Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ecchymosis, Facial discomfort, Hyperkeratosis, Lip discolouration, Skin laxity
Clinical narrative: Pfizer COVID-19 vaccine, booster: wrinkles across the bottom of her chin, underneath her chin; Pfizer COVID-19 vaccine, booster: ecchymotic, all black and blue where the neck reaches the body; Pfizer COVID-19 vaccine, booster: black and blue under her bottom lip; Pfizer COVID-19 vaccine, booster: dysphagia/Pfizer COVID-19 vaccine, booster: difficulty swallowing; Pfizer COVID-19 vaccine, booster: loose neck skin deformity under patient''s chin; Pfizer COVID-19 vaccine, booster: chin is looking disfigured; Pfizer COVID-19 vaccine, booster: debilitating, depressing experience; Pfizer COVID-19 vaccine, booster: debilitating, depressing experience; Pfizer COVID-19 vaccine, booster: skin under her chin was totally hanging, there was a huge piece of what looked like a piece of sausage or a hotdog, of skin, hanging from her neck, a bulge; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Nov2021 15:00 (Lot number: PJT611) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Caller is devastated about what is happening with her face.; "Interchange of vaccine products" (unspecified if ongoing); "bilateral mastectomy", start date: 2011 (unspecified if ongoing); "Hernia surgery" (unspecified if ongoing); "2 neuroma surgeries on her feet" (unspecified if ongoing); "Ovarian cyst" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (first dose:, Date: 18Jan2021, NDC: Unknown, Lot number: 026L20A, Expiration date: Unknown, Dose: Unknown, Route: In right arm, Caller has nothing to report, no side effects.), administration date: 18Jan2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "no side effects"; Moderna covid-19 vaccine (second dose:, Date: 20Feb2021, NDC: Unknown, Lot number: 015M20A, Expiration date: Unknown, Dose: Unknown, Route: In right arm), administration date: 20Feb2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "collagenous colitis", "terrible pain in left arm", "terrible stomach ache", "little bit tired", "fatigue"; Shingles shot (When she got the second shingles shot, her leg got red, the doctor said it's a little rash), for Immunization, reaction(s): "her leg got red", "it's a little rash". The following information was reported: HYPERKERATOSIS (disability, medically significant) with onset 23Dec2021, outcome "not recovered", described as "Pfizer COVID-19 vaccine, booster: skin under her chin was totally hanging, there was a huge piece of what looked like a piece of sausage or a hotdog, of skin, hanging from her neck, a bulge"; SKIN WRINKLING (disability, medically significant), outcome "not recovered", described as "Pfizer COVID-19 vaccine, booster: wrinkles across the bottom of her chin, underneath her chin"; ECCHYMOSIS (disability, medically significant), outcome "not recovered", described as "Pfizer COVID-19 vaccine, booster: ecchymotic, all black and blue where the neck reaches the body"; LIP DISCOLOURATION (disability, medically significant), outcome "not recovered", described as "Pfizer COVID-19 vaccine, booster: black and blue under her bottom lip"; DYSPHAGIA (disability, medically significant), outcome "not recovered", described as "Pfizer COVID-19 vaccine, booster: dysphagia/Pfizer COVID-19 vaccine, booster: difficulty swallowing"; SKIN LAXITY (disability, medically significant), outcome "not recovered", described as "Pfizer COVID-19 vaccine, booster: loose neck skin deformity under patient''s chin"; FACIAL DISCOMFORT (disability, medically significant), outcome "not recovered", described as "Pfizer COVID-19 vaccine, booster: chin is looking disfigured"; ASTHENIA (disability, medically significant), DEPRESSION (disability, medically significant), outcome "not recovered" and all described as "Pfizer COVID-19 vaccine, booster: debilitating, depressing experience". The events "pfizer covid-19 vaccine, booster: skin under her chin was totally hanging, there was a huge piece of what looked like a piece of sausage or a hotdog, of skin, hanging from her neck, a bulge", "pfizer covid-19 vaccine, booster: wrinkles across the bottom of her chin, underneath her chin", "pfizer covid-19 vaccine, booster: ecchymotic, all black and blue where the neck reaches the body", "pfizer covid-19 vaccine, booster: black and blue under her bottom lip", "pfizer covid-19 vaccine, booster: dysphagia/pfizer covid-19 vaccine, booster: difficulty swallowing", "pfizer covid-19 vaccine, booster: loose neck skin deformity under patient''s chin", "pfizer covid-19 vaccine, booster: chin is looking disfigured", "pfizer covid-19 vaccine, booster: debilitating, depressing experience" and "pfizer covid-19 vaccine, booster: debilitating, depressing experience" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: normal; chest x-ray: normal; ultrasound scan: unknown results; weight: about 130 pounds. Therapeutic measures were taken as a result of hyperkeratosis, skin wrinkling, ecchymosis, lip discolouration, dysphagia, skin laxity, facial discomfort, asthenia, depression.  