Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: suddenly, she woke up and was on the floor (patient said she fainted); woke up feeling clammy/Patient was dripping wet and cold.; Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.; sick to my stomach; Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.; Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.; Patient's arm was sore from the git go/arm still hurts from where the vaccine was put. It is not an everyday thing but still bothers; fatigued for 2 months; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (suddenly, she woke up and was on the floor (patient said she fainted)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Dry eyes. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (suddenly, she woke up and was on the floor (patient said she fainted)) (seriousness criterion medically significant), COLD SWEAT (woke up feeling clammy/Patient was dripping wet and cold.), NAUSEA (sick to my stomach), VACCINATION SITE PAIN (Patient's arm was sore from the git go/arm still hurts from where the vaccine was put. It is not an everyday thing but still bothers) and FATIGUE (fatigued for 2 months). an unknown date, the patient experienced VACCINATION SITE WARMTH (Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.), VACCINATION SITE ERYTHEMA (Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.) and VACCINATION SITE RASH (Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.). At the time of the report, SYNCOPE (suddenly, she woke up and was on the floor (patient said she fainted)), COLD SWEAT (woke up feeling clammy/Patient was dripping wet and cold.), VACCINATION SITE WARMTH (Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.), NAUSEA (sick to my stomach), VACCINATION SITE ERYTHEMA (Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.) and VACCINATION SITE RASH (Patient had a rash 9 days after getting the vaccine in the arm where she got the shot. It was hot and red.) outcome was unknown, VACCINATION SITE PAIN (Patient's arm was sore from the git go/arm still hurts from where the vaccine was put. It is not an everyday thing but still bothers) had not resolved and FATIGUE (fatigued for 2 months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Depression and Dry eyes. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, VALACYCLOVIR [VALACICLOVIR] for an unknown indication.  Company comment This case concerns a 64-year-old female patient with no relevant medical history, who experienced the serious expected event of Syncope. The event occurred on an unknown day after the first dose of the mRNA-1273. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 64-year-old female patient with no relevant medical history, who experienced the serious expected event of Syncope. The event occurred on an unknown day after the first dose of the mRNA-1273. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.