Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunosuppressant drug therapy, Infusion, Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Sore arm; it's one of the bad ones interfering with the vaccine doing it's job; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was reported), via an unspecified route of administration in arm left on an unspecified date in Apr2021 (at the age of 50-year-old) as a dose 1, single for COVID-19 immunization. Co-suspect medication included RITUXIMAB (RITUXAN), via an unspecified route of administration on an unspecified date in Oct2020 as 2 infusions 2 weeks apart every 6 months for total of 4 infusions a year for Rheumatoid arthritis. The patient's medical history (including any illness at time of vaccination) included Sjogren's syndrome, it affects moisture producing glands and they didn't work right and 5% of people end up with rheumatoid arthritis that was caused by the same process that attacks the glands. Stated her rheumatoid syndrome was caused by that and she was diagnosed at age 27 years, Rheumatoid arthritis, stated that, her rheumatoid syndrome was caused by it and she was diagnosed at age 27 years. The patient's concomitant medications were not reported. Historical vaccine included Flu shot (INFLUENZA VIRUS VACCINE), via an unspecified route of administration on an unspecified date for an unspecified indication and experienced sore arm, just a sore arm with flu shot or any shot, stated it's not a big deal. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) were reported as no. AE(s) following prior vaccinations were reported as none, just a sore arm with flu shot or any shot, stated, it's not a big deal. Stated that, did not had NDC, lot, expiry to provide. The caller stated that, she just wanted to call and report that, she got the Pfizer vaccine back on an unspecified date in Apr2021 and was fine with no side effects, it was smooth with just a sore arm on an unspecified date in 2021. Stated that, she got her last one 3 weeks later on an unspecified date in May2021 and then started reading. Stated that, she was on an immunosuppressant, Rituxan, for rheumatoid arthritis. The caller stated that, it's one of the bad ones interfering with the vaccine doing it's job on an unspecified date in 2021. The caller stated that, her rheumatologist did antibody tests in early on an unspecified date in Jul2021 and she had no antibodies to the vaccine, zero. Stated that, she had that done at the University of withheld lab and her doctor wanted her to go get another one at a different lab as not all tests are the same. Stated that, she had a 2nd antibody test done by withheld and also showed zero antibodies. Caller stated that, she works in pharma for withheld. Stated that, she was also wondered and didn't think they can give advice, all the talk about a booster but to her it didn't make sense as she didn't get anything from the 1st round. Caller was asked, whether they had safety information about getting revaccinated. Stated that, she has already talked to her primary doctor and her rheumatologist. The caller stated that, she was a licensed clinical social worker. Stated that, it was getting scarier out there now with the Delta and her doctor was testing her B cells which Rituxan kills. Caller stated that, P.S. when on Rituxan she had to wait a 6 month period until the infusion was done and she had to wait until the very end of the 6 months. Stated she waited 7 months and she was now 9 months out and she still didn't had B cells and low white blood cells. Stated that, her immune system was so weak she didn't get antibodies and it was anxiety producing. Caller stated that, she was ready to walk in and get another full round of vaccine when she gets B cells and she can't be out there with the Delta. Stated that, her doctor just was retired and she sees her new one on an unspecified date in Sep2021. Stated that, the guy that was trying to help her right now was her primary withheld. The caller declined to provide contact details. The caller stated that, her 1st antibody test was on 03Jun2021, SARS-CoV-2 serology antibodies immunoassay and it was negative for antibodies. Stated that, the 2nd antibody test was SARS-CoV-2 Antibody IGG Spike on 09Jun2021 and was negative for antibodies. Stated that, the name of the test runs off the page. Stated that, after she had the antibody tests, they did a B cell test, CD19plus, to test her level of b cells and the level was 0 on an unspecified date in Jun2021. Stated that, Rituxan dose was unknown. Stated that, she gets 2 infusions 2 weeks apart every 6 months for total of 4 infusions a year. Stated that, her last dose was on an unspecified date in Oct2020. Stated that, the manufacturer was Genentech. The caller did not have NDC, lot or expiry to provide. The caller stated that, she started it over 10 years ago and it has been great, no trouble and she had to go off it and no vaccine will work with it while she was on it. Stated that, it's not the vaccine, it's the medication that did it. Stated that, it was great for rheumatoid arthritis but not during a global pandemic. Stated that, it was such a good drug, it has saved her life. The caller stated that, she got her vaccine almost 7 months after her last dose of Rituxan. The Pfizer Covid-19 vaccine, dose 1 was on the last week of on an unspecified date in Apr2021 at (withheld) in her left arm and dose 2 was 3 weeks later on an unspecified date in May2021 in her left arm. Stated that, the caller did not recall time, she thinks they were both around the same time around 10am. Stated that, the caller did not have her card with her. No NDC, lot, expiry or dose to provide for either dose. Stated that, it's the 2nd most common besides rheumatoid arthritis but no one has ever heard of it. On an unspecified date in Jul2021, the patient underwent lab tests and procedures which included antibody tests, resulted as 0, rheumatologist did antibody tests in early Jul2021 and she had no antibodies to the vaccine, zero, CD19plus (B-lymphocyte count), resulted as 0, on an unspecified date in Jun2021, Sara-CoV-2 Antibody IGG Spike (SARS-CoV-2 antibody test), resulted as negative on 09Jun2021, SARS-CoV-2 serology antibody immunoassay (SARS-CoV-2 antibody test), resulted as negative on 03Jun2021, white blood cells (white blood cells), resulted as low on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.