Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral amyloid angiopathy, Chills, Headache, Pyrexia
Clinical narrative: Cerebral amyloid angiopathy; High fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL AMYLOID ANGIOPATHY (Cerebral amyloid angiopathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient was not diagnosed or tested positive for Covid-19. The patient had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long standing health condition.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache). In July 2021, the patient experienced CEREBRAL AMYLOID ANGIOPATHY (Cerebral amyloid angiopathy) (seriousness criterion medically significant). On 07-Mar-2021, PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, CEREBRAL AMYLOID ANGIOPATHY (Cerebral amyloid angiopathy) outcome was unknown.            No concomitant medication was provided by reporter.  Patient stated in July of 2021 she was diagnosed with Cerebral Amyloid Angiopathy. Patient explained the condition of Cerebral Amyloid Angiopathy as it happened in brain where it causes to have stroke, the blood vessels in brain are weak, and cause blood to lay around in brain, and eventually causes stroke. Patient adds she was 2/3rds there and will eventually have a stroke.  Company Comment: This spontaneous case concerns a 75-year-old, female patient with no medical history reported, who experienced the unexpected, serious (Seriousness criterion Medically Significant) event of Cerebral amyloid angiopathy approximately 4 months after the second dose of mRNA-1273. Consumer has already reported AE after 1st Moderna covid-19 vaccination. After 2nd dose, she had high fever and same things that she had previously reported in case MOD21-033499. Consumer states after the booster dose she had temperature of 103, horrible headache, and chills. She states the AEs were worse after booster dose. She took some Tylenol to alleviate the symptoms and they stopped the morning of 3rd day. Consumer adds in July of 2021 she was diagnosed with Cerebral Amyloid Angiopathy. Consumer explains the condition as it happens in brain where it causes to have stroke, the blood vessels in brain are weak, and cause blood to lay around in brain, and eventually causes stroke. She adds she is 2/3rds there and will eventually have a stroke. No relevant lab data or details regarding clinical course and treatment received were reported. Outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-456380, MOD-2021-016657 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Significant follow-up received includes patient initials updated, new events chills and Headache, events start date and stop date, outcome updated to resolved (previously was unknown) and narrative updated.; Sender's Comments: This spontaneous case concerns a 75-year-old, female patient with no medical history reported, who experienced the unexpected, serious (Seriousness criterion Medically Significant) event of Cerebral amyloid angiopathy approximately 4 months after the second dose of mRNA-1273. Consumer has already reported AE after 1st Moderna covid-19 vaccination. After 2nd dose, she had high fever and same things that she had previously reported in case MOD21-033499. Consumer states after the booster dose she had temperature of 103, horrible headache, and chills. She states the AEs were worse after booster dose. She took some Tylenol to alleviate the symptoms and they stopped the morning of 3rd day. Consumer adds in July of 2021 she was diagnosed with Cerebral Amyloid Angiopathy. Consumer explains the condition as it happens in brain where it causes to have stroke, the blood vessels in brain are weak, and cause blood to lay around in brain, and eventually causes stroke. She adds she is 2/3rds there and will eventually have a stroke. No relevant lab data or details regarding clinical course and treatment received were reported. Outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.