Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Weight increased
Clinical narrative: I was itchy on the injection site; itchy skin; the site is swollen; "its like a rash" on her right arm; drowsiness; chills; injection site pain; I was itchy on the injection site/I realized that not only was it itchy but it has the redness and it is red and itchy; pain in her arm; gained a little bit of weight; Cramp in hand; Joint pain; 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 61 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 29Oct2021 (Lot number: 30145BA) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety; "reaction to my Allergy shot" (unspecified if ongoing), notes: had a reaction to my Allergy shot (unspecified medication) that I was taking in May. Concomitant medication(s) included: OMEPRAZOLE; TETANUS TOXOID. Vaccination history included: Bnt162b2 (Dose: 1, First dose Vaccine LOT#FC3184, first dose vaccine on my left arm), administration date: 08Oct2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 30Oct2021, outcome "not recovered", described as "drowsiness"; PRURITUS (non-serious) with onset 01Nov2021, outcome "unknown", described as "itchy skin"; VACCINATION SITE SWELLING (non-serious) with onset 01Nov2021, outcome "unknown", described as "the site is swollen"; RASH (non-serious) with onset 01Nov2021, outcome "unknown", described as ""its like a rash" on her right arm"; VACCINATION SITE PAIN (non-serious) with onset 29Oct2021, outcome "recovered" (30Oct2021), described as "injection site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "I was itchy on the injection site/I realized that not only was it itchy but it has the redness and it is red and itchy"; CHILLS (non-serious) with onset 30Oct2021, outcome "unknown", described as "chills"; VACCINATION SITE PRURITUS (non-serious) with onset 02Nov2021, outcome "unknown", described as "I was itchy on the injection site"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in her arm"; WEIGHT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "gained a little bit of weight"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Cramp in hand"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of somnolence, pruritus, vaccination site swelling, rash, vaccination site pain, vaccination site erythema, chills, vaccination site pruritus, pain in extremity.  Additional information: Caller is a consumer who received her shot of Pfizer Biontech COVID19 vaccine last Friday. Caller said yesterday, she started having an itchy skin and the site is swollen and it's like a rash on her right arm. Caller stated that with the first one, the injection site pain lasted for a week and for this one would be 24 hours today. Caller added that she also had drowsiness with the vaccine which is consistent her last dose. On Friday night, she had the injection site pain while the drowsiness was on Saturday. Her right arm started to itch on Monday, then when she got home, she noticed while taking off her shirt that it has like a rash then her co-worker noticed that it was swollen. Caller stated she never had that with the first shot of the vaccine. Caller wants to know how long her symptoms would last and when to seek her doctor. Caller mentioned that today she has been using a medicine that you place for an itchy skin and unsure of what the medication is called, and she put a little on it that kind of calm her down. Upon Follow-up Concern: Consumer stated I got the shot on Friday, the second vaccine actually, so in the first time it made me drowsy which I did have side effect on the last time, on the first one I had muscle pain but this time I didn't had muscle pain, I still had a drowsiness on Saturday and then at the night I got some chills, I had little bit of (incomplete sentence) the COVID vaccine (confirmed as Pfizer COVID-19 vaccine), so yesterday I have little bit of chills and of course the injection site pain started Friday night, which was when I had the first time, when I took the first dose, but today when I was at work I was itchy on the injection site, when I came home and I took of the shirt, I realized that not only was it itchy but it has the redness and it is red and itchy so I put some ice on it, which kind of calmed it down, I found that okay, but now I am reading and I am going through this and then I went online because I am like, can I use something on this site, I also took my allergy tablet too, which may have calmed it down some while but for the last one (incomplete sentence, further clarification unknown). Consumer was informed about the role of Pfizer drug safety department and asked for permission for further probing, consumer stated I mean I was reading it on the web, I was reading general information, because I googled it, what can I take? So it was saying that it may have not occurred in the first day it could take a couple of days to occur but they were saying it is not the life threatening, it's something that will probably go away in a week, this was just on the website I googled it so you know I am just trying to see is when this happens or this has happened, worked in if I need to use something like that you would need to have a, if you have rash or you are not supposed to put anything on this site, right I guess I had a reaction to it and that's my reaction. Consumer was informed about Pfizer Medical Information Department and offered the number: Consumer stated So, I got to call another number, this is the number they gave me and (voice overlap). Consumer was again informed with the role of Pfizer drug safety and Pfizer medical information department. Transferring agent stated, "I do have a consumer on the other line, and she is calling about her experience with the Pfizer Covid-19 Vaccine, she received the Vaccine last Friday and she has pain in her arm, drowsiness, injection site pain on Monday, she started to notice a rash and having swollen itchy red skin on injection site, she described that she never had that with first shot. She also mentioned that she is using a medicine (treatment) which help calm her experience, but she does not know the name of the medication. Consumer was informed about the Role of Pfizer Drug Safety. When paraphrased the concern, consumer stated, yes, the drowsiness was over the weekend happened with the first dose vaccine, so I am not so surprised that it made me drowsy. I had the pain at the injection site, had itchy red, if I asked one of the Nurse at work she said if it lasts more than 2 days, then call you Doctor, she was saying just to apply Alcohol, but I don't like that. I was wondering how long I should have it so, she said if does not last within 2 days then go to your doctor so I will do that now. They used a different needle at the injection site for the first shot and they used a different type of needle bigger the regular needle. I was advised by my doctor to use Pfizer and I didn't hear anybody having these drastic side effect what I didn't know. I don't know if anybody had this side effects with Moderna vaccine. It was reported that when probed for vaccination anatomical site, consumer stated, I did first dose vaccine on my left arm, the second one I didn't want to do it on the left arm because I had taken a Tetanus shot (unspecified shot), on Sunday before in the left arm, so he said now let me do it in right arm, second dose I received in right arm. On Sunday I had a mini accident, so they said they needed to give me tetanus shot. When probed for Tetanus shot LOT# consumer stated, I don't have that. That's in University withheld. I don't remember. When probed for any Laboratory test, consumer stated, no, the immunologist did a blood work two days after the shot, which I did on Monday. When probed for any treatment for the event, consumer stated, the only thing I put on which calm it down, I used Hydrocortisone cream that's the one thing I used for rash. When I came home, I put a cold compressed for 10 minutes to calm it down, but it started up in the night then I took a Tylenol last night to calm down pain, so that I am not up in the pain. When probed for any Prior Vaccination, consumer stated, I had a reaction to my Allergy shot (unspecified medication) that I was taking in May, it was to determine allergy with the dust particle, that caused that reaction, so I discontinued weekly allergy shot but then did test to an Immunologist because I started getting cramps in my hand and joint pain. When probed for Allergic shot (unspecified medication) LOT#, consumer stated, no, those were discontinued and I haven't gone back to the Allergist for the shot because he said not going to take the chance for it, so he discontinued it, he just gave me normal allergy medications. Consumer stated, I got answer (previous Department) I just needed to know you know after how many days I needed medical attention if continued, I got the answer because I had called the Doctor and he never called and then immunologist.  Follow-up attempts are completed. No further information is expected.