Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He was vaccinated twice and boosted once with Pfizer; He was vaccinated twice and boosted once with Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6200, Expiration Date: Jun2021), on 20Mar2021 as dose 2, single (Lot number: EN6208) and on 06Oct2021 as dose 3 (booster), single (Lot number: FF3590) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2022, outcome "not recovered" and all described as "He was vaccinated twice and boosted once with Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Positive, notes: Unit: Not Provided; (01Jan2023) Positive, notes: Unit: Not Provided. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Took treatment with Paxlovid from 26Dec2022 to 31Dec2022 , 300mg/100mg twice a day by mouth for five days in tablet form. Caller stated that treatment taken was Paxlovid which finished on Saturday, and has been testing positive since. He tested himself on Sunday. He also reported that his wife was also on Paxlovid, and reported nausea and diarrhea, and a metal taste in the mouth for both of them. Agent initially says caller said his wife was still on the medication, then clarifies he said his wife finished yesterday, and he finished it Sunday. Agent reports caller said today he thinks he had a little bit of rebound COVID. He had a nap today for three hours and he never naps. Agent clarifies that caller's wife had nausea and diarrhea, and both of them had a metal taste in the mouth, which caller said since he stopped treatment the metal taste has disappeared. Caller says he threw his box away, but he still has his wife's Paxlovid box. He started taking Paxlovid 26Dec, no 27Dec, no 26Dec, in the afternoon. He finished taking Paxlovid Saturday 31Dec2022. His Paxlovid was the 300mg/100mg dose pack. AE: metal taste in the mouth: He says the metal taste in his mouth started when he started taking the medication, on either 26Dec or 27Dec, and then it went away when he finished taking the medication Saturday morning, by that night it had gone. AE Treatment: They had used candy to try to tame the taste, candies. It was a pretty strong taste. They gargled with mouth wash and water. He used cough drops, and he had a cough as well, so that helped with the cough. No further details provided about cough drops. The metal taste in the mouth happened after taking the medication, not while it was in the mouth, and it was a listed side effect, his doctor said they could have it. AE: testing positive since finished treatment: Caller says he initially tested positive for COVID on Monday December 26th, then he took one this past Sunday after treatment and was still testing positive. That was the reason for his initial call to Pfizer, to find out if there was a time frame before he could expect to test negative, since he couldn't find information about it in the literature that came with the product. The agent said that Paxlovid lessens hospitalization, deaths, and replication of the virus. He guess COVID works its way out of the body, Paxlovid doesn't eliminate it from systems. AE: had a nap today for three hours: He normally doesn't nap, and he did a lot of sleeping when he had COVID, he was tired today he guesses, a little bit. He was still isolated from his wife, they are staying in separate rooms.AE diarrhea: He didn't experience nausea, they both had diarrhea as well, though hers seemed worse. His started having diarrhea a couple days after he started the medication, then it went away after he finished it. For treatment of the diarrhea his doctor told him to eat a lot of fiber, apples and fruits. Caller says they both had had COVID vaccines and been vaccinated. He was vaccinated twice and boosted once with Pfizer, and his wife with Moderna. He had his booster shot about a year and a half ago and his wife had her last shot about year ago. Description of Product Complaint: Description of complaint: PC1) Pfizer COVID vaccine: positive for COVID. His first dose was 27 Feb 2021, NDC was not provided on handwritten vaccine card, LOT: EN6200, EXP: June 2021. His second dose was 20 Mar 2021, NDC: not provided, LOT: EN6208, EXP: not provided. He got his booster dose of Pfizer on 06 Oct 2021 with NDC: not provided, LOT: FF3590, EXP: not provided. Product strength and count size dispensed: not provided, three doses. Additional lot numbers: please see above paragraph. Was a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact not provided. PC2) Paxlovid: couldn't find information for if there was a time frame before he could expect to test negative in the literature that came with the product.