Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: experiencing itching (rash and hives) all over her body (from head to toe); developed the auto-immune disease Rheumatoid Arthritis; experiencing itching (rash and hives) all over her body (from head to toe); experiencing itching (rash and hives) all over her body (from head to toe); little bumps all over my arm and all over my body, little tiny bumps; food allergies; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534, Expiration date: Unknow), via an unspecified route of administration, in right arm on 02Apr2021 (at the age of 54-year-old) as a single for COVID-19 immunisation. The patient medical history was not reported. No investigation assessment was reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced itching (rash and hives) all over her body (from head to toe), developed the auto-immune disease rheumatoid arthritis, experiencing itching (rash and hives) all over her body (from head to toe), experiencing itching (rash and hives) all over her body (from head to toe), little bumps all over my arm and all over my body, little, tiny bumps, food allergies. Therapeutic measures were taken as a result of experiencing itching (rash and hives) all over her body (from head to toe) (urticaria), developed the auto-immune disease rheumatoid arthritis (rheumatoid arthritis), experiencing itching (rash and hives) all over her body (from head to toe) (pruritus), experiencing itching (rash and hives) all over her body (from head to toe) (rash), little bumps all over my arm and all over my body, little tiny bumps (skin disorder), food allergies (food allergy). It was reported that, Caller wanted to know if were able to provide some guidance regarding the itching that worsened after the administration of the Pfizer BioNTech Covid-19 Vaccine that she was experiencing after getting the Pfizer BioNTech Covid-19 Vaccine. Caller stated that she got Covid on February of this year. She started experiencing itching (rash and hives) all over her body (from head to toe).  On 02Apr2021, she got the first dose of the Pfizer BioNTech Covid-19 Vaccine and she stated that ever since then, her itching worsened. She also mentioned that she developed the auto-immune disease rheumatoid arthritis after the first dose, which resulted her doctor to advise her not to take the 2nd dose of the vaccine. Caller wanted to know if we have some additional data for patients who developed an autoimmune disease from the Pfizer BioNTech covid-19 Vaccine. Advised that there was no data specifically for patients who developed an autoimmune disease after a dose of the Pfizer BioNTech COVID-19 Vaccine. Caller wanted to know if there was a specialist that they could talk to regarding treatment of the side effect experienced after getting the Pfizer BioNTech covid-19 Vaccine. The patient broke out with hives, very itchy, her whole body was very itchy from head to toe; she was making herself bleed it; little bumps all over her arm and all over her body, little, tiny bumps. She ends up with a skin reaction and then when she got the vaccine it got worse. The patient was very healthy before vaccination. Consumer stated, she called so that she had a bad reaction to the Pfizer vaccine (Pfizer Covid-19 Vaccine). Her first shot. The patient was informed not to get her second shot by three different doctors." Consumer stated, no, she did not go for any lab test within two weeks. No, not within two weeks. For a month ago, she had. (Further not clarified hence not captured in tab). Consumer stated, yes, she went to see her rheumatoid arthritis doctor. She mean her allergy doctor and she was diagnosed from auto immune disorder after my vaccine was done. I was very healthy until then. She has been taking Benadryl, Serotine, yeah, she means she was itchy. So, yeah, she was taking, as in putting lotion on me and a steroid. Consumer stated, the dose is 4 milligrams, oh, no, this was the different one. This was Benadryl was over the counter. She did not know what the dose was, it's over the counter but this right here was, this medicine that she was on, she can spell it Methyl prednisone and thats 4 milligrams tablet, twice a day and then another one they put me on was Famotidine and thats 20 milligrams tablet. Family medical history related to adverse events. Consumer stated, her brother-in-law started having issue. He got his first vaccine shot and he, from Pfizer and he started having the same issues as me. Consumer stated, her reaction was she broke out with hives, very itchy. Her whole body was very itchy from head to toe and that's yeah, very itchy, itchy skin. Consumer stated, Yeah, very itching where itchy and was making herself bleed it, stop that. Little bumps all over her arm and all over her body, little, tiny bumps. When she had COVID back in February, she ends up with a skin reaction and then when she got the vaccine it got worse. Consumer stated, Okay, yeah, because she means she cannot stand that, she cannot. The patient has never been like this. She has been very healthy until she had this vaccine. The patient mean are you guys going to help me or anything. She means, that desperate. So, with you she both ready to time tackle and all that. Caller states she was calling about her Pfizer Covid Vaccine and states she wanted someone to be aware that she had a very bad reaction to the 1st dose of the vaccine and was informed by three doctors not to get the 2nd dose; states she had covid back in Feb2021 and then went on 02Apr2021 to have the 1st dose of the Pfizer COVID Vaccine and ever since then had had all kinds of health issues now that she has not had before and states she was very healthy and now has an autoimmune disorder, rheumatoid arthritis which she never had before and is breaking out and itching head to toe and the rheumatologist put her on different medications and this is just ridiculous. States she reported the lot number for the 1st dose of her Pfizer COVID Vaccine in the initial repot and does not have that information handy to report at this time. Caller states she just can't stand this and is supposed to go teach on 02Aug2021 when the kids go back and she is itching head to toe and tried everything and nothing worked and states she did over the counter Benadryl, over the counter Claritin, lotions that were Aveeno for psoriasis which is a daily moisturizing cream that relieves dry itching irritation of the skin and they put her on Prednisone as well and states for any of these medications or products she has no lots, expiry dates or NDC numbers to provide at this time. States the medications she is on now is not helping and she has been on them since Friday 16Jul2021 and they are two different medications that are Famotidine 20mg tablets taken twice daily and Methylprednisolone 4mg tablets taken three times per day and both medications are in an orange pharmacy prescription bottle with her Rx numbers but with no lots, expiry dates or NDC numbers. Caller states she just wants to start feeling better and has never been so unhealthy in her life and the itching is horrible, and she has food allergies which she never had. A male person came on the line and was provided with the call recording notification and states the caller does not have food allergies and when the caller originally had covid she had a skin rash and when she recovered from covid she still had the skin rash and the rash is ongoing since she had covid; states the rash was going away after covid and when she got the Pfizer Covid vaccine the rash came back with a vengeance and asked if Pfizer can help her because the HCP is not helping and what can she get or what can she do and they are seeking advice. Caller and male person on the line aware of reason for report and aware that Pfizer unable to offer treatment recommendation or medical advice and they would be referred to the HCP for that information. Caller asked if Pfizer has specialists working on this and they cannot leave her hanging like this and is there a referral to a specialist that deals with something or nothing but covid and these kinds of allergies. Is there a product complaint to reported as yes. Caller states she just can't stand this and is supposed to go teach on 02Aug2021 when the kids go back and she is itching head to toe and tried everything and nothing worked and states she did over the counter Benadryl, over the counter Claritin, lotions that were Aveeno for psoriasis which is a daily moisturizing cream that relieves dry itching irritation of the skin and they put her on Prednisone as well and states for any of these medications or products she has no lots, expiry dates or NDC numbers to provide at this time. States the medications she is on now is not helping and she has been on them since Friday 16Jul2021, and they are two different medications that are Famotidine 20mg tablets taken twice daily and Methylprednisolone 4mg tablets taken three times per day and both medications are in an orange pharmacy prescription bottle with her Rx numbers but with no lots, expiry dates or NDC numbers. Caller asked if Pfizer has specialists working on this and they cannot leave her hanging like this and is there a referral to a specialist that deals with something or nothing but covid and these kinds of allergies. Asked what she can get or what can she do, and they are seeking advice. No product quality compliant was reported. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.