Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: we got the result on 22 which was positive; we got the result on 22 which was positive; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9262), on 08Mar2021 as dose 2, single (Lot number: EN6199) and on 10Nov2021 as dose 3 [booster], single (Lot number: 320308D) at the age of 75 years for covid-19 immunisation; tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]); epoetin alfa (ESPOGEN); tamsulosin (TAMSULOSIN). The patient's relevant medical history included: "CABG" (unspecified if ongoing), notes: CABG; "COPD" (unspecified if ongoing), notes: COPD. Concomitant medication(s) included: ADVAIR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we got the result on 22 which was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) positive. The action taken for tamsulosin hydrochloride, epoetin alfa and tamsulosin was unknown. clinical course: When probed if patient has experienced any side effects: Reporter stated, Yes, I want to document it because this is emergency use medication and it was prescribed to me by my Primary Physician. Side effects: Reporter stated, I took all the prescribed Pfizer Paxlovid on 24Jul (Later clarified as 24Jun, 2022) by my primary physician to help me previous and help me to improve and he said to me that I am positive. Unfortunately that I believe and he believe we got it from the hospital, I think too because my husband was in the emergency in 05June to 15Jul (Later clarified as 05Jun to 15Jun) because I have been in the emergency. He was discharged on the 20Jul (Later clarified as 20Jun), he spent days in the hospital. On 20Jul (Later clarified as 20Jun), Monday, I decided to move back from the emergency. In 20Jul , he had been discharged (Later clarified as 20Jun). On 20Jul (Later clarified as 20 Jun) we had flu like symptoms like runny nose, sore throat and something like that we thought may be like and we thought it was like sinus and my doctor told that he got the Covid test, I did not really have a lot of symptoms but he has a slight rise in temperature, so we got the test on 20 and we got the result on 22. We started to have symptoms on 20July (Later clarified as 20June) and we tested, we got the results of COVID test on the 21 next day, we got the result on 22 which was positive, so we received it while we were at the hospital, so we received it together at the hospital. He was admitted in the emergency room at the hospital before we got the symptoms. Anyway I told my primarily physician doctor, my husband did not get any kind of that because we ordered the request at Pharmacy. What happened was my husband did not get the Paxlovid even if he did have a prescription for him but he never got it because the pharmacist at pharmacy told him that there is drug interaction which considered severe if my husband is taking anything but he has an prescription for me. I think there is nothing elaborated so he was telling me that he wants me to take the Paxlovid and I did ask is there any kind of side effect or are you sure this is safe, he assured me that it is going to be fine, he said I would rather give it to you because of my age, I am 74 but I have vaccine both doses and the booster, we both had it and we get better. What happen was I took the first dose on the evening of 24Jul (Later clarified as 24Jun). We ordered it from, so he ordered that and my husband never got it from the guy, he did not get it but he said I should take it. LOT# (Pfizer COVID-19 Vaccine): Reporter stated, And ever since we are having problems with you know and I had to fill up the report. Before we end this call I just want to ask you something you know as a drug safety person. For me the first is a Pfizer COVID Vaccine the LOT# is EL9262, I received this in 11Feb2021. The second is the Pfizer COVID also the LOT is EN6199, I received this on 08Mar2021. Yeah, we have the same LOT# for the first and the second, both of us have the same one and then did you want the booster which is the third one? Okay, the booster was received in the store, retail store they have the pharmacy there. Its the LOT# is for me to receive is 320308D I received this in 10Nov2021 and then my husband he also got this from the store it same date but the LOT# 320308D so, its the same LOT# same time, the same date, the same store.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.