Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 1 | — | LA |
COVID-19; COVID-19; This is a spontaneous report received from a consumer from medical information team. A 75-year-old female patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), in Jul2025 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Sep2025, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Influenza virus test: (22Sep2025) Unknown results; SARS-CoV-2 test: (22Sep2025) Positive. The patient went to a facility yesterday (22Sep2025) as she wasn't feeling well in which she was diagnosed with COVID and prescribed nirmatrelvir/ritonavir (PAXLOVID). The patient has COVID, and she had received a COVID vaccine previously (thinking two months ago was when she got the COVID vaccine but does not remember exactly when). However, she isn't sure who the manufacturer was. The pharmacy was going to charge her over $400 for the Paxlovid in which she did not get. The patient was also prescribed acetaminophen. The patient found that Paxlovid has a program that offers a copay card. The patient was asking if she should go back to her doctor and have them give her Paxlovid once she seeks out financial assistance. Therapeutic measures were taken as a result of covid-19.
Test Date: 20250922; Test Name: Flu test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20250922; Test Name: COVID-19 test; Test Result: Positive