Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Atrial fibrillation, Body temperature, Cellulitis, Dehydration
Clinical narrative: Cellulitis; AFib; Asymptomatic COVID; Asymptomatic COVID; dehydrated; This is a solicited report from a non-Pfizer sponsored program, PSP-ELIQUIS-CONDUENT: PSP-ELIQUIS-CONDUENT-CW3050920, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-070250), license party for apixaban (ELIQUIS).  This 70-year-old male patient was involved in a patient support program described as "PSP-Eliquis-Conduent-CW3050920" (Protocol: PSP-Eliquis-Conduent). The patient received APIXABAN. The report describes a case of CELLULITIS and ATRIAL FIBRILLATION (AFib). The occurrence of additional non-serious events is detailed below. Co-suspect products included Covid-19 Vaccine for an unknown indication. height: "5 7". The patient's past medical history included Hospitalisation. On 05-Jul-2021, the patient started APIXABAN (Oral), (5 milligram, twice a day). On an unknown date, the patient experienced CELLULITIS (seriousness criterion medically significant), ATRIAL FIBRILLATION (seriousness criterion medically significant), ASYMPTOMATIC COVID-19 (Asymptomatic COVID) and DEHYDRATION (dehydrated). The dose of APIXABAN (Oral) was not changed. At the time of the report, CELLULITIS, ATRIAL FIBRILLATION, ASYMPTOMATIC COVID-19 and DEHYDRATION outcome was unknown. The registered pharmacist (who is also the patient) reported that he was receiving Eliquis 5mg tablet for atrial fibrillation. He started Eliquis while he was in the hospital. The RPH enquired that what kind of antibiotics work well with Eliquis. He said he took COVID vaccine. Thought that he got cellulitis, so he has that. He enquired which antibiotics work best for that diagnosis while taking Eliquis. Reconfirmed request. He stated there is a range of antibiotics he has used. Lack of information on what drugs can be used in conjunction with Eliquis and AFib. He asked what we feel comfortable with, What was our experience. He was a pharmacist for 35 years. He has cellulitis. He has a lot of faith in his General Practitioner. He was dealing with AFib that may have nothing to do with this. Probably due to temperature. Could have been due to cellulitis because he got dehydrated. It could be due to multiple issues. Anyways, the antibiotics he was most interested in were Cephalexin, Clindamycin, Levaquin, Dicloxacillin and Doxycycline. He has COVID, but never knew he had it. Provided response to the reporter. Also provided OM referral / referral to prescriber for classification of those 5 medications to determine if they fall in either of those 2 scenarios listed in the Drug Interactions section. Asked "So, you do not see any direct mention of those in the PI" Correct. Re-read the Drug Interactions section several times per his request. Stated he can sort this out himself now that he knows both of those categories. He stated "That gives me something to go off of. Thanks". He mentioned he was looking at a Clinic and WebMD. He sees Side effect profile with Levaquin increase in the QRT on EKG. Let him know we can not speak to anything on the internet. We are only permitted to speak from our internal approved resources. He confirmed understanding. When enquired for the onset dates, the reporter stated that he had asymptomatic COVID, so there was no onset. He decided  to get a serological test before getting vaccine, in case he already had it, which he did. He did not offer any other onset dates (even though asked about all events he mentioned above). Asked if I was asking when he was 1st diagnosed with AFib. Let him know don't need that. Just needed the event onsets for the events he mentioned earlier. He did not provide any other event onset dates though. No hospitalizations after starting Eliquis. The patient did not receive any treatment for Covid. "Oxygen temp twice 99 on oxygen" and temperature  was always 97.8 F. RPH mentioned he is scheduled to see cardiologist. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.8 F units not specified and Serology test: Covid-19. For APIXABAN(Oral), the reporter considered CELLULITIS and DEHYDRATION to be not related. No further causality assessments were provided for ATRIAL FIBRILLATION and ASYMPTOMATIC COVID-19.   The reporter's assessment of the causal relationship of AFib and Asymptomatic COVID-19 with apixaban was not provided at the time of this report. The reporter's assessment of the causal relationship of AFib, Asymptomatic COVID-19, Cellulitis, Dehydration with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Follow-up (16Jul2021): This is a solicited report from a non-Pfizer sponsored program, PSP-ELIQUIS-CONDUENT: PSP-ELIQUIS-CONDUENT-CW3050920, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-070250), license party for apixaban (ELIQUIS). Amendment to file on 16-Jul-2021: BMS-2021-070243 was identified to be a duplicate of this case. All information from BMS-2021-070243 has been added to this case. BMS-2021-070243 will be deleted. Merging of file resulted in following information: This report was received from registered pharmacist who is also the patient. New events added. COVID-19 VACCINE considered as suspect. The patient details, history, lab data, suspect details, event details and narrative were updated. Sender's Comments: BMS medical evaluation comment: This patient had cellulitis and atrial fibrillation while on apixaban study therapy. Based on the infective etiology of the reported event, cellulitis is considered not related to apixaban. Considering the reported event as an electrophysiological disorder of the heart in this patient, atrial fibrillation is not related to apixaban.  Pfizer's clinical evaluation comment: A contributory role of BNT162B2 to reported events cannot be fully excluded, except dehydration, which is assessed as intercurrent medical condition. The information provided is limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. 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.