Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Investigation, Palpitations, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Stroke/brain damage; heart palpitations; COVID-19 infection and symptoms began in Dec2021 but tested never positive; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke/brain damage) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 037A21B and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included COVID-19 in December 2021. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Emphysema. Concomitant products included VITAMINS NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced SUSPECTED COVID-19 (COVID-19 infection and symptoms began in Dec2021 but tested never positive). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke/brain damage) (seriousness criterion medically significant) and PALPITATIONS (heart palpitations). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke/brain damage) and PALPITATIONS (heart palpitations) had not resolved and SUSPECTED COVID-19 (COVID-19 infection and symptoms began in Dec2021 but tested never positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) Negative, stated she never was positive and kept testing negative, said her whole family was positive.. On an unknown date, Investigation: testing for lupus for anything autoimmune comes ba (Negative) testing for lupus for anything autoimmune comes back negative.. On an unknown date, SARS-CoV-2 antibody test: 450 (High) high at level of 450 from bloodwork..         Patient's history included amoxicillin allergy, pre-existing emphysema, past flu vaccination prior to booster dose with mRNA-1273. Concomitant medications included hormone replacement therapy, vitamins, and medications for stroke.  Patient tested negative for autoimmune diseases and negative for COVID-19 in Dec 2021.On an unknown date, patient experienced heart palpitations, stroke, and brain damage due to stroke. In Dec 2021, she was suspected to have COVID-19 but tested negative with COVID-19 test. Patient sought multiple consults for her adverse events. Details on the clinical course, complete lab data, and treatments were not reported.  No treatment information's were provided. Company Comment:This spontaneous case concerns a 65-year-old, female patient, with a concurrent condition of emphysema and a concomitant medication of hormone replacement therapy, who experienced an unexpected, medically significant AESI Cerebrovascular accident in association with mRNA-1273 vaccine. Exact onset latency of the event cerebrovascular accident cannot be established without event onset date. Interval between her 2-dose primary series of mRNA-1273 vaccine was 27 days apart, and the last dose from that series was given approximately 7 months before her 3rd dose of mRNA-1273 vaccine. Non-serious events of palpitations and suspected COVID-19 may have contributed to the development of the event stroke which could possibly cause brain damage. Patient reportedly sought multiple consults. All the events have not resolved. Details on the clinical course, complete laboratory data, and treatments were not reported for medical review. Age-related cardiovascular changes, her concurrent condition of emphysema, and concomitant medication of hormone replacement therapy could be considered predisposing risk factors to the event cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.   This case was linked to MOD-2022-558205 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient, with a concurrent condition of emphysema and a concomitant medication of hormone replacement therapy, who experienced an unexpected, medically significant AESI Cerebrovascular accident in association with mRNA-1273 vaccine. Exact onset latency of the event cerebrovascular accident cannot be established without event onset date. Interval between her 2-dose primary series of mRNA-1273 vaccine was 27 days apart, and the last dose from that series was given approximately 7 months before her 3rd dose of mRNA-1273 vaccine. Non-serious events of palpitations and suspected COVID-19 may have contributed to the development of the event stroke which could possibly cause brain damage. Patient reportedly sought multiple consults. All the events have not resolved. Details on the clinical course, complete laboratory data, and treatments were not reported for medical review. Age-related cardiovascular changes, her concurrent condition of emphysema, and concomitant medication of hormone replacement therapy could be considered predisposing risk factors to the event cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.