Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), on 20Mar2021 as dose 2, single (Lot number: EP7534) and in Oct2021 as dose 3 (booster), single (Lot number: FH8020) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; LISINOPRIL; METFORMIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Clinical course: The patient was treated with Paxlovid because of COVID-19 and had a rebound case of COVID. Patient tested positive (with symptoms) 7 days after negative test and completion of Paxlovid therapy. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Negative; (11Jun2022) Positive, notes: Tested positive (with symptoms) 7 days after negative test. Therapeutic measures, Paxlovid from 30May2022 to 04Jun2022, were taken as a result of vaccination failure, covid-19.  Investigation results: For Product- Description (CR): Compound BNT162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial x 1; Lot-# (CR): EN6198; Conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6198 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 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. For Product- Description (CR): Compound BNT 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial x 1; Lot-# (CR): EP7534; Conclusion:  The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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. For Product- Description (CR): Compound Bnt 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial x 1; Lot-# (CR): FH8020; Conclusion: The complaint for lack of effect of the PFIZERBIONTECH 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.