Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Syncope
Clinical narrative: literally collapsed; could not sleep at all/One bad night; terribly itchy, horrible; rash near forearms, near wrists, looked like poison ivy; slept 12 hours/She could not take her head off the pillow; she could not take her head off her pillow, literally collapsed; rash near forearms, near wrists; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (literally collapsed) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 030M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), ANASTROZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-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 SYNCOPE (literally collapsed) (seriousness criterion medically significant), INSOMNIA (could not sleep at all/One bad night), PRURITUS (terribly itchy, horrible), DERMATITIS CONTACT (rash near forearms, near wrists, looked like poison ivy), SOMNOLENCE (slept 12 hours/She could not take her head off the pillow), ASTHENIA (she could not take her head off her pillow, literally collapsed) and RASH (rash near forearms, near wrists). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SYNCOPE (literally collapsed) and ASTHENIA (she could not take her head off her pillow, literally collapsed) outcome was unknown, INSOMNIA (could not sleep at all/One bad night) and SOMNOLENCE (slept 12 hours/She could not take her head off the pillow) had resolved and PRURITUS (terribly itchy, horrible), DERMATITIS CONTACT (rash near forearms, near wrists, looked like poison ivy) and RASH (rash near forearms, near wrists) was resolving.            Patient went to skin doctor who didn't know what it was but put a lotion on the rash. Patient reported no adverse reaction in the first two doses. Consumer mentions she does not know whether this is related to the vaccine.  This case concerns a  83-year-old, female patient with no relevant medical history, who experienced the unexpected event of Faint/Syncope. The event occurred on an unspecified date, but within the same month after the third dose (booster dose) of mRNA1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after the third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  83-year-old, female patient with no relevant medical history, who experienced the unexpected event of Faint/Syncope. The event occurred on an unspecified date, but within the same month after the third dose (booster dose) of mRNA1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after the third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.