Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: ANAYPHYLAXIS REACTION; Shortness of breath; Chest hurt; Hypertension/blood pressure was has been on 151/91; Headache; Difficulty speaking; Foggy brain; Left hand numbness; Face numbness; Injection site lump; Injection site swollen, sore; Injection site swollen, sore; injection site red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (ANAYPHYLAXIS REACTION) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction to food. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Food allergy (Food allergy to dairy, beef and cantaloupes).    On 03-Mar-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 ANAPHYLACTIC REACTION (ANAYPHYLAXIS REACTION) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest hurt), HYPERTENSION (Hypertension/blood pressure was has been on 151/91), HEADACHE (Headache), DYSARTHRIA (Difficulty speaking), FEELING ABNORMAL (Foggy brain), HYPOAESTHESIA (Left hand numbness), HYPOAESTHESIA (Face numbness), VACCINATION SITE MASS (Injection site lump), VACCINATION SITE SWELLING (Injection site swollen, sore), VACCINATION SITE PAIN (Injection site swollen, sore) and VACCINATION SITE ERYTHEMA (injection site red). At the time of the report, ANAPHYLACTIC REACTION (ANAYPHYLAXIS REACTION), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest hurt), HYPERTENSION (Hypertension/blood pressure was has been on 151/91), HEADACHE (Headache), DYSARTHRIA (Difficulty speaking), FEELING ABNORMAL (Foggy brain), HYPOAESTHESIA (Left hand numbness), HYPOAESTHESIA (Face numbness), VACCINATION SITE MASS (Injection site lump), VACCINATION SITE SWELLING (Injection site swollen, sore), VACCINATION SITE PAIN (Injection site swollen, sore) and VACCINATION SITE ERYTHEMA (injection site red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 151/91 mmHg (abnormal) 151/91 mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. Treatment medicines includes epinephrine pen, and benadryl; Sender's Comments: This case concerns a 46-year-old female with serious expected event of anaphylactic reaction, along with nonserious unexpected dyspnea, chest pain, hypertension, dysarthria, hypoesthesia, vaccination site mass, and expected headache, vaccination site pain, vaccination site swelling, vaccination site erythema. Based on 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.