Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: her heart went back into afib one; feeling tired; numbness in her hands and fingers; tingling in her hands and fingers; lower back pain on the right side/lower back starts to hurt sometimes; weakness in legs/legs are weak; shortness of breath; feeling off; black eye; This is an initial solicited report from a non-Pfizer sponsored program,  from a contactable consumer, based on information received by Pfizer.  This 79-year-old female patient was involved in a patient support program. The patient received apixaban. The report describes a case of fatigue (feeling tired), hypoaesthesia (numbness in her hands and fingers), paraesthesia (tingling in her hands and fingers), back pain (lower back pain on the right side/lower back starts to hurt sometimes) and muscular weakness (weakness in legs/legs are weak). The occurrence of additional non-serious events is detailed below. The patient's past medical history included High frequency ablation and Hospitalisation. In March 2018, the patient started apixaban (Oral), (unspecified dose, twice a day). On an unknown date, the patient experienced fatigue (feeling tired), hypoaesthesia (numbness in her hands and fingers), paraesthesia (tingling in her hands and fingers), back pain (lower back pain on the right side/lower back starts to hurt sometimes), muscular weakness (weakness in legs/legs are weak), dyspnoea (shortness of breath) and feeling abnormal (feeling off). The action taken with apixaban (Oral) was unknown. At the time of the report, fatigue, hypoaesthesia, paraesthesia, back pain, muscular weakness, dyspnoea and feeling abnormal outcome was unknown. For apixaban (Oral), the reporter did not provide any causality assessments. Patient received apixaban for the indication of Atrial fibrillation. The consumer reported that in Mar-2018 during a trip with her daughter, she began feeling tired and her legs hurt. When she returned home, she was hospitalized and diagnosed with Atrial Fibrillation.  Follow-up (18Mar2021): This is a follow-up solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer license party for apixaban.  This 79-year-old female patient was involved in a patient support program. The patient received APIXABAN. The report describes a case of ATRIAL FIBRILLATION (her heart went back into afib one). The occurrence of additional non-serious events is detailed below Co-suspect products included Covid-19 Vaccine. The patient's past medical history included High frequency ablation and Hospitalization. Concurrent medical conditions included AFib. In March 2018, the patient started APIXABAN (Oral), (unspecified dose, twice a day). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seriousness criterion medically significant), FATIGUE (feeling tired), HYPOAESTHESIA (numbness in her hands and fingers), PARAESTHESIA (tingling in her hands and fingers), BACK PAIN (lower back pain on the right side/lower back starts to hurt sometimes), MUSCULAR WEAKNESS (weakness in legs/legs are weak), DYSPNOEA (shortness of breath), FEELING ABNORMAL (feeling off) and EYE CONTUSION (black eye). The patient was treated with Surgery (heart monitor) for Atrial fibrillation. The action taken with APIXABAN(Oral) was unknown. At the time of the report, ATRIAL FIBRILLATION, FATIGUE, HYPOAESTHESIA, PARAESTHESIA, BACK PAIN, MUSCULAR WEAKNESS, DYSPNOEA, FEELING ABNORMAL and EYE CONTUSION outcome was unknown. The patient stated that she had the coronavirus Pfizer vaccine and a few days later she had a black eye. The patient was concerned about this because she takes Eliquis so she asked a healthcare professional for advice they then informed her that the vaccine had caused her black eye. She was told that she cannot miss her second vaccine and that she might have to stop Eliquis. Patient was concerned about having to stop and had some questions. The patient reported that, she had been on Eliquis for a while and she had been doing just fine. She recently took the Pfizer Covid vaccine and a week or two later she developed a "black eye". She described the color around her eye as eggplant purple. She remembered her mother would have blood vessels burst around her eye, so at first, she thought nothing of it. She said the day before yesterday she went with her daughter while she got the Moderna Covid vaccine. She asked the nurse administering her daughters Moderna Covid vaccine if the Pfizer vaccine could cause black eyes. The patient said the nurse did some research and told her the the Pfizer vaccine was known to cause hemorrhaging, and that the vaccine caused the black eye. The nurse told the patient she should go to her HCP as soon as possible and get blood work done. The patient did not say anything else was abnormal about her blood work. She told the HCP what happened to her eye after she was given the Pfizer Covid vaccine. The HCP told her that no matter what the patient should get the second Pfizer vaccine, even if she had to stop the Eliquis for a few days. The patient said she did not want to stop the Eliquis because she has been doing wonderful on the medication and did not think the Eliquis was the cause of the black eye. She said she will have a talk with her normal primary care doctor as well as her cardiologist. The patient said she rather not get the second covid then stop the Eliquis. The patient started Eliquis two years ago after her heart went into "full afib" she had an ablation procedure and they shocked her heart three times to get it back into rhythm. Since starting the Eliquis the patient said her heart went back into afib one time. She wore a heart monitor and her heart went back into sinus rhythm on its own. She also mentioned that her HCP prescribed her a diuretic but she said she has a terrible reaction to it. She was prescribed the diuretic to help with the swelling around her ankles. She said the diuretic was also to help "keep congestion from her heart". The diuretic makes her feel "terrible" so her HCP allows her to cut the pill in half or quarters and take as needed to keep swelling down. She said the diuretic makes her feel faint and she even passed out one time while walking in the mall. She said she has not taken it in a while. The patient said she had a lot of allergies to medications, to many to list. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Prothrombin time: 16.2 seconds. For APIXABAN(Oral), the reporter did not provide any causality assessments. Patient received apixaban for the indication of Atrial fibrillation. The consumer reported that in Mar-2018 during a trip with her daughter, she began feeling tired and her legs hurt. When she returned home, she was hospitalized and diagnosed with Atrial Fibrillation. The strength of Eliquis was 5 mg. Most recent follow up information received on 18-Mar-2021 from Non-Health Professional incorporated above includes : New events added, lad data, concomitant drugs and narrative updated.; Sender's Comments: BMS Medical Evaluation Comment: This 79-year-old patient had atrial fibrillation after therapy with apixaban. Elderly age and underlying atrial fibrillation can be associated with increased risk of arrhythmias and based on the absence of etiological plausibility; the reported event is considered not related to apixaban.