Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Investigation
Clinical narrative: Caller says the COVID she had before was around late Sep2021, which she was fully vaccinated; Caller says the COVID she had before was around late Sep2021, which she was fully vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN6198) and on 11Mar2021 as dose 2, single (Lot number: EN0207) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "autoimmune illness", start date: 1980 (unspecified if ongoing), notes: autoimmune illness Caller says has SLE with kidney involvement; "systemic lupus erythematosus nephritis", start date: 1980 (unspecified if ongoing), notes: autoimmune illness Caller says she has SLE with kidney involvement.; "stage three renal failure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Oxycodone for pain, reaction(s): "raised her liver levels", notes: NDC:65162-0047-10, LOT/EXP:Unk, dispensed in orange bottle manufacturer Amnea on label; Tylenol, reaction(s): "raised her liver levels", notes: NDC: 21130-124-02,LOT:P144565 EXP:Sep2023., elevated ALT and AST, it wasn't elevated like was in June. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2021, outcome "unknown" and all described as "Caller says the COVID she had before was around late Sep2021, which she was fully vaccinated". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (20Jun2022) 51, notes: Result: 51;  Unit: Not Provided; Kidney test: (Jun2022) Elevated, notes: her liver tests and kidney tests were both very elevated in June; (Jun2022) Elevated, notes: her liver tests and kidney tests were both very elevated in June. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient said she started taking Paxlovid two days ago, and the only thing she had really was a bad horrible taste in her mouth. She said she felt well which was crazy because the next morning after taking it she had felt better. She said she was super high risk and had had COVID once before in September or October last year and they had given her monoclonal antibodies. She clarified she had COVID at the end of September last year and she was really sick and the COVID affected her heart, kidneys, liver, and intestines. She said she didn't go to the hospital but her blood work went crazy and she was really sick. She said she had an autoimmune illness and was high risk so it was recommended by her doctor to try Paxlovid since it shows good efficacy. She said she had stage three renal failure so they gave her a reduced dose of the drug and she was taking two tablets twice a day by mouth for 5 days. Caller said her GFR was 51 on 20Jun so that put her in range for that dose, which she had taken three doses so far. She said she had just been reading about it, and sees that it can causer liver issues and kidney issues which her liver tests and kidney tests were both very elevated in June. Caller said she took her first Paxlovid dose July 19th in the evening. Product clarified to generic Signature Care Arthritis Pain Acetaminophen 650mg each, but caller continues to refer to product as Tylenol and clarifies multiple times that it was the generic Signature Care Arthritis Pain Acetaminophen. Caller said for the UPC there was nothing underneath barcode on bottle, and she doesn't have the box for it.Caller said the dose was  5mg and it said to take one tablet by mouth as needed for pain, which she was given ten tablets and she took a total of five. Caller clarifies that the five tablets were not taken at the same time, they were taken over time, they made her take some as soon as the pain in her hand came back after the nerve block wore off, and alternate it with the Tylenol.