Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance, Inappropriate schedule of product administration
Clinical narrative: I had a stroke on 11MAR2022 /trouble with his left side of the body/he drags his left foot and left leg. He can hardly walk with the left le; First Primary monovalent dose on 20AUG2021,2nd Primary monovalent dose on 10MAR2022; he drags his left foot and left leg/He can hardly walk with the left leg; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a stroke on 11MAR2022 /trouble with his left side of the body/he drags his left foot and left leg. He can hardly walk with the left le) in a 77-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not receive any other vaccine 4 weeks prior to COVID-19 vaccine. Prior to vaccination patient was totally healthy and was not on any medications.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 20AUG2021,2nd Primary monovalent dose on 10MAR2022). On 11-Mar-2022, the patient experienced CEREBROVASCULAR ACCIDENT (I had a stroke on 11MAR2022 /trouble with his left side of the body/he drags his left foot and left leg. He can hardly walk with the left le) (seriousness criterion medically significant). In March 2022, the patient experienced GAIT DISTURBANCE (he drags his left foot and left leg/He can hardly walk with the left leg). At the time of the report, CEREBROVASCULAR ACCIDENT (I had a stroke on 11MAR2022 /trouble with his left side of the body/he drags his left foot and left leg. He can hardly walk with the left le) had not resolved and GAIT DISTURBANCE (he drags his left foot and left leg/He can hardly walk with the left leg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 20AUG2021,2nd Primary monovalent dose on 10MAR2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that patient never had any side effects with dose 1 and forgot to get the second shot until 6 months later. Patient had stroke on 11-Mar-2022 but did not go to a doctor or hospital and was self-diagnosed. It was also reported that after second shot patient had trouble with the left side of the body and drags left foot and left leg, could hardly walk with the left leg and also reported that exercise has not helped. Treatment medications were not provided.  Company comment: This spontaneous case concerns a 77-year-old male patient with no medical history reported, who experienced serious (medically significant) unexpected AESI of cerebrovascular accident, that occurred approximately 1 day after the 2nd dose of the mRNA-1273. Additionally, there was an inappropriate schedule of product administration since interval between the 1st and the 2nd dose of mRNA-1273 was more than 35 days in primary vaccination series (approximately 6 months). Reportedly, the patient had problems with left side of his body with dragging of left foot and left leg and difficult walking with the left leg. The patient noted that exercises did not help. The patient had never been to the doctor, the diagnosis was never made by a health care professional and the patient reported he self-diagnosed himself. Reportedly, the patient was healthy prior to 2nd vaccination and had not been taking any medications. The patient's advanced age is a possible confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.