Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood cholesterol abnormal, COVID-19, Intentional product use issue, Neuropathy peripheral, Product use issue
Clinical narrative: NEUROPATHY; SURGERIES IS TO GET IMPLANTS DONE ON HER TEETH; she has a pig valve while receiving Eliquis; SHE HAS A PIG VALVE WHILE RECEIVING ELIQUIS; CHOLESTEROL BEING 200; VISION PROBLEMS; BLOOD CLOTS IN FEET; COVID; ELIQUIS 360 PATIENT SUPPORT  This is an initial solicited report from a non-Pfizer sponsored program, ELIQUIS, from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2019-019666), license party for apixaban.  PROTOCOL TITLE:  ELIQUIS 360 PATIENT SUPPORT.   This phase-IV study report was received from a consumer via BMS-Medical information.  A 65-year-old female consumer had scheduled surgery to get implants done on her teeth and she had a pig valve (drug use in unapproved population) while on therapy with apixaban for pulmonary embolism and deep vein thrombosis.  On an unknown date, the consumer started therapy with apixaban, 5 mg.  Outcome of the events was not provided. Reporter causality assessment: No Information.  BMS causality assessment: Surgery to get implants done on her teeth and she had a pig valve (drug use in unapproved population) was not related to apixaban.  Follow-up (10Oct2022): This is a solicited follow-up report received from a contactable reporter(s) (Consumer or other non HCP) from License Party (Bristol-Myers Squibb). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2019-019666 (Bristol-Myers Squibb Company).  Correction to the file done on 13-May-2020: The event term "she has a pig valve while receiving Eliquis (Drug use in unapproved population)" was re-mapped to "Intentional product use in unapproved population".   Supplemental information received on 10-Oct-2022 with the following updates: Product apixaban details, co-suspect covid 19 added and events blood clot in legs(ms), neuropathy(ms), vision problems (ns), cholesterol being 200 (ns), covid(19) 9(ns), medical history, narrative updated The caller reported that she had a blood clot in her leg years ago and was put on warfarin for a while. The caller stated that after a period of time she went off of warfarin. The caller reported that she had her aortic valve replaced in 2016. The caller stated that about three and a half years ago she developed blood clots in her lungs and leg. The caller stated that it had been about seven to eight years between the previous blood clot. The caller was put on Eliquis at this point. The caller reported that since being on Eliquis she had three different bouts with COVID. The caller stated the first experience was in Feb2019 before people knew what was going on. The caller stated the second experience was at Thanksgiving 2020 and the third experience was in May2022. The caller stated the first two were not too bad, but the last experience was much worse. The caller reported that in Jan2022 she developed blood clots in her feet. The caller stated there were four to five of them, but they were superficial. The caller stated that her deep veins were checked, and they were okay. The caller stated that she received the second dose of the COVID vaccine before the blood clots occurred in her feet. The caller also took a zinc supplement and was not sure if they helped the blood clots in her feet to occur. The caller reported using glasses for her vision. The caller stated that she was recently put on cholesterol medication due to her cholesterol being 200 and the fact that she has an aortic replacement valve. The caller reported that she experience neuropathy in her feet and at some point her dose of Eliquis was lowered to 2.5mg. The caller provided limited HCP and Product information. Agent referred caller to their HCP. AE filed. COVID - First experience: 1. When were they exposed? Feb2019 2. Where were they exposed? At hospital. Visiting a relative in the hospital. 3. What symptoms have they experienced? Sore throat, cough, loss of taste, exhaustion for a month and a half/out of it, toes all brown and red for a week/COVID Toes, lack of strength 4. How long have their symptoms been present? Month and a half 5. What treatment(s) have they received? None 6. Has their illness resolved? Yes. Couple of month to get strength back after other issues went away. COVID - Second Experience1. When were they exposed? Thanksgiving 2020 2. Where were they exposed? At home with family. 3. What symptoms have they experienced? Sore throat, headache, feeling like the flu, but not the flu, did not get exhausted this time, tested positive for COVID 4. How long have their symptoms been present? Three weeks 5. What treatment(s) have they received? None 6. Has their illness resolved? Yes COVID - Third Experience 1. When were they exposed? May2022 2. Where were they exposed? Not sure. 3. What symptoms have they experienced? Sneezing, headache, temperature of 101, felt like a cold, but not a cold, tested positive for COVID. After injection felt ten times worse. Symptoms like the first COVID experience. Exhaustion came back, neuropathy, feet changed color to purple, black, and blue. Loss of strength. 4. How long have their symptoms been present? Four days 5. What treatment(s) have they received? Tylenol, went to hospital to get injection 6. Has their illness resolved? Yes. Got strength back in Jul2022;  Apixaban is under agreement with Bristol-Myers Squibb Company.; Sender's Comments: BMS Comments: This 65-year-old patient developed blood clot in her feet and peripheral neuropathy while on therapy with apixaban and COVID-19 vaccine. Based on the nature of the event, blood clot is pharmacologically implausible with the anticoagulant nature of apixaban and considered not related. Additionally, based on the multi-factorial etiology of the events associated with elderly age as risk factor, the reported events blood clot in her feet and peripheral neuropathy are considered not related to suspect drug therapies. Pfizer comment: Based on the information provided, there is no information to suggest a causal relationship between BNT162B2 and the reported events. Case will be reassessed upon receipt of additional information.