Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: edema with rashes of the back of her hands; small amount of site pain; tired; itching on my wrists/very red and itchy on both hands, and it was worse on her left hand; very red and itchy on both hands, and it was worse on her left hand; rashes/spots on stomach, chest, toe and finger/edema with rashes of the back of her hands; little sore in arm; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6200, Expiration date: Not reported), via intramuscular route in right arm on 25Feb2021 somewhere between 14:10-14:15 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization in a convention center by a nurse who interviewed her prior to vaccination to determine if it was suggested for her not to take it. No patient's medical history/other history was reported. The patient was allergic to molds and was given with allergic pills (taking them for many years). There were no concomitant medications/other products reported. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No prior vaccinations received by the patient within 4 weeks prior to COVID-19 vaccination. Initially, it was reported that the patient experienced a small amount of site pain and she was tired on 25Feb2021. During the half an hour after the vaccine, the patient had no reaction when watched closely. She went back to the house and 4 hours later, she noticed a little bit of itching on her wrists (it started on the opposite side of the shot), but it wasn't enough to do very much about it. Six hours later, she started getting quite a lot itching and rashes on the back of both hands, quite a lot more on the left hand. She clarified that she was very red and itchy on both hands, and it was worse on her left hand. She had rashes, 6 spots on her stomach, a spot on her chest, and weirdly a spot on her toe and finger. She received the paperwork in which they didn't mention rashes as her side effects. She noticed severe allergic reactions section under which the bad rash all over the body was reported as listed. She didn't know whether her rash would be considered severe because it was not all over her body it's just spots on different parts of her body. She wanted to know whether it's a severe reaction or considered as a regular side effect. She had no reaction on her arm at the site where she got the shot and had no rash at all. There was nothing on her vaccination site arm. It was kind of sore a little in the left arm. She had no symptoms, no rash around the injection site. By 23:00 on that night, she started getting edema on the rashes of the back of her hand which was itchy, and the rash had worsened on the spots of her stomach, hands and wrists. She used some over the counter (OTC) hydrocortisone 1% cream, but it didn't really stop it, it just slowed down the edema at least. She doesn't have the hydrocortisone 1% cream. It was her son's cream who was no longer with her. At that point, she looked again at the site and she didn't really know if she was experiencing a severe allergic reaction. She wasn't having any difficulty breathing, swelling of the face, throat, or swelling of lymph nodes. She was little bit tired on 25Feb2021. The only thing that concerned her was the rash which got considerably worse. She really wasn't worried until she started having swelling/edema. The back of her hands got puffy, she never had that happen to her before. Unfortunately, by the time she noticed that it was happening, it was the weekend and she couldn't talk to her doctor until 01Mar2021. She went and showed the doctor who took a picture of it and said it was unusual. She gave her a prescription for Clobetasol Propionate 0.05% which is like what you put on a mosquito bite if it got worse and lasted a lot longer than usual. Her doctor also recommended she take an all-day allergy pill. She states she was given the generic form of cetirizine hydrochloride (ZYRTEC). She had started taking diphenhydramine hydrochloride (BENADRYL) tablets on the weekend after talking to a doctor online about it. The Benadryl inhibited the itching a little bit. The patient started taking the 2 things her doctor recommended (Clobetasol Propionate 0.05% and Cetirizine hydrochloride), the edema on her hands diminished quite a bit. Her hands are still very red, like it was a very intense kind of red, but the products have definitely helped her and thinks that these products were solving it. For the generic of cetirizine hydrochloride (ZYRTEC), she mentions she took this yesterday for the first time. Previous to this medication, she was taking Benadryl tablets after talking to the doctor online. The patient's symptoms got better. The redness had noticeably improved and her rash was fading, and edema was gone. The redness was still strong on the back of her left hand. The edema was gone, the rash on her stomach is fading, and itchiness was gone. The only places still red was on the back of her left hand and that's definitely improving with the use of medications. Her provider said considering her reaction with the first vaccine that the generic version of Zyrtec, double dosing should be started, a couple days prior to the next shot. The edema and the rash are much better as of 02Mar2021. These events didn't result in emergency room but to the physician's office visit. Her second dose was scheduled on an unspecified date (reported as Wednesday) where the doctor suggested to start double dosing on the prior days and on the day of second vaccination. As per her understanding, she would have defense against the second dose. She was concerned about the second shot and heard that the second shot was more of a punch because it's quite a lot more building up with one's immune system. Since she had this kind of reaction to first one, she was scared of taking the second dose, but at the same time she doesn't want to die of COVID. On 02Mar2021, she read that the CDC recommended if you get a severe reaction to Pfizer's first COVID vaccine, that you should get the second dose of Johnson and Johnson instead. The patient wanted to know what would be defined as a severe reaction and if she had her face and throat swell. The outcome of itching and edema was reported as recovered in 2021 while the events erythema and rash were recovering and the outcome of events vaccination site pain, tiredness and pain in arm was unknown at the time of report. It was reported that the investigator's assessment as no.   No Follow-up attempts are possible. No further information is expected.