Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Paraesthesia oral, Pruritus, Rash, Urticaria
Clinical narrative: angioedema; hives; in lips tingling at times; itching; rash; This is a spontaneous report from a non-contactable other hcp. A 33-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) dose 1 via an unspecified route of administration on Dec2020 (at the age of 32-year-old) as single, and dose 2 via an unspecified route of administration on Jan2021 as single for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported.  On 2021, Reporter's daughter had the first Pfizer vaccine in DEC 2020. The second in JAN 2021, 10 days after she broke out in hives and had some angioedema, in lips tingling at times, no throat closures.  Eye angioedema was the first sign, around the eyes, that went away and was off and on. On day 10 she woke up with this and has had it ever since. angioedema of the lips on and off.  Since Jan 21 she's been headed to toe with hives they never go away, some days her legs are just covered. On 2021, the reporter sated that, 5 days after 2nd vaccine angioedema around both eyes and that was gone now, she's been to dermatologist, immunologist and primary care physician and they've tried, prednisone, IV Benadryl, Zyrtec, Allegra, also done oatmeal baths for itching, dermatologist wanted to put her on cyclosporine, she didn't want to go on it because it's a strong antibiotic. They also gave her pepcid.  Reporter asked to have anyone else had anything like this and why it is lasting so long. Reporter stated that everyone was saying, it's an immune response, and give it time and see if it goes away.  her daughter woke up in a huge snowstorm the first time she had the angioedema with Mouth, she went to the Emergency Room, they gave her IV Benadryl, kept her there for a little while, sent her home on prednisone pack, not tapered, just 5 days of high dose prednisone. When the prednisone was finished, it came back with a vengeance. Then she went to her Primary Care Physician to see if she had any suggestions. They wanted her to go back on the Prednisone but on a tapered dose, but, she didn't' want to take it because she was afraid it would come back worse than ever.  It never got better, not even on the high dose prednisone. Other than put her on the prednisone, there wasn't really anything more. 4 Months later it hasn't settled down.  Reporter asked her daughter to come to where she lives and see Dermatologist, and he ordered a bunch of labs and got it back and it all looked fine. He wanted to start her on cyclosporine, she wanted to wait, didn't want to take it. Reporter stated, "It wipes the immune system out. They give it to transplant patients. they all say It's an immune response, it should settle down. Her daughter has been trying to change her diet, eating things low in histamines, cut out tomatoes, cut out cheeses, everything high in histamines, it doesn't make a difference.  Reporter stated, One day they are not quite so bad and then she wake's up and she was covered. Her daughter can't walk, or swim cause hot and cold makes her break out, or makes it worse, because it never goes away. The following adverse reactions have been identified during post authorization use of Pfizer BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema). The outcome of the events was reported as unknown.    No follow up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.