Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Immunisation, Insomnia, Pruritus
Clinical narrative: Outcome entered as worsened as patient re-ported event is certainly not better, in some ways she thinks event is worse; Reaction has affected her sleeping; Reaction of itching hives all over her body inside and out; Reaction of itching hives all over her body inside and out; it is killing her hand because it peels and it gets very red; it is killing her hand because it peels and it gets very red; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 13:50 (Lot number: P92ERFC3183) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing); "mosquito bites" (unspecified if ongoing); "sinus infection" (unspecified if ongoing). Concomitant medication(s) included: REMICADE LYOPHILISAT taken for rheumatoid arthritis. Past drug history included: Prednisone . Vaccination history included: Bnt162b2 (First dose, Lot: EN5318, injection in left arm at around 13:50), administration date: 17Feb2021, when the patient was 80 years old, for COVID-19 Immunization; Bnt162b2 (Second dose, Lot: EN6199, injection in left arm at around 13:50), administration date: 13Mar2021, when the patient was 80 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Sep2021 13:50, outcome "unknown", described as "booster"; SKIN EXFOLIATION (non-serious), ERYTHEMA (non-serious) all with onset Dec2021, outcome "unknown" and all described as "it is killing her hand because it peels and it gets very red"; CONDITION AGGRAVATED (non-serious) with onset 14Dec2021, outcome "not recovered", described as "Outcome entered as worsened as patient re-ported event is certainly not better, in some ways she thinks event is worse"; INSOMNIA (non-serious) with onset 14Dec2021, outcome "not recovered", described as "Reaction has affected her sleeping"; PRURITUS (non-serious), URTICARIA (non-serious) all with onset 14Dec2021, outcome "not recovered" and all described as "Reaction of itching hives all over her body inside and out". The events "outcome entered as worsened as patient re-ported event is certainly not better, in some ways she thinks event is worse", "reaction of itching hives all over her body inside and out" and "reaction of itching hives all over her body inside and out" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin exfoliation, erythema, condition aggravated, insomnia, pruritus, urticaria.  Additional information: The primary reporter for this report was the husband of the patient. The secondary reporter was the patient herself. Both reporter's provided information during report, with primary reporter referred to as caller or reporter and patient referred to as patient. The patient had a reaction to the third dose which was the booster dose of Pfizer Covid-19 Vaccine she was administered. Reaction of itching hives all over her body inside and out, time of onset was unknown. Outcome entered as worsened as patient re-ported event is certainly not better, in some ways she thinks event is worse because it is killing her hand because it peels and it gets very red, itches something horrible. Patient reported if you could see what she is talking about it's terrible; it is the most miser-able thing she's ever had. She has had mosquito bites historically, but nothing like this. She has never had any adverse events with any prior vaccinations, which was why this event was such a surprise to patient. Reaction has affected her sleeping: Time of onset was unknown and verified outcome as persistent. Patient reported that third dose/booster dose completed her prescribed therapy. First dose was administered at the Health Department in withheld. Second dose was administered at withheld where the National Guard was giving the vaccine. Third dose was administered at withheld Drugs-additional details captured in vaccine supplemental form. Patient takes Remicade for indication: Rheumatoid arthritis, ongoing condition and therapy prior to any dose of Pfizer Covid-19 Vaccine, all administered in a specialty facility that does IVs, because she had some other stuff going on they made her wait 16 weeks for her Remicade dose. Patient got the third dose of Pfizer Covid-19 Vaccine before she got the Remicade dose again, and her husband mentioned he thought her immune system started to build back up because of being off from the Remicade and that could be reason for her reaction to the third dose of Pfizer Covid-19 Vaccine. The reason for the 16 weeks waits between doses was they were trying to figure out at the beginning of the Pfizer Covid-19 Vaccine vaccinations whether she should have the Pfizer Covid-19 Vaccine with the Remicade; if that would or would not be good for her. They were trying to figure out a way for patient to get the Pfizer Covid-19 Vaccine. Patient had to wait quite a while to see if they thought she could do have the Pfizer Covid-19 Vaccine. Around Mar2021 when patient got Pfizer Covid-19 Vaccine because they finally thought it would be ok if she did; she did without the Remicade for quite a while, 16 weeks because then when got the Pfizer Covid-19 Vaccine she could not have the Remicade. Patient has no other medical conditions and there has been nothing different, just regular medicine she takes, did nothing different at all other than already reported. Patient has been to three different doctors relative to these events and talked to one doctor that she did not visit, just talked to. Regarding treatments and medical interventions relative to these events, the doctors all just suggested; then patient and her husband changed topics: They went to withheld to do a test, that was before these events happened; because she had a sinus infection which she has had off and on all her life; so they decided since the sinus infection was so bad they decided to go to withheld, made an appointment for both reporter and patient to be COVID tested. They both took a COVID test on 30Nov2021 