Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio increased, Nervousness
Clinical narrative: my blood was instead 2.5 to 3, it was 4.9/It should be a range just listen to number 2.5 to 3. My report they showed me that I am 4.9, that is big number. It is like 2 margin over/my blood is too thin; my blood was instead 2.5 to 3, it was 4.9/It should be a range just listen to number 2.5 to 3. My report they showed me that I am 4.9, that is big number. It is like 2 margin over/my blood is too thin; When I go to a surgeon tomorrow because I have wound on my foot from surgery that I had and it is not healing, it is just draining /my body me things don't heal the way they supposed to; She feels weird; her eyes are extra dry; Nervous; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL8982, expiry date; May2021), NDC number, UPC number; unknown, covid19 vaccine manufacturer; unspecified intramuscular from 28Jan2021 to 28Jan2021 at single dose on deltoid left (left upper shoulder) for COVID-19 immunisation. Patient medical history included ongoing antiphospholipid syndrome, lupus (Patient medical continuing: Yes, diagnosed around 19 years old), surgery on her feet on 04Dec2020, blood thinner. Concomitant medications included Warfarin (tablet), strength; 6 mg orally from an unspecified date to an unspecified date ongoing at 3 mg (6mg 5 days a week and 3mg two days a week) and then at 3 mg (3mg three days a week and 6mg four days a week) for blood thinner. Laboratory test included INR (International normalised ratio) done on 04Feb2021 with result as (4.9; it is very high). Additional Information for concomitant products Warfarin: Her dose varies, new chart as of todays visit states to take 6mg on Sunday, 6mg on Monday 3mg on Tuesday, 6mg on Wednesday, 3mg on Thursday, 6mg on Friday, and 3mg on Saturday. Patient reported that INR should be a range just listen to number 2.5 to 3. My report they showed me that I am 4.9, that is big number. It is like 2 margin over. When I go to a surgeon tomorrow because I have wound on my foot from surgery that I had and it is not healing, it is just draining. I don't know if one has anything to do with other but I am very suspicious about it because my blood is too thin and my body me things don't heal the way they supposed to. Consumer stated, "I have been hold for almost for 2 hours because what happens I left my number as requested for call back. I got a call back in another 2 minutes. When I press to receive a call it disconnected. So I had to start all over again. So it is been like 2 hours adventure. Firstly I need to say that someone I told to call a second number well disconnect me twice but I have something call a report number that the person I think it has same job title of you. I am not certain but her name is (Name) and she gave me report number. She asked me all the questions, I answered all the her questions including my 28Jan2021 Pfizer injection which was my first injection and I have question referring to my taking Warfarin and wanted to if there was interaction because I went to doctor today to see my blood was instead 2.5 to 3, it was 4.9 which is extremely high and the only thing I have taken, I have done differently was to have my Pfizer injection on 28Jan2021. Consumer stated, "It is already in your system because as I said before I have report number. Should I give the report number. The person I spoke a long time ago that with I have been phone said that she information from my card when you they gave that card for you come like second time for the second dose or booster as I told this call." When probed for if the consumer call the Drug safety earlier: Consumer stated, "That thing I am telling I spoke to someone by the name of (Name). She started asking by same question you did. That is why I am trying to tell you that person already asked me everything and give me report number. She wanted to transfer me because she says it is wrong department. I started here same information again. I have been on phone for far too long for this to be evening. The report number is 'number'. Consumer stated, "Concern is that I have Lupus and I take Warfarin. My INR report does part of what to do when you have lupus. You have blood measure monthly or whatever times that necessary. It is very high. It should be a range just listen to number 2.5 to 3. My report they showed me that I am 4.9, that is big number. It is like 2 margin over. I am trying to find out if the injection had interaction with warfarin that is medication I take. Blood thinner I take because I have lupus with antiphospholipid symptoms. I am trying to find out if the injection had any interaction with warfarin the blood thinner. That is the information I am trying to to get. When I go to a surgeon tomorrow because I have wound on my foot from surgery that I had and it is not healing, it is just draining. I don't know if one has anything to do with other but I am very suspicious about it because my blood is too thin and my body me things don't heal the way they supposed to. The consumer has taken the Pfizer Covid Vaccine: Consumer stated, "That is the first thing I said. I told you and then I am telling about warfarin. I said I wanted to know if the Pfizer vaccine which I took on 28Jan2021 as I said that before if it had conflicting reactions with warfarin. I explained to you I have lupus and I also have antiphospholipid syndrome which cause me to take warfarin medication. I want to know if the Pfizer injection had any negative interaction with warfarin the blood thinner." When consumer informed about Medical Information: Consumer stated, "That person transfer to me before. It was drop. So can you connect me to number. She tried to transfer me and I got nowhere to call just died. If I call I am gonna be on waiting for all over again. I already had experience consumer stated, "I have already been answered all of your questions that is why I have a reference report number that I gave you. I have been answered whole time questions. I answered everything. I just wanna be connected to get somebody because I am tired of being on the phone." Is there a product complaint to report was no. Consumer was provided with the number of Medical Information number and was requested to select option 3, timings as and 8 am to 8 pm Monday to Sundays as per (EST). Investigation Assessment: Yes. She had the first dose of the Pfizer covid19 vaccine on 28Jan2021. She is nervous. She lives with lupus and antiphospholipid syndrome, which means her blood is too thick. She is on a blood thinner, she takes warfarin. She is asking if the vaccine could interfere with warfarin. Today she had her INR checked and it was was 4.9. States a stable reading is between 2 and 3. The only different thing she has had in her body is the vaccine. Reports she is nervous and scared. She had surgery on her feet and she has a wound where a thicker scab came off, states it is draining but not drying out. She was thinking maybe this was due to her her INR being high. She will see the surgeon tomorrow. She put a bandaid on her foot where the open wound on her foot is. The next morning she checked her foot and the bandaid was wet. She put some peroxide on it. She read peroxide is not good for open wounds because it kills good bacteria so she used gauze and placed it over the open wound with tape across it. Last month her warfarin dose was 6 mg 5 days a week and 3mg two days a week. As of today she is to take 3mg three days a week and 6mg four days a week. Warfarin is 6mg tablet that is perforated, clarifies it can be broken in half. She does not think her new regimen that she was given today will bring her INR back in the range between 2 and 3. States her INR has never been that high. She will go back to see the nurse in two weeks to get her INR checked. She sees her patient medical record number listed on the card. She says pardon her grunts and moans because she grunts and moans when she moves since she is 76. She feels weird and her eyes are extra dry in 2021. She is nervous about the area where she had surgery on her feet, she does not want it to get infected. She thinks she had surgery on 04Dec2020 to have arthritis in her toes corrected. Outcome of events was unknown.