Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lip pruritus, Lip swelling, Pain in extremity
Clinical narrative: itching and swelling of her lips; itching and swelling of her lips; soreness and arm pain; felt the tightness in her lips; itching on her face and cheeks; itching on the lips; rosy cheeks; entire face swollen; Swelling of lips; sore arm; headache; This is a Follow up spontaneous report from a Pfizer sponsored program Support. A contactable nurse (patient) reported that: A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 24Aug2021 at 11:30 (At the age of 61-year-old, Batch/Lot Number: FC3181; Expiration Date: 31Oct2021) as dose 1, single for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, atopic dermatitis from an unknown date and unknown if ongoing, seborrhoeic dermatitis from an unknown date and unknown if ongoing (was not active. It was dormant, she has not had any problems or reactions), food allergy from an unknown date and unknown if ongoing, medication allergies from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing, angioedema from an unknown date and unknown if ongoing, rag weeds allergy from an unknown date and unknown if ongoing (seasonal stuff), allergy to nuts, eggs, peanuts, pecans, fresh strawberries, shellfish from an unknown date and unknown if ongoing (with these she experiences rashes and itching). The patient was allergic to penicillin products. Concomitant medications included clindamycin taken for an unspecified indication from an unspecified start date to 21Aug2021. The patient previously took lidocaine and experienced drug allergy (It causes heart palpitations, and she cannot breathe. She cannot take that stuff now. She found out when she went to the dentist. They gave her some Lidocaine to get numb. She felt like an elephant was sitting on her chest and she could not breathe. They had to give her Narcan to reverse it. She could not figure out why it felt like something was sitting on her chest and could not breathe. It was one of the newer ones.), codeine, demerol, verapamil, lisinopril, lortab, ultram and experienced rash, hives, and itching. The patient was taken epipen for previous history allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that first dose on 24Aug2021, it was before 11:00. Her appointment was at 10:00, they gave it to her about 11:30, she had to stay for 30 minutes. The most significant side effect was the soreness and arm pain and headache, but last night, she noticed a sensation and looked at herself in the mirror and discovered swelling and she felt itching around her lips. When she looked in the mirror, it was slight swelling to her upper and lower lip as well. She thought it was nothing and went to sleep, but she felt the tightness in her lips. This morning, her lips are more swollen, and she has itching on her face and cheeks. She took some Loratadine and still has it but, not as bad, it was improving. The only thing she had introduced new to herself was the vaccine. She knows there are delayed reactions like rash after receiving the Pfizer COVID-19 vaccine. She does not have any shortness of breath or anything like that. She has a lot of allergies and there may be something in the vaccine that could have caused her to experience this sensitivity to it. She thinks she was good, and it is all calming down, but the itching in her lip remains. She knows to go to the emergency department if her symptoms worsen or to see her health care professional if things do not improve. The caller was a health care professional reporting that upon getting the first dose of the Pfizer Covid-19 vaccine on 24Aug2021, last Tuesday, she experienced a sore arm. Last night, she experienced itching on her lips, and they got swollen. She took Loratadine and she noticed her face got itchy. Clarified with the caller that she took the Loratadine because of the itchiness and the swelling, that was why she took the Loratadine. It has now been 30 minutes. The reason she took the Loratadine was that she started to feel itching in the cheeks, closer to her nose. That was why she went ahead and took the Loratadine, to calm it down. She did not have any Benadryl in the house. She usually keeps liquid Benadryl but apparently there was none. It was reported that about an hour after the injection on 24Aug2021. It was still sore now, well, it was not sore, but she has pain in that left arm. It was better. She would expect soreness with any other type of vaccine. She feels it a little more now than she did last night. There was swelling too. When she looked this morning, she took a selfie of her lips before she went to bed. When she looked this morning and compared it, it was a little more swollen, just in the upper lips. The upper lip was more, and she could tell it was in the lower lips but not as bad as the upper lip. She can tell more and can also feel underneath and inside the lips. She can tell that it was swollen. She would not say that it was severe but enough that it was significant, no. Put it this way, it was somewhat significant. The sensation was there and in her facial area, like her cheeks and around the nose area and the lips. Noticing it before she took the Loratadine, it was kind of all over her face. It was significant at one point. She took the Loratadine and it kind of calmed down. Now, it was just in the area of the nose, and mouth and under the eyes. It was itching and swelling, and she did not have any shortness of breath. Just the Loratadine. She applied warm compress to the arm. She did take Tylenol as they told her to take after the injection. Caller states she does not have her glasses on. It was hard to see when you get older, and they do not want to give them contacts. She still has to use readers. She wanted to be vaccinated to protect herself and her entire family. They had already been vaccinated. She went to one of the drives through sites and they would not let her get it there. They told her to go a professional site because of all of her allergies. She also has an epi Pen. She agreed with that. She did not want to go through that in a drive through. She would think they would be at this point. She has had nothing new introduced, no new medications and no new anything. That was the only thing she had taken that was different. She did get a headache immediately after and she does not generally get headaches. She had it for a couple of days. It went away but it was not that bad. It was probably a couple of hours later. It was once she got home. She does not have headaches. She thought it was odd to have a headache. She basically had the COVID shot, and everything was good. She was on an antibiotic that she finished taking Saturday. It was before the Pfizer. She thinks it was for an ear infection, or it was the sinuses. No, caller was just wanting to know, she mentioned delayed reactions. She was trying to see if this was one of them. If she was allergic to something, it happens within the first 15 to 20 minutes, or an hour. She had not had a reaction then, last night, when she noticed it, it was still there. This morning, and it was yesterday, she had rosy cheeks and had swelling in her entire face. She took Loratadine and her entire face has calmed down. She is still itching right underneath the nose and around the lip and mouth area. With the Lisinopril, she did have angioedema and it did make her lip swell. She does not take Lisinopril because she was allergic to it. She took the first dose of Lisinopril and went to bed. She woke up that morning and had a reaction that she had when she was sleeping. Being that the onset was almost 48 hours, she was wondering if there was anything else that would be delayed and if she would have any other reactions. The adverse events were not resulted in visit to emergency room and physician office. No, she called their office and left a message. They have not called back yet. The events were reported as non-serious. There was no laboratory tests or diagnostic studies were performed. The outcome of headache was reported as resolved on an unknown date in Aug2021, itching on her face and cheeks was reported as resolving, sore arm, itching on the lips, swelling of lips was reported was not resolved and rest all events was unknown.