Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) and from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9264), in right arm, on 19Feb2021 as dose 2, single (Lot number: EL9266), in right arm and on 04Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): For lot# FE3590: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FE3590 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FE3590, fill lot FA9134, and the bulk formulated drug product lot FE5064. 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.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): For lot# EL9266: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9266 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 EL9266, fill lot EL9257, and the formulated drug product lot EL9248. 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.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): For lot# EL9264: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9264 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 EL9264, fill lot EL9255, and the formulated drug product lot EL9246. 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.