Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Lip swelling, Pharyngeal swelling, Swelling of eyelid, Swollen tongue
Clinical narrative: anaphylactic reaction; could hardly swallow; throat swelled; couldn't breathe her lip, eyelid and tongue swelled; couldn't breathe her lip, eyelid and tongue swelled; couldn't breathe her lip, eyelid and tongue swelled; chest tightness; couldn't breathe her lip, eyelid and tongue swelled; had to take the Johnson and Johnson for her next doses; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "PEG allergy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Sinus tachycardia" (unspecified if ongoing), notes: Had complete heart work, didn't find anything, might have real mild form POTS syndrome; "real mild form POTS syndrome" (unspecified if ongoing), notes: Had complete heart work, didn't find anything, might have real mild form POTS syndrome; "softball sized welts" (unspecified if ongoing), notes: in the past to other vaccines, like when she was a kid, she always got softball sized welts.; "Had allergies to old fashioned sulfa tablets from the 70's" (unspecified if ongoing), notes: Had been intermittent over the years; "rash" (unspecified if ongoing), notes: Had allergies to old fashioned sulfa tablets from the 70's. Broke out in rash; "hypothyroidism" (unspecified if ongoing), notes: Additional Information for Other medicines Synthroid: Has been taking for 30 years; "reflux" (unspecified if ongoing), notes: Additional Information for Other medicines Pepcid: Has been taking around 25 years; "allergic reactions" (unspecified if ongoing), notes: she was the only one unfortunate enough to experience this. had life long allergic reactions. Concomitant medication(s) included: COVID-19 VACCINE JANSSEN taken for covid-19 immunisation, on 22Nov2021 as dose 2, single; SYNTHROID taken for hypothyroidism (ongoing); PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease (ongoing); ASPIRIN (E.C.); ATENOLOL taken for sinus tachycardia; BENADRYL; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]. Past drug history included: Steroid, reaction(s): "rash", notes: Was injected with a steroid and got a rash and had broken out in hives.; Steroid, reaction(s): "broken out in hives", notes: Was injected with a steroid and got a rash and had broken out in hives.; Miralax, reaction(s): "broke out into a rash"; Golytely, reaction(s): "rash". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2020, outcome "unknown", described as "had to take the Johnson and Johnson for her next doses"; ANAPHYLACTIC REACTION (medically significant) with onset 19Dec2020 at 10:00, outcome "unknown"; CHEST DISCOMFORT (medically significant) with onset 19Dec2020 at 10:00, outcome "unknown", described as "chest tightness"; DYSPHAGIA (medically significant) with onset 19Dec2020 at 10:00, outcome "unknown", described as "could hardly swallow"; LIP SWELLING (medically significant), SWELLING OF EYELID (medically significant), SWOLLEN TONGUE (medically significant), DYSPNOEA (medically significant) all with onset 19Dec2020 at 10:00, outcome "unknown" and all described as "couldn't breathe her lip, eyelid and tongue swelled"; PHARYNGEAL SWELLING (medically significant) with onset 19Dec2020 at 10:00, outcome "unknown", described as "throat swelled". The events "anaphylactic reaction", "could hardly swallow", "throat swelled", "couldn't breathe her lip, eyelid and tongue swelled" and "chest tightness" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart work: didn't find anything; Weight: About 195. Therapeutic measures were taken as a result of anaphylactic reaction, dysphagia, pharyngeal swelling, lip swelling, swelling of eyelid, swollen tongue, chest discomfort, dyspnoea.   Clinical course: No Prior Vaccinations (within 4 weeks). No family Medical History Relevant to Adverse Events (AEs). Had allergies to old fashioned sulfa tablets from the 70's. Broke out in rash. Thinks it was the yellow dye in the old tablets. They didnot even make those anymore. Concomitant: Atenolol (probably been on that 7 years. It was just a little tiny dose that took care of it.), Synthroid (had been taking for 30 years) and Pepcid (Had been taking around 25 years). Used asthma inhaler but only uses certain times of the year, when asthma flared up or she was sick. Not an every day thing. Weight: About 195. Polyethylene glycol could rub on her skin and she did not have any problem. When injecting it into her body, that seemed to be when the reactions was and when ingesting it, like when she drank Golytely.  