Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Investigation, Urinary tract infection
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 79-year-old female patient received BNT162b2 (BNT162B2), on 02Jul2021 at 14:00 as dose 2, single (Lot number: EW0185) at the age of 79 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Lymphocytic Leukemia", start date: 18Sep2007 (ongoing), notes: Diagnosed with leukemia 14 years ago. She had stage 4 lymphoma.; "spinal stenosis", start date: 2015 (unspecified if ongoing). The patient has family history of high blood pressure, heart disease, cancer, and stroke. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number EW0164; Time: 03:00 PM; Anatomical Site Injection: Upper Arm; Route of administration: Left Muscle), administration date: 30Apr2021, when the patient was 79-year-old, for COVID-19 immunization. The following information was reported: BONE DENSITY DECREASED (non-serious) with onset 2021, described as "Low bone density"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Jul2021, described as "Dose 1: 30Apr2021; Dose 2: 02Jul2021"; URINARY TRACT INFECTION (non-serious) with onset 2022, described as "UTI". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not know how many shots to get. She had oral leukemia medication that did not work for her and unspecified product manufacturer, Private number of unspecified product and expiry date of unspecified product were unknown. She was calling about the Pfizer product, the Covid vaccine and stated she got the first shot late last spring on 30Apr2021 (lot-EW0164). Caller stated she was diagnosed with leukemia 14 years ago, chronic lymphocytic leukemia, that was prior to the Covid vaccines and stated it could start and stop and come back. Reporter stated she had been on oral medication and it did not work with her, not remember the product name and has no product information to provide. Product strength and count size dispensed and additional lot numbers were unknown. Oncologist told her that for 35 percent of people that took it, it would not work, stated she then started back on chemo. Unknown product information, did not remember the name of the medication, no further information provided. She was confused because she did have another hip sample taken and one oncologist told she had stage 4 lymphoma and her doctor now says it was still just CLL. Dates were unknown. HCP information was not provided. There was a product complaint to report. Information about other conditions, other products, investigations, sample of the product available to be returned, if requested and packaging sealed and intact was not provided. The patient took first 2 doses on time. The patient did not take the 3rd one in Dec2021 because she forgot. The patient went 09Apr2022, she gave a regular shot and said she would have to take one shot in 19Sep2022 and one in Jan2023. The patient learned no one could take over 4 shots. You told me to take one 19Aug2022. Reporter stated that she does not know the exact dates for UTI's in 2022 and bone density low in 2021. Reporter added that she just got back home from chemotherapy for her leukemia, that she needs to get some rest, that she has chronic lymphocytic leukemia, and that she was diagnosed with leukemia 14 years ago. Follow-Up (07Jun2022): Follow-up attempts are completed. No further information is expected. Follow-up (08Aug2022): This is a follow up spontaneous report from a contactable consumer. This consumer (Patient) reported in response to Non HCP. Updated Information included: Suspect product (vaccination facility address added, product start/stop time added for dose 2, anatomical Location and patient route of administration added, vaccination facility type captured), Start date for medical history, historical vaccine notes updated, added, lab data added and updated additional information. Follow-up attempts are completed. No further information is expected. Follow-up (09Aug2022): This is a spontaneous follow-up report received from a contactable consumer in response to Non-HCP telephonic follow-up activity. Updated information includes: clinical information. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.