Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Environmental allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: This is first case out of two cases (For husband). Reporter stated that, "I am calling to report a possible case of COVID re-bound after Paxlovid. My husband is the one that is a patient he tested positive for COVID on, he tested positive for COVID on Friday 17Jun in the morning and he started taking Paxlovid on Friday 17Jun in the late afternoon. He completed the entire five days duration per the instruction for five days. He stopped the treatment, he ended the treatment with the last pill on 21st of Jun. He had moderate symptoms, he is started feeling better the 23rd, 24th and then late night on the 25th, he started getting more and new presented with new symptoms that were very minor at the beginning of his COVID diagnosis and they became more pronounced as of yesterday so he started to get better and then goes worst and looking. So, I as well myself got COVID four days after him. I had very mild case and I am back to normal in eight days later and he is now seems too regressed. So, in mine searching online to trying to see what it could be, I put call under his health care provider who is not her back yet. I suggested that from one I read online to call Pfizer and the patient, my husband is also Pfizer double vaccinated and boosted." When paraphrased the concern, reporter stated, "That's correct." In response to Pfizer drug safety, reporter stated, "Yes, correct. I never took Paxlovid. I am Pfizer vaccinated and I had actually my booster about a month ago, so about three weeks prior to getting infected I have been boosted. I recovered, I had very minor symptoms like I wasn't know that I was sick, it was so minor and I am completely fine. I never re-bounded, I never took Paxlovid. I am fine and I am day eight." In response to further probing, reporter stated, "I want to report for him because seems that rebound is something new and no more information seems to be needed." The Reporter was informed about Pfizer Drug Safety. In response to file a safety report, reporter stated, "That's fine. I don't know because I don't have like all his dates he was vaccinated and all of that if you need all that I might request to call back if the stuff I can answer, I am happy to do it." Reporter was informed to call back Pfizer Drug Safety as Pfizer drug safety remains open 24x7. Further reporter stated, "So, do you need his date of vaccination is that you need? (Consumer was informed that Product details, patient's demographics, medical history and concomitant medication details were needed). Yeah, I can give you all of that. I don't have the actual medicine in my hand. He finished it and probably threw it away and he is in another room. So, I don't have that but I can give you everything else." First time calling Pfizer Drug Safety: Reporter stated, "Yes." When probed for height and weight, reporter stated, "He is about 5(feet)'7(inches) and he weighs approximately 165-170 pounds." When probed for the LOT# and Expiration date, reporter stated, "No, I don't have it. I couldn't give you that. I could give you the pharmacy but I don't have that." reporter stated, "Correct, I don't have any of that." When probed for the doctor's name, reporter stated, "I don't have that either because it was on call. It was on call doctor, wasn't his regular doctor." " When probed for the pharmacy name, reporter stated, "It's (pharmacy name)." When probed for pharmacy phone#, reporter stated, "Do you want the address? The phone# is. When probed for the pharmacy mailing address, reporter stated". When probed for the dose of the Paxlovid, reporter stated, "He was taking it as directed on the box." Formulation(Paxlovid): Tablet, Frequency of taking the medication(Paxlovid): Reporter stated, "He took it as directed twice a day." Route(Paxlovid): Oral. When probed for other medical conditions, reporter stated, "He has Chron's Colitis. I think that why he was prescribed the Paxlovid because he is considered somewhere at risk. Chron's, Colitis yeah it's a same thing yeah. When probed for diagnosis date, reporter stated, "No, I don't have it." When probed for medication (Chron's, Colitis), reporter stated, "No, he is not." When probed for concomitant medication, reporter stated, "Just over the counter vitamins and Zyrtec for environmental allergies." Lab test: Reporter stated, "No." When probed to reporter that she has COVID after Pfizer vaccinations(Covid 19 vaccine), reporter stated, "Yes." In response to further probing for reporter, reporter stated, "No, that's okay. I just want to report for him, mine was, you know normal, his situation is abnormal and I wanted to report that." Further reporter stated, "That's it. Thank you."Product complaint is there for report. Description of Product Complaint: Concern: Reporter stated, "I am calling to report a possible case of COVID re-bound after Paxlovid. My husband is the one that is a patient he tested positive for COVID on, he tested positive for COVID on Friday June 17th in the morning and he started taking Paxlovid on Friday 17Jun in the late afternoon. He completed the entire five days duration per the instruction for five days. He stopped the treatment, he ended the treatment with the last pill on 21st of Jun. He had moderate symptoms, he is started feeling better the 23rd, 24th and then late night on the 25th, he started getting more and new presented with new symptoms that were very minor at the beginning of his COVID diagnosis and they became more pronounced as of yesterday so he started to get better and then goes worst and looking. So, I as well myself got COVID four days after him. I had very mild case and I am back to normal in eight days later and he is now seems too regressed. So, in mine searching online to trying to see what it could be, I put call under his health care provider who is not her back yet. I suggested that from one I read online to call Pfizer and the patient, my husband is also Pfizer double vaccinated and boosted." When probed for the LOT# and Expiration date, reporter stated, "No, I don't have it. I couldn't give you that. I could give you the pharmacy but I don't have that." When probed for product details , reporter stated, "Correct, I don't have any of that."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.