Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash macular, Skin disorder, Vaccination site erythema, Vaccination site pain
Clinical narrative: swollen lymph nodes; the injection site got red/ left arm red at the muscle; the injection site got red, kind of splotchy like, and was still sore.; the injection site got red, kind of splotchy like, and was still sore.; the injection site got red, kind of splotchy like, and was still sore; Right Arm Swelling; Knots on left arm; feeling tight in the bend of her arm, on the inside near the elbow; arm swelled up that day in the bend of her elbow; Inside of Left arm swollen up to the elbow; feels like there is fluid in it, like a ridge/ spots of fluid/ liquid build up on both legs and wrists; white spots at left wrist; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 11:00 (Lot number: EL9263, Expiration Date: 31May2021) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFib", start date: 2018 (ongoing), notes: Verbatim: AFib; "High cholesterol" (ongoing), notes: Verbatim: High cholesterol, diagnosed over 20 years not sure; "Thyroid" (ongoing), notes: Verbatim: Thyroid, diagnosed over 20 years. Concomitant medication(s) included: XARELTO taken for atrial fibrillation, start date: 2018 (ongoing); SYNTHROID taken for thyroid disorder (ongoing); FLECAINIDE taken for atrial fibrillation, start date: 2018 (ongoing); METOPROLOL SUCCINATE taken for atrial fibrillation, start date: 2018 (ongoing); ATORVASTATIN taken for blood cholesterol. Past drug history included: Eliquis for Afib, notes: 5 mg two times a day. The following information was reported: JOINT SWELLING (non-serious) with onset 25Feb2021, outcome "not recovered", described as "arm swelled up that day in the bend of her elbow"; VACCINATION SITE ERYTHEMA (non-serious) with onset 04Mar2021, outcome "recovering", described as "the injection site got red/ left arm red at the muscle"; RASH MACULAR (non-serious) with onset Mar2021, outcome "unknown", described as "the injection site got red, kind of splotchy like, and was still sore"; VACCINATION SITE REACTION (non-serious) with onset 04Mar2021, outcome "unknown", VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "not recovered" and all described as "the injection site got red, kind of splotchy like, and was still sore."; FLUID RETENTION (non-serious) with onset 25Feb2021, outcome "recovered", described as "feels like there is fluid in it, like a ridge/ spots of fluid/ liquid build up on both legs and wrists"; SKIN DISORDER (non-serious) with onset 25Feb2021, outcome "recovering", described as "white spots at left wrist"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; PERIPHERAL SWELLING (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Inside of Left arm swollen up to the elbow"; PERIPHERAL SWELLING (non-serious) with onset 26Feb2021, outcome "not recovered", described as "Right Arm Swelling"; MASS (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Knots on left arm"; MUSCLE TIGHTNESS (non-serious) with onset 25Feb2021, outcome "unknown", described as "feeling tight in the bend of her arm, on the inside near the elbow". The events "arm swelled up that day in the bend of her elbow", "the injection site got red/ left arm red at the muscle", "the injection site got red, kind of splotchy like, and was still sore", "the injection site got red, kind of splotchy like, and was still sore.", "the injection site got red, kind of splotchy like, and was still sore.", "feels like there is fluid in it, like a ridge/ spots of fluid/ liquid build up on both legs and wrists", "white spots at left wrist", "swollen lymph nodes", "inside of left arm swollen up to the elbow", "right arm swelling", "knots on left arm" and "feeling tight in the bend of her arm, on the inside near the elbow" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of joint swelling, vaccination site erythema, rash macular, vaccination site reaction, vaccination site pain, fluid retention, skin disorder, lymphadenopathy, peripheral swelling, peripheral swelling, mass, muscle tightness.  Additional information: 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) was unknown. No additional Vaccines Administered on Same Date of the Pfizer Suspect Additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Adverse Event Time of Onset (24-hour clock): unknown. Additional Information: couple of hours after receiving immunization. The patient received no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to AE(s) was reported none. Relevant Tests were none. Description of Product Complaint: Caller stated Flecainide tablets sometimes hard to swallow, tastes terrible; usually goes down ok; no other product/lot/ndc/exp date information provided. Details documented as caller provided. Product Strength: 50mg tablets every 12 hours. Additional lot numbers: not available. No requests for sample of the product available to be returned was processed. Packaging sealed and intact was unknown. Caller stated she had the Pfizer COVID19 Vaccination shot at between 11 and 11:15am on 25Feb2021 in her Left arm. After getting the immunization, caller stated she went to the store and at that time, it started feeling tight in the bend of her arm, on the inside near the elbow. Caller stated at that time the pharmacist also noticed what he called bumps on her along with the swelling. Caller referred to them as knots. It was swollen lymph nodes or something. After taking the shot, on her arms and legs, there was fluid built up on the skin, kind of whiteish looking spots. It took a while for some of this to go away, it had been 4 weeks tomorrow. The swelling has gone down some, but it was still there. It feels like it was trying to get in the blood stream. Also, the vein in her arm, in the middle, was sticking up a little. she was wondering if this happens with the first, what will happen with the second dose. question asked if she get the dose for the second dose. She does want to report as this was kind of weird, she doesn't think the drug store reported this. She saw the doctor 2-3 weeks ago and she