Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lost weight; she has these bouts she cannot eat since the COVID booster. It is spasmodic.; She sleeps most of the time when she has it because she has no energy to do anything else; She sleeps most of the time when she has it because she has no energy to do anything else; she gets the very severe pain where she can't sit or stand or anything with pain; she gets the very severe pain where she can't sit or stand or anything with pain; she tries to have bowel movements; exertion is from her toes and she has a lot of back pain from the muscles; exertion is from her toes and she has a lot of back pain from the muscles; stress on her muscles; Overall it has worsened; spends time in bathroom and vomiting, and if it's not vomit it's mucus; spends time in bathroom and vomiting, and if it's not vomit it's mucus; Nausea; severe pain in lower abdomen and digestive system; trouble with digestion; She was in bed all day on Holiday and next few days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 24Nov2021 at 09:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: COPD, Her lung function was 40% when last tested. The diagnosis was years ago.; "Mastectomy" (unspecified if ongoing), notes: She had a mastectomy, they did a deep flap reconstruction,; "gall bladder removed" (unspecified if ongoing), notes: She had gall bladder removed as well.; "Leiomyoma sarcoma" (ongoing), notes: Leiomyoma sarcoma Started 4-5 years ago from radiation treatments.; "depressed" (ongoing), notes: Her depression has been ongoing since her diagnosis of cancer; "stage IV cancer" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (First dose , Lot number: EWO177; , NDC and Expiry unknown, given in Right Arm), administration date: 26May2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Second dose, Lot number EWO181;, NDC and Expiry unknown, given in Right Arm.), administration date: 16Jun2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; Flu (Vaccine/Brand Name: Flu, Vaccination Date: unknown), for Immunization, reaction(s): "sick". The following information was reported: BEDRIDDEN (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "She was in bed all day on Holiday and next few days"; DYSPEPSIA (non-serious) with onset Nov2021, outcome "unknown", described as "trouble with digestion"; NAUSEA (non-serious) with onset 24Nov2021, outcome "unknown"; ABDOMINAL PAIN (non-serious) with onset 24Nov2021, outcome "not recovered", described as "severe pain in lower abdomen and digestive system"; VOMITING (non-serious), SECRETION DISCHARGE (non-serious) all with onset 25Nov2021, outcome "not recovered" and all described as "spends time in bathroom and vomiting, and if it's not vomit it's mucus"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost weight"; EATING DISORDER (non-serious), outcome "unknown", described as "she has these bouts she cannot eat since the COVID booster. It is spasmodic."; ASTHENIA (non-serious), HYPERSOMNIA (non-serious), outcome "unknown" and all described as "She sleeps most of the time when she has it because she has no energy to do anything else"; PAIN (non-serious), DYSSTASIA (non-serious), outcome "unknown" and all described as "she gets the very severe pain where she can't sit or stand or anything with pain"; CHANGE OF BOWEL HABIT (non-serious), outcome "unknown", described as "she tries to have bowel movements"; MUSCULAR WEAKNESS (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "exertion is from her toes and she has a lot of back pain from the muscles"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "stress on her muscles"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Overall it has worsened". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had other conditions. She had investigations. She had not administered other products. She has been having an issue since last Nov and they haven't been able to diagnose it as yet. She has a lot of severe pain in lower abdomen and trouble with digestion. It may mean nothing but she got the booster shot for COVID the day before on Holiday and that evening she started getting the severe pain and nausea and whatever. States she ended up spending on Holiday and the next two days she was in bed. Whether that has to do with shot, she has no idea. She started taking Paxlovid one full day and night dose so far. She got concerned with her digestive system and she has stage IV cancer and COPD. Her severe pain and abdomen with digestive system started before taking Paxlovid, and after receiving the COVID booster. She received her COVID booster on 24Nov2021. She weighed 165 lbs, which has dropped. She lost weight. Last time she went to the doctor it was 180 lbs. She's dropped 20 lbs, when she has these bouts she cannot eat since the COVID booster. It is spasmodic. If she eats normal food, she will get the bout it in day or two, lasting 3-4 days where she spends the day in the bathroom and also while going to the bathroom she is vomiting. If there is nothing there to vomit it is usually mucus and water. States she is not vomiting any bile whatsoever, she doesn't think her body is producing bile at this point. She sleeps most of the time when she has it because she has no energy to do anything else regardless other than to deal with the severe pain. Nobody can tell her what is going on.  