Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he had a COVID test that was positive; he had a COVID test that was positive; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history (reported as no other conditions). There were no concomitant medications (reported as no other products). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "he had a COVID test that was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Patient had a COVID test that was positive that was one of the provided home tests, which that would have been positive around or on Monday of last week. Therapeutic measures were taken as a result of drug ineffective,, covid-19 included Paxlovid. Clinical course was reported as, Cardiac surgeon calling as patient (Pt) who says he called about Paxlovid. He says he came down with COVID two weeks ago and was put on Paxlovid and it cleared up virus he thinks or it was gone on it's own, and he was vaccinated with boosters. Paxlovid (Batch/lot number: Unknown, Expiry Date: Jan2029, NDC number of Paxlovid: 00069-1085-30), six tablets a day was started on 14Apr2022 and stopped on 18Apr2022. Pt says he had a really nasty side effect (had a strong bitter grapefruit or metallic taste in his mouth), he wants to report that he is pretty sure is related to the medication, since when he stopped the pills after completing the course two days ago, the side effect went away. He says he had a strong bitter grapefruit or metallic taste in his mouth that seemed to go away when finished taking it. Paxlovid AE began almost immediately after starting taking it, on the first day. He says this got worse after each dose, and then stopped two days after his last dose when he finished taking it. He says treatment he did was just salt water washes. Pt says he took five days worth of the course, and finished it Monday, so he started it either Wednesday 13Apr or Thursday 14Apr. He says that he probably started taking it on Thursday for the five days to end on Monday. He says he threw away the manufacturer packaging for the Paxlovid when he opened it, and only has a slip from the pharmacy. He says the Paxlovid was in blister packs, 5 trays, with 6 tablets in each tray, so 30 tablets. He says he thinks it was 100mg Ritonavir and 150mg for the other, which he took as instructed, so 6 tablets a day. Pt says that the bitter or metallic taste is not a malignant side effect, though it kept him from eating and provided him some nausea, it was nothing serious. He says to treat it he only needed to find something to get the taste out of his mouth. Pt says he doesn't have his vaccine card right now and stated he knows he got Pfizer and the Pfizer booster, one booster dose, which he got these last year sometime. No investigations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.