Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received both doses Pfizer Covid Vaccine beginning 01Apr2021 and second dose was received three weeks later and just tested positive for Covid; Received both doses Pfizer Covid Vaccine beginning 01Apr2021 and second dose was received three weeks later and just tested positive for Covid; Quite a bit of fever; Headache is mild; This is a spontaneous report from a contactable consumer (patient). A male patient of 64-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was ER8737or ER8037), first dose on Right shoulder via an unspecified route of administration on 01Apr2021 (Age at vaccination 64-year-old) as dose 1 single for COVID-19 immunization and patient received second dose also for bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was ER8729), on Right shoulder via an unspecified route of administration on 22Apr2021 for COVID-19 immunization. No medical history reported. Concomitant medications include Ibuprofen 200mg (Just prior to Covid vaccine). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After Receiving both doses Pfizer Covid Vaccine patient tested positive for Covid on 28Jul2021. Patient also experienced fever and mild headache. Patient underwent lab test and procedures SARS-CoV-2 test was positive on 28Jul2021. QA Review & Rationale:The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot ER8729 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot ER8729, fill lot EP8681, and the bulk formulated drug product lot EP8568. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot ER8729, fill lot EP8681, and the bulk formulated drug product lot EP8568. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint lot.Pfizer withheld QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective or preventative actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. 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 meets potency specifications. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the origin site.Root Cause Analysis/Identify: Pfizer withheld Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the Pfizer withheld site. Impact Analysis: Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Corrective / Preventive Action: There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8729 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8729, fill lot EP8681, and the formulated drug product lot EP8568. 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. The outcome of Events was unknown.   The lot number for the vaccine was not provided and will be requested during follow up.