Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Loss of consciousness, Pain in extremity, Vomiting
Clinical narrative: fainted; sore arm.; dizzy; vomited; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (fainted) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no concomitant disease or risk factor.  The patient's past medical history included COVID-19 (Patient was diagnosed with COVID-19) on 19-Jul-2022.    On 11-Nov-2022 at 7:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Nov-2022, the patient experienced LOSS OF CONSCIOUSNESS (fainted) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arm.), DIZZINESS (dizzy) and VOMITING (vomited). On 12-Nov-2022, LOSS OF CONSCIOUSNESS (fainted), PAIN IN EXTREMITY (sore arm.), DIZZINESS (dizzy) and VOMITING (vomited) had resolved.            No concomitant medications were reported.  On 12-Nov-2022, at 4 am patient woke up with a sore arm. Patient got out of bed to get some Advil and felt dizzy. Patient laid down on the floor to try to let the dizziness pass. Patient sat up briefly and fainted. Patient's husband laid her down on the floor again, and she came to after about 45 seconds to a minute. After regaining consciousness, she vomited. She did not experience any additional symptoms/events. There were no lab data/results available. Moderna was not authorized to communicate with the patient's / healthcare provider.  Company comment: This is a spontaneous case concerning a 46-year-old, female patient with no relevant medical history. The patient has no reported vaccination history. The patient experienced the unexpected serious (medically significant) event of loss of consciousness (fainted) along with non-serious events of pain in extremity (sore arm), dizziness, and vomiting. The events occurred approximately 9 hours after the booster dose of mRNA-1273.222 vaccine administration. Allegedly the events were described as, approximately 9 hours after the booster dose the patient woke up with a sore arm. The patient got out of bed to get some Advil and felt dizzy. The patient laid down on the floor to try to let the dizziness pass. The patient sat up briefly and fainted for approximately 45 seconds to a minute. After regaining consciousness, the patient vomited. The outcome of the events was reported as resolved within the same day. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 46-year-old, female patient with no relevant medical history. The patient has no reported vaccination history. The patient experienced the unexpected serious (medically significant) event of loss of consciousness (fainted) along with non-serious events of pain in extremity (sore arm), dizziness, and vomiting. The events occurred approximately 9 hours after the booster dose of mRNA-1273.222 vaccine administration. Allegedly the events were described as, approximately 9 hours after the booster dose the patient woke up with a sore arm. The patient got out of bed to get some Advil and felt dizzy. The patient laid down on the floor to try to let the dizziness pass. The patient sat up briefly and fainted for approximately 45 seconds to a minute. After regaining consciousness, the patient vomited. The outcome of the events was reported as resolved within the same day. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.