Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Listless, Malaise, Off label use, Pain, Pruritus
Clinical narrative: shingles; very uncomfortable; his whole chest under his beard looks like a chemical burn, under his arm looks like a chemical burn and up the back of his neck looks like a chemical burn and it''s very uncomfortable; he was just very listless; The first 2 shots they had were Moderna/they took the Pfizer; The first 2 shots they had were Moderna/they took the Pfizer; She states that he got his booster shot; that night he had a couple of little spots on him/ red bumps; he had a rough night all night he ached and hurt/Achy; yesterday he wasn't feeling good all day, he was just very listless and a lot more breaking out on the opposite side of where he got the shot/wasn't feeling well; poison ivy; did not feel right; tired; blistered and are all over his chest and back; itches; burns; rash; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's wife).   A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD0809), via an unspecified route of administration, administered in Arm Left on 08Nov2021 at 13:45 (age at the time of vaccination was 66 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at Pharmacy. Medical history included cancer survivor from an unknown date and unknown if ongoing (Caller states that she is cancer survivor, and her son has active cancer and is a cancer survivor). There were no concomitant medications. Historically the patient received Flu shot (Prior Vaccinations within 4 weeks he did get a flu shot about 3 weeks ago). Historically the patient received Moderna (Lot number: 025A21A) administered in left arm on 02Mar2021 at 11:00 as dose 1 and received Moderna (Lot number: 045A21A) administered in right arm on 30Mar2021 at 13:30-13:45 as dose 2 both for COVID-19 Immunization (age at the time of vaccination was 65 years). Additional vaccines administered on same date of the Pfizer suspect were reported as none. No AE(s) were reported following prior vaccinations. Patients Medical History (including any illness at time of vaccination) was reported as none. It was reported that the patient had the first 2 shots they had were moderna/they took the Pfizer and the reporter stated that he got his booster shot on 08Nov2021 at 13:45. On 08Nov2021, the patient experienced that at night he had a couple of little spots on him/ red bumps, he had a rough night all night he ached and hurt/achy, yesterday he wasn't feeling good all day, he was just very listless and a lot more breaking out on the opposite side of where he got the shot/was not feeling well, poison ivy, did not feel right and tired. On 09Nov2021, the patient experienced his whole chest under his beard looks like a chemical burn, under his arm looks like a chemical burn and up the back of his neck looks like a chemical burn and it was very uncomfortable and he was just very listless. On 11Nov2021, the patient experienced shingles. On an unspecified date in Nov2021, the patient experienced blistered and are all over his chest and back, itches, burns and rash. On 10Nov2021, the patient was very uncomfortable. The reporter stated that the patient got his booster shot the day before yesterday and that night he had a couple of little spots on him he did not know if it was poison ivy or something, that was like that evening he got the shot at 1pm. The reporter relayed that yesterday he wasn't feeling good all day, he was just very listless and a lot more breaking out on the opposite side of where he got the shot. The reporter stated he mentioned poison ivy as they had been doing some clearing. She stated that this morning, the patient had a rough night, all night he ached and hurt, and he just sighed a lot and was not himself at all. The reporter stated the patient had his bath this morning and his whole chest under his beard looks like a chemical burn, under his arm looks like a chemical burn and up the back of his neck looks like a chemical burn, and it was very uncomfortable. The reporter stated she called and told their doctor and she said she was afraid that the patient was having a reaction and could not get him in today to be seen so she called where they got the shot and they said to have him take 50mg of Benadryl every 4 hours and report to Pfizer. The reporter stated it is his right arm, it was all the way across his chest, she didn't look at his left side and when she saw it, she got on the phone and she knew it wasn't shingles or poison ivy. The reporter stated when she saw it reminded her of getting him to the doctor. The reporter stated that he did not complain, and he was like what was this. The reporter stated he had taken 2 Tylenol last night when he was aching so bad and that's all. He did not take anything else; he was not on any medications. Reporter stated that her husband went to the hospital and that she found out some things and had asked some questions. The reporter stated they got the booster shot and they had both originally had the Moderna. The first 2 shots they had were Moderna. That was back in Mar2021 and then Monday, they got the Pfizer. She stated they said to mix the shots and they took the Pfizer. She stated that right from the beginning, her husband did not feel right. The first day, he was just tired and achy and wasn't feeling well. Then, the next day, he woke up and had some bumps that looked more like scratches. At the time when he poked them it was like a chemical reaction. The reporter