Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: whole arm is tingling, burning feeling; whole arm is tingling, burning feeling; just very tired; it hurt and was swollen a little bit was reported as worsened/arm started swelling really bad, swelling under arm was reported as worsened.; she has a big ole red knot on her arm where the shot was at; whole arm was really swollen and red; it hurt and was swollen a little bit; it hurt and was swollen a little bit; arm started swelling really bad, swelling under arm; ran a fever; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot: EP7534), via unspecified route of administration on 22Mar2021 (at the age of 51-year-old) in left arm as a dose 1, single for COVID-19 immunization. Patient had medical history of epilepsy on unspecified date in 2004 to Ongoing, heart conditions. Reporter stated that she had heart trouble, she's had it since she was 15, and she has had to have surgeries for it in 2012 and had to have them for almost 2 years. She stated that finally had to have open heart surgery, she has electric problems. states she has A.FIB and had history of Gallbladder removal (this was done about 3 weeks ago), allergies, helps her go to sleep at night. Reporter stated that she doesn't know if this has anything to do with it but she just had surgery about 3 weeks ago, that was the only other major thing that had happened. She states she had her gallbladder out. states she had gallstones bad and had her gallbladder taken out. Patient concomitant medication includes lamotrigine (LAMICTAL), lacosamide (VIMPAT), apixaban (ELIQUIS), Metoprolol, fexofenadine hydrochloride (ALLEGRA), alprazolam (XANAX), paracetamol (TYLENOL). Prior Vaccinations within 4 weeks reporter received allergy shots 2 weeks before Covid shot. Reporter states she's not sure if that was considered a vaccine. Reporter stated she had her shot, her first shot, on Monday, about 3 in the afternoon and on 24Mar2021 it hurt and was swollen a little bit that night but then Tuesday, her and her husband both had it, they both on Tuesday on 23Mar2021 ran a fever throughout the day and night on Tuesday. Reporter states no swelling, no nothing or anything to the arms after the shot. Reporter states yesterday on 24Mar2021 her arm started swelling really bad. She states she has a big ole red knot on her arm where the shot was at and her whole arm was swollen really bad, swollen under her arm. Patient states she was supposed to get her allergy shots, but she's not getting any other shots until it quits hurting. Reporter stated that she woke up not feeling well, so the fever probably began around 9 or 10 that morning and lasted all day. states they took Tylenol and it would go down some but it would never really go away and it never broke until mid morning, really early in the morning, about 3am or 4am on Wednesday morning. Reporter stated that her whole arm was tingling, burning feeling and it was real red and feels like it's on fire to the point where now it's going down into her hand from her arm. Reporter stated that its her left arm, where her wedding rings are. Reporter states she can hardly get her rings off her hand and her watch was really tight. Reporter states that whole arm was really swollen and red. Reporter states even up in her arm up towards her neck was tingling and burning. Reporter stated that she received vaccination at 3:15PM, so states probably given about 3:20PM or 3:25PM. Reporter states she was calling us to see if all this was normal. Reporter queried for to find out if this was normal and if it was, how long will it take to go away and if its not normal and if it was normal, was there anything she can do to get rid of it. She states she just needs clarification and what she can do to get it to go away. Reporter states arm didn't start swelling until yesterday, her shot was Monday, so Wednesday. Reporter states that's what worried her that it didn't start swelling right after that much. Reporter further stated that she took a Benadryl last night about 10:00PM (One tablet, 25 mg, by mouth, 100 tablets in bottle, caller states but there's not that many in there now, LOT: P109717, EXP Mar2020), she states she doesn't have the box, it's in the bedroom. states she doesn't feel like it helped because it was still swelling, it didn't make it go down, it just stayed the same and then actually today she noticed it just keeps getting worse. Reporter states she can hold both her arms up and one of them looks like she has stood close to the fire and ones red and the other was not. The knot where the shot, it sticks out probably 2 inches from how her arm usually was and the rest was swelling. states her underarm feels really weird, its all puffy under her underarm and then today it feels like its over in her neck, patient was thinking was it going to go up in her face and keep on going. Patient stated she was not a big complainer. states her husband already said she isn't going to get the second one. states to her husband to hush, she's going to get over this and she's not going to die. And then it keeps getting worse and her neck keeps burning, like when she stands next to a campfire where it gets her body hot on one side and she just has to turn around. Reporter remarked that maybe that was why it didn't do anything, stating usually she keep it about a year after it expires as it should still be ok, but she guesses not. Reporter states she took one and it didn't seem to work. Patient states Tuesday got shot that afternoon and it burned a little bit and swelled a little bit, then it was done. states that morning she got up, she went to work. Reporter stated that she said she's just very tired, but she will make it and come on home. states she said she just needed to lay down and that's what she did. She had a Fever. states she watched the fever all afternoon, kept taking Tylenol, every so often to keep it under control. states she woke up soaking wet, she guesses their fever had broke in the middle of the night and she was just sweating big time and that was the only day of that. It was only the one day of this, just yesterday. she not had a fever today and she thought her arm she can hardly raise it. states she looked down and it was swollen and real red. Whole arm was tingling, burning feeling. Patient states throughout the day yesterday and today it's going down her arm, into her fingertips throughout the day yesterday and today its going down her arm, into her fingertips, numbness and tingling. states she has a feeling like Novacaine. states it does like a Novacaine shot, where there's a numb feeling but can still feel, that's how it's getting to feel up in her neck. Patient states yesterday, it started tingling in the top part of her arm, her underarm started swelling throughout the day. states it's like its moving from her shoulder down to her arm, elbow, and now it's in her hand. Patient stated that now her whole arm was swollen and tingling, and this afternoon now it's in her neck. states the numbness/tingling was persistent, it's not getting worse, just moving, spreading around. states it's not one spot that's getting harder and harder, just the same it's just spreading. Reporter stated that the reason she got the shot was because her husband has asthma, and they got COVID before, and he had a whole month of breathing issues. Patient stated that when she took her husband to get the shot they offered her the shot. states she had some major medical problems, she got sickly with hers, when she had COVID and she don't want to do that again. Reporter stated that she got COVID in Jun2020. Reporter states she takes all of her medications at night for the event reported. Tylenol (250 tablets, 500 mg each, LOT: 0LV2167, EXP: Sep2022) according to when she ran a fever, she took it every 4 hours. states she guesses it's just as needed. states she had taken it here recently for fever. Patient had not attended Emergency Room and physician Office for the reported events. Outcome of event it hurt and was swollen a little bit, arm started swelling really bad, swelling under arm, whole arm is tingling, burning feeling was not recovered, just very tired, it hurt and was swollen a little bit was reported as worsened/arm started swelling really bad, swelling under arm was reported as worsened, she has a big ole red knot on her arm where the shot was at, whole arm was really swollen and red was unknown, ran a fever was recovered on 24Mar2021.   No follow-up attempts are possible, No further information is expected.