Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: Lymph node swelling/ having lymph nodes on the left side of the back of her neck that were swollen; Fever; She felt really hot and sweaty for 2 days.; She felt really hot and sweaty for 2 days.; Muscle pain; She felt the pain in knees, hips, wrist, and elbows with second dose/Joint pain; She felt disabled like she can't move; Crazy fatigue; Joint pain had increased; Arm pain; Feeling like someone had punched her 10 times/ felt like someone punched her ten times at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 13:30 (Batch/Lot Number: EL9262) as 2nd dose, single for covid-19 immunisation. Medical history included autoimmune disorder (ongoing), psoriatic arthropathy (ongoing), rheumatoid arthritis (ongoing), abdominal operation (appendix removed), Joint pain, anxiety, vitamin D deficiency, palpations, arrhythmias, hysterectomy and hypersensitivity (she has lots of allergies. anaphylaxis was a concern for her). Family history included her two sisters and mom had GI symptoms after the Covid19 vaccine. One of the two sisters works in healthcare. Concomitant medications included paracetamol (ACETAMINOPHEN) ongoing since unknown years at a dose of one 500 mg, ranges from 2 to 3 a day, liquid gel for arthralgia, hypersensitivity (she took it as she had to); atenolol tablet ongoing since at least 20 years at a dose of 100 mg oral, two times daily for palpitations, arrhythmia (she had lots of allergies and when she finds something that works, she leaves it alone); levothyroxine tablet ongoing since 10-15 years at a dose of 0.05 mg oral once daily for thyroid hormone replacement therapy; alprazolam tablet ongoing since at least 20 years at a dose of 1 mg oral 3-4 times a day for anxiety; vitamin D Nos ongoing since an unknown date at a dose of 50 mcg, softgel, once a day for vitamin d deficiency (If the deficiency goes lower her doctor would have her take two but right now she takes one). No other vaccine in four weeks. The patient previously took first dose of bnt162b2 in left arm (Lot number:ER8732) on 25Mar2021 at 14:30 for covid-19 immunisation and had experienced dizziness, vaccination site pain, hyperpyrexia, fatigue, pyrexia, myalgia, condition aggravated, pain in extremity, hyperhidrosis, feeling hot and took flu shot made her unconscious. It was reported that, patient was reporting on herself and had a question. She got the first vaccine on 25MAR2021. She had the second dose on 15APR2021. She asked the doctor about it because she does have several autoimmune issues. She mentioned she had gotten a flu shot in the past but the flu shot made her unconscious. It had no after effect, and it did not do anything. She had not received the flu shot in the last 20 years and had not gotten the flu either. For the flu shot she didn't have the Lot, NDC or EXP. At that time, she was working in healthcare and made everyone do it. It was a fluke and no after-effects. She also mentioned she had lots of allergies. Anaphylaxis was a concern for her. With the first shot, she couldn't describe it, but first 10 to 15 seconds less than a minute started feeling dizzy but not really, states it was like when you first wake up from surgery where you are confused. It was an odd sensation. Then it went away. She didn't think much about it. She didn't even feel the needle prick then half hour later it felt like someone punched her 10 times, which lasted for two or three days. She decided to sit extra time in the waiting room area. She later confirmed later that this was regarding the Pfizer Covid Vaccine. She mentioned that she takes Tylenol on a daily basis but did not take it the day she got the vaccine. She went on to explain that she had a list of what to expect but the first dose it wasn't that bad. Within 8 hours of both vaccines experienced crazy fatigue and was so tired. She has joint pain normally and was in a flare due to psoriatic and rheumatoid arthritis but after the vaccines the joint pain had increased. After a couple of days, it went back to how her pain normally was. Her main issue was with the second vaccine. The second shot on 15APR2021 did expect it to be worst. Dizzy: It went away. It was less than a minute and then it was gone. It happened while she was sitting in the seat. It was so strong and then it went away in a minute, it was gone. She felt like someone punched her ten times at the injection site: occurred with both doses, the first time it occurred starting 25MAR2021 She didn't even feel the needle prick, the injection itself did not hurt, then it felt like someone punched her hard 10 times. This started 20 to 30 minutes after getting the vaccine. When she got home no redness or really even swelling. Later confirmed no swelling. She had arm pain that lasted for 2-3 days and then it went away. The same thing