Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Depression, Pruritus, Rash, Rash papular
Clinical narrative: Urticarial rash; The itching is unbearable. It is embarrassing, scratching and, people looking at her, itching, on inner thighs outer thighs, arm. Clarified, it was both thighs and left arm; knows it was like a cluster, a red bump; Starting to get depressed; real bad rash on neck, had gone from arm to back, to around stomach, rash covered whole body, all over her neck, got to side of her face, rash covered all around breasts and all around neck; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing); "knee replacement" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: ER8732), administration date: 27Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "soreness"; BNT162b2 (DOSE 2, SINGLE, LOT: EW0169), administration date: 17Apr2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "soreness"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: right arm, Batch/Lot number: looks like FJ9943 Quantity 03ml.), administration date: 30Jun2022, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "soreness"; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Anatomical Site of injection: right arm, takes flu shot there, too , Batch/Lot number: CJ2524 same quin 03ml), administration date: 01Nov2022, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "soreness"; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Anatomical Site of injection: might have been in left arm , Batch/Lot number: 081-634), administration date: 16Sep2022, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "soreness". The following information was reported: RASH (medically significant) with onset Nov2023, outcome "unknown", described as "real bad rash on neck, had gone from arm to back, to around stomach, rash covered whole body, all over her neck, got to side of her face, rash covered all around breasts and all around neck"; URTICARIA (medically significant), outcome "unknown", described as "Urticarial rash"; PRURITUS (medically significant), outcome "unknown", described as "The itching is unbearable. It is embarrassing, scratching and, people looking at her, itching, on inner thighs outer thighs, arm. Clarified, it was both thighs and left arm"; RASH PAPULAR (medically significant), outcome "unknown", described as "knows it was like a cluster, a red bump"; DEPRESSION (non-serious), outcome "unknown", described as "Starting to get depressed". The events "real bad rash on neck, had gone from arm to back, to around stomach, rash covered whole body, all over her neck, got to side of her face, rash covered all around breasts and all around neck", "urticarial rash", "the itching is unbearable. it is embarrassing, scratching and, people looking at her, itching, on inner thighs outer thighs, arm. clarified, it was both thighs and left arm" and "knows it was like a cluster, a red bump" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: Unknown results. Therapeutic measures were taken as a result of rash, urticaria, pruritus, rash papular.  Additional infromation: Call regarding Pfizer Booster shot she took Nov2023, clarified as Pfizer Covid booster shot. 3 weeks after taking shot, developed real bad rash on neck, which is why she took the vaccine. Went to (Withheld), told the lady she put a little bleach and dishwater on like she always does. Was told, maybe she had chemical reaction. They gave her Prednisone, sent her home. On 12Dec2023, went back to (Withheld), this time, rash, had gone from from arm to back, to around stomach. They gave her more Prednisone, told her she had to take those again and maybe change soap and dish detergent, went home. On 27Dec2023, went back there because, this time, rash had covered her whole body, it would come and go in spats. First, they thought she had hives, then, said it was some type of rash, that started with a U. In hospital, they gave her shot, then sent her home with steroids. Name of rash provided as Urticarial rash. Ended up in emergency room because this time, was all over her neck, got to side of her face. Asked, could there be something wrong, they kept telling her it was just a rash. Last visit, on 05Jan2024, went in because, back neck was just rash, was all over her body. Christmas day, woke up, rash was covered all around her breasts and all around her neck. The nurse on staff told her to call a dermatologist, and she did. When she went there they gave results, the one doctor told her to take shots at least twice a week, then one shot every 7days, then days 12 to 15 weeks, to make serum. Went to 2 different dermatologists, who are brothers. When she went to the other doctor, when raising up her sleeve, to get shot, they said, she did not need them. Had asked doctor for epi pen, they said she did not need that either. Is still having this rash, it comes and goes. Has really effected her since Nov2023. She took the shots 3 weeks prior to the first rash. Never had nothing like this before, in her life. The itching is unbearable. It is embarrassing, scratching and, people looking at her. Her son was asking what was wrong with her body, asked if it was contagious. It is all over her thighs, all in her back. Used Aveno lotion, tried stuff like Zema, honey stuff, hydrocortisone. Takes pills now, every day, takes Cetirizine HC 10mg. Has taken every other Covid shot, when they first came out. Has taken all of them, and booster shots, when they first came out. Never had