Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller tested positive for COVID and with her breathing difficulties; Caller tested positive for COVID and with her breathing difficulties; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (172086). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 26May2021 as dose 1, single (Lot number: EWO177), in right arm, on 16Jun2021 as dose 2, single (Lot number: EWO181) and 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, He 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, 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; "Leiomyoma sarcoma" (unspecified if ongoing), notes: Leiomyoma sarcoma Started 4-5 years ago from radiation treatments. She has stage-IV cancer. Leiomyoma sarcoma is a cancer of soft tissue and it travels and it's hard to explain and ended up in lung. It started with radiation for breast surgery.; "gall bladder removed" (unspecified if ongoing), notes: gall bladder removed; "depression" (unspecified if ongoing), notes: Her depression has been ongoing since her diagnosis of cancer. The patient took concomitant medications. Vaccination history included: Flu (Vaccine/Brand Name: Flu, Vaccination Date: unknown), for Immunization, reaction(s): "sick". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022, outcome "unknown" and all described as "Caller tested positive for COVID and with her breathing difficulties". The patient underwent the following laboratory tests and procedures: Chest X-ray: (unspecified date) Unknown result; Oxygen saturation: (unspecified date) 96-95%, notes: oxygen levels had been dropping and staying around 96-95%; SARS-CoV-2 test: (11Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Yes report is related to a study or programme. Yes Other Conditions. Yes COVID-19 BioNTech booster a Pfizer product. Additional Context: Warm transfer from #, Paxlovid Call Center IVR, CEP 172086, with consumer already taking Paxlovid, that is concerned because she has underlying issue with her digestive system for a month. She is asking if there is an adverse event while taking Paxlovid with her underlying issue? The caller confirmed the details provided by the transfer agent. 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 the holidays and that evening she started getting the severe pain and nausea and whatever. States she ended up spending the holidays 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. With her medical history, is there a chance the Paxlovid can be more harmful than helpful? 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. If she wants to retest for COVID to see if it's gotten any better, does Paxlovid effect the results of her home test? Patient Details: She weighs #withheld, which has dropped. She's lost weight. Last time she went to the doctor it was #withheld. 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. HCP details: Caller does not have a primary care doctor. The Paxlovid was prescribed by her pulmonologist, at # and Critical Care Medicine. HCP email unknown. 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 Thanksgiving 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.  Products: COVID-19 vaccines: First dose COVID-19 vaccine received 26May2021: Lot number: EWO177; NDC and Expiry unknown. Received at # Injected in Arm. Second dose of Pfizer COVID-19 vaccine received 16Jun2021: Lot number EWO181; NDC and Expiry unknown. Received at Injected in Arm. Pfizer COVID-19 BioNTech booster: Dose: unknown, it is not listed on her vaccine card. Formulation: All three vaccines were injections. Products: Paxlovid Caller has to see if she can see it, what it is it's printed in the, on the foil imprinted on the bottom. Caller is looking at the individual packs and not the box. She thinks the lot number says 9914, but is not sure. 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: Caller states just her regular medications. Other medical conditions: Will it be pertinent to what Pfizer finds or what they need to see? States 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.  Treatment: They've done testing but nobody has been able to find anything. 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. Leiomyoma sarcoma Started 4-5 years ago from radiation treatments. She has stage-IV cancer. Leiomyoma sarcoma is a cancer of soft tissue and it travels and it's hard to explain and ended up in lung. It started with radiation for breast surgery. VACCINE SUPPLEMENTAL FORM  1. Patient Details is available 2. Patient Age at Time of Vaccination in Months: or Years: 71-years 3. Pfizer Suspect Vaccine and Vaccination Details Vaccine Lot Number: 33030BD, Vaccine Lot Expire Date: unknown Time the Vaccination Was Given: early in the morning, around 0900. Anatomical Location of Administration of Pfizer vaccine considered as suspect: It would have been in Right arm. She doesn't have anything done in her left arm due to lymph nodes and the stuff they took out of her. 4. For Only: Vaccination Facility Type: Pharmacy: First two in # the booster in 5. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): First dose COVID-19 vaccine received 26May2021: Second dose of Pfizer COVID-19 vaccine received 16Jun2021:  6. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None 7. Adverse Event (AE) Details: Provide the time of onset of AE(s): 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 8. Additional Information Did any AE(s) require a visit to: Emergency Room? No; Physician Office? Yes; 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 bullshit. Aware this is discrepant, but details were confirmed and documented as provided by the caller. 9. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None 10. AE(s) following prior vaccinations: None or Unknown Adverse Event: 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 11. Patient's Medical History (including any illness at time of vaccination)? COPD, partial bottom quarter of lung removed due to cancer. Dates unknown, it was a while ago. 12. 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. 13. Relevant Tests: None or Unknown She's had tons of those, 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. 14. For Lack of Efficacy, request the following information if not included in the initial report What is the primary infection site? not applicable 15. Please specify any secondary site(s) (e.g. empyema): not applicable 16. Are there predisposing factors? Unknown/No/ Yes (e.g. immunosuppression, contact with other infected persons) 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. 17. Was a culture performed? Unknown/No/Yes. She just did a home test. 18. If Yes, was the culture positive? not applicable 19. If Yes, was serotyping done? No  20. If Yes, please specify organism(s) (and serotype if available): not applicable 21. Please specify the culture source (e.g. blood): not applicable 22. Please specify Antipyretic Use (around the date(s) of Vaccination): Product Name / Strength: Not to her knowledge. What does antipyretic mean? Is there a product complaint to report? Yes, Description of Product Complaint: Description of complaint: LOE for Pfizer COVID-19 vaccine, caller tested positive for COVID. Is a sample of the product available to be returned, if requested (Y/N): not applicable Packaging sealed and intact? not applicable. Description of complaint: Caller taking Paxlovid. She is looking at the individual packs and not the box. Caller has to see if she can see it, what it is it's printed in the, on the foil imprinted on the bottom. She thinks the lot number says #, but is not sure. Product strength and count size dispensed: not provided. Additional lot numbers: not provided. Is a sample of the product available to be returned, if requested (Y/N): not provided Packaging sealed and intact? not provided.  No follow-up attempts are possible. No further information is expected.