Event Details: She didn't report at the time because she didn't think the shot did it. Severe pain in lower abdomen: States she had the shot on the 24th and it started late that day and she had it in the morning and it continued for 3-4 days. States it stops and it restarts if she tries to eat normally. If she lives on water, crackers, and soup it doesn't happen. When it does happen it's very severe. It comes and goes. If she starts feeling normal and eats a little bit of food, about a cup of vegetables, mashes potatoes and drinks plenty of water sometimes that works. States but if she goes along 2-3 days she is back in the same thing for another 3-4 days and she has been dealing with it since then. She was in bed all day on Holiday and next few days. Spends time in bathroom and vomiting: At the beginning of the bout she gets the very severe pain where she can't sit or stand or anything with pain. With the severe pain she tries to have bowel movements the vomiting begins, so she is doing both. Sometimes it brings up nothing, sometimes fluid. It comes from, the exertion is from her toes and she has a lot of back pain from the muscles. It is so hard to explain. It is hard to say when the back pain began because it's not top priority. She attributes it to when she started straining to vomit, she thinks her back muscles got effected. She has issues with her lower back anyway, any kind of straining or pressure is going to make it worse. It was taken care of when she had shots and basically eliminated it until this started it again. She believes it's the stress on her muscles. It is ongoing, she is at the end of a bout of it right now that has lessoned because she stopped eating. Overall it has worsened. Indication: Caller tested positive for COVID and with her breathing difficulties and all that goes with it, she called her pulmonologist because she doesn't have a primary care physician, and asked if she should be on something.as her oxygen levels had been dropping and staying around 96-95% and not seeming to come up too much, and she didn't know if COVID was affecting her lung. Concomitant Medications: she stated just her regular medications. Other medical conditions: Stated she doesn't know what is pertinent other than all of her surgery history and all that bull. Caller states she doesn't think they need to know what her cancer was caused by or anything else. States if they do want to know they can call her. She wants to be able to test herself for having COVID because she has an upcoming doctor's appointment. Investigations: She's had 3-4 tests done on her abdomen and no one is getting anywhere. She is a little but depressed over this. Her depression has been ongoing since her diagnosis of cancer. States they upped the dose of her medication after she was diagnosed with cancer. Additional vaccines administered on same date of the pfizer suspect were none. Adverse Event: severe abdominal pain, Time of Onset: (24-hour clock): toward late afternoon, didn't feel anything after but late afternoon is when it started. Adverse Event: vomiting, Time of Onset: (24-hour clock): either through the night or early the next morning. She went to gastrology doctor and they did a number of different scopes. They didn't seem to find anything. She is scheduled for gastro emptying test on the 29Jun2022. ER: When it continued she went to walk-in care and they sent her to the hospital where she sat for 9 hours. They did a report, did not admit her or have a doctor look at her. She took out her IV and said she was leaving. They did write a nice report about a doctor seeing her which was not true. Aware this is discrepant, but details were confirmed and documented as provided by the caller. No prior vaccinations (within 4 weeks) administered. Adverse event prior vaccinations: was not good, and have not taken them sense, that was years, she got real sick, onset Age: cannot remember, vaccine/Brand Name: Flu, vaccination Date: unknown. Patient had COPD, partial bottom quarter of lung removed due to cancer. Dates unknown, it was a while ago. Family Medical History Relevant to AE(s): She had a mastectomy, they did a deep flap reconstruction, what it does is they cut you hip to hip and take the muscle from the lower abdomen and some of the fat tissue and essentially move it up and form a breast. They are removing muscle tissue from lower abdomen. She does have scar tissue. She questioned whether that would be a factor. She had gall bladder removed as well. She's had tons of tests, results unknown. If Pfizer wants to call they can and she will dig it out. Her chest X-ray, her doctor at # can speak to Pfizer about it. The first time she contracted COVID and it was her grandson she's pretty sure because he tested positive Thursday, and she tested positive Saturday, which is when she took the test. Culture was performed. She just did a home test.