Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Body temperature decreased, Body temperature increased
Clinical narrative: Itchy mouth; Hives; Blood pressure went up; Temperature went up; Left cheek bone got puffiness; Nostrils and ears were red; The hemoglobin was low.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 09Oct2021 (Lot number: FE3590) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (ongoing); "Hemoglobin low" (unspecified if ongoing); "Heart attack", start date: 01Nov2020 (unspecified if ongoing); "Stent placement", start date: 01Nov2020 (unspecified if ongoing), notes: Verbatim: Stent placement; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing); MESALAMINE DELAYED RELEASE taken for crohn's disease (ongoing); BABY ASPIRIN (ongoing); CLOPIDOGREL, stop date: 01Nov2021. Vaccination history included: Bnt162b2 (First Dose, Lot EN6207), administration date: 07Mar2021, when the patient was 56 years old, for COVID-19 Immunization; Bnt162b2 (Second Dose , Lot EW0150), administration date: 08Apr2021, when the patient was 56 years old, for COVID-19 Immunization.  The following information was reported: ORAL PRURITUS (non-serious) with onset 03Nov2021, outcome "recovered" (03Nov2021), described as "Itchy mouth"; URTICARIA (non-serious) with onset 03Nov2021, outcome "recovered" (03Nov2021), described as "Hives"; BLOOD PRESSURE INCREASED (non-serious) with onset 03Nov2021, outcome "unknown", described as "Blood pressure went up"; BODY TEMPERATURE INCREASED (non-serious) with onset 03Nov2021, outcome "recovered" (03Nov2021), described as "Temperature went up"; SWELLING FACE (non-serious) with onset 03Nov2021, outcome "recovering", described as "Left cheek bone got puffiness"; ERYTHEMA (non-serious) with onset 03Nov2021, outcome "recovered" (03Nov2021), described as "Nostrils and ears were red"; HAEMOGLOBIN DECREASED (non-serious) with onset Nov2021, outcome "unknown", described as "The hemoglobin was low.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient has been dealing with this before treatment with Inflectra. However, he does not know if Inflectra is causing it to not get back to normal faster or if it helped trigger this reaction. He mentioned he was on hold with withheld with Pfizer Encompass and then she was no longer on the line. He mentioned he got a dose of Inflectra and had a reac-tion he wanted to report. He also wanted to know if there was any way to get over the reaction or if it's permanent. He clarified the reaction occurred after the 5th dose, this was his 5th infusion. Fifteen minutes into it, he had gotten 5mg of Inflectra and then started to have a itchy mouth, hives on his body, his blood pressure and temperature went up. This 5th dose was admin-istered yesterday, 03Nov2021. He explained all of this happened while he was there at the infusion center. Itchy mouth, it took a while to go away, it went away within an hour. The infusion was stopped at 5mg. Hives, it was over a lot of his body. The hives went away mostly before he left. He had to stay and wait at the center for a while. However, he later confirmed it all went away yesterday. Blood pressure went up, when attempting to clarify date increased blood pressure ended he stated think it came down. He then went to check it while on the interaction. He stated his blood pressure at the time while on the call was 117/67. Temperature went up and he confirmed it went back to normal yesterday. It was 98.9 by the time he left. He later added, he forgot to mention his left cheek bone got puffiness. This started last night. It was interesting. He was watching TV with is wife. He reached up, touched his left cheek and noticed it was a little puffy. He touched his right one and it was normal. He confirmed the puffiness has come down. He assumes it's related to the Inflectra. He did not notice at the time of getting the infusion. He did not have any redness on that area of the face. He then added his nostrils and ears were red. This did start within an hour of getting the infusion. However, has gone away. While providing details he mentioned he had two Pfizer Covid shots and then a booster on 09Oct2021. He is not expecting this has anything to do with this, but never know. Blood was drawn before the infusion. It looked how it always looked. The hemoglobin was low. There was other blood related results, ratios that were problematic, but nothing unusual. He confirmed he did not have any labs/testing results to provide since the event occurred.  No follow-up attempts are possible. No further information is expected.