Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 diagnosed by rapid testing after COVID vaccine; COVID-19 diagnosed by rapid testing after COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: EN6208) as single dose, dose 2 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included no underlying conditions; 45 y/o male in good health who was likely exposed at an outdoor dinner in (withheld) where others tested positive. The patient's concomitant medications were not reported. The patient reported that he had COVID-19 diagnosed by rapid testing after COVID vaccine in 2021. Outcome of the events was unknown.  Summary of product quality Investigation for the lot Number: EN6208 was reported as follows: The initial scope of the investigation was limited to the reported finished goods lot EN6208, fill lot EN5338, and the bulk formulated drug product lot EN5329. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint batch. Pfizer 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 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 was 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 was no impact to the quality of the lot. It was unknown how the product was handled, stored, or administered after it left the site. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. 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 lot number for the vaccine, [BNT162B2], for Dose-2 was not provided and will be requested during follow up.