Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash, Tremor
Clinical narrative: can't sleep; tremor in both hands; rash to where his skin looks scalded/severe rash & severe itching all over his body/rashes disappeared all of a sudden but his body looks like his body was scalded with water/rash broke out; rash to where his skin looks scalded/severe rash & severe itching all over his body/rashes disappeared all of a sudden but his body looks like his body was scalded with water/rash broke out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), (Batch/Lot number: unknown) at every two weeks. The patient's relevant medical history included: "congested heart failure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid shot (Dose 1), administration date: 2021, for COVID-19 immunisation. The following information was reported: RASH (medically significant) with onset 2021, outcome "not recovered", PRURITUS (medically significant) with onset 2021, outcome "unknown" and all described as "rash to where his skin looks scalded/severe rash & severe itching all over his body/rashes disappeared all of a sudden but his body looks like his body was scalded with water/rash broke out"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; TREMOR (non-serious), outcome "unknown", described as "tremor in both hands". The event "rash to where his skin looks scalded/severe rash & severe itching all over his body/rashes disappeared all of a sudden but his body looks like his body was scalded with water/rash broke out" required physician office visit. The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of rash, pruritus.  Clinical course: Caller was calling about the Pfizer COVID shot he received way back in 2021. Caller stated that caller had had a rash to where his skin looks scalded and he wanted to know more information about this and how long would it last or was there any recommendation. Caller was a 71-year old male (turning 72 on 14Nov2023). Caller stated he developed a severe rash and severe itching all over his body. Caller mentioned that he visited the dermatologist and caller mentioned that he has been using the same thing his mother has been using for 71 years. Caller was enrolled in a program for Dupixent shot. Dupixent was administered on both of his legs. Caller was informed by the dermatologist that he would be getting the Dupixent every two weeks for the rest of his life. Caller then called Pfizer and he was informed that the itching and rash will last for the rest of his life. Caller stated that he took 4 shots in 8 weeks, the rashes disappeared all of a sudden, but his body looks like his body was scalded with water which made his dermatologist recommended him to stop taking the Dupixent shot. Caller stated that he went to a different dermatologist and suspected that it was the COVID shot that caused the reaction where he was prescribed with Otezla, but he did not took one as the doctor thinks that he might be healing. Caller stated that now, his body was back to what it was. Caller confirmed that he currently had rash all over his body. Caller wanted to know if this was reported with the Pfizer COVID vaccine. The patient also reported back in 2021, he went to the VA and got the first COVID shot, it was Pfizer. He went back in time that was allotted and took the second shot. Three weeks later he started itching. Pulled off the side of the road but couldn't see anything. A week later, itching became more aggressive and he saw a rash. He took a picture of his body where the rash broke out all over his body. Went to a dermatologist who told him it's the wash/powder/soap he's using. He told this dermatologist he's used the same soap and wash for 71 years so that was not true. Dermatologist said she would try to get caller into a program for the Dupixent shot. Dermatologist gave him a shot in his left leg, caller gave himself a shot in his right leg. Caller spilled 3 drops of the Dupixent shot on his leg. He asked the dermatologist what the drama was about this shot. He would have to give himself a shot every 2 weeks for the rest of his life. He called Pfizer and the girl he spoke to on the phone and before he gave her a chance, he told her it was never FDA approved and the FDA doesn't approve a drug in 6 weeks. The Pfizer representative told him about rash and itching. He told her it was going on for over 2 years and the representative told him it would be for the rest of his life. Stated his body started to heal from the rash, but the Dupixent shot changed it and now his body looks like it's been scalded. He went to Hospital Dermatology and three doctors came in. Caller told the doctors he knew what it was, that it's the Dupixent shot. The doctors told caller he was right. Now his body had returned to the same rash he had when this all started, and it all came from that shot. Stated if the brand Armorall made the cream, he's got it. Nothing works. He's got the triamcinolone acetonide cream UPS 1%. He's got more psoriasis creams. He's using soaps without any chemical in it. Nothing was working. The girl he spoke with previously at Pfizer told him he would have this the rest of his life. Caller doesn't think so. He can't sleep. He's a congested heart failure patient. Had tremor in both hands. He can't hardly handle this.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109808 same patient/product, similar event, diff vaccine type/dose;