Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Eczema, Feeling hot, Granuloma annulare, Herpes zoster
Clinical narrative: tiny little blisters that were similar to shingles or chicken pox; tiny little blisters that were similar to shingles or chicken pox; It stings; She burns and itches; She burns and itches; In Jun2021 it was prickly and rash; Granuloma Angluar; She is discombobulated with all this; she had eczema; she was hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Lot number: EW0161) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar and maniac depressive" (unspecified if ongoing), notes: caller is bipolar and maniac depressive; "sciatica" (unspecified if ongoing); "depression" (unspecified if ongoing); "Bipolar and maniac depressive" (unspecified if ongoing), notes: caller is bipolar and maniac depressive. The patient took concomitant medications. Vaccination history included: BNT162b2 (Covid19 vaccine first dose, Date: 25Mar2021, Lot: EP7534, NDC: unknown, EXP: unknown, Manufacturer: Pfizer), administration date: 25Mar2021, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "It stings", "she burns and itches", "She burns and itches", "Blister", "she was covered head to toe with tiny little blisters that were similar to shingles or chicken pox"; Flu shot (she gets flu shot yearly but did not get flu shot this year), for immunisation. The following information was reported: BLISTER (medically significant), outcome "not recovered", HERPES ZOSTER (medically significant), outcome "unknown" and all described as "tiny little blisters that were similar to shingles or chicken pox"; ARTHROPOD STING (non-serious), outcome "unknown", described as "It stings"; BURNING SENSATION (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "She burns and itches"; RASH (non-serious), outcome "unknown", described as "In Jun2021 it was prickly and rash"; GRANULOMA ANNULARE (non-serious), outcome "unknown", described as "Granuloma Angluar"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "She is discombobulated with all this"; ECZEMA (non-serious), outcome "unknown", described as "she had eczema"; FEELING HOT (non-serious), outcome "unknown", described as "she was hot". The events "tiny little blisters that were similar to shingles or chicken pox", "it stings", "she burns and itches", "in jun2021 it was prickly and rash", "granuloma angluar", "she is discombobulated with all this", "she had eczema" and "she was hot" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy: Unknown result, notes: he did two biopsies; Unknown result, notes: he did two biopsies; Blood test: Unknown result, notes: caller did blood work recently; autoimmune deficiencies: negative, notes: caller was negative for autoimmune deficiencies; pH body fluid: Unknown result, notes: They did her pH. Therapeutic measures were taken as a result of blister, herpes zoster, arthropod sting, burning sensation, pruritus, rash, granuloma annulare, confusional state, eczema, feeling hot.  Clinical Course: Reaction / Event as Reported by the Primary Source for Translation: tiny little blisters . Outcome of reaction/event at the time of last observation: Unknown. Reaction / Event as Reported by the Primary Source for Translation: Her arms were crevices and bleeding and striation, and everything felt burned. Term highlighted by the reporter: Yes, highlighted by the reporter, serious. Results in death: No Information. Life threatening: No Information. Caused/prolonged hospitalization: True. Disabling/Incapacitating: No Information. Congenital anomaly/birth defect: No Information. Other medically important condition:- No Information. Outcome of reaction/event at the time of last observation: Unknown. Dosage and Relevant Information: Batch/lot number: EW0161. Dates when patient was in hospital for Her arms were crevices and bleeding and striation and everything felt burned: Unspecified to Unspecified. Additional Context: Warm transfer from (Name withheld). Calling about Covid19 vaccine. She got the first dose 23Mar2021 and second dose 15Apr2021. A year ago. After getting those doses she was covered head to toe with tiny little blisters that were similar to shingles or chicken pox. Went to the dermatologist to get medication for blisters and the dermatologist can't provide any cream that is effective in curing that. Even until today she still had blisters. She wanted to get compensation from Pfizer. She was miserable. She burns and itches. It stings. Her arms look like she has been in a fire. She had been outgoing and athletic and a teacher of aerobics and a supervisor with the city. She was a person that would stand on stage and introduce other. She has had such a lack of energy and disappointment in how she reacted to the vaccine in her opinion. She couldn't think of anything else