Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Colonoscopy
Clinical narrative: This is a spontaneous report received from a contactable nurse (patient). A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6201; expiration date: 30Jun2021) via an unspecified route of administration, administered in deltoid left on 02Mar2021 11:00 as single dose for COVID-19 immunization. Medical history included Neuropathy, Diabetes, AFib, Anemia, bleeding ulcer, Rectal bleeding, Hypertension, knee bleed, osteoarthritis in hands, Bursitis, Cataracts, arthritis in knees, Stroke, hearing impairment, Diverticulitis, Internal hemorrhoids, Bunionectomy, Fall, broke her ankle, device implant, Transfusion, retinal surgery, Cataract surgery, had a positive COVID test, Cholesterol, Weak and cracked fingernails and keep blood thin, to prevent clots. Concomitant medications included Onglyza for diabetes mellitus, Pantoprazole for ulcer. Fish oil for blood cholesterol abnormal, Atorvastatin for blood cholesterol abnormal, Zocor, Colecalciferol (VITAMIN D 3), Biotin, Cyanocobalamin (Vitamin B12) for hypoaesthesia, ubidecarenone (COQ-10), macrogol 3350 (Miralax), acetylsalicylic acid (Baby Aspirin) for anticoagulant therapy, fexofenadine hydrochloride (Allegra). On an unspecified date, the patient experienced had sore arm and on 02Mar2021 had strong headache, stiffness/neck stiffness, chills, weakness, soreness all over the body, moderate soreness at the injection site after covid 19, joint pain, felt cold, tiny red spot at injection site about the size of a dime, back pain. The events were considered as non-serious by the reporter. Reporter stated that she was a Retired RN, and she had her first dose of the Pfizer Covid vaccine on 02Mar2021 at 11am, and she was scheduled for her second covid immunization on 23Mar2021. Caller has questions about side effects she experienced after the first dose and whether or not she should get the second immunization. Caller states she had a pretty strong reaction to the first injection. Caller states that she had the COVID disease in 22Oct2020, the caller went to the ER and had a positive COVID test because she had a fever, but she was sent home because her lungs were clear. She reported that both her son and her husband also got COVID around that time, but none of them had to be hospitalized. Stated that about an hour after her first injection, some soreness developed at the injection site. Later that afternoon she started to get a strong headache and her arm was getting sorer; in the evening, she started developing more joint pain in multiple joints, all over including, and especially, on her toes and feet; and her left arm was getting more sore, she got the chills, and she felt cold all the time, her temperature was 96.4; caller states that she also developed a tiny dime sized red spot at the injection site. Caller states that she also was thirsty, but she was a diabetic and that might have something to do with it. By the time it was time for her to go to sleep she was stiff and weak all over. She had neck stiffness, the feeling of being kind of stooped over. Caller was worried she would be unable to straighten up. The next morning, she still had weakness, stiffness and soreness, could hardly take a shower. She had to sit on side of tub and had to have her husband help her to get dressed. By about 10am the next day, everything started going away and by noon everything had pretty much cleared up completely and was gone. The pain in caller's feet and joints was gone by lunch and she did not have a fever. Caller states that at dinner that night, she was still weak though, and at the evening meal, she was so weak that she couldn't get up from the chair at the kitchen table alone. Once she was on her feet, she was okay, she could walk, but she uses a cane, especially when she was sick. About an hour or two later, she had a temperature of 99.4. But the next day, she didn't have a fever, and she could use that same chair without help. Caller states that she was fine by Friday and her blood sugar was 95, which was good. Caller states that she had a backache a few days following, but she has had backache before. Caller states that this was her history, she had the COVID, and she had a bleeding ulcer over a year ago now. Caller also saw a Cardiologist and had the watchman device implanted at the end of Sep2020, caller had this procedure to try and help get her off the Eliquis, which she had been on since having the stroke. Caller reports that she also had a Rectal bleed when she was put back on the Eliquis, and her doctors kept her on it because of the stroke. Caller states that she has silent A. Fib and that can throw little clots, so the doctors wanted her on a low dose of Eliquis but apparently that was too much for the caller too. Caller thinks the heart procedure is doing great and doing its job, but she was unable to go in for her follow up to the procedure, because she needed an esophageal echocardiogram to see if the device was sealed over by the heart muscle, and she couldn't have that until Jan2020, because she had to test negative for COVID twice. Caller states that her hemoglobin never really recovered more than 10 since her bleeding ulcer. But her hemoglobin went down to 7.4 and she was sent to the ER at the end of Jan2021, and she had two transfusions, and the next morning her hemoglobin went down to 7, the hospital staff thought that she must be bleeding. So the caller saw a GI doctor who said that the caller needed an endoscopy and colonoscopy to see where this was coming from, to make sure she was not bleeding from the ulcer. They saw the ulcer was healed but irritated, and the colonoscopy removed a couple polyps. The polyps were negative for cancer cells. After the caller had the COVID injection, she had blood in her stool. Caller went to the ER in the evening of 08Mar2021, and she stayed in the ER until the next morning. Caller states that the stool sample did show that there was some blood in her urine (captured as provided by the caller), and the ER did a CT of her abdomen, and they didn't see blood or diverticulitis. Caller does have a history of diverticulosis or internal hemorrhoids. Because things were going on last Fall, and things were rescheduled with the COVID disease, and things, the caller did not get her regular flu shot until 12Jan2021, because she needed two negative COVID tests prior to being able to get the Flu shot. She got two negative COVID tests on 24Dec2020 and 06Jan2021. Caller does not know if having had her flu shot in Jan2021, could have