Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Erythema, Hypersensitivity, Lip swelling, Liver disorder
Clinical narrative: she was in distress with her throat starting to swell, her tongue started to swell and she was covered with the hives and rash from head to toe.; her lips and tongue began to swell; her lips and tongue began to swell; rash on her palms, hands, elbows, and left hip/rash all over her body; elbows were red; hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy; developed hives/rash on her palms, hands, elbows, and left hip; WBC count was high; liver was not doing great; post COVID vaccine delayed allergic reaction; pain in her right ear; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:15 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included arrhythmia, ear infection. Concomitant medication(s) included propranolol (PROPANOLOL [PROPRANOLOL]) taken for arrhythmia from Apr2020 to an unspecified stop date.  The patient previously took augmentin [amoxicillin;clavulanic acid] for ear pain and experienced rash on her elbows and palm and arm. Caller stated on Friday 05Mar2021, which was the 11th day after getting the Pfizer COVID Vaccine although she noticed symptoms on the 10th day 04Mar2021 after receiving the vaccine, states she noticed she had a hive rash on her palm and hand and elbows/rash on her palms, hands, elbows, and left hip and it was strange and her elbows were red and were itchy on the palms like red and itchy and she could see the rash starting on the left inside forearm; from there as the day wore on into the next day the rash became worse and more areas of the body were covered with the rash. States she made an appointment on that Monday morning with her HCP and had gone into the HCP office at that time; states on 08Mar2021, she was in distress with her throat starting to swell, her tongue started to swell/ her lips and tongue began to swell and she was covered with the hives and rash from head to toe. Caller states she was started on Prednisone at her HCP office and it was one of those dose packs; states she has no lot numbers to provide. Later on that evening she needed to go to the emergency room and she had become more severe and had a big dose of Prednisone at the emergency room and at that time the HCP there did believe she was having what is considered a post COVID vaccine delayed allergic reaction and hives; states she was in the emergency room early and was there past midnight and thinks she presented to the emergency room on 09Mar2021 and then most recent results she has of her paperwork were from 09Mar2021 to 10Mar2021; no further details provided by the caller. Caller states she was in the emergency room rolled over to the next day on the 09Mar in the evening around 10:30pm and concluded her ER visit on the 10Mar after 12:30. Caller states the HCP gave her the 40mg dose of Prednisone by injection and she has no lot number; states then at the ER, they gave her Prednisone 125mg IV and she has no lot number; they gave her hydroxyzine which is Atarax by IV and gave her Pepcid for her stomach at the same time; no lots for the Pepcid or Hydroxyzine. States the reason for her visit was allergic reaction, allergy hives, post covid delayed reaction. States she let them know at the site that before the vaccine she felt like she might have had an ear infection and was not taking anything no vitamins or anything like that and no Tylenol or anything for a week or so prior because she wanted nothing to be in her system other than the vaccine should anything happen. Had the vaccine that day, later on that afternoon contacted her HCP felt like she had ear infection, no fever but had fullness and some pain in her right ear. Saw her HCP at that time and took a look inside her ear and felt that she did have an ear infection without fever but was painful to the touch around her ear underneath her ear; prescribed Augmentin which she has taken before. Started taking one Augmentin pill on the 23rd in evening which would be Tues 23Feb2021 for the 1st dose, 500mg and dose supposed to take following the next day was to take two tablets one tablet twice per day which she did finish up around 10 days of that on 04Mar. The day before all this started with the rash she finished Augmentin, went to the HCP and two things happened; she was taking Augmentin and had the Pfizer COVID Vaccine. States she had the rash on her elbows and palm and arm and she was like that coincides with the Pfizer vaccine but also was on Augmentin and had been on that before with no problems; thought it was either the vaccine or being on the Augmentin as the reason for the rash but narrowed it to the vaccine. States she ended up in the hospital that evening on Monday evening of 09Mar and it was something they had not seen but were prepared to see could happen and concluded the rash was from the vaccine. Caller states she went to see her immunologist at the conclusion of this event and she was still covered in hives and rash and did step her down on the Prednisone and prescribed her hydroxyzine and topical itch stuff. Caller states she has no lot numbers to provide for the topical stuff or the hydroxyzine or Prednisone. States the HCP concluded she could not receive the 2nd dose of the Pfizer COVID Vaccine or any other vaccine that comes forward and she is not a candidate because of this reaction he can't safely say it would be ok to get a 2nd dose of the vaccine; states she can't receive a 2nd dose of any covid vaccine and it worried her because she has to be ok with having had the 1st dose of the vaccine and wants to know where she stands with that and what to do and she just doesn't know. States it is not she herself saying she can't get the 2nd dose of the covid vaccine but under her HCP advice and two ER visits and many doses of Prednisone and she presented how she looked and that prompted the HCP to say no 2nd dose for her. States she was taking Prednisone started two days of 50mg then 2 days of 40mg, then 30mg, then 20mg, then 10mg and that brought down the amount in her system; states she was given Hydroxyzine 1-2 tablets every 4 hours of 25mg and has no lot numbers for the Prednisone or Hydroxyzine. Caller states instead of taking Benadryl she was taking the topical stuff because Benadryl was not really working and she took Benadryl 25mg tablets in the beginning to try to get the itching out of her system and she felt really really tired and was so tired from taking the Benadryl; caller states she has no lot numbers to provide for the Benadryl. She was given a prescription for Hydroxyzine and the thinks it tended to work better and she did not take a drastic amount of it but it could cause drowsiness and she did feel a lot better from taking it but did not have a really bad feeling of feeling really dopey and sleepy with it because she felt bad enough and did not want to feel bad. States she kept on this for the 10 days or more of a 14 day course and was feeling like until it started to subside. On an unspecified date it was reported that Her WBC count was high and her "liver was not doing great" but recent bloodwork shows it has returned to normal. The patient was hospitalized for the events developed hives/rash on her palms, hands, elbows, and left hip, elbows were red, hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy, her lips and tongue began to swell, WBC count was high, liver was not doing great, post COVID vaccine delayed allergic reaction. The patient underwent lab tests and procedures which included white blood cell count: returned to normal on an unspecified date, white blood cell count: high on Mar2021.  Therapeutic measures were taken as a result of the events except for WBC count high and liver was not doing great. The outcome of the events was unknown.