that would bring on such welts and blistering feelings. She was 59 now and would have been 57 then. She never had anything before. She would be outside and enjoy and now can't hardly walk her dog without literally in 10 minutes feeling blistery and rashed where she had to put wash cloths under her breast to get back to the car to rest. She had been to four dermatologists, and one did take the initiative to report it to the CDC. Caller was in a CDC journal for Granuloma Angluar. Granuloma is the lesion and Angular is the cluster of skin that is built up like the thickness. She has had 4 biopsies. The caller got them as soon as they said they were available for 50 and older. The years run together. HCP Information: She has 2 doctors that are working with her right now. Also, would like to list her allergist. The person she works with right now gives her attention and has done extra blood work and done biopsies. The caller was seeing the head director of the group now. The group was called (name withheld) Dermatology. He was the main guy and put caller on a new medicine for 8 weeks. The caller did blood work recently with him and he did two biopsies. The caller will follow up with him this week and will do blood in 2 weeks. The caller will go back to see him to see if the oral is helping. When the caller was in the hospital the dermatologist that she saw said she had eczema, which is a joke. People are saying this is not eczema. He was the doctor that came into the hospital, and she followed him when she goes out of hospital. The caller clarified that she was hospitalized from 20Jan2022 through 24Jan2022. She was in the hospital due to calling insurance and the doctor said to go to hospital. She was in misery and bleeding and striation, and everything felt burned. Caller went straight to emergency room. Her arms were oozing with pus. Then she had rash up and down leg and around neck and under arms. She was discombobulated with all this. Dr. (Name withheld) prescribed Dupixent 300ml every other week. It was an injection. It is 3000 dollars, and the caller was on a program because her insurance doesn't cover it. She was getting 6 months now. Dupixent is supposed to be for asthma. Dupixent: NDC: 0024-5915-02. LOT: 2F131A. EXP: 31May2024. It has to be in the fridge. The Dupixent is also for eczema because it stops the growth of cells from growing over and over and over. She started the loading dose which was two in 02Feb2022. She was supposed to feel better within 16 weeks, and it has been 26 weeks. The loading dose was two doses at doctor's office, but now caller gives it to herself. The caller didn't want to shake it up or drop Dupixent. Dupixent is like an Epipen. She takes it tomorrow and then will reorder for three months. The caller clarifies the NDC/LOT/EXP she provided for Dupixent is what she will use for her dose tomorrow.  She has previous cases because she sends them back in a gigantic container. She is not sure if that would be on the pen cases or not. She had one Dupixent that did not go right, and she bled out and serum came out. Then she had use another one, so they had to send her an extra one. She submitted that information previously to that company and they sent her 6 pages to fill out. She didn't understand and didn't have the time or the patience to fill that out. The caller clarified that she doesn't have any others Dupixent on hand to provide NDC/LOT/EXP for. She has also seen a Rheumatologist and doesn't have no autoimmune deficiencies. They thought it might be lupus, but it was not. Event Details: Tiny little blisters: she was at her timeshare and was completely broken and couldn't go outside. This was around 03May2021 when she started breaking out all over stomach, breast, crotch, down rear end, under arm, and around back. She is looking at pictures. In Jun2021 it was prickly and rash. Biopsy was around 15Jun2021. The caller thought she was hot, and it was (place name withheld) and then it exploded. Outcome: still experiencing severe blisters. They told her to get the booster. She is surprised they told her to get the booster. The allergist and the dermatologist said to get the booster because the evil of the two would have been catching Covid with this particular rash and her immune system shot. That would be better than not having a booster. She has no idea when she got booster and doesn't have it written down. Maybe Oct2021. Caller didn't have NDC/LOT/EXP for booster Covid19 vaccine. The caller clarified she got booster in Nov2021 because it was six months after the first two injections. She was due for booster and did not take flu shot because she was not supposed to take anything while on Dupixent. Caller clarified that she got her Covid19 vaccine booster prior to starting Dupixent. She was in misery. The allergist is Dr. (Name withheld). The caller took two allergy pills because in (withheld) everything is blooming. Went to allergist twice. One year later the allergist couldn't believe that the caller still had it. The allergist did the original biopsy.  