Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Thyroid disorder, Thyroxine, Tri-iodothyronine
Clinical narrative: Blood pressure has gone down; T3 and T4 off the charts; Blood sugar slightly high; Hives or raised bumps that are really itchy; Hives or raised bumps that are really itchy; Sleeping terrible; Rash on her leg; Fast heart rate; Getting tired and more out of breath; Getting tired and more out of breath; This is a spontaneous report from a contactable consumer. This  63-year-old female consumer (patient) reported for herself that who received second dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 19Apr2021 (Batch/Lot Number: EW0164; Expiration Date: Aug2021) (at the age of 63-years old) as SINGLE for covid-19 immunization. Medical history included ongoing Stage II kidney disease diagnosed in August. The patient historical vaccine included received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: EP7533) (at the age of 63-years old) as SINGLE for covid-19 immunization and developed joint pain, weakness, stiff, sore at injection site, lost weight, left ankle is swelling, shaking and figure out how to straighten herself up to walk. Concomitant medications included Alive Multivitamin by nature's way women's 50+ ultra potency, calcium, colecalciferol (CALCIUM + VITAMIN D3), calcium 500 mg vit D3 800IU, turmeric with bioperine 1950 mg, krill oil 1 tablet 1000 mg (she states that she use to take 2 tablets now she only takes one), collagen type 2 12 g (she states that she only take 2 tablets but the recommended is 4 tablets. She states that she thinks that it too much. The whole dose is 24 g but she takes 12g) and cyanocobalamin (B12 [CYANOCOBALAMIN]) 500 mcg; all taken for unspecified indication, start and stop date were not reported. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was reported as no. The patient has not past fall had pneumonia vaccine and flu vaccine had to get booster for shingles. had those three this past fall no reactions to them. No family medical history and relevant tests as no. The patient received second dose at 19Apr2021 and experienced increased resting heart rate at night. She has a Fitbit and her normal resting heart rate is 95bpm but now it has been 68-70 bpm. She had only experienced this after the second dose. She had tests from her doctor since her thyroid have been going crazy and has been eating away her muscle. "My body is working and taking my muscle away." since she is a fitness coach. She has been getting weaker. Her doctor will be doing some more test. She also added that she has been having rash and hives, randomly, but happens usually at night. Her itching  goes away every now and then. She noted that her main concern is her increased heart rate. She states that she got the second shot and was sitting on the sofa at midnight, she says she got the shot at 1:30 pm in afternoon, and at midnight she felt heart beating in her chest. She states what is going on, her heart rate is beating at 95 beats per minute and her normal resting heart rate is 68-70 beats per minute. She knows that because she has a fit bit. She states that the highest it went up to that night was 95 and she has been keeping an eye on it. She states that she is still having joint pain, but has not had a fever or other symptoms, except joint pain and continuing to get weaker and weak-er. She states that she called her doctor a week later, because she was really worried. She states that along with her weakness she has notice that a few days after, that if she kind of bends over she gets tremors, she states her body kind of shivers. She states that the doctor did blood tests, and checked her blood pressure. She states that her blood pressure was normal. She states that she bought a cuff because she wanted to see if it would stay normal. She states that the blood pressure was 119/62 at the doctor's but her pulse rate was at 103 beats per minute. She states that the doctor is stumped and wasn't sure what to do. She said that her doctor wanted to wait till test came back, because he didn't want to give a betablocker because it will drop her blood pressure down as well as her pulse. She states that her left ankle is swelling, well not like swelling but it is getting larger. She states that her an-kle is starting to disappear. She says she is getting cankles and she says she doesn't have them. She states that her ankle bone started melting into her skin. She states that she got her test results back from the doctor and he said that her T3 and T4 were off the charts. She asked if that would explain why muscles are getting weak to her doctor. She states that it is just eating away at her muscles, and she is loosing strength. Her doctor recommend that she go see an endocrinologist. She states that she hasn't gone because the one that she was referred to isn't taking new patients but she has an ap-pointment with another one. She states that her doctor did put her on a thyroid medication. She states that was actually Monday  03May2021. Her put her on a thyroid medication and a low dosage of a betablocker. She states that he wanted to check her A1c because he noticed her blood sugar was slightly high. She states that he is not concern for being diabetic. She states that she hasn't got those results back but she had a physical last year and all these results were normal. she states she has lost weight that's another thing that has happened. Physician Details: Caller states that she does not have an email for her doctor at this time. She states that they do send her emails but she is not sure that they are ones that allow contact threw. She states that the emails are generated through the patient portal. Event details: Caller states she kept putting it off and putting it off until she finally thought she has to tell Pfizer about her experience. She states that the doctor ordered an ultrasound on her heart or an echocardiogram, and a sonogram on her thyroid but she hasn't gotten the results back yet. Call-er states that on 30Mar2021 she had soreness at site, probably went away maybe the next day she says it didn't last very long. She says that on 06Apr2021 she really started getting weak, and the way she could tell she was weak was because she teaches senior fitness classes virtually, and that Tuesday she could not do a front arm raise with 5 lbs. worth of weight. She states she was that weak. She says she couldn't do it. She says that it was mainly her left arm that is weaker then right arm. She states she has a previous injury on right arm, so she sometimes has trouble with that arm. She says that her left arm is her strong arm normally and now it is weak. She says it seems to have gotten a little better now, but she cant sit for a long period of time she has to figure out how to straighten herself up to walk. She says starting this week she says that she has been having trouble