Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive with COVID yesterday; Tested positive with COVID yesterday; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatis C", start date: 2011 (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE (ongoing); OMEPRAZOLE (ongoing); LYRICA (ongoing); ESTRACE (ongoing); ROXICODONE (ongoing); ALBUTEROL [SALBUTAMOL] (ongoing); ATROVENT (ongoing); FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE] (ongoing); OXYBUTYNIN (ongoing); MOBIC (ongoing); AMBIEN (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization, reaction(s): "Lost my taste", "smelling things which is burning kind of smell"; Bnt162b2 (Dose 2, Single), for Covid-19 Immunization, reaction(s): "Lost my taste". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2023, outcome "unknown" and all described as "Tested positive with COVID yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Transferring agent stated, "I do have here a nurse on the line. She is calling as a consumer. Caller mentioned that she used to have a case of hepatis C back in 2011 (History) and now she was prescribed with Paxlovid. Aside from that she also mentioned that she is taking other medications, which is Oxycodone, Lyrica. She also mentioned Omeprazole and she also mentioned she is also taking Estrace. She also has Roxicodone, and she also is currently taking Albuterol and Atrovent and she is also taking Flexeril and she also has here Oxybutynin ER and she also has Mobic, and she is also taking Ambien. She also mentioned that she received three Pfizer COVID Vaccine and after receiving the vaccine although she mentions that she was already smelling things which is burning kind of smell. When she had COVID, when she received the COVID shot she lost her taste." When probed if the consumer has started taking the Paxlovid, consumer stated, "The all the information that she mentioned to me was, she did not take her morning dose. She tested positive with COVID yesterday. I am sorry I missed that information for you." consumer stated, "Back in 2011. I had hepatis C back in 2011 (History). When you all first started giving out the COVID shot and that when I took first shot because I should take it in two phases of first shot. The first shot I took I lost my taste, and I could smell stuff strong and when I got tested for COVID I did not have COVID. Then when I took the second shot the same thing happened and again, I did not have COVID, but it was just something that I told the nurse that gave the shot, and she says she is never done like that before. So, I thought of share, reported because the all of that in actual time for anything different but she said you can't be you got to have corona. You must have COVID if you do smell and I said no, I don't have it and I was tested, and I did not have that (further not clarified)." Indication (Paxlovid): Consumer stated, "Because I have COVID. I am not taking it. But it is because of COVID. I would be taking it, but I am not taking."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal association and known safety profile of the suspect , possible contributory role of the suspect for the events drug ineffective and covid-19 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300308267 same patient and drug, different events;US-PFIZER INC-202300308268 same patient and drug, different events;