Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count increased, Malaise, Nausea, Rash macular, Throat irritation
Clinical narrative: back ached; Stool was dark; Positive hemoccult; sonometer size random spots on my thigh, 1 or 2 on each arm and one or 2 on her chest/ pink in color; slightly irritated throat; feel sick to her stomach; sharp epigastric pain; change in her bowel habits; felt so unwell; Loss of appetite; thought she has gastritis; possibly her Irritable Bowel starting to flare; Now she has a GI bleed; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 23Sep2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left (left deltoid) on 20Apr2021 (Lot Number: EW0161) as single dose (at the age of 66-years-old) for COVID-19 immunization. Medical history included GI bleeds, irritable bowel. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left deltoid on 30Mar2021 (Lot Number: ER8733) as single dose for COVID-19 immunization and experienced lightheaded and little spacey. The patient previously received Pneumonia 23 in 2020 and experienced it got all red and swollen and hot to touch. The patient also previously received influenza shot in 2020 and experienced a little red. The patient experienced feel sick to her stomach on 21Apr2021, sharp epigastric pain on 21Apr2021, change in her bowel habits on 21Apr2021, felt so unwell on 21Apr2021, loss of appetite on 21Apr2021, sonometer size random spots on my thigh, 1 or 2 on each arm and one or 2 on her chest/ pink in color on Jul2021, slightly irritated throat on Jul2021, stool was dark on Aug2021, positive hemoccult on Aug2021, now she has a GI bleed on 2021, back ached on an unspecified date, thought she has gastritis on Apr2021, possibly her irritable bowel starting to flare on Apr2021. Patient received her first dose of the Pfizer COVID Vaccine 30Mar2021 and her 2nd dose on 20Apr2021. On 21Apr2021 patient reported starting to feel sick to her stomach and having sharp epigastric pain. She also experienced change in her bowel habits. She initially thought she has gastritis then questioned possibly her Irritable Bowel starting to flare. She states it has been getting worse and worse and she has never felt so unwell in her life. She cannot eat and has gone through a lot. She was seen in the ER, Carafate and another medication were given that did not help, she was given Compazine which did not help her queasy stomach either. Maalox does not work. She went through an upper and a lower endoscopy procedure and put on antibiotics which did not help either. One of the antibiotics was noted to be Flagyl. She now will have to do the prep over again and have a pill cam study done. She states she has never felt like this. She notes having sonometer size random spots on my thigh, 1 or 2 on each arm and one or 2 on her chest. Nobody knows what they are. They are pink in color. She reported being fine until next day following the second shot. She has medical conditions/health concerns and needs to get the booster but she is afraid to get it. She notes being tired of sitting in the house, "I can't plan anything because I don't know how I will feel. I can't wear tight clothes, jeans, bra, because can't stand it because it pushes on my stomach." She states she has been enduring this for 5 months. Additional Context: She hasn't been feeling well, she was just wondering, she doesn't know if it was a coincidence or what, but after her second Covid vaccine, the next day, she has been sick to her stomach, having sharp epigastric pain, change of bowel habits, seen GI, now she has a GI bleed, it happened the day after her vaccine. She didn't know if anybody has reported this. She doesn't know if it was the Covid vaccine or if this was going to happen anyway, it just seems weird, she was fine the day she got it and the next day she felt terrible. She's got these pink spots on her legs and nobody knows what they are, her primary doesn't know, the emergency department doesn't know, her dermatologist doesn't know, she just doesn't feel good. Confirms began in 2021. She just wanted to see if anybody else had these problems too or is this just a coincidence. Second dose: She confirms on 21APR2021, she began having sharp epigastric pain, she thought she was getting gastritis, it was intermittently for a while, a week or two, then she started feeling sick to her stomach, bowel habits changed, loss of appetite, she can't even wear her bra because it pushes into her epigastric, she doesn't want to eat, some days are better than others, and it all could or could not be related to the Pfizer vaccine. She states it all started 21Apr2021 and gradually it's gotten worse. She confirms even though she stated symptoms have worsened, she reports all symptoms are currently ongoing and persisting. She states in Aug2021, she started noticing her stool was dark and it had a positive hemoccult. Confirms she went to the emergency room: 25Aug2021. She states some days, it waxes and wanes, some days are better than others. She has never felt so unwell in her life. She has had gastritis before and GI bleeds before but she's never felt like this and she's had irritable bowel, and this she wouldn't wish this on anybody. She states she has a lot going on medically. Second dose: Pink spots on her legs: pink spots are about the size of a dime. She was sitting in the bathroom and she looked at her thigh and said what the heck are all these things, had one on her chest, 1 or 2 on each arm, even showed it to the cardiologist and he didn't know, it's been going on maybe 2 months, she could be wrong, so many things are going on in her life right now. Confirms began sometime in Jul2021 maybe and is ongoing, persisting. She states she also has a slightly irritated throat for the same time period, since Jul2021, it's ongoing, persisting, slightly irritating. She remembers one night in the middle of the night and she thought oh her throat is bothering her and thought maybe it was because she had a fan on her floor but she has had a fan on her floor for 34 years. All symptoms reported are medically significant. She confirms it was the Pfizer Covid 19 Vaccine that she is speaking of and received. Medical History: She states she has a lot of health issues, when she was in the Emergency room, her lymphocytes were up. Confirms that was 25Aug2021. She states at the emergency room, she had a back ache, abdomen ached, she just did not, that was the worst, she can't do this anymore, her GI doctor said if she is in that much pain go to the emergency room, but they didn't even test her for COVID in there, she knows COVID can cause GI problems, that's why she was calling. The patient underwent lab tests and procedures which included blood culture: positive on Aug2021, endoscopy: unknown on an unspecified date, lymphocyte count increased: lymphocytes were up on 25Aug2021, urine analysis: normal on 25Aug2021. Therapeutic measures were taken as a result the events. Events required Emergency Room Visit and Physician Office Visit. The outcome of the events, back ached, thought she has gastritis, possibly her irritable bowel starting to flare was unknown while for the other events was not recovered.   Reporter considered, feel sick to her stomach, sharp epigastric pain, change in her bowel habits, felt so unwell, loss of appetite, sonometer size random spots on my thigh, 1 or 2 on each arm and one or 2 on her chest/ pink in color, slightly irritated throat, stool was dark, now she has a GI bleed, positive hemoccult, as medically significant.  Causality for all symptoms: Unknown, she doesn't know if it's related or not.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events nausea, abdominal pain upper, change of bowel habit, malaise, decreased appetite, rash macular, throat irritation, faeces discoloured, occult blood positive, gastrointestinal haemorrhage, back pain, gastritis, irritable bowel syndrome and suspect drug BNT162B2 cannot be 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.