Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Loss of consciousness, Magnetic resonance imaging, Product quality issue
Clinical narrative: Blacked out 3 times; bang my head on concrete 3 times; my father has Alzheimer and I'm worried this may cause me Alzheimer later; Dizziness; I received a defective vaccine; Patient received 2nd dose 46 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out 3 times) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E021B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Head injury (40 years ago). Family history included Alzheimer's disease (Patient's father has Alzheimer) since an unknown date. Concurrent medical conditions included Atherosclerosis and Blood pressure high. Concomitant products included CLONAZEPAM for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced PRODUCT QUALITY ISSUE (I received a defective vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 46 days after 1st dose). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out 3 times) (seriousness criterion medically significant), FALL (bang my head on concrete 3 times), ANXIETY (my father has Alzheimer and I'm worried this may cause me Alzheimer later) and DIZZINESS (Dizziness). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out 3 times), FALL (bang my head on concrete 3 times), ANXIETY (my father has Alzheimer and I'm worried this may cause me Alzheimer later) and DIZZINESS (Dizziness) had not resolved and PRODUCT QUALITY ISSUE (I received a defective vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 46 days after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: results not reported Results not reported. On an unknown date, Electroencephalogram: results not reported Results not reported. On an unknown date, Magnetic resonance imaging: results not reported Results not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not had COVID diagnosis and test previously. Patient did not receive any vaccine one month prior to Moderna vaccine. Additional concomitant product included was non-specified blood pressure medicine. Patient was experiencing side effects ever since second dose of the Moderna COVID-19 vaccine. Patient stated that she received a defective vaccine batch. Three weeks ago she fell backwards and hit her head very hard on concrete. Patient was not sure of the lot number for the first dose because of the handwriting on the card. She had been to the doctor many times and had spent thousands of dollars, and that night she was getting a brain scan.  Patient did not experience similar events before.  Treatment medication was not provided by the reporter.  COMPANY COMMENT : This is a spontaneous case concerning a 67-year-old, female patient with relevant history of Atherosclerosis, Blood pressure high, family history of Alzheimer's reported, who experienced the unexpected, serious (medically significant) event of Loss of consciousness. The event occurred an unknown duration after the second dose of mRNA-1273 vaccine for the indication of COVID-19 vaccination. Inappropriate schedule of product administration (duration between the first 2 doses is 46 days, which is more than the recommended duration) was also noted. History of Atherosclerosis, Blood pressure high and Family history of Alzheimer's are confounding. At the time of report, outcome of the event was Not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up information included no new information. On 09-Feb-2022: Follow-up information received included details updated.; Sender's Comments: This is a spontaneous case concerning a 67-year-old, female patient with relevant history of Atherosclerosis, Blood pressure high, family history of Alzheimer's reported, who experienced the unexpected, serious (medically significant) event of Loss of consciousness. The event occurred an unknown duration after the second dose of mRNA-1273 vaccine for the indication of COVID-19 vaccination. Inappropriate schedule of product administration (duration between the first 2 doses is 46 days, which is more than the recommended duration) was also noted. History of Atherosclerosis, Blood pressure high and Family history of Alzheimer's are confounding. At the time of report, outcome of the event was Not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.