Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Emotional disorder, Haemorrhage, Investigation
Clinical narrative: bleeding; Her arms were crevices; everything felt burned; She was in misery; rash; Her arms were oozing with pus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar and manic depressive" (unspecified if ongoing), notes: caller is Bipolar and manic depressive; "disability for scoliosis" (unspecified if ongoing); "sciatica" (unspecified if ongoing); "depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "thyroid medication" (unspecified if ongoing), notes: Caller has been on thyroid medication for 5 years, She has no new lotion, hair products or anything.; "sports injury" (unspecified if ongoing); "curvature of spine as she got older" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Covid19 Vaccine: Dose 2, Single, Date: 15Apr2021, LOT: EW0161, EXP: unknown), administration date: 15Apr2021, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "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", "Itchy", "She is discombobulated with all this"; BNT162b2 (Covid19 Vaccine:Dose 2, Single, Date: 15Apr2021, LOT: EW0161, EXP: unknown), administration date: 15Apr2021, when the patient was 58-year-old, for Covid-19 Immunization, reaction(s): "In Jun2021 it was prickly and rash", "Granuloma Angluar", "she had eczema", "she was hot"; BNT162b2 (Covid19 Vaccine first dose, Date: 25Mar2021 , LOT: EP7534, 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"; Flu (She gets flu shot yearly but did not get flu shot this year.), for Immunization.  The following information was reported: HAEMORRHAGE (hospitalization, medically significant), outcome "unknown", described as "bleeding"; SKIN FISSURES (hospitalization), outcome "unknown", described as "Her arms were crevices"; SKIN BURNING SENSATION (hospitalization), outcome "unknown", described as "everything felt burned"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "She was in misery"; RASH (non-serious), outcome "unknown"; PUSTULE (non-serious), outcome "unknown", described as "Her arms were oozing with pus". The events "bleeding", "her arms were crevices", "everything felt burned", "she was in misery", "rash" and "her arms were oozing with pus" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results; Unknown results; Blood test: Unknown results; autoimmune deficiencies: Negative, notes: negative caller was negative for autoimmune deficiencies; pH body fluid: Unknown results, notes: They did her pH. Therapeutic measures were taken as a result of haemorrhage, skin fissures, skin burning sensation, emotional disorder, rash, pustule.  Clinical Course: was report related to a study or programme was reported as Yes, Details: 159558 Pfizer Support. She is miserable. She burns and itches. It stings. Her arms look like she has been in a fire. She had been out going 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 can't think of anything else that would bring on such welts and blistering feelings. She is 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 has to put wash cloths under her breast to get back to the car to rest. 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. Her arms were crevices 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 is discombobulated with all this. Dr. prescribed Dupixent 300ml every other week. It is an injection. It is 3000 dollars and caller is on a program because her insurance doesn't cover it. She is getting 6 months now. Dupixent is supposed to be for asthma. Dates when patient was in hospital for Her arms were crevices and bleeding and striation and everything felt burned: Unspecified to Unspecified. was Covid19 Vaccine a Pfizer product was reported as Yes. They told her to get the booster. She was 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. 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. That would be better than not having booster. She has no idea when she got booster and doesn't have it written down. Maybe Oct2021. Caller doesn't have NDC/LOT/EXP for booster Covid19 vaccine. Caller clarified she got booster in Nov2021 because it was six months after 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.. Caller takes two allergy pills because everything is blooming. Went to allergist twice. One year later the allergist couldn't believe that caller still had it. The allergist did the original biopsy. Caller states she is a mess. Medical Conditions: she did see the psychiatrist as needed for meds. Caller didn't get shingles shot and she won't because she is not supposed to with Dupixent. 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. Caller had been around hospice environment and got staph in her toe nails, like a fungus. That is the only thing that caller can think of. It was a couple of blisters and fungus. 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. Caller clarified that it burned. Caller doesn't use anything anymore. She walks her dog lays in bed naked and then walks dog. That is all she does Caller clarified the three antibiotics that didn't do it were given in the hospital through the IV and none of them worked. No further details provided about the antibiotics. Her sciatic hurts so she knows it will storm. Triamcinolone Ointment: Strength: 0.1%. It is a step down from Clobetasol. Clobetasol was a little bit stronger. At night she is 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. For compensation she is looking more for time becasue her copays weren't that bad. A whole year and a half beyond Covid was her sitting in bed trying to keep cool. That is more of the mental and depressive results she got from that reaction Saw Rheumatologist at hospital and then for follow up. The Rheumatologist took 7 vials for autoimmune deficiency and caller was negative for autoimmune deficiencies. 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 400 mg per day to aggressively try and contain the Granuloma Angular. Took Hydroxychloroquine along with prednisone 10ml that she had to taper off. Caller doesn'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 was 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. Caller had to wrap her legs and elevate them and put cold packs on them from Oct through Jan. The Hydroxychloroquine was what caused her arm because supposedly Hydroxychloroquine causes eczema. The one doctor said it was eczema and the other said Granuloma Angular. 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 was like a topical ointment. It was not a steroid. No steroids. Caller can't do any of them now because the itching was so bad. Also was on Mupirocin ointment which was like an antibiotic ointment when a sore would open. It was 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. Caller clarified the three antibiotics that didn't do it were given in the hospital through the IV and none of them worked. No further details provided about the antibiotics. Also has SSD which was for open sore. It was a sateen cream. 1% Silver Sulfadiazine Cream . She has tried two more that burned so bad from inside out that she had to get prescribed another allergy pill. Clobetasol: it was a tube ,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 form doctor because this thing was just growing up her back and up shoulder blades and neck line. 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. 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 was 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 was in pharmacy vial. The brand new one that Dr. prescribed for 8 weeks was a prescription from the pharmacy. It was Dapsone Tablets USP 100mg once a day LOT: M20215A EXP: Aug2023, NDC: 70954-136-10,was a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact was not provided, Then they put her on Triamcinolone Ointment that didn't work. NDC: 45802-055-05, LOT: 1JT0348, EXP: Aug2023, Strength: 0.1%, Dermatologist can't provide any cream that was effective in curing. Put her on Clobetasol which was like a topical ointment, NDC/LOT/EXP: unknown. Also was on Mupirocin ointment which was 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 was 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 has patches. They gave her samples and she bought 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 has her glasses and has a light on. She has to get 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 Investigations: they did 50 vials of blood while she was in the hospital. They did her pH and everything she can imagine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.