Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood test, Cardiomyopathy
Clinical narrative: elevated CPK; Unable to raise arm; arm became sore; Muscle trauma/ some kind of damage either to heart muscles to the brain or some skeletal muscle on the body; Muscle trauma/ some kind of damage either to heart muscles to the brain or some skeletal muscle on the body; This is a spontaneous report from a contactable nurse reported for herself. A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EP7534, expiration date: 31Jul2021, via an unspecified route of administration, administered in left deltoid (also reported as left arm) on 21Mar2021 at a single dose for COVID-19 immunisation; and rosuvastatin calcium, oral from an unspecified date (Lot Number: 20082811; Expiration Date: Jul2022) to an unspecified date, at 5mg every night for hyperlipidemia and Stage 3 kidney disease. Medical history included hypertension (diagnosed maybe 30 years ago, it is controlled), status ventricular tachycardia in 2001 (controlled), stroke (suffer stroke may be 12 or 13 years ago without the residual), Phase 3 renal disease/Stage 3 Kidney Disease, extracted tooth, bad tooth, aches and pain in her legs in Jan2020 and ongoing, and muscle pain. Patient did suffer stroke may be 12 or 13 years ago without the residual, it was incidental finding with the MRI with the brain because she had a bad tooth and they extracted the tooth, they decided to complain let's do a brain MRI of the brain and it showed an influx in right cerebellum but without residual she have no deficit, but they put her on Plavix first but the bruising was very severe so they changed it to Aggrenox which she successfully use Aggrenox now. Other medical conditions: Consumer stated, Folic acid, sodium bicarbonate, yes the Soda Bicarb (sodium bicarbonate) is for the Phase 3 renal disease but numbers are good, my DE creatinine all was normal but my nephrologist who happened to be a friend of mine said stage 3 renal disease. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX) taken for antiplatelet therapy, and paracetamol (TYLENOL) taken for pain. Concomitant medication: Consumer stated, "I take lots of medication, I mean I take Tylenol but none these have a direct correlation to the, I take Aggrenox, Aggrenox is antiplatelet, oh you are a pharmacist so you know that, that's Persantin and aspirin that's the combo, its antiplatelet." Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient previously took clopidogrel bisulfate (PLAVIX) and experienced bruising; folic acid, and Soda Bicarb (sodium bicarbonate) for phase 3 renal disease. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6203, expiry date: 30Jun2021, on 28Feb2021 for COVID-19 immunization. It was given in her left arm. She received the second dose of the Covid-19 vaccine on Sunday (21Mar2021). Her arm became sore on 21Mar2021. On Wednesday (24Mar2021), she was unable to raise her arm even in the shower. She saw her doctor on Thursday because she is on a statin and had aches and pain in her legs. They drew blood and found that she has an elevated CPK on 26Mar2021. It is not grossly but is elevated and has had muscle trauma. Could there be a connection? She reduced the statin to three times a week. The arm soreness is 30-40% improved. She can move her arm away from her body. It felt like she hit her elbow in the funny bone. It was an odd feeling down to her fingertips. The vaccine card indicates the vaccine was given in her right deltoid but it was given in her left deltoid (Left arm). She clarified that she is taking Rosuvastatin Calcium instead of Crestor. She added that she has Stage 3 Kidney Disease. The Nephrologist had told her that she needed to take Rosuvastatin Calcium 7 days a week instead of three. She has only had the pain since she started taking it daily. She stopped taking it daily this past Monday night. She told her doctor she will be taking it only on Monday, Wednesday and Friday. Consumer further stated, she had a very sore arm that she cannot lift over her hand, it feels like somebody hit her elbow. Consumer further reported and stated that she had the Pfizer second vaccine on Sunday (21Mar2021), by Wednesday (24Mar2021), she could not lift her arm, she went to her doctor yesterday and she was a nurse for 54 years so she did not think that was big deal, vaccine do give you a sore arm. However, she drew blood, well she didn't, the technician drew blood in that arm and her CPK is elevated, Patient stated "am I speaking to a pharmacist, doctor or, okay CPK indicated some kind of damage either to heart muscles to the brain or some skeletal muscle on the body. Mine has never been elevated, it's not growth fully elevated like indicative of cardiac event, However, it is elevated so I thought I should report this to Pfizer so I want you to know that, this is unusual finding." She was on a statin drug, she was on Crestor 5 mg once a day (clarified that she is taking Rosuvastatin Calcium instead of Crestor), however she cut it back to just 3 times a week now because her cholesterol numbers are good, my LDL and HDL are all good and the Cholesterol drug (Intent: Crestor) is known to cause this muscle aches and pain but this is so coincidental with this arm, her left arm where she received vaccine and this CPK being elevated and she thought perhaps Pfizer should be made aware. Consumer stated, "I have been a nurse, I am retired now, I am 76 but I had been a nurse for 54 years, I was at one time director of nursing, so I am familiar with the healthcare system and most medications but of course this Pfizer vaccine and Moderna and Johnson and Johnson these are brand new, this is a Covid pandemic so. Causality: Consumer stated, I kind of think there is connection there sir, because remember that it could be, muscle damage that elevates your CPK, it could be cardiac muscle, it could be a stroke, neither which I didn't have a heart attack. I was having a lot of muscle pain, prior because of the Crestor but that is the common side effect of any statin drug can cause muscle aches and pains. However, I thought there was quite a connection getting the vaccine in the right arm, not being able to raise my (incomplete sentence) now vaccine was Sunday which was I believe the 21st and this event did not happen until, I was sore Sunday evening but the unable to raise it was Wednesday, which was 3 days later yeah and the blood draw was yesterday morning and this morning my doctor called me to tell me that my CPK was elevated not grossly but enough to make the phone call. Consumer stated, the first one was on 28Feb2021 and the lot number was EN620, I need my magnify glass, there is one right here because it's so small, okay its EN62C or is it 0, it's hard to tell 3 is the last number. The second dose with lot number is EP7534. Consumer stated, Let me just look at the calendar to make sure that was Wednesday, I got the shot on 21st, yes sir, it was the 24th, the arm was sore even that evening the 21st (21Mar2021), evening of the 21st but the inability to move it was Wednesday the 24th, I could not move even move it away from my body so I was guarding it, today it's not as bad, I can move it but I still feel it like up in my shoulder. When confirmed if the event has improved, consumer stated, I would say yes but not totally gone. Consumer stated, I just took Tylenol that's all, I mean what I was going to do, I think I took, I know I took a shower last night Wednesday at night, I might let the warm water run on it, I might have, I don't remember, I took a shower regardless so." Lab test: Consumer stated, "I had blood work yesterday all my values were normal, Cholesterol was normal the only thing that was elevated was the CPK." Consumer stated, "I thought that it was necessary to report it okay, is there any way you can tell me is this a common occurrence where CPK elevates slightly." The action taken in response to the events for BNT162B2 was not applicable and for rosuvastatin calcium was dose reduced. The outcome of the events 'arm became sore, unable to raise arm, elevated CPK and muscle trauma (muscle injury)' was recovering while the outcome of the other event was unknown. The reporter considered the events 'arm soreness, unable to raise arm and elevated CPK' as serious (medically significant). The causality of the events 'arm soreness and unable to raise arm' was related to BNT162B2, and event 'elevated CPK' was related to rosuvastatin calcium.; Sender's Comments: Based on a drug event temporal association, the company cannot completely rule out a reasonable possibility that BNT162B2 caused the events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.