Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Breast enlargement, Hypersensitivity, Immunisation, Nausea
Clinical narrative: angioedema from the neck up; a severe allergic reaction; urticarial covering entire body; nausea; a persistent high fever; significant swelling under the arm that the shot was administered; doubling size of the right breast; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 13:00 (Lot number: FE3590) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0161, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 14Apr2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 23Mar2021, when the patient was 40 years old, for Covid-19 immunization. The patient had no relevant past drug history, reaction or allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination.  The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021 13:00, outcome "unknown", described as "Booster"; ANGIOEDEMA (medically significant) with onset 20Nov2021 19:00, outcome "not recovered", described as "angioedema from the neck up"; HYPERSENSITIVITY (medically significant) with onset 20Nov2021 19:00, outcome "not recovered", described as "a severe allergic reaction"; URTICARIA (medically significant) with onset 20Nov2021 19:00, outcome "not recovered", described as "urticarial covering entire body"; NAUSEA (medically significant) with onset 20Nov2021 19:00, outcome "not recovered", described as "nausea"; PYREXIA (medically significant) with onset 20Nov2021 19:00, outcome "not recovered", described as "a persistent high fever"; SWELLING (medically significant) with onset 20Nov2021 19:00, outcome "not recovered", described as "significant swelling under the arm that the shot was administered"; BREAST ENLARGEMENT (medically significant) with onset 20Nov2021 19:00, outcome "not recovered", described as "doubling size of the right breast". The events "booster", "angioedema from the neck up", "a severe allergic reaction", "urticarial covering entire body", "nausea", "a persistent high fever", "significant swelling under the arm that the shot was administered" and "doubling size of the right breast" were evaluated at the physician office visit. 30 hours after receiving the booster, patient experienced a severe allergic reaction. Sudden onset of angioedema from the neck up and urticarial covering entire body. Accompanied by nausea, a persistent high fever, and significant swelling under the arm that the shot was administered and doubling size of the right breast. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or Drug Store. The patient was treated with enormous amounts of antihistamines. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of angioedema, hypersensitivity, urticaria, nausea, pyrexia, swelling, breast enlargement.  Follow-up attempts are completed. No further information is expected.