Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable consumer reporting for sister. A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Dec2020 (Batch/Lot Number: EK5730; Expiration Date: 31Mar2021) as DOSE 1, SINGLE, second dose via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: EK9231; Expiration Date: 30Apr2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Jul2021, COVID nasal swab tested positive, patient was diagnosed with Covid after having been administered both doses of pfizer covid vaccine. The outcome of event was unknown. Investigation results from PQC group includes: Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EK9231, fill lot EK9229, and the formulated drug product lot EK9226. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer Kalamazoo QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EK9231 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 EK9231, fill lot EK9229, and the formulated drug product lot EK9226. 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.   No follow-up attempts are needed. No further information is expected.