reaction, only thing she ever had was just a little soreness. Had been hesitant about calling Pfizer. Today, is going on 4 months. The patient saw the prescribing healthcare professional when she first went to (Institute name withheld). Went there twice, went to emergency room twice. Has her own private doctor, who she is going to see in (Address withheld). Contacted him, he told her wanted to see her skin. Told doctor what dermatologist wanted to do. Wasn't sure if she wanted to go with the shots, did not want more injections in her body. She was really skeptical about calling. Over the weekend, was steady scratching. Son told her she had to call. Son had been looking and saw the side effects, that one of them was itching, hives and rash. Son told her she needed to call because that is what she is having. Took everything when they first came out with Covid vaccines, all she ever had was Pfizer shots, never had problems. Had sore arm once, that was it. When she got the shot, the medicine was like, different, when it went in her arm. Clarified, she was referring to the vaccine, the Covid vaccine when it went in her arm. Outcome of event: It had gotten worse. First, was just her arm, now has covered both thighs, lower part of back, middle part of back. When she went to emergency room last time on 05Jan2024, was like, she woke up, there was knot on back of her neck, was all around neck, collar bone was just rashed up, red. After what ever shot they gave her in hospital, she knows it was like a cluster, a red bump. Was having itching, on inner thighs outer thighs, arm. Clarified, it was both thighs and left arm. Clarified, it was just left arm today, tomorrow, may wake up and it may be clear. As soon as she puts lotion or something, on skin, does not take hot shower. Doctor says, not to take hot showers and to use this cream. Has bought so many different creams. Got ice pack, puts towel on, kind of lays down, where it is itching. That gives her some kind of relief. Then, after a while, during night, wakes up, sees she has broke out. It doesn't really ever leave the body, just goes from one part of the body to another. When she went to second dermatologist, the brother of the first dermatologist, the one told her she didn't need shots, the other told her they wanted to give her shots, for skin allergies. Never had that before, in her life. Has never had reaction like this, never. Clarified, caller was never admitted to hospital when she had gone to emergency room. In the ER, they gave her steroids, sent her home, told her to contact her primary care doctor. The last time, they said to contact dermatologist. Treatment: Clarified, she had been given steroids. They gave her Prednisone 20mg. They gave her another pill to take, Hydroxyzine HCl 25mg, they want her to take at bedtime. Clarified she was also given another pill, previously mentioned, Cetirizine Hcl 10mg. These are what the dermatologist gave her, these pills. Famotidine 20mg, they want her to take twice a day. Clarified, these were all prescribed for the rash. Clarified, as previously stated, caller also used ice packs. Got Aveno lotion, honey zema cream, Cervae lotion and Certile cream. Got Aveno, 1 percent hydrocortisone anti itch cream. Is using almost 3 or 4 different creams, wants to use just one, to stop the itching. It was reported that the patient has medical history of asthma, sometimes, does go outside, wants to stay healthy. Stays in when numbers are high, does wear masks, does go to church, does not really go out, stays in high rise, in own apartment. Just got grandkids, kids. Lost lot of friends to Covid. Concomitant medications was reported as no more than the medication she has been taking for a long time. Takes low dose blood pressure pill, takes medicine for asthma. Other than that, take vitamins. It was reported that the patient had flu shot (on right arm) on same day as last booster shot, Nov2023. Test results was reported that last time, went to dermatologist, they sent her to lab, for blood work. Had asked them what TSH stands for, was told, it was thyroid. Does not go back to this doctor until 12Apr2024. Never had problem with thyroid, does not know why they would test thyroid for a rash. That was the only test the dermatologist had her do. Clarified, she had 2 doses prior to the other doses of Pfizer Covid vaccine mentioned, clarifying she had 6 total doses Covid vaccine, including, most recent Pfizer Covid booster, Nov2023, caller stating, was before 17Nov2023. AE required visit to emergency Room; Physician Office; Is going to see primary doctor next Wednesday. He wants to see her skin. Trusts this primary doctor dearly. Starting to get depressed because, just to sit home and just scratch all day and then have this stuff all over her body, that she does not know where it is coming from. It is not a good feeling. At 69 years old, other than that, has been all right, asthma under control and patient was pretty well healthy. Only other thing is, had knee replacement. Other than that, is good. 3 years retirement, this is what she gets.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400054461 same reporter/patient/drug, different doses/AE;US-PFIZER INC-202400054517 same reporter/patient/drug, different doses/AE;US-PFIZER INC-202400054516 same reporter/patient/drug, different doses/AE;US-PFIZER INC-202400054515 same reporter/patient/drug, different doses/AE;US-PFIZER INC-202400054514 same reporter/patient/drug, different doses/AE;