Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Headache, Illness
Clinical narrative: 103 degree fever; chills; body aches; headache; feeling hot through the night; Got sick; This is a spontaneous report from a contactable consumer (the patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided, expiry date May2021), via an unspecified route of administration in the left arm on 30Jan2021 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization; and apixaban (ELIQUIS, lot number ABA8272S, NDC 0003089421, expiry date Oct2021) film-coated tablet, via an unspecified route of administration from an unspecified date to 31Jan2021 at 5 mg, twice daily for cerebrovascular accident prophylaxis. Medical history included: he had tested positive asymptomatically for COVID due to contact contamination on 02Jan2021 or 03Jan2021, blood pressure, and A-fib (atrial fibrillation). Concomitant medication included ongoing metoprolol for blood pressure. There were no vaccines administered on same date with the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that he got sick after getting the vaccine (on 30Jan2021) and had an important question. He got a fever (31Jan2021) and all that stuff that lasted like a day and a half after getting the vaccine, just like a million other people. But he missed the part about asking a doctor about taking his blood thinner, which he took as normal up through the day that he got the vaccine and the next morning, then he stopped it. The patient clarified that he got the vaccine on Saturday (30Jan2021), stopped the blood thinner on Sunday (31Jan2021), the sickness subsided around Monday (as reported), but he still hasn't gone back on the blood thinner. He wanted to know when it was safe for him to start taking the blood thinner again, and he needed to know what to do for the second vaccine. The clinical course was as follows: He got the first dose of the vaccine on 30Jan2021 at 10:00 and at 22:00 he started feeling hot through the night. On Sunday, 31Jan2021, he had 103 degree fever, chills, body aches, and a headache. He clarified that he recovered completely by Wednesday, 03Feb2021. He had been on Eliquis for years for A-Fib. He stopped taking it once he got sick after getting the vaccine and went back and read the material and noticed what it said about the blood thinner. He did not go to the emergency room or physician's office. The action taken in response to the events for apixaban was temporarily withdrawn. The outcome of the events was recovered on 03Feb2021.  Follow-up (05Feb2021): This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013684), license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: #) on 05Feb2021 and was forwarded to BMS on 09Feb2021. This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE in 58-year-old male patient who received apixaban (Eliquis) film-coated tablet (batch no. ABA8272S) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine injection for COVID-19 immunisation. Concurrent medical conditions included Blood pressure abnormal. On an unknown date, the patient started Eliquis (batch no. ABA8272S) (unknown route), 5 milligram twice a day. On 30Jan2021, the patient started Covid-19 Vaccine (unknown route) Unknown dose by injection in left arm. On 31Jan2021, an unknown time after starting Eliquis, the patient experienced PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE. Eliquis (Unknown) was interrupted due to event. On 03Feb2021, PYREXIA, CHILLS, PAIN and HEADACHE resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31Jan2021, Body temperature: 103 degree. For Eliquis (Unknown), the reporter did not provide any causality assessments.  Information about lot/batch number has been requested.