Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Illness
Clinical narrative: gets sick each time she gets the covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6199) at the age of 54 years, in left arm, on 03Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 04Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 11Feb2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (unspecified if ongoing); "Obesity" (unspecified if ongoing), notes: Illness/AE:  Obesity - Pretty much all of her life.; "Immunocompromised", start date: 2008 (unspecified if ongoing), notes: Immunocompromised - Diagnosed in the fall of 2018. Concomitant medication(s) included: MYCOPHENOLATE taken for focal segmental glomerulosclerosis, start date: 2019. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "gets sick each time she gets the covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness.  Additional Information : Other Conditions was no. Reporter (female, 55 years old ) wanted to know should she get the 5th booster shot of Pfizer covid vaccine. She stated she has already gotten 4 shots ( 2 primary series and 2 booster) and she is schedule to get her 5 dose this week. She states CDC says to get it every 3 months for immunocompromised patients, her last dose was on 11Feb2022. She stated that the vaccine only stays in her body for about 1 month. She was taking rituxan infusion (for chemo) but not anymore. she is taking mycophenolate mofetil. She stated she has "no traceable amount of the vaccine in the blood. She has Autoimmune disease but no diagnosis has been made. Reporter stated she gets sick each time she gets the covid vaccine. she was in the clinical trial studies as well. Her doctor wanted her to take evusheld twice a year along with the booster shot to get protection. but she stated it has cardiac side effects and she has cardiac/heart disease history on her father side, so she is not sure. caller wanted to know should she be getting the 5th booster shot. Caller stated that a woman got 7 shots of covid vaccine before she got the medication in her body. Caller wanted to know if there are any interaction of Pfizer covid vaccine and mycophenolate mofetil. She has a consumer on the line who is an immunocompromised person and has a question about the COVID 19 vaccine. Is there still a need to take a 3rd booster or not. She also mentioned that she already received her two booster shots. There is no traceable vaccine in her body as per her physician. She stated she was Immunocompromised before she began getting the Pfizer COVID vaccines. Her first booster was in Sep2021, and she was scheduled for Chemo in Dec2021. When trying to remember the name of the chemo, she said her mind just went blank. This was an infusion for the chemo. She later provided the name of Rituxin as the chemo. Two weeks before she went in to get it, there was traceable amounts of the vaccine in her body. Next booster was around 11Feb2022, and they had her do blood work a week after, which was 17Feb2022. Typically it takes 2 weeks for it to be detectable in blood. It did not come up. She just had another blood test 2 weeks ago and had no traceable amount. She is due for another 3rd booster anytime after Wednesday. Does it make sense for her to keep taking them and is there any benefit. She thinks it will not be in her body or it will only be in her body for maybe a month. She also said she got sick with each of the vaccines and if it is not going to be helping her, then she doesn't want to get sick anymore. She has Chronic Kidney disease and takes Mycophenolate Mofetil. She thinks that is the one that is knocking it out. She takes 1,000mg twice daily.  When going to read the bottle, she stated she needed to get her glasses.  She confirmed she has been wearing glasses since she was 5 years old. She asked if it is not giving her any protection, either because of her auto immune or medication she takes, should she get another booster dose. Each shot she is getting sick.  Why is she getting sick for nothing. Went to get vaccine on 11Feb2022, and following Thursday did blood work at (withheld). She has been testing her to see where it was or if anything in her since she was getting booster. She was concerned the chemo was going to knock it out. It was not traceable and she said it was normal because it takes up to 2 weeks and it had only been one week at that point. Last lab work was done 27Apr2022, and still none. Chemotherapy just went out of her head for some reason. She will have to think about it. She does not have a lot or expiration for them. it is not the full blown chemo that cancer patients get. It is a drug that goes into the full blown. She later provided name of Rituxin.  