Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Sore arm; Confused; Headache; Reaction to the shot; Hives on the right side of face and neck; Dizzy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Sore arm), CONFUSIONAL STATE (Confused), URTICARIA (Hives on the right side of face and neck) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history Information was reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (Dizzy). On 20-Jan-2021, the patient experienced URTICARIA (Hives on the right side of face and neck). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), CONFUSIONAL STATE (Confused), HEADACHE (Headache) and VACCINATION SITE REACTION (Reaction to the shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 20-Jan-2021, DIZZINESS (Dizzy) had resolved. On 22-Jan-2021, URTICARIA (Hives on the right side of face and neck) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), CONFUSIONAL STATE (Confused), HEADACHE (Headache) and VACCINATION SITE REACTION (Reaction to the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Sore arm), CONFUSIONAL STATE (Confused), URTICARIA (Hives on the right side of face and neck) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history Information was reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (Dizzy). On 20-Jan-2021, the patient experienced URTICARIA (Hives on the right side of face and neck). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), CONFUSIONAL STATE (Confused), HEADACHE (Headache) and VACCINATION SITE REACTION (Reaction to the shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 20-Jan-2021, DIZZINESS (Dizzy) had resolved. On 22-Jan-2021, URTICARIA (Hives on the right side of face and neck) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), CONFUSIONAL STATE (Confused), HEADACHE (Headache) and VACCINATION SITE REACTION (Reaction to the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .