Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Headache, Lip swelling, Muscle mass
Clinical narrative: had COVID twice; had COVID twice; AFib acted up so bad; her arm got hard, that arm and it was swelled up; heart racing; lost 10 pounds; rash; has knots in her muscle; swollen lips; sore arm where she received the shot; pain in her shoulder; hive on her arm; high fever; bad headaches; itchy; very tired with both shots; 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.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6198), in left arm and in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL [LISINOPRIL DIHYDRATE] taken for blood pressure measurement; AMLODIPINE [AMLODIPINE BESILATE] taken for blood pressure measurement; HYDROCHLOROTHIAZIDE taken for blood pressure measurement; LEVOTHYROXINE oral taken for thyroid disorder; CARVEDILOL ZENTIVA taken for blood pressure measurement. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID twice"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib acted up so bad"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her arm got hard, that arm and it was swelled up"; PALPITATIONS (non-serious), outcome "unknown", described as "heart racing"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 10 pounds"; RASH (non-serious), outcome "unknown"; MUSCLE MASS (non-serious), outcome "unknown", described as "has knots in her muscle"; LIP SWELLING (non-serious), outcome "unknown", described as "swollen lips"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm where she received the shot"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain in her shoulder"; URTICARIA (non-serious), outcome "unknown", described as "hive on her arm"; PYREXIA (non-serious), outcome "unknown", described as "high fever"; HEADACHE (non-serious), outcome "unknown", described as "bad headaches"; PRURITUS (non-serious), outcome "unknown", described as "itchy"; FATIGUE (non-serious), outcome "unknown", described as "very tired with both shots". The patient underwent the following laboratory tests and procedures: Allergy test: (unspecified date) no allergies; Blood test: (unspecified date) autoimmune disease, notes: I have autoimmune disease because of the arthritis; SARS-CoV-2 test: (28Dec2021) Positive; (26Feb2022) Positive; X-ray: (unspecified date) did not find any, notes: blood clot via x-ray but they did not find any. Therapeutic measures were taken as a result of drug ineffective, covid-19, atrial fibrillation, peripheral swelling, palpitations, weight decreased, rash, muscle mass, lip swelling, vaccination site pain, arthralgia, urticaria, pyrexia, pruritus.  Clinical course: Patient stated that, She had a rash on her legs and her body and her arms and she also reported swollen lips and that she had an AFib with her heart racing so, she had the shot in Mar2021 (01March2021) and right after Christmas she had COVID. So, on 26Feb2022 she had COVID again and then she also reported that she had a sore arm where she had the shot and its swelled up real hard. She got a sore arm where she received the shot and its swelled up real hard and so she went to the doctor to check if there is a blood clot but they did not find any clot and that she is on blood thinners (Treatment) because of that and she also reported having a pain in her shoulder that's why she is getting therapy. So, she also reported having an upper lip swell and a lower lip swelling and she also mentioned that there was a big hive on her arm where she received the shot so, she described it like the bottom of a water glass and it was itchy and she also mentioned that she already lost 10 pounds and that is the information that I have. She did not mentioned that it (Blood thinner) is for blood clots but that she was given blood thinners. AFib and the doctor 'put me' on blood thinners, the doctor put me on blood thinners now. That's when I had the AFib the whole week I was sick, my AFib got really bad and the doctor put me on blood thinner. I had this shot a year ago over a year ago in March so and after when I had the, after this shot my left arm where I had the shot, the arm got big around and hard and have like lumps in my muscles, in my shoulder blade you know, into that arm and on my neck. and that same arm I had that big like a hive like a big around its a bottom of water glass, it was real hard and it was 'picking' up. In response I am concerned is because my doctor keeps changing my blood pressure pill thinking that's what was causing the swollen lips and the rash. I am on number 4 blood pressure pill in the last month and a half. I think, I have been on Lisinopril my blood pressure pill for over 10 years and she stopped me with that's what causing the swollen lips and the rash. So, she took me off and put me on Amlodipine then I got swollen feet, I was only on it a day and I went off of it right away then she put me on Hydrochlorothiazide and I was on it till yesterday and now today I am on new blood pressure pill because my lips swelled up yesterday so, she switched me to another blood pressure medicine pill thinking its in the blood pressure and I kept thinking no, its can't be, its got to do with COVID shot or the COVID. I take Benadryl (Treatment), I had to take Benadryl when I get the rash on my body because it itches real bad so I had to put Benadryl or I take Benadryl to relieve the swelling of the lips and help the rash too."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.