Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
urine that has turned a much brighter yellow; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Leukemia", start date: 2004 (unspecified if ongoing), notes: Diagnosed 21 years ago. Concomitant medication(s) included: ROSUVASTATIN CALCIUM taken for blood cholesterol (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (had maybe 10 or 11 Covid shots up until now, Last Covid vaccine received was Oct2024), for COVID-19 immunization. The following information was reported: CHROMATURIA (non-serious) with onset 30May2025, outcome "unknown", described as "urine that has turned a much brighter yellow". Additional information: Caller was calling in regards to the covid vaccine booster. After caller got the covid vaccine booster last Friday i.e. 30May2025, noticed urine had turned a much brighter yellow. Agent wanting to know if there was any information about urine that has turned a much brighter yellow and if she should be concerned or what she should test for. Caller stated that she did see online there were some urological complications after the vaccine. Caller was wondering if she should be concerned. If she brought a urine sample into her doctor's office, what should they test for. Has been drinking a lot more so urine has gotten a little bit better but just her usual for her. The patient had might be 10 or 11 covid shots up until now. Later in call, clarified the last covid vaccine received was Oct2024. Caller cannot confirm manufacturer, has had both Moderna and Pfizer. No NDC, lot or expiry to provide on any covid vaccine received. Has all the paperwork but not with her. Takes a thyroid drug. It starts with an L, it was a generic, not Synthroid. Takes one of the lowest doses, a pill taken once a day. Has been taking several months and is currently taking. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Leukemia (Diagnosed 21 years ago)
ROSUVASTATIN CALCIUM