Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: Moderna second booster on 03MAY2022 and on 19MAY2022 she suffered a stroke/ Caller was paralyzed on her left side; 1st booster: 08Mar22 Lot 030A21A,2nd booster: 03MAY2022 Lot 056A22A; second booster she also had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Moderna second booster on 03MAY2022 and on 19MAY2022 she suffered a stroke/ Caller was paralyzed on her left side) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 030A21A and 939905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMINS [VITAMINS NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster: 08Mar22 Lot 030A21A,2nd booster: 03MAY2022 Lot 056A22A). In May 2022, the patient experienced PAIN IN EXTREMITY (second booster she also had a sore arm). On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (Moderna second booster on 03MAY2022 and on 19MAY2022 she suffered a stroke/ Caller was paralyzed on her left side) (seriousness criteria disability and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Moderna second booster on 03MAY2022 and on 19MAY2022 she suffered a stroke/ Caller was paralyzed on her left side), PAIN IN EXTREMITY (second booster she also had a sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster: 08Mar22 Lot 030A21A,2nd booster: 03MAY2022 Lot 056A22A) outcome was unknown.            Patient DOB (Date of Birth) was reported as 22-Apr-2021. On 08-Mar-2022, patient had first booster dose. On 03-May-2022, patient took second booster dose. Patient had to have TPA to bring her out of the stroke. It was reported that the patient would be put on Eliquis which is a blood thinner after a heart procedure.  Company Comment: This spontaneous case concerns a 69-year-old, female patient with concomitant use of Fluoxetine hydrochloride (Prozac) and no reported medical conditions, who experienced the unexpected, serious (disability, medically significant) adverse event of special interest Cerebrovascular accident. Inappropriate schedule of product administration was reported as an additional event wherein the patient received 2 booster doses with interval of 2 months - which is less than the recommended window period for boosters. The serious event occurred 16 days after receiving the second booster with mRNA-1273. Circumstances leading to the event was not provided in the case; although it was mentioned that the patient received TPA (tissue plasminogen activator) as emergency medication. She was left with left-sided paralysis after the event and was prescribed with Apixaban (Eliquis) as anti-coagulant. The patient's elderly age and concomitant use of Fluoxetine could be confounders. Additionally, cardiovascular agent Rosuvastatin (Crestor) was reported as concomitant medication and could be suggestive of an underlying heart disease, which could be considered as risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-577205, MOD-2022-577206, MOD-2022-577207 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69-year-old, female patient with concomitant use of Fluoxetine hydrochloride (Prozac) and no reported medical conditions, who experienced the unexpected, serious (disability, medically significant) adverse event of special interest Cerebrovascular accident. Inappropriate schedule of product administration was reported as an additional event wherein the patient received 2 booster doses with interval of 2 months - which is less than the recommended window period for boosters. The serious event occurred 16 days after receiving the second booster with mRNA-1273. Circumstances leading to the event was not provided in the case; although it was mentioned that the patient received TPA (tissue plasminogen activator) as emergency medication. She was left with left-sided paralysis after the event and was prescribed with Apixaban (Eliquis) as anti-coagulant. The patient's elderly age and concomitant use of Fluoxetine could be confounders. Additionally, cardiovascular agent Rosuvastatin (Crestor) was reported as concomitant medication and could be suggestive of an underlying heart disease, which could be considered as risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.