Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Presyncope, Syncope
Clinical narrative: short term memory; don't remember anything it; hit her head; syncope, it shuts down her organ; vasovagal response; blacked out; Fell to the floor; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) and SYNCOPE (syncope, it shuts down her organ) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced FALL (Fell to the floor). October 2021, the patient experienced PAIN IN EXTREMITY (leg pain). On 18-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (syncope, it shuts down her organ) (seriousness criterion medically significant), PRESYNCOPE (vasovagal response), AMNESIA (short term memory), MEMORY IMPAIRMENT (don't remember anything it) and HEAD INJURY (hit her head). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out), SYNCOPE (syncope, it shuts down her organ), PRESYNCOPE (vasovagal response), FALL (Fell to the floor), AMNESIA (short term memory), MEMORY IMPAIRMENT (don't remember anything it), HEAD INJURY (hit her head) and PAIN IN EXTREMITY (leg pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications included were, patient was taking Antibiotic, Blood thinners and Steroids.  Patient states that same events happened after the first dose and again after the second dose.  Company comment: This case concerns a 31-year-old female patient with no reported medical history who experienced the expected event of loss of consciousness and syncope.  The event occurred following an unspecified date after the third dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details pertaining to first and second doses were not disclosed. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Loss of consciousness and syncope are both medically important events.   This case was linked to MOD-2021-043122, MOD-2021-074920 (Patient Link).; Sender's Comments: This case concerns a 31-year-old female patient with no reported medical history who experienced the expected event of loss of consciousness and syncope.  The event occurred following an unspecified date after the third dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details pertaining to first and second doses were not disclosed. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Loss of consciousness and syncope are both medically important events.