Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mean platelet volume, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The caller was tested for cornonavirus and the covid 2 antigen swab and was diagnosed with covid; COVID infection/The caller was tested for cornonavirus and the covid 2 antigen swab and was diagnosed with covid; not slept for 24 hours; should be delirious; hasn't eaten either; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 14Dec2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jun2021 (Lot number: EH6181) at the age of 66 years as dose 2, single and administration date 27May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bladder cancer" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "Covid-19", start date: Feb2020 (unspecified if ongoing), notes: The caller got her vaccines after she had Covid 19., Hospitalized for Covid 19 prior to being vaccinated; "Hospitalized for Covid 19" (unspecified if ongoing); "Arthritis" (ongoing), notes: crippled with arthritis; "hardly walk with my arthritis" (ongoing); "Osteoarthritis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Hyperactive" (unspecified if ongoing); "pneumonia" (unspecified if ongoing); "very sick when she got covid" (unspecified if ongoing); "chemotherapy" (unspecified if ongoing); "menthol allergy" (unspecified if ongoing); "asthma attack from Vick's vapor rub" (unspecified if ongoing); "sneezing" (unspecified if ongoing); "runny nose" (unspecified if ongoing); "rehab", start date: 2020 (unspecified if ongoing); "drop foot", start date: 2020 (unspecified if ongoing); "getting fat" (ongoing), notes: Weight was either 146 or 147.5 or 147.6lbs, she was getting fat from eating sugar.; "chickenpox" (unspecified if ongoing); "quit smoking 5 years ago" (unspecified if ongoing); "a lumpectomy" (unspecified if ongoing). Family history included: "allergic to penicillin" (unspecified if ongoing), notes: mom was allergic to penicillin. Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis; PREDNISONE taken for rheumatoid arthritis (ongoing); VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; PROLIA; CALCIUM; FOLIC ACID. Past drug history included: Methotrexate, reaction(s): "COVID-19"; Tramadol; Prednisone, reaction(s): "COVID-19"; Anastrozole for bladder and breast cancer; Anastrozole for bladder and breast cancer. Vaccination history included: Bnt162b2 (First Dose: Received 27May2021, lot EW0178, and expiration date unknown.), administration date: 27May2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Jaw issues", "I had a sore". The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Dec2021, outcome "unknown", described as "The caller was tested for cornonavirus and the covid 2 antigen swab and was diagnosed with covid"; COVID-19 (medically significant) with onset Dec2021, outcome "unknown", described as "COVID infection/The caller was tested for cornonavirus and the covid 2 antigen swab and was diagnosed with covid"; INSOMNIA (non-serious) with onset Dec2021, outcome "unknown", described as "not slept for 24 hours"; DELIRIUM (non-serious) with onset Dec2021, outcome "unknown", described as "should be delirious"; FEEDING DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "hasn't eaten either ". The events "the caller was tested for cornonavirus and the covid 2 antigen swab and was diagnosed with covid", "covid infection/the caller was tested for cornonavirus and the covid 2 antigen swab and was diagnosed with covid", "not slept for 24 hours", "should be delirious" and "hasn't eaten either " were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (2021) normal, notes: Normal, no pneumonia; full blood count: (2021) normal; mean platelet volume: (2021) down; sars-cov-2 test: (13Dec2021) positive, notes: omicron variant. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient got two doses of the vaccine and wanted to know when she can start her Methotrexate, when she can return to that medication because she had to stop for like 2 weeks or more because she received the vaccine, and the only medication she could take was ibuprofen. Patient reported that she was crippled with arthritis and had second shot (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jun2021 at 8 in the morning. Patient can hardly walk with her arthritis and have been staying off all my medications so she can get a shot. She had to take Tramadol, she was done. Patient mentioned that she almost died when she had Covid as she was over 30 days in the hospital for Covid, and patient think she got it because she was being on Methotrexate and Prednisone because she had two forms of cancer she beat (3 years ago bladder and breast). Patient was given Anastrozole (patient not sure) I am not taking that no more. Now, she had to have them to drain her knee, she got cortisone shot in her knee because knee was twice the size, now patient want to go back on methotrexate because she could not function because she was crippled with arthritis and was literally crippled right now. Patient wanted to know how long till she can take her Methotrexate again. Patient stated that her rheumatologist: "he had senior citizens taking Methotrexate while they got a Pfizer shot, not good because I read another article saying that maybe a Pfizer shot would not work now because they were on Methotrexate, somebody has to wake up because we have problems nobody pay attention, and she pay attention to everything. She was very sick when she got covid and stated that at 4 'clock in the morning she took a Tramadol, and stated "Tramadol was just a strong aspirin". Patient had reaction to the first shot as had a sore (stated "glands" unable to clarify as she continued to talk) for a couple of hours and her second shot that she got yesterday no reaction at all to it. Patient stated she was in pain and had rheumatoid in arm and cannot hold arm now and she can hardly walk because of osteo in knees and she needed to be back on her medication as soon as she can because she was crippled. Patient was in the hospital in February and March, then in rehab for 10 days and was hospitalized for Covid 19 prior to being vaccinated. She takes prednisone and she has antibodies and stated she was fine.  The patient had no prior vaccinations (within 4 weeks).  