Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia oral, Skin swelling
Clinical narrative: Stated that she did have GI symptoms when she got home; She also had indigestion while she was sitting in the waiting area after getting her shot, so she took a Pepcid for relief; Stated that she had some heart racing, but it was probably more of a fight or flight reaction, because it slowed down once she realized that it was only her lips that were swelling; angioedema; lips were tingling and started to swell; a little puffiness left on her lips; lips were tingling and started to swell; This is a spontaneous report from a contactable nurse (patient) via Pfizer sponsored program. A 52-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular, administered in Deltoid Right on 13Sep2021 08:40 AM (at the age of 52-years-old) (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease and ongoing Blood pressure high, history of anaphylaxis and irritable bowel syndrome (IBS), both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for Hashimoto's disease from an unspecified start date and ongoing; lisinopril taken for Blood pressure high from an unspecified start date and ongoing; epinephrine (EPIPEN) taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro [ciprofloxacin] for allergic and experienced Anaphylaxis like reaction and celebrex for allergic and experienced angioedema. The patient experienced angioedema (medically significant), lips were tingling and started to swell (medically significant), a little puffiness left on her lips (medically significant), lips were tingling and started to swell (non-serious), all events on 13Sep2021 within about 5-10 minutes after vaccination. She had a history of anaphylaxis, so they told her that she would have to wait there for 30 minutes to make sure she didn't have a reaction and she brought her EpiPen with her. Then the top right of her lips started to tingle and swell. She thought it was the mask that may have been bothering her, so she took the mask down. After 30 minutes, from the midline of her lips to the right, upper and lower, was swollen. She went back to the Pharmacist who gave her the injection for evaluation and he was going to give her a Benadryl tablet, but she asked for liquid Benadryl because she thinks the liquid works better. She took Benadryl 25mg and the swelling started to go down on the right lower side. She continued to wait there at the hospital pharmacy, but the right upper side of her lips stayed swollen and it started to spread to the upper middle, but it didn't quite go all the way over. About 20 minutes after she took the Benadryl, it started to tingle on the top and bottom left of her lips, so she talked to the Pharmacist again and asked for IM Solumedrol 125mg, which was given in her left deltoid since she got her Covid shot in her right deltoid. Stated that the swelling wasn't spreading to her tongue, and she had her EpiPen with her, but didn't need it. They let her go home, and she got home at around 10:30am she took another 25mg of liquid Benadryl. She also took another 25mg of Benadryl that afternoon. Stated that the swelling had started to go down and she just a little puffiness left on her lips, but then at 10:30pm that night her lips started to swell again, so she took 50mg of liquid Benadryl and went to bed. When she woke up this morning, there was just a little swelling on the top, but at 11:00am the swelling started to come back, and it's still there. The swelling is now on her upper and lower lips, on the front and the left side. The only part that is not swollen is the bottom right, which is where the swelling originally started. Stated that she can't take Benadryl right now because she has to work, but she will take some later. It was reported that, lips were tingling and started to swell, which started on one side and then moved around but only stayed on the lips. She has taken Benadryl several times and was given 125mg of Solu-Medrol IM injection. Caller stated she did not have anaphylaxis, just angioedema. She still has swelling on her lips. As per agent, caller has had anaphylactic reactions in the past to other medications. It was reported that caller was having an allergic reaction to the Covid 19 Vaccine, and she wants to know the ingredients in the vaccine, so she knows what she was allergic to and would like to know what were the binders in the vaccine. Stated that the swelling on her lips has gone up and down with medication. The hospital didn't want to give her a Medrol pack, so they only gave her a shot of Solumedrol, but she doesn't know if that was enough, or if it just ramped things up more. None of additional vaccines were administered on same date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks. Patient did not receive any recent vaccines for any other conditions prior to the event being reported and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination, stated that it had been about 1.5-2 years since she was exposed to whooping cough and got that vaccine. When asked for seriousness, caller stated that she had Angioedema. It didn't required her to go to the ER (emergency room), but it did require extra medical attention. Stated that she did not know if she will be able to get the 2nd dose. Stated that she had some heart racing, but it was probably more of a fight or flight reaction, because it slowed down once she realized that it was only her lips that were swelling. She has had anaphylaxis in the past so once she felt the swelling she was getting worried, but then she realized it was only her lips. Angioedema- Swelling and tingling of her lips after receiving the vaccine. Stated that she did have GI symptoms when she got home, but she has IBS so she doesn't think that it was related to the vaccine. She also had indigestion while she was sitting in the waiting area after getting her shot, so she took a Pepcid for relief. The patient underwent lab tests and procedures which included blood pressure was high on an unspecified date. Therapeutic measures were taken as a result of events. Outcome of all events were not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events Angioedema, Lip swelling, Skin swelling and suspect drug BNT162B2 cannot be excluded.   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.