affected it. Caller was concerned and was wondering if she should take the second dose of the COVID vaccine or not. HCP Details: Caller hasn't spoken to her PCP since she was last in the hospital. She tried to call her HCP, but that office was getting a new computer system and they were having a high call volume for COVID stuff, so caller could not get through to them. Caller plans to email her doctor today. Everything has been overwhelming with all these things and people for doctors to juggle. Event Details: Caller reports that the soreness at her injection site, by the next morning, was up into her shoulder. Caller states that her niece, who was not a nurse, called the caller and told her to get the injection three fingers below the shoulder joint, because there were some instances of people getting injected into the shoulder joint. So, caller had soreness at the injection site, but within 24 hours, states that she was just sore all over, but it all went away by the afternoon the next day. Caller states that, she was told that she would have reactions more to the second injection than the first, so that was her concern, was she does not want to get the second injection and then it be worse than what she experienced. Caller had a lot of pain in her toes following the COVID injection, but she has diabetes that was well controlled, and she has neuropathy, and probably arthritis. But caller states that the pain in her toes was worse than normal, following receiving the COVID vaccine. Caller has had a bunionectomy, so she always has some numbness in the toe, and she fell and broke her ankle a few years later. But caller states that the very concerning thing was, following the COVID injection, the joint pain and soreness all over and weakness that she experienced. Caller had the stiffness together with some of the other things from her low hemoglobin anyway, as she has not fully recovered from the blood loss, but she was much better, and after the transfusions she had a hemoglobin of 10. And when caller went to the hospital lately, her hemoglobin was 9.4, and she was having it tested Tuesday morning again. Caller states that it was hard to say that everything she experienced was from the COVID vaccine, as she has a history of some of these things, including weakness. Caller finally got off the Eliquis when the hemoglobin went so low, she stopped the Eliquis maybe on 29Jan2021. Caller states that she was told by her Cardiologist that her symptoms at the time were from low Hemoglobin. Caller states that she was probably walking around with that low hemoglobin for a few days. Weakness: Caller states that at times she gets very fatigued, but she was not so weak right now. But caller states that weakness has been an up and down thing for her for the past few months, even before the COVID vaccine. Treatment: Caller took her normal Aspirin, but she did not take Tylenol even though she was told she could, and she did not take Allegra. She just took her normal medicines. History: When caller had her rectal bleed, she went into the ER on 08Mar2021, and she was sent home the next morning. Caller states that the ER was busy that evening and did not see the doctor until 10 or 11 that evening. But when the tests were finished up around 3am, the caller was told that she could go home or be admitted. Caller asked to go home but not until a little later in the morning, so she could call her family. Knee Bleed: Caller confirms it was aspirated and treated in the ER; she did not have to stay overnight. Caller saw orthopedic doctor a day or two later, and he did not order anything else. Caller walks with a cane now most the time because she is trying to avoid falling. Eliquis: Caller reports that the Eliquis was held for a few days after her GI bleed. She was taking 5mg twice a day from April or May2018. Caller had the GI bleed and the Eliquis was held for a few days and then she went back on it, then had rectal bleeding again. So, after that, caller's dose was reduced to 2.5mg twice day. The doctors did not want to take her off the Eliquis because of her prior stroke, so they just reduced her dose. The Eliquis had been preventing little TIAs and stuff in her hand and mouth and stuff. And that reduced dose was okay for a while. But caller states that she started getting those symptoms back, and several times a day she was getting the numbness, and she was scared she was going to have a stroke, so she said maybe because she was previously on mg twice a day, maybe she should up her dose to 7.5mg, and that worked well. So, caller took 5mg in the morning and 2.5mg in the evening. This was over a weekend, and on Monday the caller wrote her cardiologist, who said this dosing was not normally recommended, but if it was working for the caller, then that is okay. But then in July, the caller got the knee bleed. So, the doctors thought the caller's knee bleed was from the 2.5mg knee bleed but caller thinks she started to get that earlier because she had an episode that was similar before that, caller thought that episode in May or so was just arthritis. But, in Jul2020 her knee became swollen, very painful, and she could not get out of bed. Caller states that her son who was a weightlifter could not get her out of bed. She went to hospital via ambulance where her knee was aspirated. Caller reports that the Eliquis was not stopped due to the knee bleed, she was just told to go back to 2.5mg twice daily. Caller states that her heart doctor said that because she has had a stroke, she has to take the Eliquis to prevent stroke. Caller reports that she initially was not interested in the Watchman implant, but after all this, she decided to get that procedure so she could stop the Eliquis because she was a bleeder. The patient underwent lab tests and procedures which included colonoscopy: the ulcer was healed but irritated, endoscopy: the ulcer was healed but irritated, haemoglobin: 7.4 on Jan2021, haemoglobin: 7 on Jan2021. The outcome of sore arm and weakness was unknown, headache, stiffness/Neck stiffness, chills, soreness all over the body, moderate soreness at the injection site, Joint pain, felt cold, tiny red spot at injection site about the size of a dime were recovered on 03Mar2021 and back pain recovered on 09Mar2021.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of pain in arm,toe,headache,stiffness,chills,weakness,pain,joint pain,feeling cold,vaccination site erythema,pain and pain in toe. But also consider relevant medical history and concomittant drugs . 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