Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 at 12:00 as dose 1, single (Lot number: EH9899), in right arm, on 11Jan2021 at 12:00 as dose 2, single (Lot number: EH9899), in left arm and on 26Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FD8448) at the age of 65 years, in left arm 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Conclusion of Previously Completed Investigation for lot FD8448: The complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine lot FD8448 was investigated. The investigation included a reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FD8448, fill lot EY0548, and the bulk formulated drug product lot EP8652. A complaint sample was not returned. related quality issue were identified during the investigation. There is no impact on product quality. 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.  Conclusion of Previously Completed Investigation for lot EH9899: The complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine lot EH9899 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 EH9899, fill lot EH9783, and the formulated drug product lot EH9782. 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 collective/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.  Clinical course: The patient took Paxlovid as treatment from 17May2022 to 22May2022 (lot PAA183750) for treatment of COVID-19 via oral route. The patient had covid relapse after completing paxlovid on  26May2022 at 07:00. The patient had no known allergies.  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 events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.