Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Speech disorder, Thrombosis
Clinical narrative: Cannot eat; Multiple blood clot; Brain swelling and fluid in brain; Stroke; Coma for a month; Lost eyesight; Anxiety; Can somewhat speak; Can not walk/ Can not go to the bathroom; Has memory of a 5-year-old; Not like how she used to be; on feeding tube; Never got 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), THROMBOSIS (Multiple blood clot), BRAIN OEDEMA (Brain swelling and fluid in brain), COMA (Coma for a month), DECREASED APPETITE (Cannot eat) and BLINDNESS (Lost eyesight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced THROMBOSIS (Multiple blood clot) (seriousness criteria hospitalization prolonged and medically significant), BRAIN OEDEMA (Brain swelling and fluid in brain) (seriousness criteria hospitalization prolonged and medically significant), COMA (Coma for a month) (seriousness criteria hospitalization prolonged and medically significant), DECREASED APPETITE (Cannot eat) (seriousness criterion hospitalization), BLINDNESS (Lost eyesight) (seriousness criterion medically significant), ANXIETY (Anxiety), SPEECH DISORDER (Can somewhat speak), GAIT INABILITY (Can not walk/ Can not go to the bathroom), MEMORY IMPAIRMENT (Has memory of a 5-year-old), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not like how she used to be), FEEDING TUBE USER (on feeding tube) and PRODUCT DOSE OMISSION ISSUE (Never got 2nd dose). The patient was hospitalized on 06-Mar-2021 due to BRAIN OEDEMA, CEREBROVASCULAR ACCIDENT, COMA, DECREASED APPETITE and THROMBOSIS. The patient was treated with Surgery (Surgery to remove fluid in brain) for Brain oedema. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), THROMBOSIS (Multiple blood clot), BRAIN OEDEMA (Brain swelling and fluid in brain), DECREASED APPETITE (Cannot eat), BLINDNESS (Lost eyesight), ANXIETY (Anxiety), SPEECH DISORDER (Can somewhat speak), GAIT INABILITY (Can not walk/ Can not go to the bathroom), MEMORY IMPAIRMENT (Has memory of a 5-year-old), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not like how she used to be) and FEEDING TUBE USER (on feeding tube) outcome was unknown and COMA (Coma for a month) and PRODUCT DOSE OMISSION ISSUE (Never got 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Non drug treatment included physical or rehabilitation therapy. No concomitant medications were provided.  On 06-Mar-2021, patient had serious adverse event and was transported to hospital. The patient had a stroke. Upon being admitted to hospital, physicians found multiple blood clots, brain swelling, and had to perform surgery to remove fluid in brain.  Patient was put on many IVs in the hospital and had been prescribed medication for anxiety. Patient was on feeding tube.  Patient was hospitalized for a month. Patient had no problems prior to taking the vaccine and events all occurred after taking the vaccine. Patient does not have a doctor at this time.  Company's comment: This spontaneous case concerns a 67-year-old female patient with no relevant medical history who experienced serious unexpected events of cerebrovascular accident, thrombosis, brain oedema, coma. The events occurred approximately 4 days after the first dose of the Moderna COVID-19 vaccine . Reportedly, the patient was hospitalized due to cerebrovascular accident. Upon hospitalization, HCPs found multiple blood clots, brain swelling for which they performed surgery to remove fluid in brain. as well  multiple blood clots. She was also in coma for a month, lost eyesight, could somewhat speak, had memory of a 5-year-old, can't walk, can't eat, can't go to the bathroom. Patient's daughter states she was put on many IVs in the hospital. She has been prescribed medication for anxiety. She was on feeding tube. The patient had been going through multiple physical/rehabilitation therapy. It was reported that the patient did not have any problems prior to taking the vaccine. Rechallenge was not applicable since the patient did not receive the second dose so no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of product is not affected by this report; Sender's Comments: This spontaneous case concerns a 67-year-old female patient with no relevant medical history who experienced serious unexpected events of cerebrovascular accident, thrombosis, brain oedema, coma. The events occurred approximately 4 days after the first dose of the Moderna COVID-19 vaccine . Reportedly, the patient was hospitalized due to cerebrovascular accident. Upon hospitalization, HCPs found multiple blood clots, brain swelling for which they performed surgery to remove fluid in brain. as well  multiple blood clots. She was also in coma for a month, lost eyesight, could somewhat speak, had memory of a 5-year-old, can't walk, can't eat, can't go to the bathroom. Patient's daughter states she was put on many IVs in the hospital. She has been prescribed medication for anxiety. She was on feeding tube. The patient had been going through multiple physical/rehabilitation therapy. It was reported that the patient did not have any problems prior to taking the vaccine. Rechallenge was not applicable since the patient did not receive the second dose so no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of product is not affected by this report