stated that she has seen shingles and at this point it did not look like shingles. This morning, he woke up and she pretty much knew that it was shingles. The reporter stated that they were blistered and are all over his chest and back. The reporter provided the lot number for the Pfizer booster as FD0809, and it was clarified that she was referring to the Pfizer Covid booster shot. It was also clarified that when the caller referred to the first 2 Moderna shots, she was referring to the Moderna covid shots. The reporter stated she has a medical assistant background. The reporter stated that her husband did not sleep at all that night, and he woke up thinking that it was poison ivy. The reporter said that it was absolutely not poison ivy and that she really did not know what it was. They called their doctor and explained what happened. The doctor explained that they thought it was a reaction to the shot. They told them to call the pharmacy where he got the shot. They told him to take 50mg Benadryl every 4 hours. It had no effect whatsoever and it has gotten worse. It was clarified that the events mentioned, including the bumps that looked like scratches that looked pretty much like shingles, were reported in yesterday's report but have gotten worse. The reporter stated that when she talked to Pfizer yesterday, they told her that if it did not get any better or had any other symptoms to take her husband to the hospital. This morning, he had not slept, and it was worse, so she took him to the hospital. The reporter clarified that her husband was not admitted to the hospital and stated that they did give him medication. At the hospital they gave him Prednisone and Hydrocodone 5mg for pain. She thought it was Prednisone 12 and another big one that they gave him. She was thinking it was probably something to relieve the itching, but she does not know what it was. She stated that it itches and burns and in a lot of spots it looks like they were trying to open up and are blistered. She was thinking that was the first place it occurred and at first it looked like scratches. Her husband was complaining of itching and was doing really good at not scratching at it. The patient was prescribed Valacyclovir HCl 1mg tablet that he will take for 7 days, and the other medication was Prednisone, 5 tablets, that he would take daily for 5 days. The reporter clarified that both of these medications were given to the patient on that day, while he was at the hospital. The rash had gotten worse. The reporter stated that regarding her husband, she wanted to ask about the shingles. With the shot, she read they were not really 100 percent positive that shingles could be a complication. She asked if that was correct. The reporter clarified that the patient was diagnosed with shingles when he went to the hospital. The reporter asked if shingles have been reported after receiving the vaccine. Reporter seriousness for that night he had a couple of little spots on him, he had a rough night all night he ached and hurt and he just sighed a lot and was not himself at all, yesterday he wasn't feeling good all day, he was just very listless and a lot more breaking out on the opposite side of where he got the shot, his whole chest under his beard looks like a chemical burn, under his arm looks like a chemical burn and up the back of his neck looks like a chemical burn and it's very uncomfortable, had some bumps that looked more like scratches, This morning, he woke up and caller pretty much knew that it was shingles, blistered and all over his body, last night had not slept, it itches and burns and in a lot of spots it looks like they are trying to open up and are blistered and diagnosed with shingles was unspecified. Therapeutic measures were taken as a result of that night he had a couple of little spots on him/ red bumps, he had a rough night all night he ached and hurt/achy, yesterday he was not feeling good all day, he was just very listless and a lot more breaking out on the opposite side of where he got the shot/was not feeling well, his whole chest under his beard looks like a chemical burn, under his arm looks like a chemical burn and up the back of his neck looks like a chemical burn and it was very uncomfortable, yesterday he was not feeling good all day, he was just very listless and a lot more breaking out on the opposite side of where he got the shot (listless), poison ivy, did not feel right, tired, shingles, blistered and are all over his chest and back, itches, burns, rash and very uncomfortable. Investigation assessment was reported as no. Relevant tests were reported as none. It was reported that this report was not related to a study or programme. The outcome of the events that night he had a couple of little spots on him/ red bumps, he had a rough night all night he ached and hurt/Achy, yesterday he was not feeling good all day, he was just very listless and a lot more breaking out on the opposite side of where he got the shot/wasn't feeling well, his whole chest under his beard looks like a chemical burn, under his arm looks like a chemical burn and up the back of his neck looks like a chemical burn and it's very uncomfortable, he was just very listless, poison ivy, did not feel right, tired, itches, burns, rash and very uncomfortable was unknown and the outcome of the events shingles and blistered and are all over his chest and back was not recovered.  Follow-up attempts are completed. No further information is expected.