Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash pruritic, Speech disorder, Throat tightness, Tongue pruritus
Clinical narrative: coughing; Vomiting; Wheezing; swelling of throat; coughing again and gasping for air in her throat; heart rate went up; swollen uvula; has a rash and tightness in her throat; anaphylaxis/anaphylactic reaction; has a rash and tightness in her throat; tingling in tongue and roof of mouth down towards her lips; bright red rash chest, arms, face, and it became itchy; bright red rash chest, arms, face, and it became itchy; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, expiry date: 30Apr2021, intramuscular on 11Jan2021 09:00 at single dose in the left arm (deltoid) for Covid-19 vaccination. Medical history included tobacco user and quit smoking over 10 years ago (Social History). There were no concomitant medications. It was reported that the patient got the second dose of the Pfizer Covid vaccine and went into anaphylaxis/anaphylactic reaction and not sure if the hospital has informed Pfizer yet. She has already commented and reported this to CDC this morning. Reactions started about 15 minutes later after getting the vaccine and the end of the observation. Had tingling in tongue and roof of mouth and it spread and was going down towards her lips and she had to go to the emergency room. About 20 minutes later her throat was getting tight and coughing and that progressed to vomiting, wheezing, swelling of throat, and they gave her Benadryl, Solumedrol, Pepcid, Albuterol, and it got to a point she couldn't talk and was gasping for breath and was given Epinephrine. She got better after a couple of minutes and then started coughing again and gasping for air in her throat. Her heart rate went up to about 140 and she had trouble breathing and couldn't get air in. They had to gave her another shot of Epinephrine and it improved and kept her for observation. Was put on the Unit about 6 hours after and again started coughing and throat feeling tight, had wheezing, swollen uvula and they treated her with the same exact cocktail including another Epinephrine shot. She was given all that except the Pepcid. Later she was admitted to the ICU that night and the doctor decided to stop all medicines except for the Pepcid. The following morning about 10am her throat started to feel tight again and had the coughing, vomiting, and got a red rash on her arm, wheezing, and swollen uvula. She was given the same treatment with Solumedrol, Pepcid, Albuterol, Benadryl, and racemic Epinephrine in a nebulizer. The breathing got better but still had the tightness in the throat and they gave her another nebulizer treatment that night. The ICU doctor made decision for her to continue the Solumedrol Pepcid, racemic Epinephrine in a nebulizer every 12 hour and she got 2. No further vaccines given the same day or 4 weeks prior. She has never had any problems, anaphylaxis anything with any products before. She didn't realize she had the rash, but it was a bright red rash chest, arms, face, and it became itchy and she started to cough. She was told her lungs were clear and she didn't have any swelling at that point where they gave her more Solumedrol and Pepcid, Benadryl, Advair inhaler, and the racemic Epinephrine in a nebulizer. Four hours later the nurse checked on her and her face was really red and her throat tight and given another dose of Benadryl and the racemic Epinephrine in a nebulizer. The doctor changed the steroids to every 8 hours and she had to get another dose and at one point she thinks she got 60mg of Solumedrol and believes she was told to get 125mg that morning. She was then transferred to the floor and at that point she still had the rash (Improved but not completely recovered), funny feeling in the throat and that was about 8pm and was given another dose of Benadryl and another racemic Epinephrine and got scheduled for more Solumedrol at 10pm. Today she got the Solumedrol every 8 hours and Pepcid and the rash came back, but not as bad. Still has the feeling in the throat, but not as bad and she also got another dose of Benadryl, but she didn't get the dose of the racemic Epinephrine because she wants to go home. They did tell her she still had some swelling. She is still in the hospital right now. She later clarified she did have shot less than 4 weeks ago, the first Pfizer Covid vaccine was given on 21Dec2020 (Lot number of EL0140, expiry of 31Mar2021) via intramuscular in the left arm. She had no issues with that one, maybe a little tiredness and achiness the next day, but no reactions, no asthma, anaphylaxis or anything. No further details provided. Mentions taking only Multivitamins daily whenever she remembers to take them. She had a CBC, CMP, and 2 chest xrays and they were all normal. She quit smoking over 10 years ago. She wants to know the length of the reactions and if this reaction the same for those other people who have had anaphylaxis. She would like to speak to someone about this to see if this is a typical reaction. Therapeutic measures were taken as a result of all the events. The outcome of the events 'anaphylactic reaction', 'Rash', 'Rash erythematous' and 'Rash pruritic' was recovering, for event Throat tightness was unknown, while outcome for the other events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis with individual symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product.  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.