Saw Rheumatologist at the hospital and then for follow up. The Rheumatologist took 7 vials for autoimmune deficiency and caller was negative for autoimmune deficiencies. The caller stated she was a mess. Concomitant Medications: caller is Bipolar and manic depressive. She is on disability for scoliosis and sciatica and that creates depression. She is on depression medication. She is on antidepressant and antianxiety. Through the allergist caller is on allergy pills that she takes as needed. The caller was in restaurant business and would get hives from the heat in (withheld). That would be it. Basically, antidepressant and anxiety meds. Allergy pills are as needed throughout the year because (withheld) is blooming every day. She had been on those medications for 7 years. She has been on disability for 7 years due to lower back issues due to sports injury and curvature of spine as she got older. Caller also takes thyroid medication. She goes to the doctor tomorrow for blood work for thyroid. Caller has been on thyroid medication for 5 years. She has no new lotion, hair products or anything. Medical Conditions: she did see the psychiatrist as needed for meds. The caller didn't get shingles shot and she won't because she is not supposed to with Dupixent. The caller had never been in the hospital before. She has no children. She gets flu shot yearly but did not get flu shot this year. She took care of her neighbor that was 100 years old, and they brought in a hospice bed. The caller had been around hospice environment and got staph in her toenails, like a fungus. That is the only thing that the caller can think of. It was a couple of blisters and fungus. The caller blames that on the hospice bed. You never know what you will pick up. Her neighbor died in 2017 so that would have been 5 years ago, so prior to getting Covid19 vaccines. Right after biopsy they were saying she had Granuloma Angular. That felt like measles, chicken pox, and shingles from head to toe. She had to go to the eye doctor. They put her on Hydroxychloroquine starting in Jul through Oct, for 4 months. Took 400mg per day to aggressively try and contain the Granuloma Angular. Took Hydroxychloroquine along with prednisone 10ml that she had to taper off. Caller didn't have NDC/LOT/EXP to provide for Hydroxychloroquine or Prednisone. The products came from pharmacy. It was aggressive because it was such a burning situation. With Hydroxychloroquine and Prednisone, the results of quitting those medication she had purpula which is thinning of the skin on the legs that created those purple dark red blotches that people get when they hit the side of a desk or bed or end of the table when 85 years old. Her skin got extremely thin as a result of getting Prednisone as a result of Granuloma Angular in her opinion from the Pfizer Covid19 vaccine. The caller had to wrap her legs and elevate them and put cold packs on them from Oct through Jan. The Hydroxychloroquine is what caused her arm because supposedly Hydroxychloroquine causes eczema. The one doctor said it was eczema and the other said Granuloma Angular. The caller was in hospital looking like she had leprosy and was contained in the emergency room because there were no beds in hospital due to Covid. She slept because she couldn't stand the itching and they gave her Benadryl. Three antibiotics didn't do it. They gave her Norco because she had headaches. She was in the Emergency Room with at least a curtain then they said they would transfer her she said she would stay in the hallway. She didn't want to go 20 miles. They put her in the bed in the Emergency Room. She had to have bed sheets changed every four hours because of the scabbing and bloody sheets. They also put her on Clobetasol which is like a topical ointment. It is not a steroid. No steroids. Caller can't do any of them now because the itching is so bad. Also was on Mupirocin ointment which is like an antibiotic ointment when a sore would open. It is an ointment for open wounds. Mupirocin Ointment was like a Neosporin. The Clobetasol was to be rubbed on the thickness of the clubs of skin. Then they put her on Triamcinolone Ointment that didn't work. Mupirocin: NDC: 68462-180-22. LOT: 19227047. EXP: Feb2024. strength: 2% Caller clarified that it burned. Caller doesn't use anything anymore. She walks her dog, lays in bed naked and then walks the dog. That wass all she did. The caller clarified that the three antibiotics that didn't do it were given in the hospital through the IV and none of them worked. No further details were provided about the antibiotics. Her sciatic hurts so she knows it will storm. Triamcinolone Ointment: NDC: 45802-055-05. LOT: 1JT0348. EXP: Aug2023. Strength: 0.1%. It is a step down from Clobetasol. Clobetasol was a little bit stronger. Also was given Eucerin and CeraVe and have patches. They gave her samples and she bought CeraVe over the counter. Also had SSD which was for open sore. It was a sateen cream. 