Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Restlessness, Vomiting
Clinical narrative: Passed out; Dizziness; Dripping in sweat; Restleesness; Can't sleep; Vomiting on and off; Really Bad Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced DIZZINESS (Dizziness), HYPERHIDROSIS (Dripping in sweat), RESTLESSNESS (Restleesness), INSOMNIA (Can't sleep), VOMITING (Vomiting on and off), HEADACHE (Really Bad Headache) and NAUSEA (Nausea). On 23-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at a dose of 4 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep problem, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) had resolved and DIZZINESS (Dizziness), HYPERHIDROSIS (Dripping in sweat), RESTLESSNESS (Restleesness), INSOMNIA (Can't sleep), VOMITING (Vomiting on and off), HEADACHE (Really Bad Headache) and NAUSEA (Nausea) had not resolved.  The patient had no other medical history and does not take any medications  Consumer is reporting possible adverse events after receiving the 2nd dose of the vaccine. Consumer got both doses at same pharmacy. Consumer got the 1st dose of the vaccine on 23July2021, lot # 054C21A. Consumer got the 2nd dose of the vaccine on 20Aug2021, lot # 939901. Agent verified the brand and lot number for second dose twice. Consumer states she is experiencing multiple reactions after the 2nd dose. Consumer states the reactions started the day she got the 2nd dose and are still ongoing. Consumer reports having really bad headaches. dizziness, vomiting (on and off), dripping in sweat, passed out (only once on 23Aug2021), restlessness, and can't sleep. Consumer has been taking Tylenol and ibuprofen to alleviate headaches. Consumer has been taking Zofran 4 mg tablet to help with nausea. Consumer has been taking Benadryl to help her sleep. Consumer has no other medical history and does not take any medications  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Company Comment  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.; 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.