Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, SARS-CoV-2 antibody test, White blood cell count
Clinical narrative: Felt like she was coming down with something; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration (at the age of 74-years), administered in arm left on 21Jul2021 10:00 as dose 1, single for COVID-19 immunization. Medical history included ongoing systemic lupus erythematosus : Lupus she was formally diagnosed a few years ago, but her rheumatologist says she has had it her whole life, covid-19 from Mar2020 to Apr2020, cancer, immunocompromised due to lupus , very sick, her family had a history of a lot of autoimmune issues, Lupus, Rheumatoid Arthritis. The patient concomitant medications were not reported. The patient previously took first dose Moderna Covid vaccine (Lot Number: 013L20A) administered on 20Jan2021 for COVID-19 immunization and took second dose of the Moderna Covid Vaccine (Lot Number: 016M20A) administered on 17Feb2021 for COVID-19 immunization and experienced severe muscle aches, worse than when she had covid 19, sore arm after moderna vaccines and fever. On 22Jul2021, the patient experienced felt like she was coming down with something. She reported that she has already been immunized with the Moderna series but I am one of those weird people who are immunocompromised due to lupus, but my immune system goes up and down up and down, so my doctor said we should test your antibodies, of course I had it tested and it showed nothing. We decided that we needed to do this thing again", and caller reported that she got her first Pfizer shot this Wednesday, 21Jul at 10:00. We are going to do antibody testing every 2 months to make sure it works. She also reported that she had Covid previously and was very sick, as well as, I know I had a reaction to the Moderna vaccine so I am convinced I did have some antibodies but I do not think it lasts as long as some people. On 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose Vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC) and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration (FDA)o Vaccine was 100% effective in preventing COVID-19 cases, where the B.1.351 lineage is prevalento Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second doseo Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon.The press release is available: Please note that the Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity SRD has been updated to include the Press Release information. She initially received the Moderna Covid Vaccine series. She was tested for antibodies due to her history with Lupus and her antibody test was negative.She also mentioned a reaction to the Moderna vaccine. She stated that her reaction to the Moderna vaccine was after the second dose. She had symptoms that showed she was producing antibodies. She had Lupus and stated that her Lupus attacks the immune system specifically and goes up and down. She thinks that she produced antibodies after the vaccine, but that they are gone because of her Lupus. She stated that prior to her second dose of the Moderna vaccine she had only had a fever 4 times in her life. The second day after the second Moderna vaccine she had severe muscle aches that were worse than when she had Covid 19. A few hours later on the same day she had a fever. Stated that her normal temperature is 97.3 degrees. When her fever got up to 100 degrees she took a Tylenol and then she was fine. Stated the next day she was completely fine. The second day after her Pfizer Covid Vaccine, she felt like she was coming down with something. Stated that it is gone and she is fine today. She stated that her Primary Care Provider does not know the whole story. Stated he ordered the antibody test and then he went on vacation. She stated that she called her rheumatologist. She clarified that she decided to get the Pfizer vaccine on her own. Says that withheld was talking about immunocompromised patients and that they should contact their doctor to see if the patients needed a booster shot. She herself knew what the other countries were saying about people who 5-6 months after their vaccines had no protection, so the she contacted her primary care provider who agreed to do the antibody test. She then contacted her rheumatologist. Her rheumatologist told her that withheld has not put any recommendations in writing to tell doctors what to do related to booster shots. She saw withheld on television yesterday saying there was going to be a special meeting to discuss immunocompromised patients and the Delta variant of the Covid 19 virus that is taking over the country. She has not heard more about that yet, other than they are recommending everyone to wear masks, outside and inside. She stated that her rheumatologist was not against her getting the Pfizer vaccine series after getting the Moderna vaccine series. He just told the patient that he could not tell her to go and do it. She stated that she did it because she was not going to let her life go down the tubes due to government bureaucracy. She stated that she got the SARS COV2 IgG antibody test done on 15Jul2021. She got the results within a few hours and they were negative. She soreness in her arm after the Moderna vaccines; states only that it wasn't bad, says it was like normal little soreness after a shot. She stated that she thinks she got it in her left arm but is uncertain. She stated that it took forever for her to get the Moderna Vaccine because it took forever to get vaccines in her area. History and Investigations: Covid 19: Caller states that she had Covid 19 for 29 days. Says that her doctor wanted her hospitalized, but the emergency room doctor did not want her to come to the hospital. The emergency room doctor thought that due to her being sick and having a low white blood cell count she would catch something at the hospital like pneumonia or bronchitis. She went through her Covid 19 at home. Stated that she almost died from Covid. She would get up everyday at midnight and start calling places looking for someone who had the vaccines available. Stated the process is much better now than it was back then. She stated that her Covid symptoms started in Mar2020, says that Covid came to the withheld area where she lives around 11Mar2020; she estimates she got her first symptoms around 15Mar2020 and says it lasted into Apr. She denies any other medications, medical conditions, or treatments relevant to report. She mentioned that her daughter with celiac disease was on her way to withheld Clinic. Stated that withheld Hospital could not figure out what was wrong with her daughter. Her daughter had Covid 19 when the she did and has had the Pfizer Vaccines. She mentioned that her daughter has never been tested for Lupus. Stated whatever was going on with her daughter is affecting every system of her body. She stated that she is uncertain if her daughter has Covid 19 or if it is her autoimmune symptoms causing issues. She mentioned an article she read this morning. States a man had wrote in about his wife who has Rheumatoid Arthritis and Lupus. The wife of this man had the same antibody test as the caller after the Covid Vaccine and the results were negative. The man had wrote into the article asking what does that mean. She stated I have nothing against Pfizer I know this was a new disease and they did their best to come out with a treatment. Yesterday I spent the day reading journals/studies and the efficacy is still listed at 95.3% that is not true anymore, the variants have become strong, the vaccine cannot fight them off as well, but it was still a good product. The delta variant is out of control and it will get worse, we donot want people to get overconfident, so maybe the data should be updated (on the efficacy). I do thank Pfizer and they probably saved millions of lives including mine. The patient underwent lab tests and procedures which included body temperature: 97.3 fahrenheit on her normal temperature is 97.3 degrees, body temperature: 100 fahrenheit on Feb2021 her normal temperature is 97.3 degrees. When her fever got up to 100 degrees she took a Tylenol and then she was fine, sars-cov-2 antibody test: negative on 15Jul2021 Negative SARS COV2 IgG Antibody test, white blood cell count: low on an unspecified date a low white blood cell count. The adverse event does not result in physician office and emergency room visit. The patient did not take any other products. The clinical outcome of the event was reported as recovered on 23Jul2021.