Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Inappropriate schedule of product administration, Speech disorder, Staring
Clinical narrative: blank; Felt like she was having a stroke the summer after 2nd Shot/ Stroke like episodes were on and off lasting 5-7 days each time, the summer after 2nd Shot; People would talk to patient she had to sit down and could not answer the summer after 2nd Shot; Blank or fatigue when people would  talk to her the summer after 2nd Shot; Second dose received after 24 days; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Felt like she was having a stroke the summer after 2nd Shot/ Stroke like episodes were on and off lasting 5-7 days each time, the summer after 2nd Shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 626B21A and 661B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Esophageal perforation (Esophageal fissures which she had in the past and used Anesthesia medicine (Propofol) to remove them.). Previously administered products included for Esophageal perforation: Propofol (Medical history of Esophageal fissures which she had in the past and used Anesthesia medicine (Propofol) to remove them.). Past adverse reactions to the above products included No adverse event with Propofol.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received after 24 days). In July 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Felt like she was having a stroke the summer after 2nd Shot/ Stroke like episodes were on and off lasting 5-7 days each time, the summer after 2nd Shot) (seriousness criterion medically significant), SPEECH DISORDER (People would talk to patient she had to sit down and could not answer the summer after 2nd Shot) and FATIGUE (Blank or fatigue when people would  talk to her the summer after 2nd Shot). On an unknown date, the patient experienced STARING (blank). In February 2022, CEREBROVASCULAR ACCIDENT (Felt like she was having a stroke the summer after 2nd Shot/ Stroke like episodes were on and off lasting 5-7 days each time, the summer after 2nd Shot), SPEECH DISORDER (People would talk to patient she had to sit down and could not answer the summer after 2nd Shot) and FATIGUE (Blank or fatigue when people would  talk to her the summer after 2nd Shot) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received after 24 days) and STARING (blank) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient Each episode last a from 2 days to 5 days. This on and off episodes ended 7 months later. On an unknown date in Apr-2022, Neurologist did a 1-day study for epilepsy, and did not detect anything. Neurologist could not rule out that it was not some type of neurological disorder.  Patient started seeking Psych counseling. Patient thinks that the vaccine had a neurological effect on her. Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a 65-year-old female patient with no relevant medical history, who experienced the unexpected, serious, adverse event of special interest, Cerebrovascular Accident. The event was medically significant and occurred approximately 3 months after receiving the second dose of mRNA-1273 Vaccine. This is also a case of Inappropriate Schedule of Product Administration as the interval of the 1st and 2nd dose is 24 days. As reported, patient felt like having stroke after the second shot and had episodes of blank, fatigued, and unable to answer people when talked to the patient, no other clinical or treatment details were given. It was reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-580231 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65-year-old female patient with no relevant medical history, who experienced the unexpected, serious, adverse event of special interest, Cerebrovascular Accident. The event was medically significant and occurred approximately 3 months after receiving the second dose of mRNA-1273 Vaccine. This is also a case of Inappropriate Schedule of Product Administration as the interval of the 1st and 2nd dose is 24 days. As reported, patient felt like having stroke after the second shot and had episodes of blank, fatigued, and unable to answer people when talked to the patient, no other clinical or treatment details were given. It was reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.