1% Silver Sulfadiazine Cream. NDC: not provided. LOT: hard to read because she used it with her fingers around it. She has her glasses and has a light on. She has to get the flashlight out. The lot looks like L100517. She feels like she was in an eye exam. EXP: she can barely see it, looks like May2024. She had tried two more that burned so bad from inside out that she had to get prescribed another allergy pill. Clobetasol: it was a tube. NDC: unknown. LOT: unknown. EXP: unknown. Strength: .05 ointment. She quit using everything. Clobetasol was the aggressive ointment. It was the original cream that she would use as soon as she would get out of the shower. It worked with the Hydroxychloroquine and the Prednisone. It started burning then they switched her to Triamcinolone and then the sateen and then the Mupirocin. Recently came from Dr. (name withheld) because this thing is just growing up her back and up shoulder blades and neckline. Two more things they prescribed. Fluocinonide topical solution, strength .05%, apply once a day before noon. Fluocinonide kind of comes out like watery but goes on dry. It burned like hell. It said it would burn. After a couple of times she couldn't do it. Fluocinonide: LOT: AC49056. EXP: Feb2024. NDC: 516721273-4. She thinks she used Fluocinonide twice. It burned so bad. At night she was supposed to use the one that is oily and more of an ointment, Tacrolimus Ointment, strength .1%. She did it a couple of times and it burned. Tacrolimus Ointment: LOT: LW1017. EXP: Aug2023. NDC: 0168-0416-99. After she took Fluocinonide and Tacrolimus Ointment she was burning from inside out and they prescribed her Hydroxyzine HCl 25mg twice a day. Hydroxyzine HCL: NDC/LOT/EXP: unknown as product is in pharmacy vial. The brand new one that Dr. (Name withheld) prescribed for 8 weeks is a prescription from the pharmacy. It is Dapsone Tablets USP 100mg once a day. LOT: M20215A. EXP: Aug2023. NDC: 70954-136-10. She had started Dapsone to see if it will slow down the thickening. She could feel it. If she didn't put on CeraVe her skin would be like a snake, it burns and itches. Investigations: they did 50 vials of blood while she was in the hospital. They did her pH and everything she could imagine.  For compensation she is looking for more time becasue her copays weren't that bad. A whole year and a half beyond Covid were her sitting in bed trying to keep cool. That is more of the mental and depressive results she got from that reaction. Is there a product complaint to report: Yes. Description of Product Complaint: PC Not on suspect product. Description of complaint: Dupixent: Supposed to feel better within 16 weeks and it has been 26 weeks. Had one Dupixent that did not go right, and she bled out and serum came out. She submitted that information previously to that company and they sent her 6 pages to fill out. Product strength and count size dispensed: not provided. Additional lot numbers: For her dose tomorrow NDC: 0024-5915-02, LOT: 2F131A, EXP: 31May2024. The caller clarified that she doesn't have any others Dupixent on hand to provide NDC/LOT/EXP for. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact. not provided. PC Not on suspect product then they put her on Triamcinolone Ointment that didn't work. NDC: 45802-055-05, LOT: 1JT0348, EXP: Aug2023, Strength: 0.1%. PC Not on suspect product. Dermatologist can't provide any cream that is effective in curing. Put her on Clobetasol which is like a topical ointment, NDC/LOT/EXP: unknown. Also was on Mupirocin ointment, which is like an antibiotic ointment, NDC: 68462-180-22, LOT: 19227047, EXP: Feb2024, strength: 2%. Prescribed Fluocinonide topical solution, strength .05%, LOT: AC49056, EXP: Feb2024, NDC: 516721273-4. Fluocinonide kind of comes out like watery but goes on dry. Supposed to use the one that is oily and more of an ointment, Tacrolimus Ointment, strength .1%, LOT: LW1017, EXP: Aug2023, NDC: 0168-0416-99. Also was given Eucerin and CeraVe and have patches. They gave her samples and she bought CeraVe over the counter. Also has SSD, which was for open sore, 1% Silver Sulfadiazine Cream. NDC: not provided, LOT: hard to read because she used it with her fingers around it. She had her glasses and has a light on. She had to get the flashlight out. The lot looks like L100517. She feels like she was in an eye exam. EXP: she could barely see it, looks like May2024.