Drank Miralax over the counter and broke out into a rash when she drank that too. Didn't even know what the problem was until the doctor figured it out 2 years ago. With some immunizations, as a child, had no problems but, next time, would have huge welt and be running high fever. Never put it all together until she got to investigating with Covid shots. Knee was injected once with steroid and had broken out in hives. Was injected again and didn't break out. Thought some of the steroids have preservatives in them, the PEG, and some didnt. Went way back to the 70's when she was child. She was injected with a steroid and got a rash and had broken out in hives. Seems to be pretty apparent that it was the polyethylene glycol preservative.  Didn't know all that for all these years. Just knew something in it was causing this allergic reaction. A couple of times, was injected with steroids, she had broken out into hives. She had asthma and did a couple of breathing treatments that didn't help.Took Prednisone just in case, since she was leaving town and that didn't help. Patient had a unique problem and sure there was nothing Pfizer could do to help her but she was desperate, which was why she called. When she had the Pfizer vaccine Dec2020, had an anaphylactic reaction. She worked at hospital with about 800 other people and only 2 of them had severe reaction to the Pfizer vaccines. She was a nurse and had worked at hospital 35 years. Went to work every day through the Covid virus and had done her duty. Realized that the disease was not as serious as it once was but, had asthma and so to go to work unprotected because there was no vaccine she could take that did not have PEG in it. She had 2 Johnson and Johnson vaccines because that was all she could have. They won't let her get third Johnson and Johnson vaccine.  She couldnt get Pfizer because of the anaphylactic reaction she had. The Moderna had PEG in it too. She was just stuck and, had to go work as nurse with asthma every day. There was Covid and flu and RSV going around.  On 17Dec2020, she got Pfizer vaccine. Because she has had reactions in the past to other vaccines, like when she was a kid, she always got softball sized welts. They had her take Benadryl and Allegra before getting the Covid shot. Felt ok the first day. The second day, she didn't feel bad. The third morning about 10AM, had delayed reaction, where her throat swelled, couldn't breathe her lip, eyelid and tongue swelled and was having chest tightness. Finally, in evening time, could hardly swallow her supper because her throat was swollen. Went to emergency room. Clarified she was just to emergency room and was not admitted to hospital.  Went to the ER, then to the asthma doctor, who called allergist who brought her in. They gave her epinephrine and IV Solumedrol and IV Pepcid. She was feeling well enough to leave the emergency room and by the next morning, after all the steroids, was feeling tremendously better. There was only 1 other person in the hospital who responded with reaction and having blisters head to toe. No one else in the whole hospital that was vaccinated had any of these reactions. Was just the 2 of them. Clarified that the other 2 vaccines caller had were the Johnson and Johnson vaccines. They would not let her have any other Pfizer vaccine because of her reaction. The Johnson and Johnson did not contain PEG in it.Was might be 7 or 8 days, between seeing the doctor in the ER and the asthma doctor and allergist. She was sent to a specialist who said that it was a reaction to the polyethylene glycol. It had been all these years and didn't know it. The provider was not her doctor when this happened but, he knew what happened and has been trying to figure out what to do for her. Provided contacted another provider in system who told her to get another Johnson and Johnson. When she went, they wouldn't give it to her. They wanted to give her Pfizer but that vaccine had PEG in it. Had 1 anaphylactic reaction and it could be much worse this time. Knows the allergist reported the reaction but did not know if it was reported to Pfizer. Dates of 2 Johnson and Johnson Covid vaccines provided as 22Nov2021 and had booster 25Apr2022. Actually did have Covid, end of or around middle Jan2022, about year ago. Got pretty sick but did not have to go to hospital. Ended up with some kidney failure too.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.