Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: 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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 at 12:00 as dose 1, single (Lot number: EN6208), in left arm, on 29Mar2021 at 12:00 as dose 2, single (Lot number: EP7533), in left arm and on 15Oct2021 at 12:00 as dose 3 (booster), single (Lot number: Ff8839) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022 at 12:00, outcome "recovering", and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (May2022) Negative; (22May2022) Positive. After finishing Paxlovid patient tested negative for Covid 19. Week later symptoms are back and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  This is a notification generated from the system. 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 Q1215 and/or Q1252.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot FF8839 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 FF8839, fill lot FF8833, and the bulk formulated drug product FA9148. 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 Injectable lot EP7533 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. 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 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.  No follow up attempts are possible. No further information is expected.