Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 10:00 as dose 1, single (Lot number: EN6204), in left arm, on 07Apr2021 at 10:00 as dose 2, single (Lot number: EP6955), in left arm, on 04Nov2021 at 13:00 as dose 3 (booster), single (Lot number: Ff2588), in left arm and on 04Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim", notes: Known allergies : Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 26Nov2022 to 01Dec2022.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FJ4991 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ4991, fill lot FJ4988, and the bulk formulated drug product lot FJ4985.  A complaint sample was not returned. The following potential quality issue was identified during the investigation: all test points of TFF permeate stream flow meters failed during their annual calibration. A QAR was opened and a child record of the quality investigation was opened to track the product quality impact of lots that ran on the TFF skid from its previous calibration to the annual recalibration activities, including reported finished goods lot FJ4991. This investigation will be updated pending the closure of the action item for impact assessment. 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: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FF2588 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FF2588, fill lot FF2557, and the bulk formulated drug product lot FE5319. 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 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: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging atch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. 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.  Conclusion of Previously Completed Investigation:  The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6204 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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201355572 Same patient, same drug/different dose, different AE;