was swollen up pretty good. The doctor asked if they gave the shot there and the caller told her, it was giving in the shoulder, referring to the swelling under her arm. She had a couple pharmacist as her that too. She kept thinking it was going to get better, it will go down. This had been a weird experience. The caller explained that she went to 2 different stores after getting the shot, by the time she left the second store she reports that the where the bandage was it started feeling tight. It started to hurt a little bit. When she got home and took off her sweater off and she saw it, she thought my goodness. She went to the drug store that she got, and her son came and looked at it too. Then it got in both arms, it was given in the left arm. She guesses it got in her blood stream. She went back to the pharmacist that gave it to her and he took her in the back where she showed him the little white spots on her legs, but he didn't say anything. She says that people get excited about thing though. She got the shot at 11 or 11:15, she stayed the 15 minutes and felt ok. About a week later in that arm where he gave the shot, it got all red but not streaked, just red. A lot of time she had shots; the flu shot will do her that way sometimes. She confirms the tightness was at the bend of her arm on the inside. Caller described it as being the same side of your arm that the little finger is on. Caller stated that by the time she got home it was swollen to a pretty good size. That same evening about 6pm she went back down to the pharmacy where she got the shot to show the pharmacist; and at that time, it had white spots on her arms and around the left wrist as well. Caller stated when she woke up on 26Feb2021 her right arm had become swollen as well. Caller stated the swelling has gone down a bit but was still there and the knots feels like it had little ridges in it, makes the vein in the middle of your arm stick up a little. She stated that she went to her usual # today to get some medicine and showed her and the pharmacist the inside of her arm and her pharmacists asked if that's where they gave her the shot. Caller stated she told the pharmacist no but notes that this was not the first time someone has asked her if the affected area was the area where she received the shot. Caller clarified around this same time, she also noticed little spots of what appeared to be liquid under her skin on both her legs and wrists. The pharmacist told her it was something in her lymph nodes. She guesses the medicine going in her body after being put in that muscle. Caller stated they are cleared up now. Caller stated about a week later her left arm got all red up in the muscle. Caller commented that she is aware that flu shots sometimes will do that too. No further information provided on this event. Details documented as provided by patient. Caller stated that she has her second Pfizer COVID 19 Vaccination shot scheduled for tomorrow and is wondering if she should still get it being that she had these reactions, and they still persist. Caller also asked if the dosage of the second immunization is the same as the first. If that's ok, if they should she push her second shot back. Caller stated she had only used a heating pad and taken no medication for these events. Caller also stated that she heard on the news that they will call other people if people don't show up for their shots instead of leaving it on shelf. Question asked if the expiration date on the paperwork mean that they leave it on the shelf until that date. DETAILS OF PATIENT: Caller stated she weighs anywhere between 123-125 pounds. HEALTHCARE PROVIDER: Caller was unsure about spelling of (Withheld) first name. She knows it's (Withheld) with a Ph, but she is unsure of the spelling. (Withheld) was the PA at the doctor's office, and caller stated she had a wellness appointment previously scheduled. She cannot remember the date at this time, but she knows it was after receiving her Pfizer COVID 19 vaccination and during this appointment she did show (Withheld) the events she was experiencing. EVENTS: Caller stated the spots of fluid build-up/liquid on both legs and wrist went away a couple of weeks ago but cannot recall a specific date. Caller does confirm they are all gone. Left arm red at the muscle: no further information provided. details documented as caller provided. PRODUCTS: Caller unsure what this number was but requests to share it because it was on her Pfizer COVID19 Vaccination Paperwork: #Caller got her PFizer Covid 19 Vaccination at #. Caller shares that she had history of AFib and she thinks that was how she got on the list. Caller stated that her sister went to get her COVID Immunization and after her sister got it, her sister told her that they said they would look into the caller getting it as well. Caller stated all of sudden she got a call and found out she could get it the next day, which she did. Eliquis: Caller was on Eliquis first then the insurance wouldn't pay for it and she was put on Xarelto, which the insurance pays for. No Eliquis product/lot/ndc/exp date information available. Caller took 5mg twice per day. Caller stated she heard from her doctor that when you hit 80 years old, you should take less, but the Xarelto was 20. Caller stated she asked her doctor and he said this was ok. Flecainide Tablets: Caller stated Flecainide tablets are sometimes hard to swallow, tastes terrible; usually goes down ok; no other product/lot/ndc/exp date information provided. Details documented as caller provided. Atorvastatin: About 20years ago Atorvastatin 10mg for a long time and then the doctor told her to cut it back to 5. been a long time ago, the doctor went out of practice and went to teaching. bottle or packaging information not available. Prednisone: Caller stated she doesn't like this product as it makes her all flushed and hot. She knows some medications have reactions, like makes her get red. She learned that many years ago. No further information provided.  No follow-up attempts are possible. No further information is expected.