Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives are basically in the buttocks, upper thighs, lower abdomen, side of the abdomen, lower back, upper back, mostly on lower trunk area/hives are extremely erythematous; They are very red and are very itchy; This is a spontaneous report from a contactable physician (patient himself) via Medical Information Team. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0198, Expiration date: Unknown) via an unspecified route, administered in Left arm on 16Jul2021 at 14:00 (66-year-old at vaccination) as Dose 1, single for COVID-19 immunization (reported as preventing the Covid-19 virus, preventative health). The patient's relevant medical history, family medical history relevant to AE was reported as none. He does not have any food allergies and he was a fairly healthy person. The patient's concomitant medications included fish oil and ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin B 12 NOS, vitamin D NOS, vitamin E NOS, vitamin K NOS, xantofyl, zinc (CENTRUM SILVER MEN) which he had been taking forever for many years, decades. The patient was not related to a study or programme. Vaccination facility type was reported as Pharmacy/Drug Store. The patient did not had history of all previous immunization with the Pfizer vaccine considered as suspect. The patient was not administered with any additional vaccines on same date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) the patient had received any other vaccine and the last time he had a vaccine was probably 20 or 30 years ago. The reporter stated he was calling regarding the Pfizer Covid vaccine. It was a couple of days ago, he himself had been experiencing since last Thursday evening, an adverse reaction. He got the first dose Friday 16Jul2021 around 2:00pm and he had no reaction to it at all until Thursday 22Jul2021. At around 7:00 PM on Thursday, 22Jul2021, he had a mild case of hives in his upper thighs. He went to sleep and then woke up Friday morning, 23Jul2021, and was covered in hives of his upper torso, upper thighs, front, back, buttocks and all over, which of course, he immediately took Benadryl 25mg. The Benadryl seemed to help with the localized hives. However, he needed a second and third dose of the Benadryl on Friday, 23Jul2021, as well as Saturday, 24Jul2021, and Sunday, 25Jul2021. He confirmed he took Benadryl that Friday morning. He also took 2 doses already today and 3 doses of Benadryl on Sunday and 3 doses on Saturday. Some of these hives are a large as the palm of his hands and some are as small as a thumbprint. They are mostly on his torso. He did get the injection in the left upper arm. However, he does not have Covid arm. The hives are basically in the buttocks, upper thighs, lower abdomen and the side of the abdomen, as well as the lower back. There are some hives on his upper back, but the vast majority are in the lower trunk area. The reporter stated he does have a queries 21 days after 16Jul2021, he was obviously due for the second Pfizer shot. However, he had been scouring the literature looking for information about this. He does saw that a lot of other hives have been reported a week or more after the first dose. However, he does not see any guidance whether to take the second dose or if he should be on low dose steroids or if he was going to take the second dose, wanted to know if he should he stop all Benadryl 5 days prior. He doesn't see any guidance to help him. This was all happening now, in real time. He stated that the hives are extremely erythematous. The hives are certainly raised, not flat. They are very red and are very itchy. He did have a physical about a month ago, which was fine. He was supposed to go back in a couple of weeks for the second half of his physical. All of the blood work was fine, there were no issues. His urinalyses were fine. The first half of the physical was fine. He was going back for an EKG, but everything else was fine. No relevant tests were reported. Stated that he had noticed that if he does not take the Benadryl, the hives come back. He kind of did a little experiment to saw how bad the hives would get by waiting a half hour, hour, up to 2 hours, and the hives got pretty bad. He would not consider it life threatening, but serious, because if he did not take Benadryl, he was sure it would continue and didn't want it to turn into something worse. The Benadryl was holding the hives at bay. Of course, he doesn't want to be on Benadryl for the rest of his life. He Had taken nothing else, aside from the Benadryl. The hives kind of multiply dramatically. He just pops a 25mg of Benadryl and within an hour or so, maybe an hour and half after taking the Benadryl, the hives started dissipating. The hives would be the same unless if he doesn't take the Benadryl, the hives really multiply. He though last night, he had to take 1 dose of Benadryl at 9:00 pm but he didn't take it soon enough. He probably should have taken it at 7:00 pm, but he wanted to see if the hives would get worse and they did. He confirmed he took a 25mg dose of Benadryl at 9:00 pm and then by 11:00 pm, he had to take another one because that was how bad the hives were. He commented that, he was kind of his own physician's office. He confirms he did not go to the ER and did not go to the doctor over the weekend. Quite frankly, he did not want to bother them when he could just take a Benadryl and everything was okay. So far, so good. He saw online and did some research over the weekend that there are reported cases of localized hives on the body- not COVID arm, but other parts of the body. He could see some information about PEG which he guessed in the vaccine and a possible allergic reaction to PEG. He asked if any other person with reference to localized hives. The outcome of the events was not recovered. The physician assessed the causality of the event hives as 100 percent related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events urticaria and pruritus and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.