Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got COVID/tested COVID: positive/little fever/tired and fatigued; got COVID/tested COVID: positive/little fever/tired and fatigued; This is a spontaneous report received from a contactable reporter (consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 6 (booster), single (batch/lot number: GH9694) at the age of 72 years for COVID-19 immunization; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (batch/lot number: EL9264) at the age of 71 years, on 22Feb2021 as dose 2, single (batch/lot number: EN6201) at the age of 71 years, on 13Aug2021 as dose 3 (booster) at the age of 71 years, single (batch/lot number: FA7485), on 17Jan2022 as dose 4 (booster), single (batch/lot number: 331308A) at the age of 72 years and on 17May2022 as dose 5 (booster), single (batch/lot number: F54989) at the age of 72 years for COVID-19 immunization. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing); "AFib" (unspecified if ongoing); "blood pressure high" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing), notes: allergies during the spring time. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Oct2022, outcome "recovered" (2022) and all described as "got COVID/tested COVID: positive/little fever/tired and fatigued". The events "got covid/tested covid: positive/little fever/tired and fatigued" required physician office visit. The patient underwent the following laboratory tests and procedures: fever: (Oct2022) 101; home test: (Oct2022) positive, notes: for next 2 days; tested COVID/COVID test (25Oct2022) positive, notes: for a week. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: the patient informed that on 24Oct2022, he got COVID then his doctor recommended that he get an antibody treatment from (withheld). The patient informed that after 6 hours of the treatment, he still got COVID, however he didn't really got sick though, only a little fever. He didn't get restless. It cleared up real quick. He feels better now. The patient wanted to know if getting an antibody treatment due to COVID can have an effect on his Pfizer-Biontech COVID vaccination. His doctor told him it didn't have an effect and that (withheld) didn't have information on that. On 07Nov2022, the patient clarified that that it would 3 boosters in total now and then he got the antibody treatment. The patient informed that his COVID symptoms lasted about a week and half, he didn't have to go to the hospital. It just felt like a bad cold, in which he was tired and fatigued. His doctor directed him to get the antibody treatment. After the 6 shots and with his age his immune system isn't what it used to be, getting COVID probably helped his immune system. The patient confirmed that doses 1 to 5 were monovalent COVID vaccines, and only his last dose he received the sixth dose was the bivalent COVID booster. He initially stated that he tested positive for COVID 24Oct2022 with an at home test, later corrected this date in the call. When he called his doctor, he was told to not bother coming in, and will just send him over to get the antibody treatment. The patient received his antibody treatment on 26Oct2022 but also later corrects this date. The patient corrected his dates, he was actually tested positive for COVID on 25Oct2022 and received the monoclonal antibody Bebtelovimab on 27Oct2022. The patient clarified that on 24Oct2022 Monday was when he noticed he was getting sick, he then tested the next day and called the doctor who told him not to bother testing every day and to not come into the office, on the 25th the doctor said they will just call in his antibody treatment, then on 27Oct2022 he had the antibody treatment at the hospital, it was just a onetime administration. The patient informed that 6 hours after that treatment he did an at home test and it was positive for next 2 days. The patient clarified his COVID test was positive for a week, but he didn't really feel that sick, he had a fever of 101, but it didn't get worse than that. He hoped his shots protected him. The patient informed that the facility of vaccine administration was, for the first and second dose just sets up a line, he clarified that it was an institute (name withheld), that would set up a drive thru lane, and it was not a facility. The next 4 doses were at an institute (name withheld), he either got 3 doses in (withheld) and the bivalent booster at (withheld) 2 doses at (withheld) and the last 2 doses at (withheld). The patient wanted to know the effects of the vaccine on his antibodies and if it was like normal like have got six doses and still got COVID. The patient wanted to know if there was an interaction between monoclonal antibodies and the Pfizer COVID-19 Vaccine.  On 08Nov2022 product quality group investigation results for the complaint 24Oct, he got COVID with product description: Compound BNT 162 COVID-19 Vaccine Suspension For Intramuscular 2ML Vial X 1 Adult 10 X 2.25ML Multiple Dose Bivalent BA.4/5, Lot # GH9694; Comirnaty suspension for injection 195X0.45ML, Lot # 33130BA; Comirnaty suspension for injection 195X0.45ML, Lot # FA7485; Comirnaty suspension for injection 195X0.45ML, Lot # EN6201; Comirnaty suspension for injection 195X0.45ML, Lot # EL9264. The conclusion of previously completed investigation: The complaint for "Pfizer-BioNTech COVID-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed. The conclusion of previously completed investigation: The complaint for a lack of effect in a vial of Pfizer-BioNTech COVID-19 Vaccine was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled, and packaged by Pfizer #. The final scope was determined to be lot 33130BA. No quality issues were identified during the investigation. There is no impact on product quality. An was not issued for the complaint. No regulatory notification were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met all release specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior to any lot being released to the market. The conclusion of previously completed investigation: The complaint for lack of effect of the Pfizer-BioNTech COVID-19 Vaccine lot FA7485 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FA7485 fill lot EY0541, and the formulated drug product lot EP8645. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The conclusion of previously completed investigation: The complaint for lack of effect of the Pfizer-BioNTech COVID-19 Vaccine lot EN6201 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The conclusion of previously completed investigation: The complaint for lack of effect of the Pfizer-BioNTech COVID-19 Vaccine lot EL9264 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EL9264, fill lot EL9255, and the formulated drug product lot EL9246. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specification.  No follow-up attempts are possible. No further information is expected.