Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Tremor
Clinical narrative: The patient reports that 5 minutes after receiving the vaccine that she felt faint.; I was also shaking; experienced overall weakness; severe headache in the back of my head; Generalized inflammatory reaction; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (The patient reports that 5 minutes after receiving the vaccine that she felt faint.), TREMOR (I was also shaking), ASTHENIA (experienced overall weakness) and HEADACHE (severe headache in the back of my head) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Aortic aneurysm (mild) and Bicuspid aortic valve. Concomitant products included POTASSIUM CHLORIDE (K-DUR) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced DIZZINESS (The patient reports that 5 minutes after receiving the vaccine that she felt faint.) (seriousness criterion medically significant), TREMOR (I was also shaking) (seriousness criterion medically significant), ASTHENIA (experienced overall weakness) (seriousness criterion medically significant), HEADACHE (severe headache in the back of my head) (seriousness criterion medically significant) and INFLAMMATION (Generalized inflammatory reaction). On 05-Aug-2021, DIZZINESS (The patient reports that 5 minutes after receiving the vaccine that she felt faint.), TREMOR (I was also shaking), ASTHENIA (experienced overall weakness) and HEADACHE (severe headache in the back of my head) had resolved. At the time of the report, INFLAMMATION (Generalized inflammatory reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, Blood pressure measurement: 170/90 (High) Increased. On 02-Aug-2021, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient symptoms started after5 minutes of receiving the vaccine. Physician assistant who saw the patient felt that it s a generalized inflammatory reaction. Patient was discharged from the emergency room with no new medication & was advised to rest. Patent had routine Echocardiograms.  Treatment medications was not provided.  Company Comment: This case concerns a 61 year-old, female subject with a history of mild aortic aneurysm and bicuspid aortic valve, who experienced the  unexpected events of  Dizziness, tremor, asthenia and headache. The event occurred on the same day of the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The medical history of mild aortic aneurysm and bicuspid aortic valve remain as confounders. The benefit-risk relationship of drug Spikevax is not affected by this report.; Sender's Comments: This case concerns a 61 year-old, female subject with a history of mild aortic aneurysm and bicuspid aortic valve, who experienced the  unexpected events of  Dizziness, tremor, asthenia and headache. The event occurred on the same day of the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The medical history of mild aortic aneurysm and bicuspid aortic valve remain as confounders. The benefit-risk relationship of drug Spikevax is not affected by this report.