Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Asthenia, Biopsy, Blood test, Clostridium difficile colitis
Clinical narrative: C-diff; irritable bowel; she was screaming bloody murder in the bathroom for 5 hours and doing nothing but standing up and sitting down; falling asleep; worn out most of the time; pooping; feet swell; bloating; malabsorption; has lost 45 pounds; can't eat or drink anything; no energy; dysentery; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing), notes: take pain medication. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Lot number: EN6200), administration date: 24Feb2021, when the patient was 73 years old, for Covid-19 Immunization, reaction(s): "sore in the arms"; Flu shot (maybe in her 30s or 20s), for Immunization, reaction(s): "had a severe reaction". The following information was reported: DYSENTERY (medically significant) with onset 2021, outcome "unknown", described as "dysentery"; DIARRHOEA (medically significant) with onset 2021, outcome "unknown", described as "diarrhea"; CLOSTRIDIUM DIFFICILE COLITIS (medically significant), outcome "unknown", described as "C-diff"; IRRITABLE BOWEL SYNDROME (medically significant), outcome "unknown", described as "irritable bowel"; WEIGHT DECREASED (medically significant) with onset 2021, outcome "unknown", described as "has lost 45 pounds"; FEEDING DISORDER (medically significant) with onset 2021, outcome "unknown", described as "can't eat or drink anything"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "no energy"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "she was screaming bloody murder in the bathroom for 5 hours and doing nothing but standing up and sitting down"; SOMNOLENCE (non-serious), outcome "unknown", described as "falling asleep"; FATIGUE (non-serious), outcome "unknown", described as "worn out most of the time"; CONSTIPATION (non-serious), outcome "unknown", described as "pooping"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "feet swell"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "bloating"; MALABSORPTION (non-serious), outcome "unknown", described as "malabsorption". The events "dysentery", "diarrhea", "irritable bowel", "pooping" and "malabsorption" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: negative; blood test: negative; colonoscopy: unknown results, notes: it was ok; stool analysis: unknown results; weight: lost 45 pounds. Therapeutic measures were taken as a result of dysentery, diarrhoea, irritable bowel syndrome, weight decreased, feeding disorder, asthenia, constipation. The clinical course was reported as follows: For the past 9 months from the 2nd dose, the patient had horrible dysentery and diarrhea that was full blown diarrhea. Multiple test and doctors told her that it is not vaccine related. Told anything to do with the vaccine she has been taking imodium and pepto. Her dautghter found a report indicateing that one of the ingredients of the vaccine, polyethylene glycol causes this side effects. The patient had 9 months of uncontrollable diarrhea and was forced into a colonoscopy and all of the blood tests and labs were forced upon her. Stated she has spent 9 months in the bathroom. One day, she was screaming bloody murder in the bathroom for 5 hours and doing nothing but standing up and sitting down. It has totally disrupted 9 months of her life, along with the Covid looming around and Pfizer made it worse. The doctor finally diagnosed her back in Jul2021 and was saying that a lot of people were getting this. He put her on Questran, which is a cholesterol drug and they were using it for its constipation effects. Then, they put her on a pill because she could not get out of the bathroom. She has lost 45 pounds in this whole process. She has not been able to get out of the bathroom and cannot eat anything or drink anything but put protein drinks. That is all she can get down most of the time. This was all after the second shot, she did not have this with the first one. With the first one, she was sore in the arms and everything but was no big deal. The second one, every time she sat down, she was falling asleep. She had no energy and was worn out most of the time. She did not know whether she was sick or was having a reaction. Her much younger daughter had a weekend of it. Everybody else in her family had the Pfizer and she is the only one who had this big of a deal. After 3 weeks, she thought it was a little better. She had been trying to lose weight and when she called the doctor, she told him she could not keep anything in. She kept pooping it out and could not hold anything in. They did not know why. She had taken a full bottle of Imodium, Pepto, you name it, she was taking it. The Imodium was making her feet swell and causing bloating issues. They did the colonoscopy and she had been through the prep. After the prep comes in, they said it all looks good but she said it was not good. She stated that something has to be wrong with her. She had been waiting from results from the biopsy which came back negative. She stated there was nothing from the colonoscopy. She has been going through Imodium by the boxful and gallons of Pepto. Then, she finally took a Pepto pill. She has been burning a lot of calories. She states that she also had been taking Kaopectate, tons of it. Because she has arthritis, she has to take pain medication. With the Hydrocodone, she should be locking up like gangbusters but, she is not. She pleaded with the doctor because she had colon prep. He had her stop taking the Questran and said not to take any of those pills and that would help with the prep. She states that it did help, she pooped 2 days before she started the prep and that was after she had not eaten in 24 to 48 hours. That was the best she felt. The doctor wanted to put her on Dicyclomine for irritable bowel and she was taking that with the Questran. After they ran all of these stool samples they told her that if she was still experiencing symptoms, they could give her antibiotics. They told her it would work in the gut. Patient did not want to do that because of C-diff and diarrhea and she did not need any more of that. Her mother died of Ovarian cancer and Johnson did nothing, her mother had cancer and had chemo induced diarrhea but that hardly qualifies. Clarified that she took Imodium, Pepto and Kaopectate and they did not work. She tried not to take these pills. She only takes them when she cannot stand up without it, like when she was leaking all over the floor. She does not want to go in the other direction. She can take the Questran 4 or 5 times a day. She still could not get it to stop but the Questran, they told her she can take it up to 4 times a day and is supposed to clog you up like a bad pipe. Her doctor told her she could take it up to 6 times a day but she said she does not want to do that. She states that she has just been taking it one time a day but now, she is not eating. After she had the colonoscopy, they said it was ok. The doctor put her on an elimination diet and told her to stop everything. She does not do artificial sweeteners or dairy anymore. She does not have coffee or anything with seeds or fresh fruit. She has had no beef and could not even get a good steak. She could only eat celery and only a little bit of peanut butter. That was the only thing that helped her not poop for 4 days. When she went to the doctor, she got malabsorption and everything just went straight out.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.  The 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 notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.