Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: allergic reaction; redness at the injection site; swelling at the injection site; redness and swelling at the injection site that moved down his arm/then it traveled; redness and swelling at the injection site that moved down his arm/then it traveled; itching at injection site; pain at injection site; several hours before checking infection site; bump, it was typical like what it says in the brochure, as time went on, it got red, in a spot by injection site, then it traveled/middle of injection site there was a white area, raised; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 75-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 09:15 at a single dose for covid-19 immunization. Medical history included cholesterol (blood cholesterol abnormal) and blood pressure blood pressure abnormal). Concomitant medication included hydrochlorothiazide for blood pressure, atorvastatin for cholesterol, fish oil and vitamins NOS (MULTIVITAMIN). The patient reported that he got the first dose of the covid vaccine on Friday (22Jan2021) and he had symptoms following the injection which included redness and swelling at the injection site that moved down his arm. The patient also mentioned that he experienced like a bump, it was typical like what it says in the brochure, as time went on, it got red, in a spot by injection site, then it traveled. The patient mentioned that he was seen at his PCP and reports that he was told he had an allergic reaction to the shot, hopefully it would not spread any further, and states his doctor seemed to be very concerned his physician prescribed him with an epi pen to have for if he gets the second dose of the vaccine and the reporter stated that he has never diagnosed with allergies. The patient inquired if the injection wasn't put in correctly and it was put in the tissue and not the muscle. The reporter mentioned that his wife said the needle didn't go in as much as when she got her injection, so he was wondering if it was administered in the right way and also asking if part of the needle could have broken off and if that is what is causing the redness and swelling to his arm. His doctor assured him the needle could not break and stated that his said that it did not look like the injection was as deep as hers since she was watching him get his vaccine. The reporter also inquired if that could have caused an issue if it was not administered deep enough. He mentioned that he waited several hours before checking infection site [pending clarification] and noticing the swelling and redness. States it is also itchy and painful, not a painful to the touch but an itchy, knifey kind of pain, states sometimes it feels like he needs to rub it and sometimes it feels like someone is stabbing him. The outcome of the event allergic reaction was unknown while the outcome of the other events was not recovered.  The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021077371 Same reporter/drug, similar events, different patient