Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Clostridium test, Condition aggravated, Diarrhoea, Parasite stool test
Clinical narrative: Loose stools; The loose stools began again/after the first dose it started to get formed then after the second dose, she can't get it to be formed again; It was like flakey, it was not solid or watery it was more like flecks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP).  A 74-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EN6200) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PEDIALYTE [CALCIUM CHLORIDE;GLUCOSE;MAGNESIUM CHLORIDE;POTASSIUM CHLORIDE;SODIUM CHLORIDE;SODIUM LACTATE] taken for electrolyte imbalance; PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]; POLYETHYLENE GLYCOL 3350; IMODIUM taken for flatulence, abdominal distension; BENEFIBER FIBER SUPPLEMENT; PROBIOTICS. Vaccination history included: Bnt162b2 (Dose 1, single; Lot number: EL9263; anatomical location: left arm, deltoid), administration date: 02Feb2021, when the patient was 74 years old, for Covid-19 Immunization, reaction(s): "Loose stools". The following information was reported: DIARRHOEA (non-serious) with onset 24Feb2021, outcome "not recovered", described as "Loose stools"; CONDITION AGGRAVATED (non-serious) with onset 24Feb2021, outcome "unknown", described as "The loose stools began again/after the first dose it started to get formed then after the second dose, she can't get it to be formed again"; ABNORMAL FAECES (non-serious) with onset 24Feb2021, outcome "unknown", described as "It was like flakey, it was not solid or watery it was more like flecks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, condition aggravated, abnormal faeces. Additional information: Husband calling about his wife, who got second shot, he said that 4 days after she got the first shot, everything was fine but then she started having loose stool and she called her doctor and he recommended some food for her to eat and then it started clearing up pretty well. She told her primary doctor she was nervous about getting the second shot and he told her to definitely still get the second dose so she went to go get the second shot on 23Feb2021 and she has been having loose stool ever since. It was like flakey, it was not solid or watery it was more like flecks. He put his wife on the phone to speak about it. She says the primary care put her on the BRAT diet. She confirms it was flakey but occasionally it was watery but like it happens when she was sitting there and all of sudden it comes out. She says after the first dose it started to get formed then after the second dose, she cannot get it to be formed again. She had an O and P and ac C-diff test and they were negative, she knows about C-diff because she worked with it as a nurse. she was taking Pedialyte, she has not had any of that for a while now, she was just taking that as a supplement for losing any electrolytes. She did not mean that Pedialyte was not effective as she was just using it to supplement electrolytes, she clarifies she was hoping it would help though. She doesn't have any Pedialyte anymore to provide lot number and expiry for that. She was taking Pepto Bismol Ultra, she has already gone through one bottle but she has the other one, Pepto Bismol Ultra, expiration Jan2023, lot number 1046171951. The bottle she has already been through has been discarded and she does not have lot number expiry for that. She does not know if it was the polyethylene glycol that started all of this, she says probably. She would like to know what the heck can she do to help this. She has been to both her primary care after the first dose and then a gastroenterologist after the second dose and he told her to increase fiber and she has been having fiber and nothing seems to be working. She clarifies the Prebiotic she has been taking was the Benefiber. She also has been taking a probiotic that just says Critical Care Doctor Formulated Probiotic and it says use by Nov2022 and lot number: 50250678. She was taking Benefiber 2-3 timer per day. The Benfiber they just got, the expiration: Jun2023, Lot number: 3X9E. She had the second dose 23Feb2021 and the loose stools began again probably the next day 24Feb2021. She says it was ongoing. She went to her gastroenterologist and his PA told her in April to take fiber and she was and now she specifically bought Benefiber and stuff and nothing was helping to form it. She says it was persisting about the same, sometimes she goes a little bit more often like in the day and sometimes not, like at night or whatever. She says there was another she just thought of, Imodium Multi-symptom for gas or bloating. She says this one has the lot number and expiration stamped into the packaging, it was punched into the white, she has to see if she can read it. It was hard to see what the second thing looks like, she thinks it was LJ6041, she clarifies this box was old, she put the new one they just bought in the older box because it says expiration Jul2019 because she knows she got new one. She was going to look on the medicine itself. On the medicine itself she provides lot number 0M6909 and expiration Oct2022. She confirms lot number 0M6909 as the lot number that she has used that was not helping. Event details: The first dose was 02Feb2021. The loose stools began about 4 days after the first dose. She says it probably lasted about 4-6 days. She clarifies that was when she asked the doctor if she should get the second one, she guess it was better to have this than have the virus. She says she waited a little while to call the doctor so she clarifies the time line after it started was that she had loose stools for about 3-4 days and then she contacted (withheld) and he told her to have the BRAT diet and she continued to do that and it was starting to get better 4 days after contacting him. She says that the loose stools last about 8 days total. Lot number from the second dose was EN6200 or it could be ENG200, given on 23Feb2021. She does not see any NDC or expiration. Time the Vaccination Was Given: She says the first dose the appointment was in the morning but by the time they got in line and did the drive through it was early afternoon. The second dose was in the morning. she confirmed no other history with the product. No emergency room and she confirms that she has not been to the physicians office but she has talked over the phone with 2 doctors. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE following prior vaccinations were reported as none. Family medical history was reported as none.  No follow-up attempts are possible. No further information is expected.