Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Burning sensation, Hot flush, Urticaria
Clinical narrative: I had extreme hives I had angioedema hives; I had extreme hives I had angioedema hives; My arm is also burned by the vaccine; I have flash burn on my arm as well; flash burn on my arm as well; This is a spontaneous report from a contactable nurse (Licensed practical Nurse, patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer product), dose 2 via an unspecified route of administration, administered in Deltoid Left on 21Jul2021 (expiration Date: 30Sep2021) (at vaccination age of 43-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension. Prior vaccination within 4 weeks was no. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization, at vaccination age of 43-year-old. Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), losartan for hypertension. The patient experienced 'I had extreme hives i had angioedema hives', 'my arm is also burned by the vaccine', 'I have flash burn on my arm as well'; all in Jul2021. As reported that nurse stated, "I had an adverse reactions to the Pfizer, the Pfizer Vaccine (Covid-19 Vaccine). I went in for emergency care on the 06Aug2021. I had some serious shot of season steroid medication and I was on Benadryl (voice distorted). Two days when resolved my doctor told me to file a report that I had an adverse reactions." Nurse was informed about the role of Pfizer Drug Safety. Nurse confirmed that she had received both the dose and had experienced adverse events after the second dose. About the expiration date, the nurse stated, "Don't have this, I think it was 30Sep2021. I do remember that." Nurse stated, "Yes, because also my arm is also burned by the vaccine as well. I have flash burn on my arm as well. So yes, I totally believe that it was caused by the vaccine or everything that happened." Nurse stated, "Yes, the burn I did nothing I didn't treat it. It's still there. I have steroid given to me injected steroid into my right hip and I have all steroids as well and I was administered on the 06Aug2021." When probed if Nurse was still experiencing the adverse event, nurse stated, "No it's gone, its faded away. I had extreme hives I had angioedema hives." Her doctor told her that she was no longer able to take any vaccines for any booster or anything; if they kill her when she took it.Therapeutic measures were taken as a result of 'I had extreme hives I had angioedema hives'. The outcome of all the events was recovered in 2021.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Angioedema, Hives, Burning sensation and Flash hot. 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.