Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Swelling face
Clinical narrative: After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; The symptoms progressed to redness swelling of the face, including swelling around the eyes; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; The symptoms progressed to redness swelling of the face, including swelling around the eyes; slight dehydration.; This is a spontaneous report from a contactable 86-year-old female non-pregnant patient (nurse) received first dose BNT162B2 (Solution for injection, lot number: EL3247, COVID 19, brand: Pfizer) on 19Jan2021 12:30 PM on Arm Left for COVID-19 Immunization. Patient medical history included Hypetension, mitral valve prolapse, cornea transplants both eyes, Allergies: sulfa. Concomitant medications included metoprolol, furosemide (LASIX), KCL, losartan, apixaban (ELIQUIS), cefalexin (KEFLEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks even after taking an antihistamine, Allegra after the 3rd day of onset of symptoms on 21Jan2021. The symptoms progressed to redness swelling of the face, including swelling around the eyes on 21Jan2021. No shortness of breath. Went to physician on 05Feb2021 who prescribed lab work and chest X-ray to rule out SVC syndrome; chest X-ray was normal. Lab work was normal. With exception of slight dehydration on 21Jan2021. He gave her a shot of steroids and a prednisone dosing pack as well as ointment for the arms and hands which were still red and itching on that day. Redness of face was much improved within 24 hours and most facial swelling resolved by 08Feb2021. The physician did advise her not to take the second COVID shot. He do have photographs of the reaction on her face, arms and hands. No Seriousness criteria reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship. Clinical presentation is suggestive of allergic reaction.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.