Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Immunisation, Nausea, Off label use
Clinical narrative: fourth one; fourth one; had a rash on my face and it was hot to touch and itchy and swollen little bit; still have a rash on my face; 5 days and it hasn't gone away; I got a fever; it was like right at 100; Nauseated; my face got hot; rash on the face; it is on my neck a little bit/ it was hot to touch and itchy and swollen little bit;5 days and it hasn't gone away; had a rash on my face and it was hot to touch and itchy and swollen little bit; still have a rash on my face; 5 days and it hasn't gone away; 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.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Mar2022 (Lot number: FK9895) at the age of 72 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Verbatim: Type 2 diabetes; "Blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "flash" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Tachycardia" (unspecified if ongoing); "my racing heart condition" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL taken for blood pressure abnormal, palpitations; LISINOPRIL taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal; ESCITALOPRAM taken for anxiety, depression, exhibitionism; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "fourth one"; SWELLING FACE (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "had a rash on my face and it was hot to touch and itchy and swollen little bit; still have a rash on my face; 5 days and it hasn't gone away"; PYREXIA (non-serious), outcome "unknown", described as "I got a fever; it was like right at 100"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; FEELING HOT (non-serious), outcome "unknown", described as "my face got hot"; RASH (non-serious), outcome "unknown", described as "rash on the face; it is on my neck a little bit/ it was hot to touch and itchy and swollen little bit;5 days and it hasn't gone away". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated that patient had the three series of shots for COVID. Patient was 72 years old and then it was recommended that he get the fourth one six months later, get another one because I am immunocompromised (Further clarification unknown). he had no reaction, no bad reaction to the series of the three but this fourth one he has gotten, he got a fever, he has got 'when over 100', it was like right at 100. Then he was nauseated, my face got hot and 'flashed' in my ears and then that was last Friday, and then Saturday he had a rash on my face, and it was hot to touch and itchy and swollen little bit, not swollen a lot, just a little bit and then, as of today, he still has the rash on my face. he did I called my doctor and reported. he is taking Benadryl (Later clarified as generic) which helped it but he still has it today and this is Wednesday, so that is 5 days and it hasn't gone away. Is this something I need to be concerned about. He has no other symptoms as far as throat problems or breathing problems or heart problems or anything (Further clarification unknown). He has Tachycardia (Further clarification unknown) which is one reason I got this next shot, and I am Type 2 Diabetic. But I am not having any problem except the rash on the face. And it did not spread, it is on my neck a little bit, but it didn't spread anywhere else." The Benadryl was taken 2, 25mg. Normally only he took 1 for my allergies at night, but he said he can take 2, 25mg, every 4 hours (Further clarification unknown). But not to take more than 300mg a day (Further clarification unknown). Consumer stated that yes, everything else is okay. No fever, no not feeling bad at all, just the rash on my face is still there and he was still taking the Benadryl every four hours and I did put some Hydrocortisone on my face and that seemed to relieve it from the hotness and the itchiness. I knew, I should report it to you guys because not too many people are getting a fourth one and that is the immunocompromised people (Further clarification unknown). Yes, is COVID-19 Vaccine a Pfizer product. Consumer stated that not taken any prior vaccination (within 4 weeks). Yes there a product complaint.