Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Seizure like phenomena, Tinnitus, Urticaria, Weight
Clinical narrative: it's like when someone is like seizure; DOSE 3 (BOOSTER); She had a bad rash all over the body, hives; the rash and hives it's like eruption; heat becomes the rash and not much hive anymore but it's a generalized rash that moved all way down to my leg; Heart rate increased; hives; the rash and hives; I have like a pop in in my ear and heard pop like in my inner ear; it's like when someone is like seizure; The eruption usually last about 45 minutes and 1 hour and then it goes away after that; it starts getting very hot. In my ear and my ear feel like they will fly off my head and that heat travels down my body; itching; This is a spontaneous report from a contactable other healthcare professional (nurse, patient) via Pfizer-sponsored program. A 61-years-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: 30145A; Expiration Date: Nov2021) via an unspecified route of administration in Arm Left on 05Oct2021 (at the age of 61-Years-old) as DOSE 3 (BOOSTER),single dose for covid-19 immunisation. The patient's medical history included heart rate abnormal. It was reported All she took was for her heart and she don't have hypertension it's just to lower her heart rate, this was the only time. Concomitant medication included vitamin c [ascorbic acid] taken for an unspecified indication and vitamin d [vitamin d nos] taken for an unspecified indication. After patient had the shot she had problems with her heart rate so she took supplements. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection) via an unspecified route of administration, on 08Feb2021 (at the age of 60-Years-old) as single dose for covid-19 immunisation. Historical vaccine included second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, lot number EN6198) via an unspecified route of administration, on 11Mar2021 (at the age of 60-Years-old) as single dose for covid-19 immunisation and experienced rash/It was under my breast area. The rash started about the third day about 2 days later but it was minor in her cubicle area. It was under her breast area. On 05Oct2021, 10 minutes later she had a bad rash all over the body, hives; the rash and hives it's like eruption; heat becomes the rash and not much hive anymore but it's a generalized rash that moved all way down to my leg and heart rate increased. On the same day she felt it's like when someone is like seizure, hives; the rash and hives, she had like a pop in her ear and heard pop like in her inner ear; it's like when someone is like seizure; the eruption usually last about 45 minutes and 1 hour and then it goes away after that, it starts getting very hot in her ear and her ear feel like they will fly off her head and that heat travels down her body, itching. She had same outbreak every single day and it was now 03Nov2021 so it's almost 30 days and it did not go away and she got it back every day. She wanted to know if there was something Pfizer can advise her to do and why was it happening. She never had this reaction. She was looking for some advice. She had consulted her doctor, she tried Prednisone 40 mg initially and it got worst with the prednisone and she also developed few sensitivities with the prednisone so, she couldn't take that. She took antihistamine like every day. She did tried Benadryl that can't do too much. She tried Vertex few days and as she said being a Nurse she worked and had two dogs so, she was active during the daytime and Benadryl gave her a very bad hangover. She took vertex and Benadryl when she don't have to work next morning. Benadryl, she took up to 50 mg and the Vertex and she usually tried to take in morning. 10 mg, just regular. On the weekend, when she did not go to work a day after she just had Benadryl but still get the rash during the day at some point. It has never happened at night, it always during the day. The rash and hives it's like eruption. She told them coming on, she had like a pop in her ear and heard pop like in her inner ear. It's like when someone had seizure and they had an aura and it always legitimated in her inner ear and then it started getting very hot. In her ear and her ear felt like they will fly off her head and that heat travels down her body and the heat becomes the rash and not much hive anymore but it's a generalized rash that moved all way down to her leg. Its huge kind a in her back or her hip area for a while. It felt like it works on a 'cart sheep' that's how her back and bottom felt like. The eruption usually lasted about 45 minutes and 1 hour and then it goes away after that. It was reported that the first week was high in rash and rash was much more longer and now it has stay the same. She saw daily outbreak, even now she had itching. It seems to have threshold. Later reported as it got better. The patient underwent lab tests and procedures which included heart rate increased on 05Oct2021 After she had the shot she had problems with her heart rate, weight was about a 198 or 197 lbs on an unspecified date. Therapeutic measures were taken as a result of events. At the time of this report the outcome of event she had a bad rash all over the body, hives; the rash and hives it's like eruption; heat becomes the rash and not much hive anymore but it's a generalized rash that moved all way down to my leg was recovering and other events was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported seizure like phenomena cannot be completely excluded based on temporal association. 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.,Linked Report(s) : US-PFIZER INC-202101511810 Same patient and drug, different event separated in time