Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), on 23Mar2021 as dose 2, single (Lot number: EP7534), on 26Sep2021 as dose 3 (booster), single (Lot number: FF2587) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing), notes: CAD; "dyslipidemia" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "CABG x 5" (unspecified if ongoing), notes: CABG x 5; "Carotid atherosclerosis" (unspecified if ongoing), notes: carotid atherosclerosis; "Sulfa antibiotics" (unspecified if ongoing), notes: known allergies Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 33; SARS-CoV-2 test: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Anti viral details product of oral Paxlovid from 21May2022 to 26May2022. product quality group providing investigation results: As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q# and/or Q#. PR ID (CR): 7266074 Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 Lot-# (CR): EN6205. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6205 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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. PR ID of Previously Completed Inv: 5801756 PR Link (Previously Investigated CR): 5797466 PR ID (CR): 7266076. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1Lot-# (CR): EP7534. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 5862218. PR Link (Previously Investigated CR): 5851167. PR ID (CR): 7266080. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): FF2587. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF2587 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 6446122. PR Link (Previously Investigated CR): 6443978. PR ID (CR): 7266082. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): FJ9943. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FJ9943 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. 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. PR ID of Previously Completed Inv: 7121106. PR Link (Previously Investigated CR):7120223. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q# and/or Q#. PR ID (CR): 7266074. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): EN6205. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6205 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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. PR ID of Previously Completed Inv: 5801756. PR Link (Previously Investigated CR): 5797466. PR ID (CR): 7266076. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): EP7534. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 5862218 PR Link (Previously Investigated CR): 5851167. PR ID (CR): 7266080. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 Lot-# (CR): FF2587. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF2587 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 6446122. PR Link (Previously Investigated CR): 6443978. PR ID (CR): 7266082. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): FJ9943. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FJ9943 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. 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. PR ID of Previously Completed Inv: 7121106  PR Link (Previously Investigated CR):7120223. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q# and/or Q#. PR ID (CR): 7266074. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): EN6205. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6205 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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. PR ID of Previously Completed Inv: 5801756. PR Link (Previously Investigated CR): 5797466. PR ID (CR): 7266076. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 Lot-# (CR): EP7534. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 5862218. PR Link (Previously Investigated CR): 5851167. PR ID (CR): 7266080. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for. intramuscular 2ml multiple dose vial X 1. Lot-# (CR): FF2587. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF2587 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 6446122. PR Link (Previously Investigated CR): 6443978. PR ID (CR): 7266082. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): FJ9943. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FJ9943 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. 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. PR ID of Previously Completed Inv: 7121106. PR Link (Previously Investigated CR):7120223. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q# and/or Q#. PR ID (CR): 7266074. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): EN6205. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6205 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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. PR ID of Previously Completed Inv: 5801756. PR Link (Previously Investigated CR): 5797466. PR ID (CR): 7266076. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): EP7534. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 5862218 PR Link (Previously Investigated CR): 5851167. PR ID (CR): 7266080. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 Lot-# (CR): FF2587. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF2587 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 6446122. PR Link (Previously Investigated CR): 6443978. PR ID (CR): 7266082. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-# (CR): FJ9943. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FJ9943 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. 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. PR ID of Previously Completed Inv: 7121106. PR Link (Previously Investigated CR):7120223; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported event and suspect  cannot be excluded.The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate