Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: got covid; got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: E13247), on 12Feb2021 as dose 2, single (Lot number: E19269) and on 07Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (ongoing), notes: Asthmatic takes medication as needed diagnosed as a kid; "Labyrinthitis" (unspecified if ongoing), notes: Labyrinthitis takes Anitvert as needed. Was diagnosed years ago.; "Lactose intolerant" (unspecified if ongoing), notes: Lactose intolerant will take a Lactaid pill before something with milk; "slipped disc" (unspecified if ongoing), notes: slipped disc in back L4-L5 take Nabumetone 750mg one pill twice a day with meals for pain.; "acid reflux" (unspecified if ongoing), notes: acid reflux sometimes will take something like Tums that is over the counter; "tumor by her left kidney caused by IGG4" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Menopause" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "preventative for heart" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing); "CML" (unspecified if ongoing); "IGG4" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, on 11Oct2021 as dose number unknown, single; PREDNISONE taken for renal neoplasm, start date: Oct2021; ATORVASTATIN taken for blood cholesterol increased; LEVOTHYROXINE taken for hypothyroidism; PREMPRO oral taken for menopause; RAMIPRIL taken for hypertension; ECOTRIN taken for cardiac disorder; RESTASIS taken for dry eye; FAMOTIDINE taken for gastrooesophageal reflux disease; CORTISONE, start date: Oct2021; OMEPRAZOLE taken for gastrooesophageal reflux disease. Vaccination history included: Zoster, for immunisation; Shingrex, for immunisation; Flu shot, for immunisation; Tdap, for immunisation; Pneumonias, for immunisation.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "got covid". The event "got covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) Unknown results; (unspecified date) less than 1% detectable CML; Blood test: (Jan2022) liver and kidneys were toxic; Platelet count: (unspecified date) lowered her platelet count, notes: lowered her platelet count in her blood; (unspecified date) 2.1 million; SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Caller stated the drug saved her life and lowered her platelet count in her blood. Caller states it did what it was supposed to do. She was 74 years old when she found out she has CML, which was leukemia, and her platelet numbers were critical and she was a senior citizen. Her platelets were 2.1 million and they should be 200-300 thousand. She was put on Bosulif after a bone marrow biopsy and in short order it brought her platelets down to where they are supposed to be. Her CML was less than 1% detectable. She thought it was a death sentence and she was now walking 6-8 miles a day and dancing at concerts and eating out. She has 2 life threating diseases, she has CML and a rare newly discovered IGG4. The fact she was dealing with both medications and diseases and out doing her thing was amazing. States she was started on Bosulif 400mg in Jan2022 and it made her liver and kidneys toxic and she went to another hospital for a second opinion. She was told there that 400mg was too hard for her body to tolerate and was changed to 300mg and she tolerates that and her numbers are down. Clarifies that at her age it was like 400mg for someone much younger so she was staying at 300mg. She started Bosulif 400mg on 14Jan2022 and within maybe 2 weeks she took a blood test and her liver and kidneys were toxic and she took a drug holiday and went in for a second opinion and they said no it was too strong for her age and she needs to be on 300mg. She thinks she was tolerating it nicely. She has had drug holiday twice. When she went back on 400mg she went back into toxicity. Started Bosulif Jan2022 and by Apr2022 her numbers were down right away. They can only take specialty blood tests and send out of state every 3 months. She had to be on the medication for 3 months before they would take tests and see leukemia was less than 1% detectable. Her regular blood tests saw her regular platelets going down. They did not know it knocked it less than 1% until 3 months later. She had another grant she was getting from somewhere else, it was not with Pfizer until Aug2022 when that grant ran she out applied to Pfizer. She went toxic probably end of Jan2022 and end of Feb2022. 