Reporte zur Charge IN8730

Symptomtext

Hives on injection arm just below the injection site; Affected area which roughly covers a 4 x 2 inch surface area red and hard and hot to the touch; Affected area which roughly covers a 4 x 2 inch surface area red and hard and hot to the touch; Affected area which roughly covers a 4 x 2 inch surface area red and hard and hot to the touch; The area is both itchy and tender.; The area is both itchy and tender.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: IN8730) via an unspecified route of administration in the left arm on 23Mar2021 at 15:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and chronic low vitamin d levels. The patient had no known allergies to medications, food or other products. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12) and multivitamin; all for an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 19:00, the patient experienced hives on injection arm just below the injection site. Affected area which roughly covers a 4 x 2-inch surface area was red, hard and hot to the touch. The area was both itchy and tender. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event hives on injection arm just below the injection site, affected area which roughly covers a 4 x 2-inch surface area red and hard and hot to the touch, itchy and tender were not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 15:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.