She has a menthol allergy she stays away from it now. The patient's mom was allergic to penicillin. The patient had and asthma attack from Vick's vapor rub. She mentioned she has allergies, so when she started sneezing and having runny nose initially she didn't think anything of it. She had measles shots when she was a child and the measles shots they gave her were no good, they found out the measles shots she got were no good; but she never caught measles or mumps and only had 2 pock marks from chickenpox. The only sickness she ever had was bladder cancer from smoking and she quit smoking 5 years ago; she had double negative breast cancer because her body didn't get rid of the estrogen so she had a lumpectomy. As of 14Dec2021, patient reported that she was diagnosed with covid 19 in Feb2020, got vaccinated May2021 and Jun2021 with Pfizer covid vaccine. Yesterday (13Dec2021) she tested positive for covid. She takes Prednisone and Methotrexate and received monoclonal antibodies today. She has a different strain of covid and that's why it messed up her breathing. She got the first and second dose of the covid 19 vaccine in May2021 and Jun2021 and got positive with covid and right now the caller has tested positive. She has pneumonia the second time and was taking antibiotics. The patient clarified and confirmed that the first time she ever got covid was in Feb2020 and she almost died. She got the covid vaccines 27May2021 and 27Jun2021. The patient's doctor said she should wait until February to get the booster dose. Now the patient got tested and was positive for covid. She was taking Methotrexate and Prednisone 2.5 mg and was waiting for her doctor to call her back because she was told if she gets any covid at all to stop taking the Methotrexate. The patient didn't stop taking her Methotrexate when she got the vaccine. She would have never known she had covid and she felt a little tired but that it. She went to the hospital to get tested for covid and was in there for 12 hours. Everyone around had the flu and was so sick, patient had not had a flu vaccine this year. The patient got the Monochronal antibody infusion the first time she had covid but it was too late. She has a pulmonary doctor, PCP, and an Infectious Disease doctor from the last time she had covid. She had pneumonia in her lung last time she had covid. She had the covid 3 of 4 days ago. About a week ago, she had a runny nose and was sneezing and she thought that was really weird and it was part of the covid. Patient asked what would have happened if she got the booster and didn't know she was going have the covid. After the first dose she was sore and then had no reaction with the second shot. Because she had a reaction with the first shot it showed it was working. So she didn't know if the vaccine wore off or what. The patient ended up in the hospital with covid when she wasn't vaccinated. She had male nurse and would throw her oxygen on the floor and told him: if you can't breathe in your sleep you'll wake up. They couldn't get the caller's blood pressure when she was in the hospital. She has bladder cancer and breast cancer and they had no problem giving her an IV when she the infusion. She didn't have cancer veins because she has a port.  She was in a rehab last year (2020) because she had drop foot. She had osteoarthritis and rheumatoid arthritis from the cancer treatment (unspecified). If the Methotrexate keeps giving the covid she didn't want to take it anymore. She got the Monoclonal antibodies but it was too late because she already had pneumonia. The first time the patient had covid she was in the hospital for over a month then went to a rehab. This time the patient went to the emergency room to get the rapid test and another type of test. The patient was tested for cornonavirus and the covid 2 antigen swab and was diagnosed with covid. The patient has not slept for 24 hours and should be delirious and hasn't eaten either (Dec2021). She got the monoclonal antibodies today. She didn't have pneumonia right now. Last time, she  got double pneumonia so the shot may have prevented her from getting pneumonia this time. The events required emergency room visit.  She got tested positive with the new Omicron variant of COVID (13Dec2021). She was currently taking methotrexate because she was immunocompromised and a medication for rheumatoid arthritis. She felt slightly tired but just flu like symptoms she mentioned, but not too much. She was diagnosed with COVID omicron variant on 13Dec2021. She clarified that she did not have any questions, she knew that now she has to wait 90 days after she was administered the monoclonal infusion on 14Dec2021 to get the booster shot of Pfizer Covid-19 Vaccine. She was diagnosed with COVID omicron variant on 13Dec2021: Onset date is unknown; initially provided as 4 days prior to diagnosis, which would have been 09Dec2021, but then she reported it could have been earlier than that, she does not know date of onset of symptoms. She was diagnosed in emergency room where she went on 13Feb2021 but couldn't be get the monoclonal infusion until 12 hours later on 14Feb2021 at 10:00. She never knew that she had the COVID omicron variant until diagnosed. She just had sneezing spells, like sneezing 15-20 times in a row, slight runny nose, and a little tired-but with Rheumatoid Arthritis she has that-tired. She had no fever, no loss of taste or smell and had no respiratory or breathing problems. She had no nausea. She is lactose intolerant and she ate cheesecake so she does not know if the cramping and sore bowels with diarrhea was from the cheesecake or it could have been a sign of COVID omicron variant, she was not sure, but those symptoms disappeared. She caught COVID omicron variant from her daughter's child who she babysits. Caller's daughter, daughter's child and daughter's husband all caught COVID omicron variant and got sick, daughter's husband got real sick. If her primary care doctor had listened to her and let her get the booster shot early then she did not think she would have gotten COVID omicron variant; but he told her she was supposed to wait 6-9 months after second dose of Pfizer Covid-19 Vaccine to get the booster shot of Pfizer Covid-19 Vaccine. She thinks the Pfizer Covid-19 Vaccine doses she was administered saved her. Regarding outcome of event patient reported she has had no symptoms since 3 days ago. In response to diagnosis of COVID omicron variant she was administered monoclonal infusion at 10:00 on 14Dec2021. Now she has to wait 90 days to get the booster shot of Pfizer Covid-19 Vaccine. She was reading a report saying people that have a second breakthrough after the second shot in the end those are the ones who will become totally immune to the COVID. So she will probably become one of those people.  She mentioned she knew other people who had the other shot and one had triple bypass, another had diabetes, but they got the other shot, the Moderna shot, not Pfizer or Johnson; and they did not catch COVID omicron variant so the shots must be doing something. She does not know if they got their Moderna shots before or after her, and she declined to complete reports for those patients.  The complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine Injectable lot EW0178 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished EW0178, fill lot EP8729, and the bulk formulated drug product EP8610. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   The lot number for bnt162b2 (dose 1) was not provided and will be requested during follow up.