Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Gait disturbance, Thrombosis
Clinical narrative: she had pain in her knee; it was hard for her to walk; blood clot found in right leg; This is a solicited report from a non-Pfizer sponsored program, PSP-ELIQUIS-CONDUENT-USA: PSP-ELIQUIS-CONDUENT-USA-CW3050920, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-051474). This case was split from master case 2021623975 for Covid-19 vaccine with she had pain in her knee and it was hard for her to walk. An 88-year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at an unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies. Concomitant medication included apixaban (ELIQUIS) (batch no. 1798944, expiration date: SEP 2023) via oral route at 5 milligram, twice a day taken for venous thromboembolism from an unspecified date in Jan 2021. On an unspecified date she had pain in her knee, it was hard for her to walk and on an unspecified date in Jan2021 the patient experienced blood clot found in right leg. The patient underwent lab tests and procedures which included blood pressure measurement: normal. This 88-year-old female patient was involved in a patient support program described. The patient received APIXABAN. The report describes a case of HOSPITALISATION. The occurrence of additional non-serious events is detailed below. In January 2021, the patient started APIXABAN (batch no. 1798944) (Oral), (5 milligram, twice a day). On an unknown date, the patient underwent hospitalisation (seriousness criterion hospitalization), OEDEMA PERIPHERAL (Swelling in her feet/fluid in her feet) and arthralgia (Bad knee pain). The patient was hospitalized for 2 days due to Hospitalisation. The action taken with apixaban(oral) was unknown. At the time of the report, hospitalisation and oedema peripheral outcome was unknown and arthralgia did not resolve. The patient reported that she was in hospital for two days. The consumer stated her feet swells up. After receiving the coronavirus vaccine she had pain in her knee and it was hard for her to walk. Patient was inquiring if she can take green leafy vegetables with Eliquis. Patient started on Eliquis for a blood clot found in her right leg in Jan-2021. Patient reported that she believes the blood clot was there longer because her feet would become swollen. Patient re-ported that her feet were swollen today however, it will go away tomorrow. The swelling will go away for three or four days, sometimes up to a week. Patient reported that there was nothing all winter, the swelling was down. There was increased swelling with the warmer weather. Doctor told her the blood clot should go away. She went back to the doctor because she still had swelling. The doctor told her she has fluid in her feet. Her doctor told her to follow up with her primary physician because she never had a blood clot before and she should have her medications checked. Patient reported that after receiving the vaccine she can run but she still feels pain in her knee. The strength of apixaban was 5 mg For APIXABAN(Oral), the reporter did not provide any causality assessments. The primary reporter was the consumer Most recent follow up information received from the consumer incorporated above includes: 26-May-2021: Event Hospitalisation was added, Event verbatim was amended from Swelling in her feet to Swelling in her feet/fluid in her feet, Covid-19 vaccine was changed from suspect to concomitant drug, product attributes, event attributes, patient demographic details and narrative updated. BMS Medical evaluation comment: This patient had hospitalized for unknown reason after apixaban therapy. Based on the limited information regarding hospitalization details, laboratory reports, treatment details, it cannot be ascertained that the suspect drug contributed to the reported event. Outcome of the events was unknown.