Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Syncope, X-ray
Clinical narrative: Family found me on the floor/fainted; Low blood pressure 60-70 over 40"; Fever; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Family found me on the floor/fainted), HYPOTENSION (Low blood pressure 60-70 over 40"), PYREXIA (Fever), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Low blood pressure, Mitral valve prolapse (it is mild and she is "not treated") and Asthma.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SYNCOPE (Family found me on the floor/fainted), HYPOTENSION (Low blood pressure 60-70 over 40"), PYREXIA (Fever), MYALGIA (Muscle pain) and NAUSEA (Nausea). At the time of the report, SYNCOPE (Family found me on the floor/fainted), HYPOTENSION (Low blood pressure 60-70 over 40"), PYREXIA (Fever), MYALGIA (Muscle pain) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood glucose: 89 (abnormal) 89. In April 2021, Blood pressure measurement: 60-70 over 40 (Low) 60-70 over 40. In April 2021, Blood test: normal (normal) Normal. In April 2021, Electrocardiogram: normal (normal) Normal. In April 2021, X-ray: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment drug was provided by reporter. The patient states she suffers from low blood pressure, but it was even lower perhaps "60-70 over 40".  The patient fainted and her family "found her on the floor".  She was taken to the hospital and they admitted her.  She remained in the hospital for about three hours.  They performed very thorough testing including an EKG, Xrays and bloodwork.  She states they "couldn't find anything."     Patient said about 10-11 hours after receiving the second dose of the Moderna vaccine she had low blood pressure and the only abnormality was her blood sugar was 89.  Company comment: This case concerns a 54-year-old, female patient with medical history of Low blood pressure, Mitral valve prolapse (it is mild and she is "not treated") and Asthma, who experienced the unexpected non serious events of syncope and hypotension and expected events of nausea, myalgia, and pyrexia. The events occurred approximately 28 days after the first dose of mRNA-1273. The patient was taken to the hospital after experiencing lowblood pressure and syncope and was found on floor by family members. The patient remained in hospital for about three hours with very thorough testing preformed including an EKG, X rays and bloodwork and no significant findings. The rechallenge was unknown since no information about the second dose was disclosed. The patient's medical history of low blood pressure remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 54-year-old, female patient with medical history of Low blood pressure, Mitral valve prolapse (it is mild and she is "not treated") and Asthma, who experienced the unexpected non serious events of syncope and hypotension and expected events of nausea, myalgia, and pyrexia. The events occurred approximately 28 days after the first dose of mRNA-1273. The patient was taken to the hospital after experiencing lowblood pressure and syncope and was found on floor by family members. The patient remained in hospital for about three hours with very thorough testing preformed including an EKG, X rays and bloodwork and no significant findings. The rechallenge was unknown since no information about the second dose was disclosed. The patient's medical history of low blood pressure remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.