Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: Positive with COVID; has taken the Pfizer Vaccine; Positive with COVID; has taken the Pfizer Vaccine; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID: .  A 74-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 23Feb2021 as dose 2, single (Lot number: EL9266) and on 08Dec2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive with COVID; has taken the Pfizer Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Weight: 130, notes: "My weight is 130. I am just estimating.". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Product Quality Group provided investigational results on 31Jan2024 for BNT162b2: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 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 EN5318, fill lot EN5317, and the formulated drug product lot EN5316. 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: The complaint for lack of effect of the PFIZER-BIONTECH 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: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 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 FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. 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.  Follow-up (31Jan2024): This is a follow-up report from product quality group providing investigation results. Updated information: investigation results added and event recoded to Drug ineffective.