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Headache is consistent with the product known safety profile.