Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Limited energy; Extremely tired; Almost passed out/Thought she was going to pass out; Lightheaded; Knocked her down; Could not do things/Unable to get in the kitchen to eat, brush teeth etc; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Almost passed out/Thought she was going to pass out) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 9B333ADA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (HBP) since 2019 and High cholesterol (Hi cholesterol) since 2020. Concomitant products included AMLODIPINE and ROSUVASTATIN for an unknown indication.   On 23-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced LOSS OF CONSCIOUSNESS (Almost passed out/Thought she was going to pass out) (seriousness criterion medically significant). February 2021, the patient experienced DIZZINESS (Lightheaded), FALL (Knocked her down) and IMPAIRED WORK ABILITY (Could not do things/Unable to get in the kitchen to eat, brush teeth etc). February 2021, the patient experienced FATIGUE (Extremely tired). On 25-Feb-2021, the patient experienced ASTHENIA (Limited energy). In February 2021, LOSS OF CONSCIOUSNESS (Almost passed out/Thought she was going to pass out), DIZZINESS (Lightheaded), FALL (Knocked her down) and IMPAIRED WORK ABILITY (Could not do things/Unable to get in the kitchen to eat, brush teeth etc) had resolved. At the time of the report, ASTHENIA (Limited energy) and FATIGUE (Extremely tired) outcome was unknown.            Treatment information was not provided.  Concomitant medication dose detail: amlodipine (2.5 unit not provided) and rosuvastatin (5.0 unit not provided).  The patient had two Moderna shots, and was wondering about getting third one. The patient had somewhat event effect in the second Moderna.  The first day after getting the second dose of the vaccine patient was fine but the second day was lightheaded and thought was going to pass out, it knocked the patient down, patient could not do things, but it was just that day.  The patient was extremely tired the day after the vax and in the early eve (evening) patient took a shower and almost passed out, was unable to get in the kitchen to eat, brush teeth etc. That was Friday 24-Feb-2021. On 25-Feb-2021, the patient was able to take care of self but limited energy.  Company Comment: This case concerns a 77 year old female with history of HTN and High cholesterol who experienced serious unexpected event of loss of consciousness 2 days after receiving the second dose of Moderna Covid 19 vaccine. Medical conmed of amlodipine and age are confounders. Rechallenge is not applicable as it now known if there were events after the first dose. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Included patient demographics, past relevant history, batch number for 1st dose, anatomical location, concomitant medications, new events and narrative updated.; Sender's Comments: This case concerns a 77 year old female with history of HTN and High cholesterol who experienced serious unexpected event of loss of consciousness 2 days after receiving the second dose of Moderna Covid 19 vaccine. Medical conmed of amlodipine and age are confounders. Rechallenge is not applicable as it now known if there were events after the first dose. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.