Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter (nurse) from product quality group. The reporter is the patient.  A 79-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 79 years intramuscular, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: FK9231), on 05Feb2021 as dose 2, single (Lot number: EL8982), on 30Aug2021 as dose 3 (booster), single (Lot number: FC3183) and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9895) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Oct2022, outcome "recovered" (16Oct2022) and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Oct2022) Positive; (22Oct2022) Positive, notes: Rebound COVID; (23Oct2022) Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: The patient took all five COVID shots and had no reaction to it. She then reported that she tested positive for COVID for the first time on 12Oct2022 and felt better on 16Oct2022. She was started on Paxlovid from 12Oct2022. She only took two doses of Paxlovid because of the metallic taste, she could not tolerate it. She then experienced rebound COVID; she tested positive for COVID again on 22Oct2022 and 23Oct2022. She also mentioned that she had a flu shot given intramuscularly in right upper arm on 23Sep2022.   Product Quality Group provided investigational results on 25Oct2022 for BNT162b2 and BNT162b2, BNT162b2 OMI BA.4-5: The complaint for lack of effect of PFIZER BIONTECH COVID-19 VACCINE lots "EK9231" (as reported), EL8982, FC3183, FK9895, and GJ5342 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, analytical release test results (for lot FC3183), and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EK9231, fill lot EK9229, and the formulated drug product lot EK9226; lot EL8982, fill lot EL8977, and the formulated drug product lot EL8975; lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657; lot FK9895; and lot GJ5342. A complaint sample was not returned. Photographs were not received (for lot EK9231). No related quality issues were identified during the investigation. There is no impact to product quality. There is also no impact on regulatory, validation and stability (for lots FK9895 and GJ5342). No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: A contributory role of BNT162B2 to event Tested positive for COVID cannot be excluded based on temporal association and available information.