Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Cerebrovascular accident, Diplopia, Dizziness, Inappropriate schedule of product administration
Clinical narrative: Diagnosed with Bell´s Palsy; Stroke; Second dose scheduled 2 days past her 42 days; terrible dizziness; double vision; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and FACIAL PARALYSIS (Diagnosed with Bell´s Palsy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol, Hypertension and Thyroid disorder.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), DIZZINESS (terrible dizziness) and DIPLOPIA (double vision). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Diagnosed with Bell´s Palsy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 2 days past her 42 days). The patient was hospitalized from 28-Mar-2021 to 31-Mar-2021 due to CEREBROVASCULAR ACCIDENT, and then from 10-Apr-2021 to 13-Apr-2021 due to FACIAL PARALYSIS. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), FACIAL PARALYSIS (Diagnosed with Bell´s Palsy), DIZZINESS (terrible dizziness) and DIPLOPIA (double vision) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 2 days past her 42 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a stroke that affected her right side and affected her vision. She stated she had a very mild case of bells palsy, her mouth and her left side was drooping a bit, her left eye did not blink and would not close, she could chew and she could talk pretty good, she had to drink with the right side with a straw.  Products known to have been used by the patient, within two weeks prior to the event, included unspecified cholesterol medication, high blood pressure medication and unspecified thyroid medication. Treatment medications included: prednisone, 5 or 6 medications for the heart and valacyclovir HCL 1g tablet.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (stroke, facial paralysis, dizziness, and diplopia), a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (stroke, facial paralysis, dizziness, and diplopia), a causal relationship cannot be excluded.