Clinical Course: Caller is devastated about what is happening with her face. Caller is calling because she got the Pfizer booster, her regular shots were Moderna but she had a bad reaction to Moderna, so she got the Pfizer booster. Caller confirms her 3rd shot was the Pfizer COVID-19 vaccine booster. Caller is calling to report adverse events and she would like Pfizer to help her solve her problem. Caller has already been to 6 or 7 doctors. What happened to her is going to be very costly to fix. Caller has a (Privacy) license, Licensed (Privacy) but she hasn't practiced in years Caller had reactions to the Moderna and Pfizer vaccines but her reaction to the Pfizer booster is at the moment 10 times worse. Her reaction is different with the Pfizer COVID-19 vaccine booster. This is the caller's first time calling Pfizer but Moderna knows her by first time. Caller states there is a God because what happened with Moderna, after 6 months, went away. This is very different. No adverse events until about 5 weeks after getting the vaccine. Caller had a bilateral mastectomy in 2011, and when she had the mastectomy she had pain in her left arm because her left breast was giving her trouble, her right breast was good. Caller developed, collagenous colitis about 5 weeks after the vaccine. About 5 weeks after the vaccine, caller was a little bit tired, but she was fine, no pain in her arm, she iced her arm. Nothing to speak of. Caller is going to be 80-years-old, she thought maybe that's why she is tired. Caller states a collagenous colitis symptom is a terrible stomach ache. Caller went to see the doctor and, and they said they hope it goes away. 6 months later the collagenous colitis was gone. Caller knew the Moderna booster vaccine was half because it was probably more potent, so they cut the vaccine booster in half. They didn't give anyone the full syringe. Caller confirmed the collagenous colitis went away. Caller had no side effects until 4 or 5 weeks later. She has pictures. Caller woke up in the morning on 23Dec2021 and the skin under her chin was totally hanging, there was a huge piece of what looked like a piece of sausage or a hotdog, of skin, hanging from her neck, a bulge. She had wrinkles under her chin, line, line, line. In the days after, the thing hanging waned and waxed. Sometimes it was like a big pull, flat, but pulling, a big wrinkle, it wasn't all puffy like in the beginning. Now it's not puffy, it's just a big pull, under the chin. Caller has all of those wrinkles across the bottom of her chin, underneath her chin. Caller has seen 4 dermatologists, 2 family doctors, 1 plastic surgeon. Caller has appointments for 2 more plastic surgeons and an appointment scheduled with a hematologist in April, because in addition to the adverse events she already mentioned, she was all ecchymotic, all black and blue, where her neck reaches her body, she is still a little black and blue. Caller is also black and blue under her bottom lip. The plastic surgeon gave her an estimate of Dollar 27,500 to fix things. His name is (withheld). Caller went to him this week. Caller has another appointment with a plastic surgeon on Friday. Her HCP told her to go see these other people, with the term used as, "loose neck skin deformity under patient's chin" and gives a diagnoses of dysphagia. Caller states she did have difficulty swallowing. Caller states she is a lovely looking woman and to wake up and see this horrible disfigured collection of skin on her neck close to her face, it was overwhelming and that's when she started going to doctors. The dermatologist gave her cream, Halobetasol ointment, which did not work. NDC, lot number, expiration date: unknown, she did not know where that would be. Caller also used Mometasone, this was the first cream she used, Dr (withheld) gave the Mometasone to her. Caller states the cream makes it look better but it doesn't go away. Caller mentions she used Amlactin and Cerave ointment, but nothing helped, some made it worse. Some made her skin irritated, red, and sensitive. NDC, lot numbers, expiration dates for products: For the 2 prescriptions she has the bills with a whole bunch of numbers. Caller doesn't know which number is what and her printer is broken. There are a million numbers on the receipts she has. She can give the numbers at a later date. For her adverse events with Moderna they told her to take Famotidine. Caller states this is still debilitating, a depressing experience. If anyone at Pfizer can help her she would be elated and eternally grateful. Moderna said no one had the side effects caller did, she saw (Privacy) on television saying 50 women, they did a study, had the exact same things in their stomach from the Moderna, so she wasn't crazy. Maybe there are some people who have the same thing, hanging skin, with Pfizer. Caller saw an ear nose and throat man who did a sonogram of her neck. Nothing came up except it was wrinkled. Caller had blood tests and a chest x-ray. Everything was normal for the moment. Caller hasn't had the hematologist do blood work yet, it could be a different scenario.; Sender's Comments: Based on the information provided and the known side effect profile of the vaccine, the events Hyperkeratosis, Skin wrinkling, Ecchymosis, Lip discolouration, Dysphagia, Skin laxity, Facial discomfort and Depression are most likely unrelated and asthenia is assessed as related to BNT162B2 administration.