with opening the cap of a Deer Park water bottle. She says the weakness is getting worse. She says that the shaking started on the 13Apr2021 still ongoing, not a constant, the shaking body or trembling happens when she hinges from her hips, when she is leaning over or bends over. She states that it also happens when she is extending her arms out to reach. She says that's when she trembles getting worse. She states that her heart rate started on 19Apr2021 the very evening of the second dose. She states she does have a history in fit bit that she can look back and actually see what is ongoing. She states that it is still going on now, been taking very low dose of a betablocker since 03May2021 and her heart rate now is at 95 but that is probably because she is talking. She states that her heart rate did go down as low as 86 but still hovers around about 90s. She states the medication has not brought down her heart rate to her resting heart rate. She states that she is getting tired and more so out of breath. She states that the tiredness and out of breath and everything, is just progressing here. She states that she lives on the 4th floor and she walks up the steps most of the time. She states that when she is carrying something she gets really out of breath, She states that she use to be able to carry a case of water up the stairs but now she has to break it up. She states that she should of written down the dates of when exactly she started with be-ing tired and out of breath but she states that it sometime last week and it is getting worse. She states that her blood pressure has gone down. She states that she is also sleeping terrible. She states on the 25Apr2021 she did not sleep well at all. She states that it is on going and hasn't improved. She states that is because her joints in her shoulder are so bad. She says she sleeps on her side and she tries to carefully toss and turn. She says she doesn't sleep well at all and will wake up several times during the night. She states that she has noticed a slight rash on her leg on 24Apr2021, and it is still there, but just a spot. She says that what has been happening and started on 26Apr2021 is that at any random given time during the day but usually in the evening she has been getting hives or raised bumps that are itch-ing patches that form on the body, usually on her legs, arms, or torso area. She states that she doesn't know if this is happening because of the medicine she just stated taking or this or allergy, she cant de-scribe it. She states that it is really, really itchy for a couple hours and then goes away. She states that this is really odd for her because she is a fitness instructor and she does cardio and strength training and all these symptoms counter productive to what she does and are terrible. She states that the rash has not improved, it comes and goes. It is persisting. She states that the hives or bumps come and go, and they are hand and hand with the rash. They happen together. She states that her ankle growing in size, started 13Apr2021 and right now she is looking at her ankle and she can see the bones. She says she can see her ankles but the left side of her foot is slightly, just a little bit bigger but it has gone down. She states that it appears randomly. She states that it doesn't stay, it happens and then goes away. She states that she got her thyroid tests done on 28Apr2021 and went back to doctor on 03May2021 for the results. Her T4 results were: 4.42 and the normal range is suppose to be between 0.76 - 1.46. The T3 results were: 19.6 with a reference range of 1.5 - 3.5. She states that her doctor told her that the TSH result is 0 and the reference range is .36 - 3.74. She says she is at zero. He gave her the results of the thyroid and took more blood for other tests and no results have come back. She states that he did the other blood test on 03May2021. She says that her blood sugar results were: 108 and the normal range 70-100. Product Details: Caller confirms there is not an expiration for the first dose, NDC number, or dosing information on the vaccine card. She got it on her left arm because she figured that was her strong arm but it isn't any more. indication: She states that she was really reluctant to do it, but she is a fitness instructor for seniors and the adult population ages 55 and over. She states that a majority of her job is in senior living facilities and in order for her to get back in there she has to get the vaccine. She states that she is still doing most of her classes virtually, but has started going back to the community. She states that she is currently going down the steps while talking to the CH. She states that she has a client picking up Zumba toning sticks and the client is in parking lot waiting for her. She states the client is 84. Caller states that at her results of the physical last year the doctor diagnosed her with stage 2 kidney disease. She states that she wasn't having symptoms. She states that she asked the doctor what does this mean and what does she do. She states that this is where she gets a little winded. Caller is walking back up the stairs from meeting with the client and states, let her catch her breath. She states that in august she was diagnosed with stage 2 kidney disease, and that the doctor said there is nothing he can do because she wasn't having symptoms. She states that she was not on any medication, well she was not until last week, until 03May2021 when she was put on the beta-blocker and thyroid medication. She states that right now her heart rate is 129 and that was really not that high. Treatment: methimazole 5 mg twice daily started 03May2021 and still ongoing metoprolol: tablets 25 mg. half a tablet once a day or 12.5 mg started 3 may ongoing. As per PSCC COMMUNICATION: PC filed. Outbound call placed in QR on 14May2021 at 8:58:23 AM to obtain a lot number for the Metoprolol. NDC- (withheld), Expiry and Lot is unknown, it is in a pharmacy bottle. ININ: (withheld). Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Patient is taking metoprolol for a fast heart rate and it is still staying hovering around 95 beats per minute. she says that it has not gotten to her normal heart rate since she has been taking it. She states she is taking a low dose. She also says that her blood pressure has lowered since she has been on it. Product strength and count size dispensed. The patient underwent lab tests and procedures which included T4 (thyroxine) as 4.42, T3 (tri-iodothyronine) as 19.6 blood sugar as 108, blood pressure as 119-62, blood thyroid stimulating hormone (TSH) was 0 and vitamin B12 as 23 on 28Apr2021 whereas heart rate as 95 on 19Apr2021 and heart rate as 129 on 13May2021; all units not provided. Therapeutic measures were taken as a result of fast heart rate (heart rate increased). The outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected.