Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: tested positive to COVID-19 on 05Jul2021; tested positive to COVID-19 on 05Jul2021; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received both doses of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 12Apr2021 (Lot Number: EW0153) and dose 1 on 16Mar2021 (Lot Number: EN6206) both intramuscular (at the age of 39-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient got COVID vaccine and tested positive to COVID-19 on 05Jul2021.  The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 05Jul2021.  The patient outcome of the event was unknown. Subsequently, the complaint group via company reported that Conclusion: the complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed. Subsequently, the complaint group via company reported that Conclusion: the complaint for lack of effect of the Pfizer BioNTech COVID-19 vaccine lot EW0153 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 EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. 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. Subsequently, the complaint group via company reported that Conclusion: the complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.