Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident, Inappropriate schedule of product administration
Clinical narrative: lost eyesight in one eye; stroke; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS UNILATERAL (lost eyesight in one eye) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 09-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS UNILATERAL (lost eyesight in one eye) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), BLINDNESS UNILATERAL (lost eyesight in one eye) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medications were not reported. It was reported that patient did not remember  the date of his booster, nor when he received it or not. Patient went to the emergency room after the stroke. Patient reports he lost eyesight in one eye due to the stroke.  Treatment medications were not reported.  Company comment: This Spontaneous case concerns a 64-year-old, male patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of blindness unilateral and AESI of Cerebrovascular accident. Cerebrovascular accident occurred approximately 1 month and 14 days after receiving the second dose of mRNA-1273 vaccine and he lost eyesight in one eye consequently. Interval between first and second dose exceeds 35 days (46 days) and he reported to have received a booster dose; however, he did not remember the date. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 64-year-old, male patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of blindness unilateral and AESI of Cerebrovascular accident. Cerebrovascular accident occurred approximately 1 month and 14 days after receiving the second dose of mRNA-1273 vaccine and he lost eyesight in one eye consequently. Interval between first and second dose exceeds 35 days (46 days) and he reported to have received a booster dose; however, he did not remember the date. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.