Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; Dose Number: 1, 2, 3; COVID 19 Treatment; Dose Number: 1, 2, 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 56 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "COVID 19 Treatment; Dose Number: 1, 2, 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Positive; (10May2022) Negative; (11May2022) Negative; (19May2022) Positive; (21May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown If patient recovered, no treatment for event, No Known allergies, Treatment of Covid-19 was received from 03May2022 to 07May2022. No Other medications in two weeks. 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. Refer to the below table for details:  Product-Description (CR): Compound Bnt162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1   Lot-# (CR): FF2589: Conclusion of Previously Completed Investigation: The complaint for 'Lack of Effect' of the PFIZER BIONTECH COVID-19 VACCINE lot FF2589 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 FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. 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/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. Product-Description (CR): Compound Bnt 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1   Lot-# (CR): EN6208: 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.  Product-Description (CR): Compound Bnt 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1   Lot-# (CR): EN6202 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6202 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 EN6202, fill lot EN5334, and the formulated drug product lot EN5323. 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.  When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.  Follow-up attempts are completed. No further information is expected.