Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood test, Inflammation, Investigation, Muscle strength abnormal
Clinical narrative: peel the skin\the skin started peeling; One blister on her foot went to 4 blisters, it was her left foot; was burning down to layers of her skin. It was like she was taking layers of her skin; Foot swollen up, twice it's size; some red dots that turned into blisters\blisters started on her feet, left foot; lesions on her skin\they became lesions, they were  clumps of lesions; The left leg started getting real dark; All they could find was that it was all inflamed; some red dots that turned into blisters\little red dots; painful\the pain was so bad; was getting drop feet; physical therapy to get muscle strength back; a big effect on her nerves; muscular dystrophy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 (Lot number: EW0170) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Muscular dystrophy" (unspecified if ongoing); "charcot tooth" (unspecified if ongoing), notes: Verbatim: charcot tooth; "peripheral nerve disorder" (unspecified if ongoing), notes: Verbatim: peripheral nerve disorder; "Osteopetrosis" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN (ongoing); ALENDRONATE taken for osteopetrosis (ongoing). Vaccination history included: Bnt162b2 (dose:1st , LOT: EW0162, Caller states the only other number on the card is the patient medical number, #), administration date: 19Apr2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset 14Jun2021 11:09, outcome "unknown", described as "some red dots that turned into blisters\little red dots"; BLISTER (non-serious) with onset 27Jun2021, outcome "unknown", described as "some red dots that turned into blisters\blisters started on her feet, left foot"; SKIN LESION (non-serious) with onset 22Jun2021, outcome "unknown", described as "lesions on her skin\they became lesions, they were clumps of lesions"; SKIN BURNING SENSATION (non-serious) with onset 30Jun2021, outcome "unknown", described as "was burning down to layers of her skin. It was like she was taking layers of her skin"; PERONEAL NERVE PALSY (non-serious) with onset 2021, outcome "unknown", described as "was getting drop feet"; MUSCLE STRENGTH ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "physical therapy to get muscle strength back"; NERVE INJURY (non-serious) with onset 2021, outcome "unknown", described as "a big effect on her nerves"; MUSCULAR DYSTROPHY (non-serious) with onset 2021, outcome "unknown", described as "muscular dystrophy"; SKIN EXFOLIATION (non-serious) with onset 01Jul2021 16:17, outcome "unknown", described as "peel the skin\the skin started peeling"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "painful\the pain was so bad"; PERIPHERAL SWELLING (non-serious) with onset 29Jun2021 19:49, outcome "unknown", described as "Foot swollen up, twice it's size"; BLISTER (non-serious) with onset 01Jul2021 16:17, outcome "unknown", described as "One blister on her foot went to 4 blisters, it was her left foot"; SKIN DISCOLOURATION (non-serious) with onset 22Jun2021, outcome "unknown", described as "The left leg started getting real dark"; INFLAMMATION (non-serious) with onset 22Jun2021, outcome "unknown", described as "All they could find was that it was all inflamed". The events "some red dots that turned into blisters\little red dots", "some red dots that turned into blisters\blisters started on her feet, left foot", "lesions on her skin\they became lesions, they were clumps of lesions", "peel the skin\the skin started peeling", "painful\the pain was so bad", "one blister on her foot went to 4 blisters, it was her left foot" and "all they could find was that it was all inflamed" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash macular, blister, skin lesion, skin burning sensation, muscle strength abnormal, skin exfoliation, pain, peripheral swelling, blister, skin discolouration, inflammation.  Additional information: No additional vaccines administered on same date of the Pfizer suspect. She saw him for a month and for 2 weeks, he took care of her with all the blisters and the lesions. They had to give her Morphine Sulfate, the pain was so bad. Little red dots started on 19Jun2021 with these red dots on her right leg, below her knee and in the left leg. 14Jun2021 at 11:09am, they appeared. Maybe 22Jun2021, they became lesions, they were clumps of lesions. They just started on the lower legs, the right and left. The left leg started getting real dark, trying to peel the skin was. This was 22Jun2021. She was packing it with ice and then the blisters started. 27Jun2021 blisters started on her feet, left foot. It was the whole left foot and was turning brown, almost black from the toes up to the ankles. The lesions were above the leg, this was 27Jun2021. The skin started peeling and more lesions would come on. Then, the only thing that would cool it down was cold, cold, cold water. 28Jun2021, little blisters started, and they would not believe the pictures she has. Foot swollen up, twice its size on 29Jun2021 at 7:49 pm. She couldn't see the ankles and bones at all, they were twice the size of her foot. 30Jun2021, she was packing both of her legs in gallon ice packs and wraps. It was burning down to layers of her skin. It was like she was taking layers of her skin off. It was very bad. She went to the dermatologist, and they didn't want to pop no blisters or anything. All they could find was that it was all inflamed and they sent her to a rheumatologist. 01Jul2021, one blister on her foot went to 4 blisters, it was her left foot and was at 4:17pm. 01Jul2021, that right leg, above her knee, was nothing but huge lesions. They formed on the inside of her calf to the outside and was solid red now. She knew that skin was going to peel and more would be coming back. It was taking layers of her skin. She would love to be able to send all these pictures. She went to urgent care and was then sent to the hospital. They said they were dumbfounded and had never seen anything like that before in their life. As soon as she started breaking out and it got painful, she went to urgent care. She was in the ER in the hallway. They did tests on this and that and sent in an infectious disease person who had never seen that before. She was then sent to a rheumatologist. She was in the ER for 9 and a half hours and was not admitted to the hospital. She went to the rheumatologist, and he took care of her. They put her on Hydroxychloroquine and that wasn't working either. Even the dermatologist was putting special cream on, and nothing was working. She went to urgent care, and they told her to go to the hospital. She was in the ER for 9 and a half hours and they were doing tests to make sure it was not blood clots. They were baffled and didn't know; they had never seen that before. Adverse events blisters, lesions required a visit to Emergency Room/Physician Office. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. No relevant medical history (including any illness at time of vaccination). No relevant family medical history to adverse event. Caller asks what the ingredients are from the first shot to the second shot. She states that she wants to see what it is because she wants to go get her booster shot. The special cream that didn't work as, Epiceram, skin barrier, 90grams and states that it says to apply to affected area twice a day as needed on all the lesions. History of all previous immunization with the Pfizer vaccine considered as suspect included Pfizer Covid-19 vaccine, first dose. the expiration date of 29Jun2022 then provides an EXP: Feb2023. Clarified that the 29Jun2021 is the date the medication was prescribed, and the correct expiration date is Feb2023. LOT: 69836. she could not find the NDC number but then provides it as NDC: 68040-752-17. Description of product complaint: The caller was reporting that she had lesions and blisters after the second dose of the Pfizer Covid-19 vaccine. She stated that they put her on Hydroxychloroquine and that wasn't working either. Even the dermatologist was putting special cream on, and nothing was working. They told her to stop taking them because it was not working. It was not improving anything. She stated that the Hydroxychloroquine was written 13Jul2021. That was on the bottle. Product strength and count size dispensed: The prescription says to take 2 tablets by mouth, twice a day and there were 180 tablets. NDC: 57664-0761-88 was provided. The second bottle is the same prescription and provides the NDC: 57664076188, stating it is the same number and states they were a month apart. She asked what the ingredients are from the first Covid shot to the second shot. She states that she wants to see what it is because she wants to go get her booster shot. She was fine before all this and had no problems at all. It was after the second shot that she had all these problems.