Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The patient stated she got sick with COVID three weeks after the injection.; The patient stated she got sick with COVID three weeks after the injection.; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 66-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 10:35 as dose 1, 0.3 ml single (Lot number: HG4589) at the age of 66 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 05Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Nov2023, outcome "recovered" (01Dec2023) and all described as "The patient stated she got sick with COVID three weeks after the injection.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Nov2023) Positive; (24Nov2023) Positive; (01Dec2023) Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient asked if the Comirnaty 12 years of age and older 2023-2024 that she received on 20Oct2023 was the latest Pfizer COVID-19 vaccine and what was the difference between Comirnaty NF 12 years of age and older 2023-2024 and Comirnaty SDV 12 years of age and older 2023-2024. She was wondering since she got one and her husband got the other. The patient received a single injection of Comirnaty 12 year of age and older 2023-2024 formulation (NDC 00069-2362-10) on 20Oct2023. The patient stated she got sick with COVID three weeks after the injection. No other conditions and no investigations. When paraphrased, consumer (Retired Nurse) stated, "Right, she got the vaccination on 20Oct and came down in Sep then her girlfriend got it and then she got it from her, and she got it 13Nov and its Monday she tested positive." When confirmed that patient got diagnosed with COVID-19 on 13Nov2023, consumer stated, "Yes. Still positive with COVID-19, consumer stated, "No not now. I tested negative on I think it's Friday the 1st (01Dec2023). I still tested positive on the 24th that makes the difference. On the 13th I tested positive for the first time, on the 24th I still tested positive but on the 01Dec, (clarified as 01Dec2023) I tested negative." No treatment received. The patient did not take any other vaccine on the same. When probed if patient took any other vaccine 4 weeks prior to Comirnaty, consumer stated, "she did she took the over 65 Flu vaccine two weeks prior to that. 20Oct she got the Covid vaccine (Comirnaty) and then 05Oct2023, she got the Fluzone vaccine, consumer stated, "It's the Fluzone over for 65." Consumer stated, "So, you don't want to know what the symptoms were and you don't not want to know that my girlfriend did not get the vaccine and she got covid the same, two days before her, she mean you don't want to know any of that stuff you just want to document that she got the Covid after she got the vaccine so basically that is what it is?" When probed to clarify if patient's girlfriend took Comirnaty vaccine, consumer stated, "No (hence spilt not made) She got Covid two days before I did and I know I get it from her because we spend the whole week together and we weren't awake for a week (general statement) and she got Friday before I did so I know she did not took the vaccination so I am thinking that the vaccination helps me as I did not get it as bad as she did and I did not get it as hard as she did. She got a hard impact to make up with it I think that is what save me from the vaccination, but I did definitely get it, and I was down for the count of 4 days or very sick." When paraphrased the concern, consumer (Retired Nurse) stated, "Right, I got the vaccination on 20Oct and came down in Sep then my girlfriend got it and then I got it from her, and I got it 13Nov and its Monday I tested positive." Reportedly serious: No.; Sender's Comments: Based on the known the information available the Causal relation between the events Vaccination Failure, Covid 19 and suspect drug cannot be excluded completely