Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Stomatitis, Vaccination site pain
Clinical narrative: Passed out; Sore Throat; Sores in the inside of the mouth; Sores in the inside of the gum; Could not eat or drink; Rash started to appear in her lower left abdomen, back, upper legs and upper arms.; The site of the injection was painful; Shivers/Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse drug reaction.    On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), STOMATITIS (Sores in the inside of the mouth), GINGIVAL PAIN (Sores in the inside of the gum), FEEDING DISORDER (Could not eat or drink), RASH (Rash started to appear in her lower left abdomen, back, upper legs and upper arms.), VACCINATION SITE PAIN (The site of the injection was painful), CHILLS (Shivers/Chills) and PYREXIA (Fever). On 01-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). The patient was treated with DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), OROPHARYNGEAL PAIN (Sore Throat), STOMATITIS (Sores in the inside of the mouth), GINGIVAL PAIN (Sores in the inside of the gum), FEEDING DISORDER (Could not eat or drink), RASH (Rash started to appear in her lower left abdomen, back, upper legs and upper arms.), VACCINATION SITE PAIN (The site of the injection was painful), CHILLS (Shivers/Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient was also prescribed Benadryl for when the effect of the previous long lasting steroid effect wore off . The 28-Sep-2021, at 5PM she started to have fever, shivers, chills, sore throat, sores in the inside of the mouth and swelling of the throat. Also the site of the injection was painful and a rash started to appear in her lower left abdomen, back, upper legs and upper arms. On 01-Oct-2021 she passed out in the floor and was taken to the emergency room where she was diagnosed whit dehydration  (the sore throat prevented her from eating and drinking).  Company comment: This case concerns a 34-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred 3 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 34-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred 3 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.