Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood cholesterol, COVID-19, SARS-CoV-2 test, Vaccination failure, Vitamin D
Clinical narrative: COVID-19 DELTA/Pfizer COVID-19 vaccine (1st dose : 23-Dec-2020 and 2nd dose : 13-Jan-2021; COVID-19 DELTA/Pfizer COVID-19 vaccine (1st dose : 23-Dec-2020 and 2nd dose : 13-Jan-2021; This is a solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-083107), license party for apixaban.  This 63-year-old female patient was involved in a patient support program. The patient received APIXABAN. The report describes a case of COVID-19 (COVID-19 DELTA). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (all at 62 years old) dose 2 via an unspecified route of administration on 13Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 23Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation, apixaban, oral from 2018 (Batch/Lot Number: 1802259; Expiration Date: Oct2023) to an unspecified date, at 5 milligram, bid for cerebrovascular accident prophylaxis. The patient's past medical history included AFib, Blood cholesterol abnormal (on medication), Vitamin D deficiency (on medication) and Allergy (on medication). Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; pilocarpine hydrochloride taken for an unspecified indication, start and stop date were not reported; magnesium oxide taken for an unspecified indication, start and stop date were not reported; estradiol taken for an unspecified indication, start and stop date were not reported; colecalciferol taken for an unspecified indication, start and stop date were not reported; mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for an unspecified indication, start and stop date were not reported. Previously administered products included for COVID-19 immunization: Pfizer COVID-19 vaccine (1st dose : 23-Dec-2020 and 2nd dose : 13-Jan-2021) from 23-Dec-2020 to 13-Jan-2021; for Product used for unknown indication: Prednisone. Past adverse reactions to the above products included Heartbeats increased with Prednisone. In 2018, the patient started APIXABAN (batch no. 1802259) (Oral), (5 milligram, twice a day). On 13-Aug-2021, the patient experienced COVID-19 (COVID-19 DELTA). The patient was treated with azithromycin (Zithromax) for COVID-19,. The action taken with APIXABAN(Oral) was unknown. At the time of the report, COVID-19 did not resolve. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. For APIXABAN(Oral), the reporter did not provide any causality assessments. Therapy with apixaban was given for prophylaxis stroke. It was reported that 'she has had fever, not productive coughing, nasal discharge that seemed like a sinus infection, really bad jaw pain, ocular pain (felt like eyes would pop out), and headaches. she was prescribed Zithromax and Prednisone. she has taken the Zithromax but she has not fill the prescription for Prednisone. she is going to have an IV treatment called bamlanivimab. she stated that her doctor thinks that the COVID-19 vaccine effectiveness maybe waning for her'. The outcome of the events was not recovered.  Causality of event COVID-19 for drug Apixaban was assessed by the reporter as no information, by company (Bristol-Myers Squibb) as not related.; Sender's Comments: Based on temporal association, a causal relationship between the events and bnt162b2 cannot be completely excluded.  The events are unrelated to apixaban. The case will be reassessed when additional information becomes available.