Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Inflammation, Obstructive airways disorder, Pruritus
Clinical narrative: hives/small wheels on her back/wheals started showing up on her cheek, a little on the face; itching/little itching in hands, slight itching in her head progressed in neck, head, face; neck it was so red; whole neck became inflamed; airway obstruction at no time; This is a spontaneous report from a contactable nurse (reported for herself). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 13Aug2021 15:00 (at the age of 59-year-old) (Lot Number: EW0179) as dose 1, single for covid-19 immunisation. Medical history included ongoing allergy to medications, ongoing hypertension (onset in her late 20s; she just left her doctor 2 weeks before events and her blood pressure was excellent, everything was good), and allergy to polysorbate. Additional medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient is known to have allergies to Tagamet; Percodan; Codeine; Sulfa drugs; Aspirin; Aleve; dust; dog; cats; roaches; pollen; ragweed. There were no concomitant medications. The report is not related to a study or programme. No prior vaccination within 4 weeks and no corresponding events (no other vaccines since she was in her 30s). The patient received first dose of the vaccine on 13Aug2021. 3 days later, she developed hives and itching - they had determined to be allergic to polysorbate and not advised to get the 2nd dose - she never got hives in 15 years until she took the 1st dose of the vaccine - it started having a little itching in hands, slight itching in her head progressed in neck, head, face, small wheels on her back - she mentioned that she really has bad allergy to medications - she went to a pharmacist and advised that polysorbate won't stay long in the system - she wanted to know the expected duration of hives and itching. She was administered the first dose of Pfizer Covid-19 Vaccine on 13Aug2021. She developed itching and hives after that administration and had an allergy to polysorbate which is in the Pfizer Covid-19 Vaccine. She was not able to take the second dose of Pfizer Covid-19 Vaccine due to these events and allergy - they refused to administer the second dose to her because the Pharmacist researched the events and allergy and told her the events might be worse than the first time, she might be out of there in an ambulance the next time. She called to ask what the expected duration of these events are, and what the expected duration for polysorbate to clear the system are. She reported that (State name) was getting ready to make it mandatory to get the vaccination. Itching and Hives: when her hands started itching from the beginning and from her head, all around her neck it looked like she had a lobster around her neck it was so red when went back around to get the second dose of the Pfizer Covid-19 Vaccine that the Pharmacist refused to administer the vaccine to her. She has permanently discontinued Pfizer Covid-19 Vaccine relative to these events. She has been researching trying to see what it was exactly that caused these events. She hadn't done anything different other than getting the Pfizer Covid-19 Vaccine and had not had a case of hives in 15 years prior to these events. She did all the tracing back from onset of events. She wasn't sure of the time or date of onset of itching because she didn't develop hives until 3 days after the vaccine was administered-but remembered itching probably started the same date: 13Aug2021 because her head was itching. She thought maybe her scalp was dry so that day; thought maybe it was just regular itching so she didn't pay attention to it, didn't think anything of it until the hives appeared. When the itching continued and the hives started she thought that's like the old times when she had hives historically. Onset of hives also described as wheals started showing up on her cheek, a little on the face; then her ears started itching inside and out; her nose started itching inside and out. Then the itching and hives went to head like crazy and a couple days later her whole neck became inflamed. For a whole week the back of her neck started first, then her whole neck around her neck, she was clawing at herself, felt like she was almost taking her skin off. In response to these events, she went to the urgent care where they only told her to take Benadryl and that was it. That was at (name). They also told her to go see her regular doctor when she came back in; but they weren't going to give her anything else as long as she was not experiencing airway obstruction; and she experienced airway obstruction at no time. She reported events were ongoing, still here, her head was still itching, hands were still itching, back of her ears were still itching and base of neck on the back was still itching. She was talking to her doctor today. At first the doctor was going to tell her, she just got off the phone with them; but the doctor was going to say take 2 Benadryl and patient said not going to take 2 Benadryl because Benadryl makes her sleepy and she has to work. The Pharmacist she talked to this morning said the polysorbate will eventually leave her system, it won't stay in there, but she wanted to get a second opinion from Pfizer about that. Seriousness criteria for these events she initially explained that hers was kind of mild; but could have been life threatening; but being who she was and noticing the effects right away, she would pretty much would say they were medically significant. The primary doctor was talking with her today; telling her to take Benadryl, but she ate 25mg of Benadryl twice a day for a week and didn't want to do that again, taking it night and day. Before she got the Pfizer Covid-19 Vaccine she talked to the doctor who told her not to get the Moderna Covid Vaccine because she already knew it contained things that she was allergic to; so the doctor advised her to try the Pfizer Covid-19 Vaccine, that it might be better for her; so the patient went on her advice and got the Pfizer Covid-19 Vaccine. She never received any dose of Moderna Covid Vaccine. Due to hives and itching, the patient visited physician office at urgent care, no emergency visit, and not hospitalized. Relevant tests: none. Causality of events: if she was not a Biology major nurse she would say no; but being that she was a biology major nurse and looked up all the ingredients she did believe there was causality relationship between product and these events. The outcome of the events hives and itching was not recovered; and for other events was unknown.  Relatedness of drug to reaction(s)/event(s): Reaction assessed: Hives; Source of assessment: Primary Source Reporter; Method of assessment: Global introspection; Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Itching; Source of assessment: Primary Source Reporter; Method of assessment: Global introspection; Drug result: Related.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported event Urticaria and Pruritus 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.