Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Endoscopy, Neuralgia, Sigmoidoscopy, Ultrasound joint
Clinical narrative: I had terrible diarrhea; Symptoms of neuralgia; This is a spontaneous report received from a contactable consumer. A 54-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in right arm on 08Mar2021 at 04:00 as dose 1 single (at the age of 54-year-old) for COVID-19 immunization. Medical history included Multiple sclerosis, Ileostomy, Blood clot in my arm back in 2014, Crohn's Disease. Concomitant medications included gabapentin 100 mg capsule, valaciclovir hydrochloride (VALTREX) 1 g, 3 times a day, diazepam 2.5 mg tablet, 3 times a day, ondansetron (ZOFRAN MELT), oxycodone 7.5 g, tablet 4 times a day, lansoprazole (PREVACID) 20 mg, once a day, vedolizumab (ENTYVIO) 300 mg for Crohn's disease. It was reported that (after first dose)  patient experienced terrible diarrhea and symptoms of the neuralgia and then she was lucky enough to have her Entyvio 300 mg for Crohn's and it helped somewhat diarrhea. Patient received second dose of BNT162b2 on 29 of the March. It was reported that coming out the second dose on 29th immediately was really bad like pain and shortness of breath and she have had a back surgery so and she always feel bad so I did not think anything of it but then she ended up after the second dose into ER and discovered that my Crohn's had caused really bad flare up. Her foot was looking strange but she just was too tired and left ER. She went back to the hospital and couple days later they told me that actually she had deep vein thrombosis now in her legs. She also had superficial clot in that left leg that was the pain began on the edges through eventually the vaccine is basically started and that it's started the Crohn's flare up and now on but I always trying to get back on a shorter time period of Entyvio and she was also on blood thinners now for a blood clot. She have had a blood clot in my arm back in 2014 and also have had it before. So she was kind of fine now because which is she don't know, you know what to do but I just want to make sure it just got reported because I have seen Johnson & Johnson and other getting reports of products. Consumer stated, Because of diarrhea and Crohn's problem she was down to 91 and now in hospital they gave me Prednisone 40 mg, Tablet so the things are coming up. I am just above 100 right now but I have been in the hospital for 5 days now with the clot and Crohn's Flare. Consumer stated, Yes I had Multiple Sclerosis and I have Crohn's disease with ileostomy and I have an ileostomy where I no longer use my large intestine, I just use a bag. So, I just have the small intestine and I have a flare. When probed if still experiencing the events, Consumer stated, Yes she was still experiencing, the arm is much better now. You know that's not really sore. Crohn's is terrible and the blood clot they have me on the Xarelto. She was getting a bit tired and the pain it's pretty bad and Neuralgia is still pretty bad. The diarrhea was getting better so I am just trying to get healthy enough to leave the hospital. So, I can get on Entyvio because her insurance won't allow them to do the Entyvio in the hospital. So it's kind of frustrating but she was also experiencing extreme shortness of breath, extreme fatigue she couldn't get any oxygen to her muscles. She was realizing that was the blood clot. Consumer further stated, She was just wondering had you been hearing any reports of blood clots from the BioNTech Pfizer at all. The patient underwent lab tests and procedures which included endoscopy: nil, sigmoidoscopy: nil, Ultrasound of legs: nil on an unspecified date. The outcome of the event terrible diarrhea was unknown and outcome of the event neuralgia was not recovered.  No follow-up attempts are needed. No further information is expected.