occurred with the second dose on 15APR2021. Then it resolved on its own. She used icepack as a treatment. it did not kill the pain but made it more tolerable. She was just more sensitive. She confirmed that she recovered completely from the feeling like someone had punched her 10 times from both the first and second dose. Fatigue: It started 8 hours after vaccine on both 25Mar2021 and 15Apr2021. She thought she was home free. It was weird. She also mentioned with fatigue she started having a fever, muscle pain, and horrible joint pain all at the same time. They lasted 2-3 days and then she recovered completely. Fever: Started 25MAR2021 after the first vaccine and then started again on 15 APR 2021 after the second vaccine. She felt really hot and sweaty for 2 days. She said she does not feel get fevers very often. She had it 8 hours after both injections she wasn't sure why it took 8 hours. The first-time highest temperature about 101. Both times she took Tylenol every 6 hours for two days and as soon as the Tylenol wore off the fever would come back but the temperature would be lower. She confirmed she recovered completely after both occurrences. Caller initially stated she was taking Tylenol and then later clarified she was taking CVS brand acetaminophen. She mentioned she takes this one because she had a lot of allergies and cannot take the regular Tylenol brand due to the fillers in it, Tylenol bothers her. Caller referred to CVS acetaminophen as Tylenol throughout the report and then clarified at the end. Tylenol clarified as CVS brand acetaminophen. Did not had lot number, expiration, NDC. The lot number and expiration date are rubbed off the bottle and she cannot read them, there is a black smear where it says lot/exp. Muscle pain: Hit all at once and lasted 2 days for both vaccine doses. She recovered completely from both occurrences. and started within 8 hours for both doses. Joint pain: It started within the same time. Within 8 hours of both doses. She had joint pain every day but it amplified after vaccine doses. She felt disabled like she can't move. There was a difference. First time mostly was in her knees and hips. The second time it seemed to last longer, it aggravated the flare already there. She felt the pain in knees, hips, wrist, and elbows with second dose. States the wrist joint pain was really bad and she sometimes gets that with her rheumatoid arthritis but she was not having pain in arms, in her wrists and elbows before the injection. She has pain now but its the normal pain that she had felt prior to the injection. Lymph Node swelling: on saturday the 17APR2021 noticed her lymph nodes were swelling. She had a mammogram appointment. It was located under her left armpit. She called your doctor next day on the 18th because it was getting more painful. She was also having lymph nodes on the left side of the back of her neck that were swollen. That was part of the reason that she was calling because she wanted to see if that was normal. The lymph nodes swelling are all still there and they hurt. When probed for outcome caller did not clearly provide. She just mentioned that she was aware that it could happen under the armpit and figured that it would go away. But then she got one on the back of her neck which is also on the left side. She knows overtime that side effects have been added to our list. The doctors said if its persisting longer to call back and come in. Asked if it was normal. She did not have a cold or anything that would be causing it. she thought that the shingles vaccine was due next for her since she would turn 50, but she did not think she would get that. Treatment was received for events. The outcome of event lymphadenopathy was not recovered, whereas recovered for all other events.  Description of Product Complaint: Description of complaint: While reporting on the Covid 19 vaccine caller mentioned details on other products. She first mentioned details about the flu shot. She mentioned she has gotten a flu shot in the past, but the flu shot made her unconscious. It had no after effect. She has not received the flu shot in the last 20 years and has not gotten the flu either. For the flu shot she doesn't have the Lot #, NDC or EXP. She also mentioned details about Tylenol clarified as CVS brand acetaminophen. She took Tylenol every 6 hours and as soon as the Tylenol wore off the fever would come back but the temperature would be lower. Did not have lot number, expiration, NDC. The lot number and expiration date are rubbed off the bottle and she cannot read them, there is a black smear where it says lot/exp. She mentioned she taken this one because she has a lot of allergies and cannot take the regular Tylenol brand due to the fillers in it, it bothers her.  No follow-up attempts are needed. No further information is expected.