Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Glomerular filtration rate, Illness, Investigation
Clinical narrative: 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) at the age of 61 years for covid-19 immunization. The patient's relevant medical history included: "autoimmune illness", start date: 1980 (unspecified if ongoing), notes: autoimmune illness caller says she has SLE which is systemic lupus erythematous nephritis with kidney involvement; "systemic lupus erythematous nephritis", start date: 1980 (unspecified if ongoing), notes: autoimmune illness caller says she has SLE which is systemic lupus erythematous nephritis with kidney involvement; "stage three renal failure" (unspecified if ongoing); "hand surgery" (unspecified if ongoing), notes: she had hand surgery and was given Oxycodone and Tylenol. There were no concomitant medications. Past drug history included: Oxycodone for pain, reaction(s): "raised her liver levels", notes: NDC: 65162-0047-10, dispensed in an orange pharmacy bottle with manufacturer anemia on label. they made her take some as soon as the pain in her hand came back; Tylenol for pain, reaction(s): "raised her liver levels", notes: 21130-124-02, LOT: P144565, EXP: Sep2023. 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. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Provider Address/Phone Number/Email Address: Unknown, partial address documented as provided. Oxycodone and Tylenol: raised her liver levels: Caller says she had hand surgery and was given Oxycodone and Tylenol for a few days after that which raised her liver levels, so she was wondering since she doesn't know her recent liver levels, if based on data they have so far if she should stop taking the Paxlovid Tylenol UPC/LOT/EXP: 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 is the generic Signature Care Arthritis Pain Acetaminophen. Caller says for the UPC there is nothing underneath barcode on bottle, and she doesn't have the box for it. She provides Signature Care Arthritis Pain Acetaminophen NDC: #, LOT: P144565, EXP: Sep2023. Oxycodone NDC: #, LOT/EXP: Unknown, dispensed in an orange pharmacy bottle with manufacturer Anemia on label. Caller says the dose is 5mg and it says 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. She says the Tylenol and Oxycodone caused her liver tests to go way up, which Tylenol does make her liver tests go up, but she is assuming it was the Oxycodone that made them go way up. The Caller says the COVID she had before was around late Sep2021, which she was fully vaccinated. She says her first vaccine dose was 19Feb2021 and her vaccine card says Pfizer LOT: EN6198, She says her card is handwritten and they didn't provide NDC/EXP for her first dose. She says her second dose was 11Mar2021 and says Pfizer LOT: EN0207. She says NDC/EXP were not provided for that dose either. She says on 10Dec2021 she had her booster dose and that one is on a sticker so it has NDC number on it and says Pfizer NDC: #, LOT: FJ8757, which she can't read that number. She provides the number and clarifies the LOT on the sticker was typed out and the sticker was stuck on vaccine card. She provides booster dose EXP: 30Dec2021. Caller says all of the vaccine doses made her very sick, they all made her very sick, and then she had shingles a month after she had the booster. She says that the treatment for shingles was Valacyclovir, which she also gets sores in her mouth from her lupus so she has had her Valacyclovir refilled so many times for the sores in her mouth, and she has also got something for the blisters on her back. Valacyclovir NDC/LOT/EXP: Caller says she doesn't have this medication with her at this time to provide. Caller says she had recent liver tests in Feb or Mar where the liver test had elevated ALT and AST from Tylenol use, but it wasn't way elevated like it was in Jun, which she doesn't know if she told the PA that so she was a little concerned. She says her most recent levels were on 20Jun so the PA knew what those were.