Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epistaxis, Incomplete course of vaccination, Nasal cavity packing, Vascular cauterisation
Clinical narrative: short of breath; nose bleed/lost a lot of blood/bleeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9263 and expiry date unknown, via unspecified route of administration on 26Jan2021 at single dose for Covid-19 immunization, and eicosapentaenoic acid ethyl ester (VASCEPA), acetylsalicylic acid (BABY ASPIRIN); both via unspecified route of administration from unspecified date to 31Jan2021 at unknown dose and frequency for unspecified indication. Medical history was none. Concomitant medication was not reported. The patient had taken the first shot of the Pfizer shot on 26Jan2021 (Tuesday) and the patient seemed to managing it pretty well, she got short of breath one night (unspecified date) but in general, she felt okay. But several days later, 5 days later Sunday (31Jan2021), on Sunday morning she felt okay, what happened was she leaned a little bit, she bent down to wash her hands in the sink and she had a huge nose bleed, it was nothing like she ever had before, she was just wiping, spurting a lot of blood so this was 5 days. It was the morning of the 5th day and they had to call an ambulance to take her to the hospital and then she left the hospital. The patient had lost a lot of blood in the ambulance, they said they had never seen so much blood, they could not stop it, they kept giving her towels and the same thing in the hospital, in the emergency room. The patient was just bleeding over everywhere. The patient informed that for the last several years she has been having one baby aspirin and has been taking for the last few months or two, two or four Vascepa which was a fish oil supplement that can thin the blood but she has never had anything like this and they said go to her ENT, and she went up going ENT, and first time she went she would not take out the packing. The patient informed that it was too severe for her to take out the packing and, when she went back with her following time she took some of the packing and it started to bleed again and she cauterized it in a lot of places and you know would wait and do it again. And then she end up putting some kind of bandage that was going to help the blood clotting. Now, she has been subsequently going back to her and it was still in the very end of. The patient informed that she was still passing some very small blood clots, it has not even stopped. The patient informed that she was on 19 days passed already, since she had the bleed. The patient was very concerned. The patient informed that she was supposed to get her second vaccine in 2 to 3 days, Tuesday and she thought that this was the very bad experience that she had. The patient wanted to know if the aspirin and fish oil could have contributed to this, she stopped these as of 31Jan2021. The patient was talking to her daughter and her daughter has a friend whose mother lives in the same area and had her first Pfizer vaccine and had a small nose bleed right afterwards and then when she has second vaccine, she had another, a very bad. The patient informed that her daughter and a friend of hers said that a similar reaction occurred to her mother after the first dose of the Pfizer vaccine, she had two small nasal bleeds and right afterwards, when she took the second vaccine she had a very big one, like hers, where she had to be taken to the hospital. The patient was concerned, she has been told that the response to the 2nd vaccine was stronger than the first. The patient further informed that she had no nose bleed like this before, like her husband was a physician, that she never had anything like this before, this was very serious kind of situation to happen, and this after the very first vaccine that she had. She had a very severe nosebleed, she had to go to the hospital to stop it. She was on a baby aspirin and some fish oil as well. The patient informed that she wasn't warned that this could thin her blood, that this was enough of a dose to do anything to create this deluge of bleeding.  The patient informed that she was few days out from getting her second shot and she had stopped the baby aspirin and the fish oil about three weeks ago. The patient informed that she was not going to take second. The patient wanted to know how long she was going to wait, how long she was going to test her antibody and see that she don't have any more antibodies and will go take the other brand vaccine. The patient added she was reporting that she had a terrible nosebleed and wanted to file a safety report. The patient wanted to know that if she choose not to get the 2nd vaccine, because of her worry of having this reaction again, how long would it be before she could get another vaccine; how long can she wait to get the second dose, or can she get a second dose from another manufacturer. The patient was requested to contact physician. The action taken in response to the events for eicosapentaenoic acid ethyl ester (VASCEPA) and acetylsalicylic acid was permanently withdrawn. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the BNT162B2 and the event nosebleed cannot be excluded.  This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021191054 same reporter, similar drug/events, different patient