400mg was just too strong for her. Started Bosulif 400mg on 15Jan2022 and had liver and kidney toxicity both times. Clarifies she thinks the 1st time was her liver and 2nd time was liver and kidney. She started the Bosulif 300mg right after the 2nd holiday probably in Feb2022 they started that. Clarifies her calendar says no chemo 15Feb2022 that was one drug holiday and she stopped chemo on 9Mar2022. She restarted on 1Mar2022 after the 1st stoppage. And restarted on Bosulif 300mg on 17Mar2022. We have to know on 25Mar2022 she went for a 2nd opinion to (Name Withheld) in (City Name Withheld), she went to him for 2nd opinion and talked to staff and he said she should be on Bosulif 300mg. She had started 300mg before she saw him, they had talked about rasining the dose again and they said no at her age she cannot go to 400mg. States she was on a lot of medication with the IGG 4. High doses of cortisone but she does not know if that has anything to do with that also. Bosulif 100mg filled on 25Jul2022. Sees 89189 on the bottle. Qty 90. Her platelets were critical, over 2.1 million and also with her age. She felt nothing though they detected it at usual check up. The lab called her doctor at 3am and they did a bone marrow biopsy and she was told she has Philadelphia chromosome, that was part of CML. Diagnosed with IGG 4 right after CML diagnosis. They gave her 2 infusions in JuL2022, 2 weeks apart of Rituximab 1000mg each. The cortisone was not working, the tumor was growing so they tried the Rituximab instead and it was supposed to shrink the tumor. Prednisone - caller refers to this as cortisone through report. Clarified it was Prednisone. NDC, lot and expiry unknown as she was taking so many different bottles. The information provided was from the last bottle she did not finish. Prednisone 10mg tablets. depending on dosage taking may have taken a couple daily or cut in half depending on how she took them. They are in a pharmacy bottle. Does not have NDC, lot or expiry to provide. Qty 240 tablets, thinks that was for 3 months. This bottle was not the one she was taking when she was toxic. This was a refill that occurred after. She was taking so much and the toxicity was the beginning of the year. She has to wait 4 moths before she can take MRI to see if the infusions worked. She was on acid reflux medication and had to stop it with Bosulif. It was omeprazole, she thinks 20mg daily. It was working and when they took her off she got rebound and was really sick. No further details provided. She was put on Famotidine 40mg twice a day when she started with Bosulif in Jan2022 for gastro reflux. She got Covid in Apr2022 and was worried with her Medical history so she went to ER and wanted to get the Paxlovid which they gave to the president and his wife. they would not give it to her because on Bosulif. They gave her IV push of Monoclonal antibodies, Bebtelovimab by IV push. Does not know the dose. That helped her. She was with cortisone, chemo and had Covid and was walking 8 miles every day. She was up to date on inoculations, shingles and various pneumonia shots. With Covid she took the 1st booster shot beginning Oct2021 but with high doses of cortisone and she took the infusion she cannot take anymore vaccines it will negate the vaccines effect. She has to wait 9-12 months. They are thinking of giving her Evusheld, when her antibodies drop to give her extra protection. She took a blood test and she has more than 25,000 or 250,000 she cannot recall. It was sufficient and she does not need it right now. She went on cortisone end of Oct2021 and was no longer able to take the flu vaccine or another booster of the Covid vaccine. She did poorly with 2nd Covid shot, she started passing out. She had had to drive to (Place Name Withheld) for the shot and as soon as she got it she got light headed and dizzy. They asked if they needed to call EMS to look at her and she said no and put her head down and waited half hour and felt better was able to drive home. Prior Vaccinations (within 4 weeks) was had her flu shot after her booster dose. got flu vaccine on 11Oct2021. AE(s) following prior vaccinations was just sore arms sometimes tiredness nothing like 2nd Covid shot. States flu vaccine thinks shingles she does not know, does not remember. They give several pneumonias and had zoster and shingrex and takes flu shot, TDaP, flu every fall. Has taken so many she does not recall. No further details to provide. Every 3 months she has specific blood tests that tells detection of leukemia this one and the last one showed less than 1% detectable CML. They normally expect that after a year and hers happened much quicker. Also told her if you stay on the Bosulif you handle it well and continue with these numbers for a minimum of 2 years she may be in remission and may be able to take drug holiday. They have had several people do that and that would be incredible if it allows patients to do that. Would have to go for blood tests to make sure do not fall out of remission. This medication gave her the push to go on with her life. it was like a diabetic and insulin. It was a disease that wo not go away but she takes this medication and she forgets about it and goes on with her life. She thought it was a death sentence when she was told she has leukemia. She lives blood test to blood test she was so grateful right now. We have to know that everyone dealing with her here to sign up for funding or getting the medication delivered have been fabulous, patient and courteous.