Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; 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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 at 11:00 as dose 1, single (Lot number: EN5318), in right arm, on 20Feb2021 at 11:00 as dose 2, single (Lot number: EN6198), in right arm, on 28Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 05Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FK9729) at the age of 67 years, in left arm for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19; Anti-viral details: Paxlovid, treatment start date: 16May2022 and treatment stop date: 21May2022.  This is a notification generated from the gQTS 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 BNT 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1. Lot-# (CR): EN5318. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH 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. Product-Description (CR): Compound BNT 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1 . Lot-# (CR): EN6198. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EN6198 was investigated. The investigation included a review of manufacturing and 5837648 5833942 packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319. 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. Product-Description (CR): Compound BNT 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1 Adult 10 X 2.25ml Multidose. Lot-# (CR): FE3592. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EN6198 was investigated. The investigation included reviewing manufacturing and 6342499 6342349 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 FE3592, fill lot FF2553, and the bulk formulated drug product lot FA9141. 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. 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.  No follow-up attempts are possible. No further information is expected.