Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: treatment of COVID 19; treatment of COVID 19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Feb2021 as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "acid reflux" (unspecified if ongoing), notes: treatment for acid reflux for years; "chronic lymphocytic leukemia", start date: 2007, stop date: 2019, notes: she has a history of leukemia and has been in remission since the end of 2019., She was diagnosed with CLL in 2007.; "fibromyalgia" (unspecified if ongoing), notes: Caller also has a history of fibromyalgia. The patient's family history included: "immunocompromised" (unspecified if ongoing), notes: They are both immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Shingrix vaccine (Dose: 1), administration date: Dec2021, for Immunization; Shingrix vaccine (Dose: 2), administration date: Jun2022, for Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Dec2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID 19". The patient underwent the following laboratory tests and procedures: Antibody test: greater than 25,000, notes: her antibodies were greater than 25,000; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Reporter is the patient. Stated the retired Nurse is Calling regarding "Any new products we (Pfizer) may be working on for the treatment of COVID 19 besides Paxlovid." Caller stated she received a Moderna primary dose on 07Feb2021 and the 2nd primary Moderna dose was on 07Mar2021. She received a Moderna (half dose) vaccine in the summer of 2021 for immunocompromised patients and She received the Bivalent Pfizer vaccine booster dose 4-5 months ago. After receiving the primary Moderna vaccines she had arm soreness but no fever, "a few weeks later I had joint pain, muscle pain, digestive issues, insomnia, brain fog, dry and dry mouth and dry eyes. "She continues to have these symptoms. She has seen a rheumatologist who was pushing drugs for osteoporosis. She has also been diagnosed with fibromyalgia. Caller states she has osteoporosis from treatment for acid reflux for years and taking Prilosec/ Nexium. The caller states she has a history of leukemia and has been in remission since the end of 2019. She stated she was part of a study. Periodically there would be a lab slip in my email and I would go to the lab to get an antibody count. (antibodies for Covid 19). Caller stated she always had antibodies after receiving her Covid 19 vaccines. Evusheld was being administer IM to patients that were immunocompromised (and not producing their own antibodies) and the Evusheld (2 combined antivirals) was administered to give the immunocompromised patients (put in their bodies) the antibodies they did not generate from the vaccines they received." Caller states "this is no longer being done and of course immunocompromised patients are panicking because of the risk of Covid 19 and lack of antibodies." Caller is concerned when she has to go back into treatment for leukemia (no cure and never goes away) and will need to get IV steroids before the IV infusion of targeted immunotherapy. Had a reaction to Rutuxin and Bendamustine during treatment. Caller also has a history of fibromyalgia. The most recent vaccine she received, Pfizer Bivalent vaccine, her antibodies were greater than 25,000. If you are in treatment for Leukemia you don't make antibodies to vaccine. This is why she wants to see what other drugs/ vaccines are being researched. Her husband has been taking prednisone since the fall of 2020 and has osteoporosis from this. He takes 2.5mg of prednisone. Someone called her from Pfizer while she was out. and she was just returning the call. The individual she just spoke with thought she might have had an adverse reaction and had reported it to VAERS or something, but she said no. Transferred here. She just had a little sore arm and some redness swelling after. She did not have any adverse reaction. Just the typical stuff. She knew that Pfizer, Merck, Moderna, Lilly, and the other companies like that are trying to work on something to treat Paxlovid with. Knows that the only weapon to fight this disease with right now is Paxlovid. She is immunocompromised and has chronic lymphocytic leukemia (CLL). Her husband has cancer of the esophagus and gets chemo and radiation. They are both immunocompromised and don't make antibodies for vaccines because of they compromised immune systems. At the cancer care center in (State name withheld), they were giving patient's Evusheld. It was an injection given every 6 months, she believes to help immunocompromised patients make antibodies. It putting antibodies directly in that patients versus them going to get the vaccine and waiting a few weeks to go have the antibody levels tested. Now the variants that are popping out of omicron know how to evade some of this stuff. Is there anything in the pipeline to take care of these new variants. It is only Paxlovid right now. Had heard about another medication. She's unsure of how to spell it. mon- something, but it ends with vir. She takes acyclovir twice a day, and she has been doing that twice a day for four years. Her specialist said to stay on the acyclovir a little while longer because it would not hurt anything. Maybe the medication she heard about it spelled, momulpivir. She cant remember, but she is just wanting to call and see if there are there any more oral agents coming out. Denies any adverse reaction with the Covid-19 vaccine. Had no fever, wasn't ill, didn't feel like she couldn't get out of bed, or anything like that after the Covid-19 vaccine. She had the Moderna Covid-19 vaccine on 07Feb2021. Got the second dose one month later on 07Mar2021 and in the summer of 2021 talked to the CDC and, they came out with an extra dose for the elderly or immune compromised, and she got that in October. A lot of people thought that was the first booster, but it wasn't. It was a half dose extra of the primary series. Back then there was still Johnson and Johnson that was once and done. Got that little half dose and the most recent dose she got was the Pfizer Covid-19 vaccine in December. That one was the Pfizer vaccine for the new variants. She did okay. Went to a laboratory. She was in a study two years ago through the leukemia and oncology society. Doctors wanted to know how the CLL patients did because it took a long time for doctors to agree that the Shingrix vaccine was okay for the CLL population. She is 73 now, but around when she was 50, you could get the shingles shot if you were right age, but if you weren't you had to pay for it out of pocket. Didn't remember if she had CLL at that time. She was diagnosed with CLL in 2007, but doctors said she may have had the beginnings of it as far back as 2004. Surprised she went all the way to Jul2018 before she needed treatment for her CLL based on her biomarkers. Now, they have have the non-live Shingrix vaccine, and she got the first one in Dec2021 and the second in Jun2022. So she is actually all up to date on her vaccines. Had greater than 25k antibodies from the Pfizer omicron vaccine. She is really only calling to find out about any new Covid treatments for people like her who don't make antibodies. Her husband had treatment for esophageal cancer yesterday and they left the needle in, so they had to go back down to (City and State name withheld), which is about a 35-40 mins ride to have them de-access her husband's port. He could get an infection or something if they left the needle in there. That is why she missed the call today. Sometimes when she talks to the CDC, they will send her an attachment to her email so she always has the information. She has not filed a safety report. She might have called to see if Pfizer was working on some other weapon for the Covid arsenal. Other than that, she wouldn't have called. Especially after she heard that the Evusheld was taken off because of the stupid new variants that have found away to evade it. Evusheld is a combo of two antiviral drugs that was given to immune comprised people. When it was taken away, it just left Paxlovid. Just called to see if there was anything else left like that. Her husband has to have back surgery and with her being a retired nurse, she is hoping they will let her stay there with him. He doesn't hear good. Paying bills and reading and writing he is not so good at that, but he used to build houses and such. If he does have the back surgery, hopefully it will be at the cancer hospital since they know he has cancer and will take care of him.   The information on the batch/lot number for [BNT162B2] has been requested and will besubmitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.