and both of them got negative results, no COVID, they were ok. For treatment patient tried a number of different things for the reaction, the hives. The one thing patient did do that she was sorry she did was antihistamine-Benadryl; she took one of those. She could not have anything that has any inkling of aspirin in it. Patient was told to try Benadryl, and patient knows it has Tylenol in it, but it could be the diphenhydramine in the Benadryl; but the reaction of itching hives all over her body inside and out was clearing up; and then she took a Benadryl for her sinus, and the next day and that night she started breaking out again with the reaction of itching hives all over her body inside and out. It's probably been about 3 weeks ago that patient took the Benadryl and had the breaking out again. Then patient had to go to another doctor and that doctor is the one that gave patient the Prednisone. The Prednisone was given to patient on 01Dec2021 for the reaction of itching hives all over her body inside and out which she took for 10 days, and it was a strong Prednisone. Patient has had to be on Prednisone before for her Rheumatoid arthritis but this time when she took it starting 01Dec2021 the Prednisone did nothing for the reaction of itching hives all over her body inside and out. She also tried Hydrocortisone 2.5 percent or 2.5mg, both strengths provided by reporter. When the doctor said he was going to give the patient the Prednisone she thought great, because every time she has had to use Prednisone before for a bad flare up of her Rheumatoid arthritis Prednisone has worked. This time the Prednisone for reaction of itching hives all over her body inside and out did not do anything. The Hydrocortisone when patient first started using it, reporter would put the Hydrocortisone all over her entire back, and the Hydrocortisone would stop the itching for a while. Now the Hydrocortisone did not stop the itching, it has become ineffective, evidently patient's immune system has built up a resistance to the Hydrocortisone reporter and reporter guessed. Patient has been very, very healthy her whole life until she got the Rheumatoid arthritis. These events are the first-time patient has ever really had anything like this. It was very hard because she did not like itching, she was very frustrated, and reaction has affected her sleep too, sleeping since reaction about the same. Patient had no reaction to the first 2 doses of Pfizer Covid-19 Vaccine that she got, not even a slight headache or anything. Patient mentioned originally being from state of withheld. Reporter mentioned that he himself got the first dose of the Pfizer Covid-19 Vaccine prior to patient's date of first dose; Reporter got that first dose in city, state of withheld. Reporter's brother and his wife also got the Pfizer Covid-19 Vaccine the same day as reporter's first dose; Reporter's brother and his wife have had 2 doses each of the Pfizer Covid-19 Vaccine and reporter's brother and his wife have not had any reaction at all from the first two doses. Reporter has had total of 3 doses of Pfizer Covid-19 Vaccine and has not had any reaction from any of those 3 doses. No one, but the patient in this report has had any reaction to the Pfizer Covid-19 Vaccine. Reporter provided reporter's Pfizer Covid-19 Vaccine vaccination record reference number: P173540, and Lot: FN5318. Reporter got his second and third doses on the same dates and at same facilities as the patient's second and third doses. Clarification of information further not provided, as this was not relevant to report for this patient, and reporter verified having no adverse events related to Pfizer Covid-19 Vaccine. The reporter stated that the reaction of itching hives all over her body inside and out was clearing up. Sinus infection she has had off and on all her life was so bad patient given COVID test negative for COVID result. Then took Benadryl for sinus infection, next day and night started breaking out again with reaction of itching hives all over her body inside and out-about 3 weeks ago. Every time Prednisone taken before for bad flare up of Rheumatoid arthritis Prednisone worked. This time Prednisone 10-day course starting 01Dec2021 for reaction of itching hives all over her body inside and out did not do anything. Hydrocortisone: when first started, Hydrocortisone would stop itching for a while. Now Hydrocortisone did not stop itching, has become ineffective, evidently patient's immune system has built up resistance to Hydrocortisone reporter and caller guess. Patient has taken Prednisone before for Rheumatoid arthritis; tried Hydrocortisone 2.5 percent or 2.5 mg, both strengths provided by reporter. Prednisone: Lots/NDCs/Expiries: Unknown, products dispensed in standard pharmacy bottles. Benadryl: Lots/NDCs/UPCs/Expiries: Unknown, caller and patient did not have product or this information to provide. Hydrocortisone: Lots/NDCs/UPCs/Expiries: Unknown, caller and patient did not have product or this information to provide. Remicade: for Rheumatoid arthritis. Lots/NDCs/Expiries: Unknown, all administered in specialty facility that does IVs. The report was not related to a study or programme. Pfizer Covid-19 Vaccine was a Pfizer product. NDC number and Expiry Date of Pfizer Covid-19 Vaccine was unknown. Pfizer Covid-19 Vaccine: Dosage previously discontinued/treatment completed. The patient was taking Pfizer Covid-19 Vaccine (Verbatim) because she did not want anyone else to get it if she got it. Additional vaccines administered on same date of the Pfizer suspect-If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. AE(s) did not require a visit to emergency room. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were reported as none. AE(s) following prior vaccinations, family medical history relevant to AE(s) were reported as none.  No follow-up attempts are possible. No further information is expected.