Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram, COVID-19, Electroencephalogram, Epilepsy, SARS-CoV-2 test
Clinical narrative: He stated that technically he does, but didn't get physical epilepsy; One test was COVID positive; looks like infarct thalamus; He reported that November of last year, he had light speech difficulty for about 15 seconds, could not speak; This spontaneous case was reported by a physician and describes the occurrence of THALAMIC INFARCTION (looks like infarct thalamus), TRANSIENT APHASIA (He reported that November of last year, he had light speech difficulty for about 15 seconds, could not speak) and EPILEPSY (He stated that technically he does, but didn't get physical epilepsy) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CPAP since an unknown date. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (dose 1, lot-C11J20LI) on 28-Dec-2020, Moderna COVID-19 Vaccine (dose 2, lot-not readable) on 25-Jan-2021, SPIKEVAX (dose 3, lot-076C21A) on 29-Oct-2021, SPIKEVAX (dose 4, lot-658A22-2A) on 05-Jun-2022, SPIKEVAX (dose 5 and lot-not readable) on 21-Oct-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, SPIKEVAX, SPIKEVAX and SPIKEVAX. Concurrent medical conditions included Sleep apnea (on CPAP) since 2020. Concomitant products included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX), INFLUENZA VACCINE (INFLUENZA) and RSV VACCINE for an unknown indication.    On 13-Aug-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2023, the patient experienced THALAMIC INFARCTION (looks like infarct thalamus) (seriousness criterion medically significant), TRANSIENT APHASIA (He reported that November of last year, he had light speech difficulty for about 15 seconds, could not speak) (seriousness criterion medically significant) and COVID-19 (One test was COVID positive). On an unknown date, the patient experienced EPILEPSY (He stated that technically he does, but didn't get physical epilepsy) (seriousness criterion medically significant). The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) ongoing since an unknown date at an unspecified dose and frequency. In 2023, TRANSIENT APHASIA (He reported that November of last year, he had light speech difficulty for about 15 seconds, could not speak) and COVID-19 (One test was COVID positive) had resolved. At the time of the report, THALAMIC INFARCTION (looks like infarct thalamus) had resolved and EPILEPSY (He stated that technically he does, but didn't get physical epilepsy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2023, Angiogram: It showed "looks like infarct thalamus.". On 06-Nov-2023, Electroencephalogram: something is abnormal: neurological, not COVID. On 06-Nov-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that in November of last year, the patient had light speech difficulty for about 15 seconds, he was unable to speak and did not know what he was going to say. One of his children, his second son called him and a similar thing happened. While talking, he halted speech. He said, he didn't know what was going to happen and this happened twice. His symptoms appeared the weekend of Nov 4 and 5, 2023. He went to the emergency room on 06-Nov-2023.  The patient had many tests. One test was COVID positive. COVID was resolved, the patient had mild symptoms. The patient had slight symptoms, head cold, slight temperature, never took it and mentioned as nasal cold, The patient had no chills, nothing to indicate anything wrong, had runny nose, did not felt well and had headache, which was transient, maybe one or two days. He was not admitted. He was there from 10:00 a.m. to 10:00 p.m. EEG was also done. The EEG was abnormal and it was in the center in left temporal region which can activate and get epilepsy. He was unable to speak momentary 10 or 15 seconds. The doctor stated that these tests were indicating something was abnormal: neurological, not COVID. Another test conducted was CT Angio. It showed "looks like infarct thalamus." When the patient was discharged, they gave about 30 papers and the patient had mixed feelings. The patient was on Keppra and taking regularly now.   This case was linked to US-MODERNATX, INC.-MOD-2024-764951 (E2B Linked Report).  Copany comment: This is a Spontaneous case concerning an 85-year-old male patient with medical history of CPAP and concurrent sleep apnoea and concomitant vaccination with Pneumovax, Influenza and RSV Vaccine, who experienced the serious (per medically significant) unexpected events of Thalamic infarction (AESI), Epilepsy (AESI) and Transient aphasia which occurred about three months after a dose of mRNA-1273.Bivalent .222 received as the sixth dose for COVID-19 Vaccination. It was reported that the patient received 1st to 6th Moderna's vaccines doses. The patient reported episode of slight speech difficulty for about 15 seconds that happened twice. EEG was abnormal at the center in left temporal region which can activate and get epilepsy. CT Angio revealed suspicion of thalamus infarction. It was also reported that the patient was tested positive for COVID-19 with slight symptoms which remains a confounder. Medical history of CPAP and concurrent sleep apnoea remain as confounding cardiovascular risk factors. Patient's advanced age remains confounding. Previous vaccination with RSV vaccine remains a confounder. Events of aphasia and epilepsy could be in connection with thalamic infarction. Treatment information was not reported. The benefit-risk relationship of mRNA-1273.Bivalent .222 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-764951:same reporter, different patient