All of the COVID vaccines and boosters were Pfizer products. No medical treatment was required for any event. Because she is immunocompromised, they say she should still get it. She just kept thinking, she is having all the side effects each time she gets the vaccines, and again, will it protect her from deadly virus. Will she catch it? She had side effects from each shot. They are the same with each one and she recovered completely to each within 4-5 days. She did not have any medical treatment for any symptoms. She did not wish to provide any specific information related to her side effects. There were traceable amounts back in Nov2021 of the vaccine, and she had the Rituxin in 03Dec2021 and 17Dec2021. That was two months out, and it was in her body. Chances are after two rounds of the infusions, she had them two weeks apart in Dec2021, if she were to test her in Jan2022 or directly afterwards, they would not have found anything. She said the chemo was strong and probably knocked everything out. She did not have a lot or expiration for the Rituxin chemo that she had. She is required to take blood work a week before and it was late Nov2021, and had traceable amounts in late Nov2021, right before first infusion. She had infusions in Jun2021, but she does not know because they did not test until after the booster in Feb2022. She was thinking at that point, that the CDC said every 5 months and then said every 3 months, so she rushed in to get an appointment for another one. If it was every 3 months and she should have gotten another booster that she would have gotten the infusion but she could not. Adjustments have been made with dosage to the Mycophenolate Mofetil. With first two shots, the dosage at that point was at half. It did not seem to be helping her kidneys and then they switched. At that point, she was taking half of what she was taking. That was just switched in Oct2021. It was after she took that. Her kidneys started to decline more and they said maybe they should go back to the original dose. It did not seem to help, but it stabilized it. The last booster she was on 1,000mg twice daily. The one in Sep2021, she thinks she was still on half dosage VACCINE SUPPLEMENTAL FORM   Patient Age at Time of Vaccination in Months: or Years: 55.Time the Vaccination Was Given: 14:00. They were all given in the afternoon. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Injected in upper left arm. Vaccination Facility Type: Pharmacy. First two were at the (withheld) at a county place. Vaccine Administered at Facility was no . 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): 1st Pfizer Vaccine expiration is unknown. Injected in upper left arm. 2nd one expiration is unknown. Injected in upper left arm. 1st booster expiration is unknown. Injection in upper left arm. 2nd booster on expiration is unknown. injection in upper left arm.  Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: none. Adverse Event (AE) Details: Provide the time of onset of AE(s): Non specified side effects with each vaccine- Unknown time and each lasted 4-5 days. The side effects were the same with each one. Additional Information Did any AE(s) require a visit to: No medical treatment required. 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): She got flu shot separate in Oct2021. Unknown manufacturer, lot and expiration.  AE(s) following prior vaccinations: She got side effects from the flu vaccine. She got it at Safeway. She does not have a manufacturer, lot or expiration. Patient's Medical History (including any illness at time of vaccination)? None or Unknown Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesityIllness/AE: Obesity - Pretty much all of her life. Immunocompromised - Diagnosed in the fall of 2018. Family Medical History Relevant to AE(s) was none Relevant Tests: Was in a research study with NIH and has a rare kidney disease and this was prior to getting the vaccines. They have done all kinds of tests. The Blood tests were done and shows no active vaccine in her blood. Is there a product complaint to report? Yes Description of Product Complaint: 1) Description of complaint: Mycophenolate Mofetil was not working to improve her kidney function. Product strength and count size dispensed: 500mg, count not provided. Additional lot numbers: none. Is a sample of the product available to be returned, if requested (Y/N): No Packaging sealed and intact? not provided. 2)Description of complaint: After receiving the Pfizer COVID vaccines and two booster doses, she does not have any traceable amounts of the vaccine in her blood. Product strength and count size dispensed: Unknown. Additional lot numbers: 2nd one on 03Apr2021, Lot EW0150, expiration is unknown. Injected in upper left arm. 1st booster on 04Sep2021, Lot FC 3182, expiration is unknown. Injection in upper left arm.  2nd booster on 11Feb2022, Lot FK9896, expiration is unknown. Injection in upper left arm. Is a sample of the product available to be returned, if requested (Y/N): No. Packaging sealed and intact? not provided