Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fall, Feeling abnormal, Loss of consciousness
Clinical narrative: passed out; woke up the next day, caller said she did not remember anything of what happened; hallo feeling in the top of my head/funny feeling; Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed; like a short neckless, red round in the top right of my head, that symptom lasted the whole; Chills; sore left arm for 2 or 3 days; This case was received via an unknown source on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included TIZANIDINE, SERTRALINE, FUROSEMIDE, ATENOLOL, CLONIDINE, GABAPENTIN, COLESTIPOL and VALSARTAN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MEMORY IMPAIRMENT (woke up the next day, caller said she did not remember anything of what happened), FEELING ABNORMAL (hallo feeling in the top of my head/funny feeling), FALL (Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed), ERYTHEMA (like a short neckless, red round in the top right of my head, that symptom lasted the whole), CHILLS (Chills) and VACCINATION SITE PAIN (sore left arm for 2 or 3 days). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MEMORY IMPAIRMENT (woke up the next day, caller said she did not remember anything of what happened), FALL (Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed), ERYTHEMA (like a short neckless, red round in the top right of my head, that symptom lasted the whole), CHILLS (Chills) and VACCINATION SITE PAIN (sore left arm for 2 or 3 days) outcome was unknown and FEELING ABNORMAL (hallo feeling in the top of my head/funny feeling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. 2nd dose scheduled  on 05Apr2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age along with concomitant medications may have been contributory for the occurrence of the events.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age along with concomitant medications may have been contributory for the occurrence of the events.